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Cited by 2Mindfulness and Compassion InterventionsLGBTQ Health, Identity, and PolicyAnxiety, Depression, Psychometrics, Treatment, Cognitive Processes

A randomized trial of acceptance-based behavioral therapy to improve mental health outcomes for LGBTQ+ persons: Study protocol

Open access
Moitra, Ethan, Brick, Leslie A., Cancilliere, Mary Kathryn, Elwy, A. Rani, Erbe, A. Maximillian, Fenn, Natalie, Nunn, Amy S., Salhaney, Peter +1 more·2023·Contemporary Clinical Trials
DOI 10.1016/j.cct.2023.107211PMC PMC10155421
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Abstract

Background: During the COVID-19 pandemic, public health measures limited social interactions as an effective and protective intervention for all. For many, however, this social isolation exacerbated mental health symptoms. People who identify as lesbian, gay, bisexual, transgender, and queer (LGBTQ+) were already at elevated risk of anxiety and depression, relative to cisgender and heterosexual populations, and pandemic-related social isolation likely heightened these disparities. In our prior work with sexual and gender minorities, we developed and established feasibility and acceptability of a novel acceptance-based behavioral therapy (ABBT) intervention for HIV treatment. ABBT showed promise in improving social support and reducing mental health symptoms. In the current study, we investigate the efficacy of ABBT, compared to a treatment-as-usual control condition, in a full-scale randomized controlled trial to improve social support for LGBTQ+ persons living with anxiety and depression. Methods: Two hundred forty LGBTQ+ adults with anxiety and/or depressive symptoms will be recruited and equally randomized to receive: (a) the ABBT intervention, consisting of two 30–40 min sessions plus treatment-as-usual (TAU), or (b) TAU only. Primary outcomes are interviewer-assessed anxiety and depressive symptoms. Secondary outcomes are self-reported anxiety and depressive symptoms. Experiential avoidance and social support are hypothesized mediators and presence of an anxiety and/or depressive disorder is a hypothesized moderator. Conclusions: ABBT represents a novel, identify-affirming real-world approach to promoting social support as a means of improving mental health among individuals who identify as LGBTQ+. This study will contribute actionable data establishing the impact, mediational mechanisms, and effect modifiers of ABBT. Clinicaltrials.gov registration: NCT05540067 © 2023 Elsevier Inc.

Integrity signals

Registry

Crossref · 10.1016/j.cct.2023.107211

Cites

48 of 48 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

12 of 27 cited sources checked · 2 supported · 0 flagged · accuracy not yet measured

  • Premisecitation

    Minority stress theory suggests that mental health disparities among LGBTQ+ individuals might be explained by chronic and unique stressors such as discrimination, stigma, and prejudice.

    “According to minority stress theory, these disparities might be explained by the chronic and unique stressors (e.g., discrimination, stigma, prejudice) that many LGBTQ+ individuals experience.”
    Quote in the paperSubstantial claim2 of 2 sources checked
    • cites [3] source

      The Group-Specific Processes passage says minority stress theory links discrimination and other stigma-related stressors to mental-health disparities among sexual minorities. The paper frames its discussion around sexual minorities and LGB populations; it does not establish the claim for the broader LGBTQ+ population. (LLM, conf=0.85)

      Experimental — accuracy not yet measured
    • cites [4] source

      The Discussion (Summary; page not provided) says the minority stress model explains higher rates of mental disorders among LGB people through excess social stressors related to stigma and prejudice. The cited paper addresses lesbian, gay, and bisexual populations, but the claim extends that explanation to LGBTQ+ individuals more broadly; our copy does not establish it for the additional groups. (LLM, conf=0.86)

      Experimental — accuracy not yet measured
  • Premisecitation

    LGBTQ+ persons often report a lack of access to affirming care.

    “Importantly, LGBTQ+ persons often report a lack of access to affirming care [15].”
    Quote in the paperSubstantial claim1 of 1 sources checked
    • cites [15] source

      The Results (Provider Characteristics; page not provided) describe participants who valued LGBT-knowledgeable providers and one who felt uncomfortable with a provider's stereotypical views. The Abstract (Results; page not provided) also reports difficulty finding suitable care and help locating LGB-affirming services. The study concerns mental health care for Black and Hispanic LGB young adults, so it does not establish how often LGBTQ+ persons generally report this barrier across care settings. (LLM, conf=0.85)

      Experimental — accuracy not yet measured
  • Premisecitation

    The COVID-19 pandemic contributed to an exacerbation of pre-existing mental health disparities in the LGBTQ+ community due to social disruptions.

    “In sum, the COVID-19 pandemic contributed to an exacerbation of pre-existing mental health disparities in the LGBTQ+ community due to social disruptions [9].”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [9] source

      The Abstract says LGBTQ people have pre-existing mental health disparities that may be exacerbated by pandemic trauma and social isolation measures. The Structural Vulnerability section likewise describes exacerbation as a possibility. The citing sentence overstates this as an established effect caused by social disruptions; page numbers were not provided. (LLM, conf=0.86)

      Experimental — accuracy not yet measured
  • Premisecitation

    Prior to the pandemic, LGBTQ+ individuals reported inadequate care due to stigmatizing experiences in health care settings.

    “Prior to the onset of the pandemic, LGBTQ+ individuals reported inadequate care due to having stigmatizing experiences in health care settings [13] and lack of provider knowledge about their unique health care needs [14].”
    Quote in the paperSubstantial claim1 of 1 sources checked
    • cites [13] source

      In Results > Stigma (page unavailable), participants describe stigma affecting communication with providers and their confidence in the care they receive. Results > Access gives an example of a participant reporting an offensive diagnosis, but she says her care was medically good for her primary condition. The study concerns lesbian, gay, and bisexual people, not the full LGBTQ+ population, and does not establish that participants generally received inadequate care because of stigmatizing experiences. (LLM, conf=0.84)

      Experimental — accuracy not yet measured
  • Premisecitation

    LGBTQ+ persons are more likely to seek mental health services compared to the general population.

    “Although LGBTQ+ persons are more likely to seek mental health services compared to the general population [10,11], this group consistently demonstrates unmet mental health treatment needs [12].”
    Quote in the paperNot a substantial claim1 of 2 sources checked
    • cites [10] source

      The Conclusion reports higher rates of mental health and substance-use treatment among LGB people than heterosexual people, and the Discussion reports a greater propensity to use mental health services. The study addresses sexual orientation, not the full LGBTQ+ population; it does not establish the claim for transgender people as a group. (LLM, conf=0.86)

      Experimental — accuracy not yet measured
    • cites [11] source
  • Classified as probably not a substantial claim. 17
  • May combine two claims. 13

  • Probably not a substantial claim: may not pass S1 (asserted). May combine two claims.

    Premisecitation

    Greater minority stress is associated with lower social support, which in turn is associated with more mental health problems.

    “Moreover, greater minority stress is associated with lower social support, which in turn is associated with more mental health problems [5].”
    Quote in the paperNot a substantial claim1 of 1 sources checked

  • May combine two claims.

    Premisecitation

    For individuals who lost social connections or could not adapt to maintain connections, social support decreased and loneliness worsened, increasing risk of anxiety and depressive symptoms.

    “For individuals who lost social connections or were unable to adapt to maintain their connections, social support decreased and loneliness worsened [7], putting them at elevated risk of anxiety and depressive symptoms.”
    Quote in the paperSubstantial claim1 of 1 sources checked
    • cites [7] source

      The paper’s results and discussion (page unavailable in our copy) report decreased contact with family and friends and increased loneliness after the pandemic began. They do not measure social support or separately analyze people who lost connections or could not adapt to maintain them. The sentence places the anxiety-and-depression risk statement after the citation; the paper reports increased social anxiety but only modest depressive symptoms. (LLM, conf=0.86)

      Experimental — accuracy not yet measured

  • May combine two claims.

    Premisecitation

    Public health measures such as limits on social interaction, isolation, and quarantine contributed to loneliness, anxiety, depression, insomnia, self-harm or suicidal behavior, and substance use.

    “Public health measures, specifically limits on social interaction and isolation and quarantine, contributed to loneliness, anxiety, depression, insomnia, self-harm or suicidal behavior, and substance use [6].”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [6] source

      In “COVID 19 and its mental health consequences” (page not supplied), the paper lists all the claimed outcomes and links them to self-isolation and quarantine. It presents that link as a WHO speculation about what the measures may lead to, rather than an established causal finding as “contributed to” suggests. (LLM, conf=0.87)

      Experimental — accuracy not yet measured

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    The COVID-19 pandemic significantly worsened mental health in the U.S.

    “The COVID-19 pandemic significantly worsened mental health in the U.S.”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [6] source

      The section “COVID 19 and its mental health consequences” (page not supplied) describes pandemic-related mental health harms and reports increased mental illness in India. It discusses a possible global impact, but does not establish that mental health significantly worsened in the U.S.; the claim is more geographically specific and more certain than the paper. (LLM, conf=0.87)

      Experimental — accuracy not yet measured

  • May combine two claims.

    Premisecitation

    Only one ABBT intervention specifically targeted social supports, and it was among traumatized military veterans.

    “However, to our knowledge, only one ABBT intervention specifically targeted social supports, and it was among traumatized military veterans [25].”
    Quote in the paperSubstantial claim1 of 1 sources checked

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Telemedicine is expected to promote high retention in study activities.

    “As in our previous studies, we expect telemedicine to promote high retention in study activities (e.g. [35],).”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [35] source

      The Results (Acceptability and feasibility; page unavailable) report high retention in study assessments, and the Methods (Participants; page unavailable) say follow-up assessments could be completed by telephone. The paper does not attribute that retention to telemedicine; its behavioral intervention was delivered at clinic appointments. (LLM, conf=0.85)

      Experimental — accuracy not yet measured

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    In 2015, 37% of sexual minority adults had mental illness, compared to 17% among heterosexual adults.

    “A national survey found that 37% of sexual minority adults had mental illness in 2015, compared to 17% among heterosexual adults [2].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [2]

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Clinical supervision will be provided by the study's lead investigator during weekly teleconference sessions throughout the RCT.

    “Clinical supervision will be provided by the study's lead investigator during weekly teleconference sessions throughout the RCT.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Fidelity rating training will continue until adequate reliability is achieved (ICC > 0.80).

    “Once these steps are completed, the two raters will rate a random selection of ABBT sessions until adequate reliability is achieved (ICC > 0.80).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    We will adjust for baseline values of outcome measures as applicable.

    “However, we will adjust for baseline values of outcome measures as applicable.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    Per intent-to-treat (ITT) principle, missing data will be handled with multiple imputation or maximum likelihood estimation and assumptions checked with sensitivity analyses.

    “Per intent-to-treat (ITT) principle, missing data will be handled with multiple imputation or maximum likelihood estimation and assumptions checked with sensitivity analyses.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductreasoning

    With a final sample of 210, we are powered to detect effects as low as f = 0.08, which corresponds to Cohen's d = 0.16, far below those observed in prior meta-analyses.

    “With a final sample of 210, we are powered to detect effects as low as f = 0.08, which corresponds to a Cohen's d = 0.16, far below those observed in prior meta-analyses.”
    Quote in the paperSubstantial claim
    • The authors state this as an assumption: The study anticipates a 10–15% attrition rate.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Adherence to the treatment manual will be assessed using a previously developed coding system used in pilot work.

    “Adherence to the treatment manual will be assessed in a previously developed coding system used in the pilot work.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    At the conclusion of the RCT, two trained postdoctoral students who are not part of the study will rate 50% of the randomly selected ABBT sessions.

    “At the conclusion of the RCT, two trained postdoctoral students who are not part of the study will rate 50% of the randomly selected ABBT sessions.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    Randomization will be stratified by severity of anxiety and/or depressive symptoms (mild, moderate, severe; 9 strata) to increase likelihood of balance across intervention arms.

    “In order to increase the likelihood of balance across intervention arms, randomization will be stratified by severity of anxiety and/or depressive symptoms (mild, moderate, severe; resulting in 9 strata) based on the Quick Inventory of Depressive Symptomatology – Clinician Rating (QIDS-C [30,31];) and the Hamilton Anxiety Rating Scale (HAM-A [32];).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    In a large cross-sectional survey during the first three months of the COVID-19 pandemic, LGBTQ+ individuals were significantly more likely to have anxiety and depressive symptoms and were particularly affected by social isolation.

    “In a large cross-sectional survey of sexual and gender minority and cisgender heterosexual respondents during the first three months of the COVID-19 pandemic, LGBTQ+ individuals were significantly more likely to have anxiety and depressive symptoms and they were particularly affected by the social isolation [8].”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [8] source

  • May combine two claims.

    Premisecitation

    According to numerous reviews, such as Eaton et al., interviewer-assessments of mental health symptoms are more rigorous, less prone to bias, and have better sensitivity and specificity than self-reports.

    “According to numerous reviews, such as Eaton et al. [37], the use of interviewer-assessments of mental health symptoms are more rigorous, less prone to bias, and have better sensitivity and specificity than self-reports.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [37] source

  • Classified as probably not a substantial claim.

    Study design and conductnone given

    Primary outcomes will be assessed using blinded rater assessments.

    “We will examine the QIDS-C and HAM-A total for change in depressive and anxiety symptoms based on blinded rater assessments, respectively.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Treatment arm assignments will be made in blocks of 4 or 6 participants (randomly ordered).

    “Treatment arm assignments will be made in blocks of 4 or 6 participants (randomly ordered).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductreasoning

    We will conduct sensitivity analyses that introduce statistical control for post-randomization variables (e.g., other treatments received) as well as explore other possible treatment effect modifiers or subgroups.

    “As patients might be receiving other non-study treatments during the trial (assessed at baseline and all follow-ups), we will conduct sensitivity analyses that introduce statistical control for post-randomization variables (e.g., other treatments received) as well as explore other possible treatment effect modifiers or subgroups that differentially respond to treatment to inform future intervent”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    An investigative team member will set up randomization tables in REDCap, and other research staff will not have access to the tables.

    “An investigative team member will set up randomization tables in REDCap [33,34] (a secure web-based service for building and managing online surveys and databases), and other research staff will not have access to the tables.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    This study will have a data and safety monitoring board comprised of three external experts.

    “This study will have a data and safety monitoring board comprised of three external experts.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    A recent review of ABBT interventions among LGBTQ+ samples identified only five studies, of which only three were randomized trials.

    “However, a recent review of ABBT interventions among LGBTQ+ samples identified only five studies, of which only three were randomized trials [26].”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [26] source

  • May combine two claims.

    Premisecitation

    ABBT is an empirically supported treatment approach for depression, anxiety, obsessive-compulsive disorder, and chronic pain.

    “Acceptance-based behavior therapy (ABBT) is an empirically supported treatment approach for depression, anxiety, obsessive-compulsive disorder, and chronic pain [16], and has been successfully applied to various medical conditions and sub-syndromal concerns, such as stigma [17,18].”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [16] source

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    We will examine statistical assumptions for all variables and test for baseline differences between groups on study measures and key demographics.

    “Prior to analysis, we will examine statistical assumptions for all variables and test for baseline differences between groups on study measures and key demographics.”
    Quote in the paperNot a substantial claim
25 of 25

  • The authors state this as an assumption.

    The study anticipates a 10–15% attrition rate.

    “We anticipate a 10–15% attrition rate, leaving us with about 210 study completers.”

  • The paper relies on this without support.

    The approach/consent rate in similar studies is greater than 50%.

    “Our approach/consent rate in similar studies is >50% as these individuals might not be actively seeking treatment.”

  • The paper relies on this without support.

    There is no gold standard social support-focused behavioral intervention for LGBTQ+ persons.

    “Because there is no gold standard social support-focused behavioral intervention for LGBTQ+ persons, and to demonstrate an effect beyond usual care, our control condition will be the clinic's usual care procedures (TAU).”

  • The paper relies on this without support.

    In community-based clinics, use of the QIDS-C and HAM-A is unlikely.

    “We recognize that in community-based clinics, the use of the QIDS-C and HAM-A is unlikely.”

  • The paper relies on this without support.

    ABBT helps patients overcome forms of avoidance that can lead to problems, particularly avoidance of uncomfortable internal states and the situations that trigger such states.

    “ABBT helps patients overcome forms of avoidance that can lead to problems, particularly avoidance of uncomfortable internal states and the situations that trigger such states.”

  • The paper relies on this without support.

    In the authors' prior work with sexual and gender minorities, they developed and established feasibility and acceptability of a novel ABBT intervention for HIV treatment.

    “In our prior work with sexual and gender minorities, we developed and established feasibility and acceptability of a novel acceptance-based behavioral therapy (ABBT) intervention for HIV treatment.”

  • The paper relies on this without support.

    ABBT showed promise in improving social support and reducing mental health symptoms.

    “ABBT showed promise in improving social support and reducing mental health symptoms.”

  • The paper relies on this without support.

    ABBT is not a traditional mental health intervention.

    “Because our brief ABBT is not a traditional mental health intervention, we suggest that it can be complementary to other treatment approaches.”

  • The paper relies on this without support.

    ABBT's effects do not vary depending on comorbid substance use.

    “Yet, our prior data do not show that ABBT's effects vary depending on comorbid substance use.”
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Authors
Moitra, E., Brick, L. A., Cancilliere, M. K., Elwy, A. R., Erbe, A. M., Fenn, N., Nunn, A. S., Salhaney, P., & Chan, P. A.
Affiliations
Brown University (US)
Corresponding author
Moitra, Ethan
ORCID
Venue
Contemporary Clinical Trials
Publisher
Elsevier BV
Published
2023-07
Volume
130
Pages
107211
ISSN
1551-7144 (ISSN-L)
DOI
10.1016/j.cct.2023.107211
PMC
PMC10155421
OpenAlex
W4367839959
Semantic Scholar
2259af17b4334272dfb58d1cddb6917fc4e3bf7f
Cited by
2
References
49
Citations by year
2026: 2
FWCI
0.58
Type
journal article
Language
en
Open access
Licence
Locations
  • Contemporary Clinical Trials (acceptedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
National Institute of Mental Health (RF1 MH132348)
Topics
  • Social Sciences › Psychology › Clinical Psychology › Mindfulness and Compassion Interventions
  • Social Sciences › Psychology › Social Psychology › LGBTQ Health, Identity, and Policy
  • Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
Keywords
LGBTQ mental health, anxiety symptoms, depressive symptoms, social support, experiential avoidance, sexual and gender minorities, COVID-19 social isolation, brief psychotherapy, mediating and moderating effects
MeSH terms
Sexual and Gender Minorities, COVID-19, Adult, Behavior Therapy, Female, Humans, Male, Randomized Controlled Trials as Topic, Outcome Assessment, Health Care, Pandemics

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