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Implementing LGBTQ-affirmative cognitive-behavioral therapy: implementation strategies across five clinical trials

Implementation Science Communications volume 5, Article number: 124 (2024) Cite this article

Abstract

Background

LGBTQ-affirmative cognitive-behavioral therapy (CBT) is an evidence-based treatment for reducing transdiagnostic mental and behavioral health concerns among LGBTQ individuals. Preserving the effects of this intervention as it is translated into practice can maximize public health benefits. This study systematically identifies and evaluates implementation strategies for LGBTQ-affirmative CBT.

Methods

First, we identified and operationalized implementation strategies used across five trials of LGBTQ-affirmative CBT using the Pragmatic Implementation Reporting Tool. Second, we evaluated the relative importance of these strategies via a quantitative assessment (N = 31 unique trial implementers). Survey responses were analyzed descriptively within each trial. Across all trials, we organized strategies as (1) high priority, (2) moderate priority, and (3) optional (if resources are available) for implementing LGBTQ-affirmative CBT.

Results

Within each trial, we identified 20 or more implementation strategies that were used, many of which overlapped across trials. We identified nine high priority strategies (e.g., working with clients to engage them in LGBTQ-affirmative CBT), nine moderate priority strategies (e.g., conducting ongoing training in LGBTQ-affirmative CBT), and nine optional/resource dependent strategies (e.g., showing visual indicators of LGBTQ affirmation within the physical spaces where LGBTQ-affirmative CBT is delivered).

Conclusions

LGBTQ-affirmative CBT is a complex intervention requiring a package of implementation strategies. Our findings provide guidance for implementers in settings with different levels of resources regarding the highest priority strategies that may be needed to preserve the effectiveness of LGBTQ-affirmative CBT as it is translated into real-world settings.

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Background

LGBTQ individuals (i.e., those who identify as lesbian, gay, bisexual, transgender, queer, or another sexual or gender minority identity) experience elevated rates of mental health concerns, including depression, anxiety, suicidality, and substance use [1,2,3,4]. These disparities have been explained by the disproportionate risk of minority stress faced by LGBTQ individuals [5,6,7]. Given these mental health disparities, there is a need for implementing identity-affirming evidence-based mental health interventions for LGBTQ individuals. Until recently, no evidence-based treatment rooted in an identity-affirmative approach had been tested for LGBTQ clients. However, recent development and efficacy of such treatments provide an opportunity to examine strategies for implementation in mental health settings.

LGBTQ-affirmative cognitive-behavioral therapy (CBT) is an evidence-based transdiagnostic mental health treatment that has been adapted to address the minority stress pathways contributing to mental health concerns among LGBTQ individuals (see [8] for an overview of the intervention). To date, LGBTQ-affirmative CBT has been found to be efficacious across clinical trials among varying subgroups of the LGBTQ community and delivered via different modalities. In a randomized controlled trial (RCT) with young adult sexual minority men (N = 254), LGBTQ-affirmative CBT was compared to two control groups (i.e., non-protocolized LGBTQ-affirmative psychotherapy or HIV testing and counseling). Although the trial did not show comparatively stronger effects on certain preregistered outcomes (i.e., depression, anxiety, sexual behavior that could lead to HIV acquisition), LGBTQ-affirmative CBT was efficacious in reducing substance use and comorbid mental health concerns, compared to the control conditions [9]. In a pre-registered follow-up study, moderation findings indicated that the efficacy of LGBTQ-affirmative CBT on comorbid substance use, depression, anxiety, and sexual behavior that can lead to HIV acquisition was particularly strong for Black and Latino sexual minority men [10]. The observed reduction in comorbidities provides a logical evaluation of the impact of LGBTQ-affirmative CBT given that its transdiagnostic approach simultaneously targets co-occurring mental, behavioral, and sexual health concerns.

Similar LGBTQ-affirmative CBT outcomes have been shown in clinical trials with different LGBTQ communities. In a waitlist-controlled trial with young adult, gender diverse sexual minority women (N = 60), participants who received LGBTQ-affirmative CBT reported significant reductions in depression and anxiety, and marginally significant reductions in problematic alcohol use compared to the waitlist group [11, 12]. In an asynchronous online delivery of the treatment (i.e., LGBTQ-affirmative internet-based CBT [ICBT]), LGBTQ youth (N = 120) in the US were randomized to receive the treatment or a control condition consisting of monitoring weekly mental health symptoms and minority stress. Despite nonsignificant differences between groups, participants who received LGBTQ-affirmative ICBT and lived in counties with high structural stigma toward LGBTQ individuals demonstrated the greatest reduction in psychological distress [13]. In a similarly designed RCT of LGBTQ-affirmative ICBT with young sexual minority men in China (N = 120), the treatment showed significant, moderate-size effects (e.g., depression, anxiety, alcohol use), with particularly strong effects for participants with greater stigma experiences [14]. In addition to findings from RCTs, pilot studies have supported its feasibility and acceptability, including a group format for young Black and Latino sexual minority men [15].

As the evidence base for LGBTQ-affirmative CBT builds, there is a need to plan for implementation to maximize public health impact. Currently, there are about 200 LGBTQ community centers across the US that deliver mental health services to approximately 48,000 LGBTQ clients per year [16, 17]. These centers face resource and funding limitations, resulting in their reliance on individuals who may not be trained in evidence-based practice (e.g., volunteers, peer support workers) to deliver such treatments; in fact, most centers currently offer non-evidence-based practice in the form of supportive psychotherapy [17]. It is also unknown the degree to which mental health providers in LGBTQ community centers implement evidence-based interventions in general (e.g., CBT) [18, 19] and when implemented, whether implementation is done with fidelity.

LGBTQ community centers report a strong desire to be trained in LGBTQ-affirmative CBT, with 83% of center directors indicating their mental health staff would benefit from such training [17]. Qualitative data suggest that requests from LGBTQ clients for affirmative, evidence-based treatment outpace available resources in local centers [17]. A recent waitlist RCT found that mental health providers in LGBTQ community centers (N = 121) who completed an LGBTQ-affirmative CBT online training showed large effects in knowledge and skills in providing this treatment [20]. Collectively, findings suggest that LGBTQ-affirmative CBT implementation is highly relevant in community settings that provide affirming mental health treatment to LGBTQ clients.

CBT is recognized as an evidence-based intervention [18, 19, 21] suitable to address the comorbid mental and behavioral health concerns affecting LGBTQ individuals. However, given that CBT is not inherently an LGBTQ-affirmative intervention, even in treatment settings where CBT is being delivered with fidelity to LGBTQ clients, there is likely variation in the degree to which CBT therapists are knowledgeable about LGBTQ-affirmative principles [22,23,24]. Research finds that evidence-based interventions that are culturally adapted for minoritized groups yield better outcomes than non-tailored interventions [25], underscoring the potential benefits of implementing an adapted version of CBT, such as LGBTQ-affirmative CBT, in real-world settings for LGBTQ clients. Although there have been no comparative efficacy studies of non-tailored CBT versus LGBTQ-affirmative CBT, some studies have examined outcomes of CBT between sexual minority and heterosexual clients. Results of these studies have been mixed, with some suggesting no differences [26, 27] and others suggesting less benefit for sexual minority clients compared to heterosexual clients (e.g., [28]) overall or for specific subgroups of LGBTQ individuals, including bisexual clients (e.g., [26]). Given the relative paucity of treatment studies documenting LGBTQ client status, existing research is not definitive regarding whether LGBTQ clients benefit equally from CBT compared to heterosexual clients [29]. Thus, implementing LGBTQ-affirmative CBT may fill an important gap even in settings where non-adapted, evidence-based mental health interventions are being delivered to LGBTQ clients.

Identifying implementation strategies used in clinical trials of LGBTQ-affirmative CBT can elucidate concrete ways that clinicians can implement this treatment in healthcare settings, addressing the research-to-practice gaps described above. Challenges often arise in translating research to practice, including but not limited to the “voltage drop,” wherein evidence-based interventions show reduced effects in real-world versus controlled settings [30]. Although not specific to LGBTQ-affirmative CBT, Rudd and colleagues [31] argue that implementation strategies – methods or techniques used to facilitate reach, adoption, implementation (e.g., fidelity), or sustainment of clinical interventions [32] – used in clinical trials need to be identified and reported to reduce the “research-to-practice” gap. Reporting guidelines exist for documenting implementation strategies used within clinical trials, such as the Standards for Reporting Implementation Studies guidelines [33]. Despite the role of implementation strategies in efficacy studies and available guidelines for documenting them, minimal to no reporting of these strategies in publications (aside from intervention fidelity) creates challenges related to implementation in real-world settings [31]. Correspondingly, the implementation strategies in prior clinical trials of LGBTQ-affirmative CBT have not been systematically reported to date. By addressing this reporting gap, we seek to simultaneously increase scientific knowledge regarding the strategies used to implement LGBTQ-affirmative CBT and provide guidance to researchers on how to report implementation strategies earlier in the translational pathway, thereby addressing a gap in the implementation science literature at large and paving the way for transitioning from efficacy/effectiveness to implementation trials.

Accordingly, the present study sought to systematically identify the implementation strategies used to implement LGBTQ-affirmative CBT across five published trials [9, 11, 14, 15, 34]. The aims of the study were to: (1) identify and operationalize the implementation strategies used across these five clinical trials, following established reporting guidelines and (2) assess the relative importance of the identified strategies for implementing LGBTQ-affirmative CBT. Across these aims, our goal is to facilitate real-world implementation of LGBTQ-affirmative CBT by identifying implementation strategies that may have contributed to the efficacy of this intervention within trial settings, thereby addressing research-to-practice gaps. Simultaneously, our goal in carrying out this work is to demonstrate the utility of integrating implementation science into efficacy and effectiveness trials.

Methods

Study aims and setting

We selected five LGBTQ-affirmative CBT clinical trials and documented the implementation strategies used in each, as well as the strategies’ relative importance within and across these trials. We included in the current study these five trials because they represented all completed or ongoing trials of our approach to LGBTQ-affirmative CBT [35, 36], we had access to individuals who could comprehensively report the implementation strategies used in these trials, and we had access to trial implementers who could respond to the survey. Trials included: (A) ESTEEM: a RCT (N = 254) to evaluate the efficacy of LGBTQ-affirmative CBT for improving young sexual minority men’s (ages 18–35) mental and behavioral health compared to LGBTQ-affirmative community treatment as usual and HIV testing and counseling [9], (B) EQuIP: a waitlist-controlled RCT (N = 60) to evaluate the efficacy of LGBTQ-affirmative CBT to address mental health and alcohol use among gender-diverse sexual minority women [11, 37] (C) ESTEEM ConneCT: a single-arm trial (N = 21) to evaluate the feasibility and acceptability of LGBTQ-affirmative CBT in a group format for Black and Latino gay and bisexual men [15], (D) LGBTQ-affirmative internet-based CBT (ICBT): an RCT (N = 120) to evaluate the efficacy of LGBTQ-affirmative ICBT for LGBTQ young people compared to an assessment-only control [34], and (E) China ICBT: an RCT (N = 120) to evaluate the efficacy of LGBTQ-affirmative CBT, culturally adapted for Chinese gay and bisexual men using an ICBT format to address sexual and mental health, compared to an assessment-only control [38]. Trials were approved by the Institutional Review Boards of their corresponding institutions (i.e., Yale University, University of Miami, Central South University).

Study design, data collection, and data analysis

We completed a two-step process to document and evaluate the relative importance of implementation strategies used across the five trials.

Step 1. Identifying and Operationalizing Implementation Strategies. This step was guided by Rudd and colleagues’ [31] Pragmatic Implementation Reporting Tool. The Pragmatic Implementation Reporting Tool guides researchers to document implementation strategy use in clinical trials by naming and defining each strategy used in the trial. The tool recommends using the Expert Recommendations for Implementation Change (ERIC) taxonomy, a list of 73 implementation strategies [39] to name and define the implementation strategies used. Next, the Pragmatic Implementation Reporting Tool guides researchers to operationalize each strategy using Proctor and colleagues’ [32] guidelines. This involved identifying:

  1. (a)

    The actor or person who performed the action.

  2. (b)

    The context (physical or social) in which the action took place [40].

  3. (c)

    The dose or intensity of the implementation strategy (e.g., time spent, frequency).

  4. (d)

    The action target, which refers to the person or thing that the implementation strategy was directed toward or trying to change. We used the Consolidated Framework for Implementation Research [41] to identify the action target (e.g., complexity, patient needs and resources, knowledge). We then identified the unit of analysis for the action target, which referred to the level at which the action target would be measured (e.g., clinical supervisor, clinician) [42].

  5. (e)

    The temporality, or, when in the implementation process the strategy took place. We used the EPIS framework [43] to identify the temporality of the strategy. We also indicated whether the strategy was planned or added during the trial.

  6. (f)

    The implementation outcomes, which were based on Proctor and colleagues’ [32] implementation outcome taxonomy, including acceptability, appropriateness, feasibility, and fidelity. Proctor and colleagues [32] also identified service outcomes relevant to implementation, including equity; therefore, these could also be identified as outcomes that the implementation strategy may have been striving to affect. We also used RE-AIM, which includes implementation outcomes of reach, effectiveness, adoption, implementation, and maintenance [42].

  7. (g)

    The justification, which is a theoretical, pragmatic, or empirical justification for the strategy.

Four authors (AH, ZAS, KB, BGR) completed the Pragmatic Implementation Reporting Tool for the five trials, selected based on their experience implementing each of the trials. For the first three trials (i.e., ESTEEM, EQuIP, LGBTQ-affirmative ICBT), two authors per trial independently named and defined the strategies used in the trial, followed by consensus discussions to resolve discrepancies. For the remaining trials (i.e., China ICBT, ESTEEM ConneCT), one author named and defined the strategies, then met with the first author to review and clarify as needed. After naming and defining the implementation strategies for each trial, one author per trial operationalized each strategy, as described above, within the context of that trial. The author who completed the initial implementation strategy operationalization within the Pragmatic Implementation Reporting Tool met with the first author to review and refine their operationalization. Once the team incorporated the first author’s feedback, the Pragmatic Implementation Reporting Tool was complete. Of note, within each strategy from the ERIC taxonomy, there were sometimes multiple operationalizations of that strategy. For instance, the ERIC strategy “intervene with clients to enhance uptake and adherence” was often operationalized in multiple ways (e.g., reminder calls, covering the cost of transportation).

Step 2. Evaluating the Relative Importance of Implementation Strategies. To evaluate the relative importance of the implementation strategies identified in Step 1, we developed a survey to collect implementation strategy importance ratings from the implementers of each trial. The authors used the Pragmatic Implementation Reporting Tool that was completed for each trial in Step 1 to develop the survey. Each strategy listed within the Pragmatic Implementation Reporting Tool became a survey item. The survey was also designed based on Waltz and colleagues [44], who assessed implementation strategy importance for implementing evidence-based mental health interventions in the U.S. Department of Veterans Affairs.

We invited individuals who were involved in implementing each of the five trials (hereafter, “trial implementers”) to complete the implementation strategy importance survey. Trial implementers included therapists, clinical supervisors, and research assistants/postgraduate associates, and project coordinators. Respondents could rate each strategy from 1 (absolutely essential for implementing this intervention) to 4 (absolutely inessential for implementing this intervention) patterned after Waltz and colleagues’ work [44]. Each trial had its own set of items, corresponding to the strategies identified in Step 1. The survey had branching logic so that trial implementers rated the importance of the strategies in each of the trials in which they were involved. Surveys were collected via Yale Qualtrics. This project was deemed “not human subjects research” by the Yale University Institutional Review Board.

Survey responses were analyzed descriptively at the item level, except in cases in which there were multiple items assessing the same ERIC implementation strategy within a single trial.Footnote 1 Specifically, if the ERIC strategy was operationalized as having multiple components, we developed multiple survey items to assess the importance of each component of the strategy. In those cases, we assigned a rating for a multi-item strategy based on the lowest rated item within the given ERIC strategy. For example, if there were three items assessing one strategy, and a participant rated those items as 1 (completely essential), 2 (somewhat essential), and 3 (somewhat inessential), their score for that ERIC strategy was a 1 because they found at least one component of that strategy to be completely essential. We then computed the overall sample-level mean score of the importance (at the trial implementer level) for each strategy within a given trial.

To maximize the utility of our findings for implementation planning, we developed a system to prioritize implementation strategies for implementing LGBTQ-affirmative CBT. Our goal in doing this was to help organizations and implementers with varying levels of resources to understand which strategies might be most essential for implementing LGBTQ-affirmative CBT when allocating limited resources. To provide overall priority rankings for each strategy, we computed a mean score, at the trial level, for strategies that were reported in at least three of the five trials. Strategies used in only one or two trials were considered to have insufficient data for making conclusions about overall importance. Then, we organized the ranked strategies into three groups: [1] high priority strategies (mean scores in top third), (2) moderate priority strategies (mean scores in middle third) and (3) optional strategies that could be implemented depending on available resources (mean scores in bottom third). All strategies used in three or more trials had a mean importance rating (across trials) that was in the “likely essential” to “absolutely essential” range, therefore labels of “moderate priority” and “optional-resource dependent” do not suggest the strategy was unimportant.

Results

Pragmatic implementation reporting tool findings

All trials used a variety of strategies to implement LGBTQ-affirmative CBT. ESTEEM used 28 strategies, EQuIP used 25 strategies, ESTEEM ConneCT used 27 strategies, LGBTQ-affirmative ICBT used 22 strategies, and China ICBT used 22 strategies. The Pragmatic Implementation Reporting tool for each trial is presented in additional files 1–5, and a summary of how the identified strategies were operationalized within each study is provided in Table 1.

Table 1 Implementation Strategies as Operationalized Within Each LGBTQ-affirmative CBT Trial
Full size table

Table 1 also shows which ERIC strategies were used within which LGBTQ-affirmative CBT trial. Many of the identified implementation strategies were used in all trials. For example, all trials used the strategy providing clinical supervision operationalized as supervising LGBTQ-affirmative CBT therapists. All trials also used the strategy identifying and preparing champions which involved selecting trial implementers with expertise in the population being served, such as LGBTQ clients in general, LGBTQ people of color, or Chinese gay and bisexual men. Another example of a strategy that was applied across all trials was using mass media, which referred to developing culturally appropriate outreach campaigns to engage potential clients.

ERIC strategies are general terms that require further specification to be interpretable within a given implementation context. Table 1, and to a greater extent, additional files 1–5, show that many of the ERIC strategies were operationalized similarly across LGBTQ-affirmative CBT trials; however, some had unique meanings across trials. Strategies in the “engaging consumers” section of the ERIC taxonomy varied the most in their trial-specific operationalization. For example, in the ESTEEM trial – a trial of an in-person, individually delivered version of LGBTQ-affirmative CBT for young sexual minority men in New York City, NY and Miami, FL – intervening with clients to enhance uptake and adherence meant providing compensation to cover parking and transportation costs, offering flexible scheduling and rescheduling, and training therapists to address retention in every session using motivational interviewing and problem-solving skills. In contrast, in the LGBTQ-affirmative ICBT trial – a trial of an online, asynchronous version for LGBTQ young people – the same strategy was operationalized differently. There, the strategy involved providing a virtual “welcome call” and “2-week check in call,” modifying the online intervention content to be more engaging and providing client reminders to complete treatment modules.

Another finding from completing the Pragmatic Implementation Reporting Tool for each trial is that the ERIC strategies, as operationalized within these trials were sometimes specific to implementing an intervention for LGBTQ clients and were sometimes more general. For example, the commonly used strategy of creating a new clinical team (i.e., a group of individuals responsible for coordinating and delivering LGBTQ-affirmative CBT) for each trial was not LGBTQ-specific; it was a general strategy that involved “teaming” to ensure there was a structure in place to support the implementation effort. In contrast, recruiting, designating, and training for leadership, which was also used across all trials, was operationalized in an LGBTQ-specific way. Our operationalization of this strategy was that those with leadership roles on the trials needed to have expertise in LGBTQ mental health.

Implementation strategy importance: survey findings

Trial Implementers. We invited 38 trial implementers to participate in the survey. Of those invited, 31 responded (81.5%). Across all five trials, 23 (74.2%) responders evaluated strategies in only one trial and 8 (25.8%) were implementers in two or more trials, therefore they evaluated strategies in all trials in which they were involved. Of the 31 respondents, 16 identified as cisgender men (51.6%), 10 identified as cisgender women (32.3%), 4 identified as non-binary (12.9%), 2 identified as genderqueer (6.5%), and 1 identified as genderfluid (3.2%). In terms of sexual orientation,Footnote 2 14 identified as gay (45.2%), 12 identified as queer (38.7%), 6 identified as heterosexual (19.4%), 5 identified as bisexual (16.1%), 2 identified as lesbian (6.5%), 1 identified as pansexual (3.2%), and 1 identified as fluid/mostly straight (3.2%). In terms of racial identity, 16 trial implementers were White (51.6%), 8 were Asian (25.8%), 5 were African American/Black (16.1%), and 2 were multiracial (6.5%). Two trial implementers indicated their ethnicity as Hispanic or Latino/a/x (6.5%). Trial implementer roles in the trials and titles are reported in Table 2.

Table 2 Implementer Descriptive Information*
Full size table

Overall Importance Ratings. Table 3 shows the mean importance ratings for each strategy within each trial, as well as the ranked importance of each strategy for implementing LGBTQ-affirmative CBT across trials. Here, we describe strategies within their groupings of high priority, moderate priority, and optional-resource dependent.

Table 3 Importance Ratings by Trial
Full size table

High priority strategies (i.e., top third mean importance scores; means ranged from 1.20 to 1.43) included recipient-focused strategies such as intervening with clients to enhance uptake and adherence, using mass media to deploy culturally appropriate outreach campaigns, and preparing clients to be active participants in LGBTQ-affirmative CBT. Strategies that helped therapists balance fidelity in their delivery of LGBTQ-affirmative CBT while maintaining client-centeredness were also high priority. For example, promoting adaptability (e.g., being clear about adaptable vs. core components of LGBTQ-affirmative CBT) and tailoring strategies helped therapists clarify how they could deliver LGBTQ-affirmative CBT with fidelity, while also being able to adapt to client needs. Reminding clinicians via treatment manuals or “cheat sheets” to ensure high fidelity delivery of LGBTQ-affirmative CBT was also high priority. Other therapist-focused high priority strategies included conducting educational meetings via training in LGBTQ-affirmative CBT and centralizing technical assistance to ensure therapists had adequate administrative and technical support to deliver LGBTQ-affirmative CBT.

Moderate priority implementation strategies (i.e., middle third mean importance scores; means ranged from 1.46 to 1.61) were nearly all focused on providing resources and support to therapists delivering LGBTQ-affirmative CBT. These strategies likely built on more basic supports, such as providing initial training, reported in the high priority strategies. For instance, implementers across trials identified providing clinical supervision, conducting ongoing training beyond the initial training in LGBTQ-affirmative CBT, creating new clinical teams to implement LGBTQ affirmative CBT, and recruiting, designating, and training for leadership individuals with a pre-existing commitment to LGBTQ mental health as strategies that fell into the moderate priority range.

Finally, the optional-resource dependent strategies (i.e., bottom third mean importance scores; means ranged from 1.64 to 2.52) were still considered important by trial implementers, but not rated as highly as those in the prior two groups. Strategies in this group tended to be more focused on the infrastructure in which LGBTQ-affirmative CBT is delivered and may be ideal but not in themselves necessary for implementing LGBTQ-affirmative CBT. Changing physical structure and equipment to show visual indicators of LGBTQ affirmation (e.g., safe space signs) and changing the physical space in which treatment is delivered to be warm and welcoming (e.g., art showing same sex couples, providing refreshments) was considered important, but potentially less actionable or necessary, in resource constrained contexts. Trial implementers also rated the strategy of using a train-the-trainer strategy wherein individuals become trained in LGBTQ-affirmative CBT and then train others in this optional-resource dependent range. High priority strategies may need to precede these resource-dependent, but still useful, strategies.

Seven implementation strategies were used in less than three trials; therefore, we did not evaluate their overall importance; however, their mean importance scores by trial are shown in Table 3. Several of these strategies were rated within the “essential” range within a specific trial of LGBTQ-affirmative CBT. For example, using data experts, operationalized as working with a consultant to store ICBT data in an online platform, was in the essential range for the LGBTQ-affirmative ICBT and China ICBT trials. This is likely because these two trials delivered LGBTQ-affirmative CBT online, making the strategy highly relevant. Strategies not rated for overall importance may still be critical to implementing certain formats of LGBTQ-affirmative CBT.

Discussion

This study found that within clinical trial contexts, implementing LGBTQ-affirmative CBT generally involved a package of more than 20 implementation strategies, and within these, certain strategies were deemed to be of highest priority. LGBTQ-affirmative CBT is a “complex intervention” given its multiple interacting and important components [45, 46]; complex interventions often require a greater number of implementation strategies than simpler interventions [47, 48]. The purpose of the present study was to facilitate community implementation of LGBTQ-affirmative CBT; therefore, we also identified strategies that were highest priority for implementing the intervention, which may help organizations allocate limited resources for implementation.

The overall implementation strategy importance scores revealed that strategies used in three or more trials were generally considered important; however, we recognize that using all the strategies rated as important may not be feasible in real-world settings with limited resources. To help implementers make challenging decisions between important strategies, we grouped high priority, medium priority, and optional-resource dependent strategies based on mean scores across trials. These groupings revealed that future implementers may need to meet “basic” implementation needs, such as receiving an initial training in LGBTQ-affirmative CBT and having sufficient demand from clients, as a first implementation step. After meeting these basic needs, implementers can use moderate priority and resource-dependent strategies to build on those higher priority strategies, for instance through securing committed LGBTQ leadership, forming clinical teams, and providing ongoing training/supervision. Considering these implementation strategies not as unimportant but part of a menu of options may help implementers prioritize their investments, particularly in the earlier stages of intervention adoption and implementation. Furthermore, some of these strategies may already be in place in implementation settings; rather than requiring additional resources, settings with generalized versions of these strategies could modify them to implement LGBTQ-affirmative CBT. For example, most mental health practice settings already provide clinical supervision, which could be re-allocated for clinical supervision of LGBTQ-affirmative CBT. Thus, only the training for supervisors in LGBTQ-affirmative CBT would require additional resources, and following this training, clinical supervision on LGBTQ-affirmative CBT would leverage an existing structure within implementing settings.

The present study also revealed that some implementation strategies may be more relevant to certain formats of LGBTQ-affirmative CBT than others. Although LGBTQ-affirmative CBT was originally tested in-person as an individual intervention, the treatment has been adapted for socio-culturally diverse groups and contexts, including Black and Latino gay and bisexual men in groups settings; Chinese young gay and bisexual men using an asynchronous online delivery; and young LGBTQ people in the U.S. using asynchronous online delivery. Our overall importance ratings reveal a “core” set of strategies that may be important for implementing any format of LGBTQ-affirmative CBT, but implementers may need to select additional strategies based on the format of LGBTQ-affirmative CBT they are using, intended recipients, therapist experience, or cultural/organizational implementation context. For example, train-the-trainer was rated in the “absolutely essential” range for ESTEEM and EQuIP (i.e., individual, in-person delivery for sexual minority men and gender diverse sexual minority women, respectively), but in the “likely inessential” range for ESTEEM ConneCT (i.e., group format for Black and Latino sexual minority men), which may have been due to the size of these different implementation teams. In the ESTEEM and EQuIP trials, the PI trained many different “trainers” to train and supervise clinicians, whereas in ESTEEM ConneCT there was a smaller implementation team, reducing the need for this system. Translating our findings to community settings, train-the-trainer may be an essential strategy in large implementation contexts, when numerous trainees are involved, or turnover is high. Prior research has similarly suggested that train-the-trainer is useful for addressing employee attrition [49] and when efficient training models or capacity building is needed [50]. As another example, shadowing experts, operationalized in the current study as viewing session recordings, was “optional” overall, but ESTEEM implementers rated this strategy in the “absolutely essential” range. In ESTEEM, none of the trial implementers had prior experience with LGBTQ-affirmative CBT, therefore this strategy might have been relevant and useful, whereas in the other trials the implementers had prior exposure to LGBTQ-affirmative CBT, making shadowing less relevant. Translating our findings to community settings, shadowing may be most useful in organizations where no prior implementation of LGBTQ-affirmative CBT has occurred. Our interpretation of the current study’s findings is consistent with prior research suggesting that shadowing is a particularly useful strategy for overcoming implementation barriers such as low provider self-efficacy and low access to knowledge and information [51].

Our approach to identifying implementation strategies contrasts with approaches typically used in implementation science. For instance, implementation mapping is an approach for designing implementation strategies that begins by identifying determinants and maps strategies onto those determinants [52]. To apply an approach like implementation mapping, these determinants need to be known. When we began the current study, there had not yet been systematic research to identify LGBTQ-affirmative CBT implementation determinants. We view our approach as an innovative, complementary approach to implementation research that begins with identifying determinants and based on those findings, operationalizes relevant implementation strategies. Our approach could also be extended to a “reverse” approach in which strategies already in use could be rated in terms of importance and linked backward to relevant determinants to inform decisions regarding strategies to use moving forward. Early research that was not specifically evaluating implementation determinants suggested that some potential implementation challenges for LGBTQ-affirmative CBT in LGBTQ community centers could be limited time for LGBTQ-affirmative CBT training, lack of available/affordable training resources for LGBTQ-affirmative CBT, and limited professionally trained therapists [17]. Strategies identified in our current study might help to address these and other determinants as they are systematically documented.

Implementing individuals and organizations may use these findings to select the most important and relevant implementation strategies for their specific context. At the same time, implementation strategies require adaptation to context for maximum impact [48, 53]. Therefore, the “form” of the strategies used in these trials may be different in practice settings, despite having a similar “function” [52]. For example, the develop educational materials strategy involved iteratively refining the treatment manual for each trial, whereas in real-world practice, this strategy would likely involve leveraging published treatment manuals that are not specific to one delivery format of LGBTQ-affirmative CBT [35, 36]. Additionally, some strategies may not have been used in these trials but would likely be helpful in real-world practice. For instance, in these trials, the intervention developer and experts in LGBTQ mental health research were the implementers, and therefore had extensive knowledge of evidence-based CBT and LGBTQ-affirming practice. We leveraged this expertise to train trial implementers and this expertise likely made training and supervision more efficient than a setting where implementers do not have the same knowledge or attitudes. As such, it may be helpful in non-LGBTQ-specific practice settings to conduct a baseline assessment of therapists’ attitudes and knowledge about LGBTQ-affirmative practice to allow for tailored training and addressing any gaps or biases prior to implementation. In practice settings that are not LGBTQ-specific or where providers are not already familiar with CBT, strategies identified in the current study, such as training and supervision, may need to be modified to include more ongoing knowledge building in CBT and LGBTQ-affirmative mental health than was required in our trials.

This research lays the groundwork for additional implementation research to advance the science and practice of implementing LGBTQ-affirmative CBT. For example, as LGBTQ-affirmative CBT is implemented in real-world contexts, it will be important to identify key implementation determinants (i.e., barriers and facilitators) to further tailor implementation strategies for different practice settings [54]; tailoring implementation strategies to context has been described in other areas of mental health evidence-based practice implementation [55, 56]. Although the current study is limited in generalizability (i.e., limited to a specific study team and a specific intervention in particular contexts), it represents a useful starting point for considering implementation strategies to test in terms of their impact on implementation outcomes, which would yield more generalizable knowledge and fill gaps in the implementation science literature [57, 58]. Hybrid effectiveness-implementation studies of LGBTQ-affirmative CBT are underway or in the planning stages which can help to produce this generalizable knowledge [59].

This study is not without limitations. None of these trials were designed for observing or documenting implementation strategy use; therefore, our process, despite being systematic, took place after the trials started or were completed, limiting our ability to determine the relative importance of the strategies in real-time. Additionally, rating strategy importance in real-world contexts would likely identify additional important strategies given that trials are highly controlled; for instance, session fidelity ratings were high in ESTEEM due to the requirements of the efficacy trial [9]. Another limitation of the current study is that we rated strategies based on the single dimension of importance (based on precedent from Waltz and colleagues [44] and for parsimony); however, there are other, multidimensional approaches to evaluating implementation strategies (e.g., Prioritizing Implementation Barriers toolkit) [60] that could be used in future research to evaluate other dimensions (e.g., feasibility, equity). Another limitation of this study is that we were not able to account for respondent clustering (i.e., the same responders included in multiple trials). We attempted to examine strategy ratings solely among trial implementers who were unique responders to each trial to account for clustering, but these data were too sparse. As such, there could be unaccounted-for implementer-level effects within our findings. Finally, because the identified strategies are not linked to specific implementation outcomes, we were unable to objectively evaluate the effectiveness of each strategy on implementation outcomes or use other approaches, such as qualitative comparative analysis, to evaluate the strategies. However, the study adds value to the scientific literature regarding innovative ways to identify important implementation strategies early on, which can pave the way for building generalizable knowledge via implementation trials.

Conclusions

This study makes significant contributions to knowledge in implementation science. We addressed gaps in the reporting of implementation strategies used within clinical trials in general, and LGBTQ-affirmative CBT trials in particular [47]. We also addressed a common issue in implementation science wherein even when implementation strategies are reported, they are insufficiently operationalized, making it difficult to replicate or know what exactly was done [32] via our use of the Pragmatic Implementation Reporting Tool and use of standardized reporting guidelines [33]. Finally, this study advances the science of LGBTQ-affirmative CBT and lays groundwork for increased implementation of this efficacious intervention in real-world practice as well as further implementation research in pursuit of this goal.

Data availability

The data (without identifiers) used to support the findings of this study may be made available upon reasonable request (e.g., methodologically sound proposal and signed data use agreement) from the corresponding author following publication. Analyses with this data would only be used to achieve the aims in the approved proposal.

Notes

  1. The Pragmatic Implementation Reporting Tool as applied to each trial in the supplementary materials shows specific ERIC strategies (e.g., intervene with patients/consumers to enhance uptake and adherence) that, when operationalized within a given trial were comprised of multiple components (e.g., using problem solving to promote continued engagement, offering flexible scheduling/rescheduling to retain participants, encouraging participants to take an active role in their treatment by completing home practice).

  2. Sexual orientation was not a mutually exclusive variable.

Abbreviations

CBT:

Cognitive Behavioral Therapy

ERIC:

Expert Recommendations for Implementation Change

ICBT:

Internet based Cognitive Behavioral Therapy

LGBTQ:

Lesbian, gay, bisexual, transgender, queer

StaRI:

Standards for Reporting Implementation Studies

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Acknowledgements

We would like to thank all the implementers of LGBTQ-affirmative CBT for contributing their knowledge about the implementation process to this work.

Funding

This research was supported by the National Institutes of Health: R01MH109413 (Pachankis), R01MH109413-02S1 (Pachankis), R21TW011762 (Pachankis & Li), P30MH062294 (Clearly), T32MH020031 (Layland), P30MH133399 (Safren), P30MH11686 (Safren), K23MD015690 (Harkness). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The research was also supported by the Lesbian Health Fund, Yale Fund for LGBTQ Studies, and David R. Kessler, MD,’55 Fund for LGBTQ Mental Health Research at Yale.

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Authors and Affiliations

  1. School of Nursing and Health Studies, University of Miami, Coral Gables, FL, USA

    Audrey Harkness

  2. Department of Psychology, Miami University, Oxford, OH, USA

    Zachary A. Soulliard

  3. Department of Human Development and Family Sciences, University of Delaware, Newark, DE, USA

    Eric K. Layland

  4. Department of Psychology, Syracuse University, Syracuse, NY, USA

    Kriti Behari

  5. Department of Psychiatry, Chobanian & Avedisian School of Medicine Department of Psychiatry, Boston University, Boston Medical Center, Boston, MA, USA

    Brooke G. Rogers

  6. Psychology Department, University of Miami, Coral Gables, FL, USA

    Bharat Bharat & Steven A. Safren

  7. Department of Social and Behavioral Sciences, Yale School of Public Health, New Haven, CT, USA

    John E. Pachankis

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Contributions

Author contributions are as follows: Conceptualization (AH, JEP), Methodology (AH, ZAS, EL, KB, BGR), Formal Analysis (AH, ZAS, EL, KB, BGR, BB), Investigation (AH, ZAS, KB), Writing – Original Draft (AH, ZAS, KB, BB), Writing – Review & Editing (AH, ZAS, EL, KB, BGR, BB, SAS, JEP), Supervision (AH, JEP), Project Administration (AH, ZAS, EL, KB, BGR, BB). All authors read and approved the final manuscript.

Corresponding author

Correspondence to Audrey Harkness.

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This project was deemed “not human subjects research” by the Yale University Institutional Review.

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Competing interests

Drs. Harkness, Safren, and Pachankis report that they receive royalties for books related to LGBTQ-affirmative mental health treatments published by Oxford University Press. Dr. Safren also receives royalties for books published by Guilford Publications and Springer/Humana Press.

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Harkness, A., Soulliard, Z.A., Layland, E.K. et al. Implementing LGBTQ-affirmative cognitive-behavioral therapy: implementation strategies across five clinical trials. Implement Sci Commun 5, 124 (2024). https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s43058-024-00657-x

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Implementation Science Communications

ISSN: 2662-2211