An interventional study of EQuIP (Empowering Queer Identities in Psychotherapy) in Sexual Minority Stress, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2022-01-26.
Sponsored by Yale University · Not applicable, Interventional, and Treatment
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).
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.
Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
For Phase 3
Inclusion Criteria:
Exclusion Criteria:
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 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.
Also known as: ESTEEM (Effective Skills to Empower Effective Men) for Women
Depression
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)
Brief Symptom Inventory
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)
Alcohol Use
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)
Overall Depression Severity and Impairment Scale
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)
Overall Anxiety Severity and Impairment Scale
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)
Suicidal Ideation Attributes Scale
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)
Lesbian, Gay, and Bisexual Identity Scale-Internalized Homonegativity Subscale
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)
| Milestone | Therapy | Waitlist |
|---|---|---|
| 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 |
| Withdrew: Lost to follow-up | 5 | 3 |
| Withdrew: Adverse event | 0 | 1 |
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.
| score on a scale | Therapy | Waitlist |
|---|---|---|
| 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 | — |
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).
| units on a scale | Therapy | Waitlist |
|---|---|---|
| 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 | — |
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.
| score on a scale | Therapy | Waitlist |
|---|---|---|
| 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 | — |
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.
| score on a scale | Therapy | Waitlist |
|---|---|---|
| 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 | — |
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.
| score on a scale | Therapy | Waitlist |
|---|---|---|
| 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 | — |
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.
| score on a scale | Therapy | Waitlist |
|---|---|---|
| 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 | — |
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.
| score on a scale | Therapy | Waitlist |
|---|---|---|
| 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 | — |
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.
| score on a scale | Therapy | Waitlist |
|---|---|---|
| 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 | — |
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.
| score on a scale | Therapy | Waitlist |
|---|---|---|
| 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 | — |
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.
| score on a scale | Therapy | Waitlist |
|---|---|---|
| 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 | — |
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.
| score on a scale | Therapy | Waitlist |
|---|---|---|
| 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 | — |
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.
| score on a scale | Therapy | Waitlist |
|---|---|---|
| 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 | — |
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).
| score on a scale | Therapy | Waitlist |
|---|---|---|
| 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 | — |
Collected over From baseline through study completion (up to 6 months).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Therapy | 0/60 (0%) | 1/60 (1.7%) | 0/60 (0%) |
| Waitlist | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Event | Therapy | Waitlist |
|---|---|---|
| Active suicidalityPsychiatric disorders | 1/60 | 0/30 |
| Age, Continuous(years) | Therapy | Waitlist | Total |
|---|---|---|---|
| Mean | 25.27 ± 3.35 | 25.90 ± 3.20 | 25.58 ± 3.26 |
| Sex/Gender, Customized(Participants) | Therapy | Waitlist | Total |
|---|---|---|---|
| Cisgender women | 13 | 21 | 34 |
| Gender diverse (transgender, gender queer, nonbinary, gender fluid) | 17 | 9 | 26 |
| Ethnicity (NIH/OMB)(Participants) | Therapy | Waitlist | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 5 | 10 |
| Not Hispanic or Latino | 25 | 25 | 50 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Therapy | Waitlist | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 2 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 3 | 6 |
| White | 22 | 19 | 41 |
| More than one race | 2 | 6 | 8 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(Participants) | Therapy | Waitlist | Total |
|---|---|---|---|
| United States | 30 | 30 | 60 |
| Sexual Orientation(Participants) | Therapy | Waitlist | Total |
|---|---|---|---|
| Lesbian | 6 | 3 | 9 |
| Queer | 15 | 18 | 33 |
| Other (asexual, bisexual, pansexual, uncertain) | 9 | 9 | 18 |
| Education level(Participants) | Therapy | Waitlist | Total |
|---|---|---|---|
| Some college/currently in college | 5 | 8 | 13 |
| 4-year college degree | 17 | 17 | 34 |
| Some graduate school or higher | 5 | 4 | 9 |
| Not reported | 3 | 1 | 4 |
| Employment status(Participants) | Therapy | Waitlist | Total |
|---|---|---|---|
| Full-time (40+ hours per week) | 18 | 15 | 33 |
| Part-time employment (<40 hours per week) | 8 | 8 | 16 |
| Student | 3 | 4 | 7 |
| Unemployed | 1 | 3 | 4 |
2 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Yale University