Project EQuIP: Empowering Queer Identities in Psychotherapy

Sponsor
Yale University (Other)
Overall Status
Completed
CT.gov ID
NCT03721276
Collaborator
National Institute of Mental Health (NIMH) (NIH)
60
1
2
12
5

Study Details

Study Description

Brief Summary

The aim of this study is to develop an evidence-based psychosocial intervention for sexual minority women. This intervention will specifically target the adverse mental and behavioral health outcomes disproportionately experienced by sexual minority women, including depression, suicidality, and alcohol abuse, which are known to be driven by stigma-related stressors associated with their sexual orientation (i.e., minority stress processes).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: EQuIP (Empowering Queer Identities in Psychotherapy)
N/A

Detailed Description

The purpose of this study is to adapt ESTEEM (Effective Skills to Empower Effective Men), developed by Dr. John Pachankis, to simultaneously target the multiple adverse health outcomes sexual minority women disproportionately face, including depression, suicidality, and alcohol abuse, that are linked to minority stress processes.

Project EQuIP will adapt the ESTEEM program for sexual minority women in three distinct phases. The focus of this registered protocol will be Phase 3, however Phases 1, 2 and 3 are described below.

Phase 1 will involve conducting interviews with 20 sexual minority women (SMW) who report experiencing depression, suicidality, and alcohol abuse. Information from these interviews will be used to gather insight from participants that can help inform the adaptation of a cognitive-behavioral treatment approach to specifically target sexual minority women's unique experiences with minority stress.

Phase 2 will involve consultation interviews with 10 community-based mental health experts who treat psychosocial health problems among at-risk SMW. Involvement of key community members in intervention design optimizes intervention dissemination and allows frontline professionals to shape the intervention that they would be most willing to implement. Input of mental health experts working with the SMW community will be used in order to translate existing, but largely untapped, clinical wisdom regarding SMW's minority stress experiences, mental health, and alcohol use into the development of the intervention.

Phase 3 will involve pilot testing the adapted cognitive-behavioral treatment through a randomized controlled trial with 60 SMW who report experiencing depression, anxiety, and alcohol abuse.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Masking Description:
Patients will either be immediately enrolled or wait listed for the intervention.
Primary Purpose:
Treatment
Official Title:
Project EQuIP: Empowering Queer Identities in Psychotherapy
Actual Study Start Date :
Jul 18, 2018
Actual Primary Completion Date :
Jul 18, 2019
Actual Study Completion Date :
Jul 18, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Therapy

Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse.

Behavioral: EQuIP (Empowering Queer Identities in Psychotherapy)
Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse.
Other Names:
  • ESTEEM (Effective Skills to Empower Effective Men) for Women
  • Other: Waitlist

    Individuals assigned to waitlist will be put on a waitlist for 3 months after baseline assessment, after which they will also receive the same treatment as the therapy group.

    Behavioral: EQuIP (Empowering Queer Identities in Psychotherapy)
    Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse.
    Other Names:
  • ESTEEM (Effective Skills to Empower Effective Men) for Women
  • Outcome Measures

    Primary Outcome Measures

    1. Depression [Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)]

      The measure depression in participants, the Center for Epidemiological Studies - Depression Scale (CES-D) will be used. An overall depression score is computed as the sum of the 20 items, with Items 3, 11, 14, and 16 reversed. In cases with internally missing data (items not answered), the sums were computed after imputation of the missing values: # items on scale / # actually answered, multiplied by the sum obtained from the answered items. A higher score indicates more depressive symptomatology during the past week. Range is 0 - 60.

    2. Brief Symptom Inventory [Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)]

      The Global Severity Index of the 18-item BSI provides a mean score across depression, anxiety, and somatization subscales, and assesses psychological distress (e.g., "feeling nervousness or shakiness inside") on a 5-point scale from 0 (not at all) to 4 (extremely) for the past 7 days. Scores range from 0-72, with higher scores indicating worse outcomes (greater symptoms severity).

    3. Alcohol Use [Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)]

      Alcohol use will be measured using the Short Index of Problems for Alcohol (SIP-A). The SIP-A is a 15-item, binary response (yes/no) measure that has a range of scores from 0-15. The highest score of 15 is an indicator of the greatest amount of alcohol use related problems.

    Secondary Outcome Measures

    1. Overall Depression Severity and Impairment Scale [Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)]

      ODSIS is a 5-item scale that asks individuals to rate the severity and impairment associated with past-week symptoms of depression (e.g., "In the past week, when you have felt depressed, how intense or severe was your depression?) from 0 (little or none: Depression was absent or barely noticeable.) to 4 (extreme: Depression was overwhelming.). Scores range from 0-20, with higher scores indicating greater depression and associated impairment in the past week.

    2. Overall Anxiety Severity and Impairment Scale [Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)]

      OASIS is a 5-item scale that asks individuals to rate the severity and impairment associated with past-week anxiety symptoms (e.g., "In the past week, when you have felt anxious, how intense or severe was your anxiety?") from 0 (little or none: Anxiety was absent or barely noticeable.) to 4 (extreme: Anxiety was overwhelming. It was impossible to relax at all. Physical symptoms were unbearable). Scores range from 0-20, with higher scores indicating greater anxiety and associated impairment in the past week.

    3. Suicidal Ideation Attributes Scale [Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)]

      SIDAS is a 5-item scale that assesses past-month frequency and controllability of suicidal thoughts, how close one has come to making an attempt, and distress and impairment associated with thoughts of suicide (e.g., "In the past month, how often have you had thoughts about suicide?"). Responses range from 0 (never or not at all) to 10 (always or extremely) on each item, with item 2 reverse scored. Scale scores range from 0-50, with higher scores indicating more (worse) suicidal ideation.

    4. Lesbian, Gay, and Bisexual Identity Scale-Internalized Homonegativity Subscale [Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)]

      Internalized stigma was assessed us- ing the mean score on a three-item scale, the Lesbian, Gay, and Bisexual Identity Scale-Internalized Homonegativity Subscale, that asks individuals to rate thoughts and feelings related to their LGBTQ identity (e.g., "If it were possible, I would choose to be straight"). Responses range from 1 (disagree strongly) to 6 (agree strongly). Scores range from 3-18 with higher scores indicating higher internalized stigma.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    For Phase 3

    Inclusion Criteria:
    • sexual minority status operationalized as identity (e.g., lesbian, bisexual, pansexual, queer)

    • aged 18-35

    • self-identification as a woman with the option of selecting multiple gender identities

    • symptoms of anxiety or depression within the past 90 days (≥ 2.5 on the BSI-4 for either anxiety or depression)

    • at least one instance of past-90-day heavy drinking (i.e., ≥ 4 drinks in one sitting)

    • 6-month NYC residential stability and availability

    • English fluency

    Exclusion Criteria:
    • active psychosis or active mania

    • active suicidality or active homicidality

    • currently in mental health treatment exceeding one day per month

    • having received any cognitive-behavioral therapy treatment in the past 12 months

    • evidence of gross cognitive impairment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yale LGBTQ+ Mental Health Initiative - Research Lab New York New York United States 10010

    Sponsors and Collaborators

    • Yale University
    • National Institute of Mental Health (NIMH)

    Investigators

    • Principal Investigator: John Pachankis, PhD, Associate Professor of Public Health (Social and Behavioral Sciences)

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Yale University
    ClinicalTrials.gov Identifier:
    NCT03721276
    Other Study ID Numbers:
    • 2000020997
    • R01MH109413
    First Posted:
    Oct 26, 2018
    Last Update Posted:
    Jan 26, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Therapy Waitlist
    Arm/Group Description Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. EQuIP (Empowering Queer Identities in Psychotherapy): Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. Individuals assigned to waitlist will be put on a waitlist for 3 months after baseline assessment, after which they will also receive the same treatment as the therapy group.
    Period Title: Overall Study
    STARTED 30 30
    Three-month Pre-intervention 0 30
    Immediate Pre-intervention 30 29
    Post-intervention 25 26
    Three-month Follow-up (Post Intervention) 25 0
    COMPLETED 25 26
    NOT COMPLETED 5 4

    Baseline Characteristics

    Arm/Group Title Therapy Waitlist Total
    Arm/Group Description Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. EQuIP (Empowering Queer Identities in Psychotherapy): Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. Individuals assigned to waitlist will be put on a waitlist for 3 months after baseline assessment, after which they will also receive the same treatment as the therapy group. Total of all reporting groups
    Overall Participants 30 30 60
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    25.27
    (3.35)
    25.90
    (3.20)
    25.58
    (3.26)
    Sex/Gender, Customized (Count of Participants)
    Cisgender women
    13
    43.3%
    21
    70%
    34
    56.7%
    Gender diverse (transgender, gender queer, nonbinary, gender fluid)
    17
    56.7%
    9
    30%
    26
    43.3%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    5
    16.7%
    5
    16.7%
    10
    16.7%
    Not Hispanic or Latino
    25
    83.3%
    25
    83.3%
    50
    83.3%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    2
    6.7%
    2
    6.7%
    4
    6.7%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    3
    10%
    3
    10%
    6
    10%
    White
    22
    73.3%
    19
    63.3%
    41
    68.3%
    More than one race
    2
    6.7%
    6
    20%
    8
    13.3%
    Unknown or Not Reported
    1
    3.3%
    0
    0%
    1
    1.7%
    Region of Enrollment (Count of Participants)
    United States
    30
    100%
    30
    100%
    60
    100%
    Sexual Orientation (Count of Participants)
    Lesbian
    6
    20%
    3
    10%
    9
    15%
    Queer
    15
    50%
    18
    60%
    33
    55%
    Other (asexual, bisexual, pansexual, uncertain)
    9
    30%
    9
    30%
    18
    30%
    Education level (Count of Participants)
    Some college/currently in college
    5
    16.7%
    8
    26.7%
    13
    21.7%
    4-year college degree
    17
    56.7%
    17
    56.7%
    34
    56.7%
    Some graduate school or higher
    5
    16.7%
    4
    13.3%
    9
    15%
    Not reported
    3
    10%
    1
    3.3%
    4
    6.7%
    Employment status (Count of Participants)
    Full-time (40+ hours per week)
    18
    60%
    15
    50%
    33
    55%
    Part-time employment (<40 hours per week)
    8
    26.7%
    8
    26.7%
    16
    26.7%
    Student
    3
    10%
    4
    13.3%
    7
    11.7%
    Unemployed
    1
    3.3%
    3
    10%
    4
    6.7%
    Personal Income, annually (Count of Participants)
    Less than $29,000
    15
    50%
    17
    56.7%
    32
    53.3%
    $30,000-49,999
    10
    33.3%
    2
    6.7%
    12
    20%
    More than $50,000
    5
    16.7%
    11
    36.7%
    16
    26.7%
    Relationship status (Count of Participants)
    Single or casually dating
    16
    53.3%
    13
    43.3%
    29
    48.3%
    Partnered
    13
    43.3%
    17
    56.7%
    30
    50%
    Not reported
    1
    3.3%
    0
    0%
    1
    1.7%

    Outcome Measures

    1. Primary Outcome
    Title Depression
    Description The measure depression in participants, the Center for Epidemiological Studies - Depression Scale (CES-D) will be used. An overall depression score is computed as the sum of the 20 items, with Items 3, 11, 14, and 16 reversed. In cases with internally missing data (items not answered), the sums were computed after imputation of the missing values: # items on scale / # actually answered, multiplied by the sum obtained from the answered items. A higher score indicates more depressive symptomatology during the past week. Range is 0 - 60.
    Time Frame Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)

    Outcome Measure Data

    Analysis Population Description
    Participants in the Therapy started therapy immediately after randomization, and therefore, have no data for the three-month waiting period prior to receiving the intervention. Participants in this arm started therapy three months after randomization (waitlist) and therefore, were not assessed at the three-month follow-up time point due to completion of the study.
    Arm/Group Title Therapy Waitlist
    Arm/Group Description Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. EQuIP (Empowering Queer Identities in Psychotherapy): Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. Individuals assigned to waitlist will be put on a waitlist for 3 months after baseline assessment, after which they will also receive the same treatment as the therapy group.
    Measure Participants 30 30
    Three-month pre-intervention
    27.57
    (1.80)
    Immediate Pre-intervention
    29.70
    (1.84)
    26.86
    (1.91)
    Post-intervention
    20.44
    (1.80)
    24.83
    (2.44)
    Three-month Follow-up (Post Intervention)
    19.00
    (2.18)
    2. Primary Outcome
    Title Brief Symptom Inventory
    Description The Global Severity Index of the 18-item BSI provides a mean score across depression, anxiety, and somatization subscales, and assesses psychological distress (e.g., "feeling nervousness or shakiness inside") on a 5-point scale from 0 (not at all) to 4 (extremely) for the past 7 days. Scores range from 0-72, with higher scores indicating worse outcomes (greater symptoms severity).
    Time Frame Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)

    Outcome Measure Data

    Analysis Population Description
    Participants in the Therapy started therapy immediately after randomization, and therefore, have no data for the three-month waiting period prior to receiving the intervention. Participants in this arm started therapy three months after randomization (waitlist) and therefore, were not assessed at the three-month follow-up time point due to completion of the study.
    Arm/Group Title Therapy Waitlist
    Arm/Group Description Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. EQuIP (Empowering Queer Identities in Psychotherapy): Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. Individuals assigned to waitlist will be put on a waitlist for 3 months after baseline assessment, after which they will also receive the same treatment as the therapy group.
    Measure Participants 30 30
    Three-month pre-intervention
    1.80
    (0.10)
    Immediate Pre-intervention
    1.74
    (0.14)
    1.85
    (0.09)
    Post-intervention
    1.38
    (0.11)
    1.64
    (0.11)
    Three-month Follow-up (Post Intervention)
    1.16
    (0.14)
    3. Primary Outcome
    Title Alcohol Use
    Description Alcohol use will be measured using the Short Index of Problems for Alcohol (SIP-A). The SIP-A is a 15-item, binary response (yes/no) measure that has a range of scores from 0-15. The highest score of 15 is an indicator of the greatest amount of alcohol use related problems.
    Time Frame Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)

    Outcome Measure Data

    Analysis Population Description
    Participants in the Therapy started therapy immediately after randomization, and therefore, have no data for the three-month waiting period prior to receiving the intervention. Participants in this arm started therapy three months after randomization (waitlist) and therefore, were not assessed at the three-month follow-up time point due to completion of the study.
    Arm/Group Title Therapy Waitlist
    Arm/Group Description Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. EQuIP (Empowering Queer Identities in Psychotherapy): Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. Individuals assigned to waitlist will be put on a waitlist for 3 months after baseline assessment, after which they will also receive the same treatment as the therapy group.
    Measure Participants 30 30
    Three-month pre-intervention
    3.93
    (0.54)
    Immediate Pre-intervention
    3.63
    (0.57)
    3.34
    (0.60)
    Post-intervention
    2.16
    (0.37)
    2.80
    (0.64)
    Three-month Follow-up (Post Intervention)
    1.92
    (0.44)
    4. Secondary Outcome
    Title Overall Depression Severity and Impairment Scale
    Description ODSIS is a 5-item scale that asks individuals to rate the severity and impairment associated with past-week symptoms of depression (e.g., "In the past week, when you have felt depressed, how intense or severe was your depression?) from 0 (little or none: Depression was absent or barely noticeable.) to 4 (extreme: Depression was overwhelming.). Scores range from 0-20, with higher scores indicating greater depression and associated impairment in the past week.
    Time Frame Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)

    Outcome Measure Data

    Analysis Population Description
    Participants in the Therapy started therapy immediately after randomization, and therefore, have no data for the three-month waiting period prior to receiving the intervention. Participants in this arm started therapy three months after randomization (waitlist) and therefore, were not assessed at the three-month follow-up time point due to completion of the study.
    Arm/Group Title Therapy Waitlist
    Arm/Group Description Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. EQuIP (Empowering Queer Identities in Psychotherapy): Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. Individuals assigned to waitlist will be put on a waitlist for 3 months after baseline assessment, after which they will also receive the same treatment as the therapy group.
    Measure Participants 30 30
    Three-month pre-intervention
    6.17
    (0.78)
    Immediate Pre-intervention
    6.30
    (0.83)
    7.69
    (0.73)
    Post-intervention
    4.09
    (0.71)
    5.85
    (0.82)
    Three-month Follow-up (Post Intervention)
    3.88
    (0.69)
    5. Secondary Outcome
    Title Overall Anxiety Severity and Impairment Scale
    Description OASIS is a 5-item scale that asks individuals to rate the severity and impairment associated with past-week anxiety symptoms (e.g., "In the past week, when you have felt anxious, how intense or severe was your anxiety?") from 0 (little or none: Anxiety was absent or barely noticeable.) to 4 (extreme: Anxiety was overwhelming. It was impossible to relax at all. Physical symptoms were unbearable). Scores range from 0-20, with higher scores indicating greater anxiety and associated impairment in the past week.
    Time Frame Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)

    Outcome Measure Data

    Analysis Population Description
    Participants in the Therapy started therapy immediately after randomization, and therefore, have no data for the three-month waiting period prior to receiving the intervention. Participants in this arm started therapy three months after randomization (waitlist) and therefore, were not assessed at the three-month follow-up time point due to completion of the study.
    Arm/Group Title Therapy Waitlist
    Arm/Group Description Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. EQuIP (Empowering Queer Identities in Psychotherapy): Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. Individuals assigned to waitlist will be put on a waitlist for 3 months after baseline assessment, after which they will also receive the same treatment as the therapy group.
    Measure Participants 30 30
    Three-month pre-intervention
    8.20
    (0.46)
    Immediate Pre-intervention
    8.80
    (0.64)
    8.03
    (0.46)
    Post-intervention
    6.00
    (0.70)
    6.08
    (0.60)
    Three-month Follow-up (Post Intervention)
    6.17
    (0.68)
    6. Secondary Outcome
    Title Suicidal Ideation Attributes Scale
    Description SIDAS is a 5-item scale that assesses past-month frequency and controllability of suicidal thoughts, how close one has come to making an attempt, and distress and impairment associated with thoughts of suicide (e.g., "In the past month, how often have you had thoughts about suicide?"). Responses range from 0 (never or not at all) to 10 (always or extremely) on each item, with item 2 reverse scored. Scale scores range from 0-50, with higher scores indicating more (worse) suicidal ideation.
    Time Frame Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)

    Outcome Measure Data

    Analysis Population Description
    Participants in the Therapy started therapy immediately after randomization, and therefore, have no data for the three-month waiting period prior to receiving the intervention. Participants in this arm started therapy three months after randomization (waitlist) and therefore, were not assessed at the three-month follow-up time point due to completion of the study.
    Arm/Group Title Therapy Waitlist
    Arm/Group Description Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. EQuIP (Empowering Queer Identities in Psychotherapy): Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. Individuals assigned to waitlist will be put on a waitlist for 3 months after baseline assessment, after which they will also receive the same treatment as the therapy group.
    Measure Participants 30 30
    Three-month pre-intervention
    5.03
    (1.42)
    Immediate Pre-intervention
    4.13
    (1.51)
    5.59
    (1.58)
    Post-intervention
    2.09
    (1.04)
    2.73
    (1.05)
    Three-month Follow-up (Post Intervention)
    1.46
    (0.75)
    7. Secondary Outcome
    Title Lesbian, Gay, and Bisexual Identity Scale-Internalized Homonegativity Subscale
    Description Internalized stigma was assessed us- ing the mean score on a three-item scale, the Lesbian, Gay, and Bisexual Identity Scale-Internalized Homonegativity Subscale, that asks individuals to rate thoughts and feelings related to their LGBTQ identity (e.g., "If it were possible, I would choose to be straight"). Responses range from 1 (disagree strongly) to 6 (agree strongly). Scores range from 3-18 with higher scores indicating higher internalized stigma.
    Time Frame Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)

    Outcome Measure Data

    Analysis Population Description
    Participants in the Therapy started therapy immediately after randomization, and therefore, have no data for the three-month waiting period prior to receiving the intervention. Participants in this arm started therapy three months after randomization (waitlist) and therefore, were not assessed at the three-month follow-up time point due to completion of the study.
    Arm/Group Title Therapy Waitlist
    Arm/Group Description Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. EQuIP (Empowering Queer Identities in Psychotherapy): Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. Individuals assigned to waitlist will be put on a waitlist for 3 months after baseline assessment, after which they will also receive the same treatment as the therapy group.
    Measure Participants 30 30
    Three-month pre-intervention
    1.49
    (0.13)
    Immediate Pre-intervention
    1.72
    (0.19)
    1.32
    (0.10)
    Post-intervention
    1.63
    (0.16)
    1.36
    (0.12)
    Three-month Follow-up (Post Intervention)
    1.49
    (0.13)
    8. Post-Hoc Outcome
    Title Sexual Minority Women's Rejection Sensitivity Scale
    Description The Sexual Minority Women Rejection Sensitivity Scale asks participants to rate 16 vignettes in terms of how concerned or anxious each would make them about being rejected because of their sexual orientation, and their likelihood of attributing the rejection to their sexual orientation. For example, one item states, "You are on a date with a woman at a restaurant. Your waiter provides you and your date with poor service." Responses to the anxiety and likelihood stems range from 1 (very unconcerned/very unlikely) to 7 (very concerned/very likely). Total score is the sum of the products of anxiety and likelihood scores for all items. We adapted the scale to indicate "woman, gender nonconforming, or non-binary partner" and "heterosexual, cisgender" as relevant. Scale scores range from 16-112, with higher scores indicating higher rejection sensitivity.
    Time Frame Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)

    Outcome Measure Data

    Analysis Population Description
    Participants in the Therapy started therapy immediately after randomization, and therefore, have no data for the three-month waiting period prior to receiving the intervention. Participants in this arm started therapy three months after randomization (waitlist) and therefore, were not assessed at the three-month follow-up time point due to completion of the study.
    Arm/Group Title Therapy Waitlist
    Arm/Group Description Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. EQuIP (Empowering Queer Identities in Psychotherapy): Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. Individuals assigned to waitlist will be put on a waitlist for 3 months after baseline assessment, after which they will also receive the same treatment as the therapy group.
    Measure Participants 30 30
    Three-month pre-intervention
    24.98
    (1.63)
    Immediate Pre-intervention
    25.19
    (1.38)
    23.03
    (1.58)
    Post-intervention
    22.10
    (1.51)
    22.12
    (1.76)
    Three-month Follow-up (Post Intervention)
    22.78
    (1.72)
    9. Post-Hoc Outcome
    Title Sexual Orientation Concealment
    Description In the Sexual Orientation Concealment Scale, participants rate the degree to which they have disclosed their sexual orientation on a scale from 1 (out to none) to 4 (out to all). The total score is the mean of responses in the following domains: "family," "LGBTQ friends," "straight, cisgender friends," "co- workers", and "health care providers." Scores range from 1-4 with higher scores indicating lower sexual orientation concealment.
    Time Frame Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)

    Outcome Measure Data

    Analysis Population Description
    Participants in the Therapy started therapy immediately after randomization, and therefore, have no data for the three-month waiting period prior to receiving the intervention. Participants in this arm started therapy three months after randomization (waitlist) and therefore, were not assessed at the three-month follow-up time point due to completion of the study.
    Arm/Group Title Therapy Waitlist
    Arm/Group Description Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. EQuIP (Empowering Queer Identities in Psychotherapy): Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. Individuals assigned to waitlist will be put on a waitlist for 3 months after baseline assessment, after which they will also receive the same treatment as the therapy group.
    Measure Participants 30 30
    Three-month pre-intervention
    1.89
    (0.12)
    Immediate Pre-intervention
    1.87
    (0.11)
    1.67
    (0.12)
    Post-intervention
    1.74
    (0.12)
    1.77
    (0.14)
    Three-month Follow-up (Post Intervention)
    1.75
    (0.13)
    10. Post-Hoc Outcome
    Title Difficulties in Emotion Regulation Scale-Short Form
    Description In the Difficulties in Emotion Regulation Scale-Short Form (DERS- SF), an 18-item scale, individuals are asked how much each statement regarding emotion regulation (e.g., "When I'm upset, I acknowledge my emotions") applies to them from 1 (almost never) to 5 (almost always). Scores range from 18-90 with higher scores indicating greater difficulties in emotion regulation.
    Time Frame Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)

    Outcome Measure Data

    Analysis Population Description
    Participants in the Therapy started therapy immediately after randomization, and therefore, have no data for the three-month waiting period prior to receiving the intervention. Participants in this arm started therapy three months after randomization (waitlist) and therefore, were not assessed at the three-month follow-up time point due to completion of the study.
    Arm/Group Title Therapy Waitlist
    Arm/Group Description Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. EQuIP (Empowering Queer Identities in Psychotherapy): Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. Individuals assigned to waitlist will be put on a waitlist for 3 months after baseline assessment, after which they will also receive the same treatment as the therapy group.
    Measure Participants 30 30
    Three-month pre-intervention
    49.37
    (1.92)
    Immediate Pre-intervention
    47.50
    (1.82)
    47.07
    (1.74)
    Post-intervention
    40.74
    (1.89)
    45.85
    (1.72)
    Three-month Follow-up (Post Intervention)
    40.58
    (1.64)
    11. Post-Hoc Outcome
    Title Multidimensional Scale of Perceived Social Support
    Description The mean score on the Multidimensional Scale of Perceived Social Support (MSPSS), a 12-item scale, indicates the perceived support that individuals report receiving from family (e.g., "My family really tries to help me"), friends (e.g., "I have friends with whom I can share my joys and sorrows"), and significant others (e.g., "I have a special person who is a real source of comfort to me") on a scale ranging from 0 (very strongly disagree) to 7 (very strongly agree). Scores range from 0-72 with higher scores indicating greater perceived social support.
    Time Frame Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)

    Outcome Measure Data

    Analysis Population Description
    Participants in the Therapy started therapy immediately after randomization, and therefore, have no data for the three-month waiting period prior to receiving the intervention. Participants in this arm started therapy three months after randomization (waitlist) and therefore, were not assessed at the three-month follow-up time point due to completion of the study.
    Arm/Group Title Therapy Waitlist
    Arm/Group Description Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. EQuIP (Empowering Queer Identities in Psychotherapy): Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. Individuals assigned to waitlist will be put on a waitlist for 3 months after baseline assessment, after which they will also receive the same treatment as the therapy group.
    Measure Participants 30 30
    Three-month pre-intervention
    3.39
    (0.25)
    Immediate Pre-intervention
    3.72
    (0.21)
    5.39
    (0.14)
    Post-intervention
    4.31
    (0.28)
    5.35
    (0.17)
    Three-month Follow-up (Post Intervention)
    5.12
    (0.24)
    12. Post-Hoc Outcome
    Title Ruminative Responses Scale-Brooding Subscale
    Description The sum of the five items on the Ruminative Responses Scale- Brooding Subscale (RRS) indicates the frequency with which participants experience brooding thoughts in response to depressed mood (e.g., "Think 'what am I doing to deserve this?'") along a scale ranging from 1 (almost never) to 4 (almost always). Scores range from 5-20 with higher scores indicating greater rumination.
    Time Frame Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)

    Outcome Measure Data

    Analysis Population Description
    Participants in the Therapy started therapy immediately after randomization, and therefore, have no data for the three-month waiting period prior to receiving the intervention. Participants in this arm started therapy three months after randomization (waitlist) and therefore, were not assessed at the three-month follow-up time point due to completion of the study.
    Arm/Group Title Therapy Waitlist
    Arm/Group Description Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. EQuIP (Empowering Queer Identities in Psychotherapy): Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. Individuals assigned to waitlist will be put on a waitlist for 3 months after baseline assessment, after which they will also receive the same treatment as the therapy group.
    Measure Participants 30 30
    Three-month pre-intervention
    13.57
    (0.55)
    Immediate Pre-intervention
    13.80
    (0.45)
    13.52
    (0.54)
    Post-intervention
    12.91
    (0.57)
    12.04
    (0.66)
    Three-month Follow-up (Post Intervention)
    11.25
    (0.48)
    13. Post-Hoc Outcome
    Title Simple Rathus Assertiveness Schedule-Short Form
    Description The Simple Rathus Assertiveness Schedule-Short Form (SRAS-SF), a 19-item scale, asks individuals to rate the personal typicality of assertive and unassertive behavior (e.g., "I find it embarrassing to return merchandise," "I have avoided asking questions for fear of sounding stupid") along a scale from 1 (very uncharacteristic of me) to 6 (very characteristic of me), for a summed total score. Scores range from 19-114 with higher scores indicating greater unassertiveness (scale was reverse-scored).
    Time Frame Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)

    Outcome Measure Data

    Analysis Population Description
    Participants in the Therapy started therapy immediately after randomization, and therefore, have no data for the three-month waiting period prior to receiving the intervention. Participants in this arm started therapy three months after randomization (waitlist) and therefore, were not assessed at the three-month follow-up time point due to completion of the study.
    Arm/Group Title Therapy Waitlist
    Arm/Group Description Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. EQuIP (Empowering Queer Identities in Psychotherapy): Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. Individuals assigned to waitlist will be put on a waitlist for 3 months after baseline assessment, after which they will also receive the same treatment as the therapy group.
    Measure Participants 30 30
    Three-month pre-intervention
    62.80
    (2.67)
    Immediate Pre-intervention
    66.87
    (3.10)
    57.86
    (2.11)
    Post-intervention
    62.43
    (3.05)
    59.42
    (2.29)
    Three-month Follow-up (Post Intervention)
    62.46
    (3.13)

    Adverse Events

    Time Frame From baseline through study completion (up to 6 months).
    Adverse Event Reporting Description Participants' risk for suicide was assessed at baseline, 3-month follow-up and 6-month follow-up assessments using the Brief Symptom Inventory and Suicidal Ideation Attributes Scale, and through participant self-disclosure (e.g., during therapy). Participants randomized to waitlist were assessed for the 3-month waiting period, and then assessed while in therapy for the 3-month period. Participants randomized to immediate therapy were assessed for adverse events for the full 6 months.
    Arm/Group Title Therapy Waitlist
    Arm/Group Description Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after randomization, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. EQuIP (Empowering Queer Identities in Psychotherapy): Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse. Individuals assigned to waitlist will be put on a waitlist for 3 months after randomization, after which they will also receive the same treatment as the therapy group.
    All Cause Mortality
    Therapy Waitlist
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/60 (0%) 0/30 (0%)
    Serious Adverse Events
    Therapy Waitlist
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/60 (1.7%) 0/30 (0%)
    Psychiatric disorders
    Active suicidality 1/60 (1.7%) 1 0/30 (0%) 0
    Other (Not Including Serious) Adverse Events
    Therapy Waitlist
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/60 (0%) 0/30 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. John Pachankis
    Organization Yale University
    Phone 6463444060
    Email john.pachankis@yale.edu
    Responsible Party:
    Yale University
    ClinicalTrials.gov Identifier:
    NCT03721276
    Other Study ID Numbers:
    • 2000020997
    • R01MH109413
    First Posted:
    Oct 26, 2018
    Last Update Posted:
    Jan 26, 2022
    Last Verified:
    Jan 1, 2022