Trial Outcomes & Findings for Project EQuIP: Empowering Queer Identities in Psychotherapy (NCT NCT03721276)

NCT ID: NCT03721276

Last Updated: 2022-01-26

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)
• Results posted on: 2022-01-26

Participant Flow

Participant milestones

Measure	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. 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.	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.
Overall Study STARTED	30	30
Overall Study Three-month Pre-intervention	0	30
Overall Study Immediate Pre-intervention	30	29
Overall Study Post-intervention	25	26
Overall Study Three-month Follow-up (Post Intervention)	25	0
Overall Study COMPLETED	25	26
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Measure	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. 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.	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.
Overall Study Lost to Follow-up	5	3
Overall Study Adverse Event	0	1

Baseline Characteristics

Project EQuIP: Empowering Queer Identities in Psychotherapy

Baseline characteristics by cohort

Measure	Therapy n=30 Participants 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.	Waitlist n=30 Participants 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 n=60 Participants Total of all reporting groups
Age, Continuous	25.27 years STANDARD_DEVIATION 3.35 • n=5 Participants	25.90 years STANDARD_DEVIATION 3.20 • n=7 Participants	25.58 years STANDARD_DEVIATION 3.26 • n=5 Participants
Sex/Gender, Customized Cisgender women	13 Participants n=5 Participants	21 Participants n=7 Participants	34 Participants n=5 Participants
Sex/Gender, Customized Gender diverse (transgender, gender queer, nonbinary, gender fluid)	17 Participants n=5 Participants	9 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	19 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Sexual Orientation Lesbian	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Sexual Orientation Queer	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Sexual Orientation Other (asexual, bisexual, pansexual, uncertain)	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Education level Some college/currently in college	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Education level 4-year college degree	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Education level Some graduate school or higher	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Education level Not reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Employment status Full-time (40+ hours per week)	18 Participants n=5 Participants	15 Participants n=7 Participants	33 Participants n=5 Participants
Employment status Part-time employment (<40 hours per week)	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Employment status Student	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Employment status Unemployed	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Personal Income, annually Less than $29,000	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Personal Income, annually $30,000-49,999	10 Participants n=5 Participants	2 Participants n=7 Participants	12 Participants n=5 Participants
Personal Income, annually More than $50,000	5 Participants n=5 Participants	11 Participants n=7 Participants	16 Participants n=5 Participants
Relationship status Single or casually dating	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Relationship status Partnered	13 Participants n=5 Participants	17 Participants n=7 Participants	30 Participants n=5 Participants
Relationship status Not reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)

Population: 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.

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.

Outcome measures

Measure	Therapy n=30 Participants 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.	Waitlist n=30 Participants 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.
Depression Three-month Follow-up (Post Intervention)	19.00 score on a scale Standard Error 2.18	—
Depression Three-month pre-intervention	—	27.57 score on a scale Standard Error 1.80
Depression Immediate Pre-intervention	29.70 score on a scale Standard Error 1.84	26.86 score on a scale Standard Error 1.91
Depression Post-intervention	20.44 score on a scale Standard Error 1.80	24.83 score on a scale Standard Error 2.44

PRIMARY outcome

Timeframe: Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)

Population: 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.

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).

Outcome measures

Measure	Therapy n=30 Participants 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.	Waitlist n=30 Participants 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.
Brief Symptom Inventory Three-month pre-intervention	—	1.80 units on a scale Standard Error 0.10
Brief Symptom Inventory Immediate Pre-intervention	1.74 units on a scale Standard Error 0.14	1.85 units on a scale Standard Error 0.09
Brief Symptom Inventory Post-intervention	1.38 units on a scale Standard Error 0.11	1.64 units on a scale Standard Error 0.11
Brief Symptom Inventory Three-month Follow-up (Post Intervention)	1.16 units on a scale Standard Error 0.14	—

PRIMARY outcome

Timeframe: Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)

Population: 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.

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.

Outcome measures

Measure	Therapy n=30 Participants 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.	Waitlist n=30 Participants 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.
Alcohol Use Three-month pre-intervention	—	3.93 score on a scale Standard Error 0.54
Alcohol Use Immediate Pre-intervention	3.63 score on a scale Standard Error 0.57	3.34 score on a scale Standard Error 0.60
Alcohol Use Post-intervention	2.16 score on a scale Standard Error 0.37	2.80 score on a scale Standard Error 0.64
Alcohol Use Three-month Follow-up (Post Intervention)	1.92 score on a scale Standard Error 0.44	—

SECONDARY outcome

Timeframe: Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)

Population: 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.

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.

Outcome measures

Measure	Therapy n=30 Participants 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.	Waitlist n=30 Participants 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.
Overall Depression Severity and Impairment Scale Immediate Pre-intervention	6.30 score on a scale Standard Error 0.83	7.69 score on a scale Standard Error 0.73
Overall Depression Severity and Impairment Scale Three-month Follow-up (Post Intervention)	3.88 score on a scale Standard Error 0.69	—
Overall Depression Severity and Impairment Scale Three-month pre-intervention	—	6.17 score on a scale Standard Error 0.78
Overall Depression Severity and Impairment Scale Post-intervention	4.09 score on a scale Standard Error 0.71	5.85 score on a scale Standard Error 0.82

SECONDARY outcome

Timeframe: Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)

Population: 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.

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.

Outcome measures

Measure	Therapy n=30 Participants 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.	Waitlist n=30 Participants 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.
Overall Anxiety Severity and Impairment Scale Three-month pre-intervention	—	8.20 score on a scale Standard Error 0.46
Overall Anxiety Severity and Impairment Scale Post-intervention	6.00 score on a scale Standard Error 0.70	6.08 score on a scale Standard Error 0.60
Overall Anxiety Severity and Impairment Scale Immediate Pre-intervention	8.80 score on a scale Standard Error 0.64	8.03 score on a scale Standard Error 0.46
Overall Anxiety Severity and Impairment Scale Three-month Follow-up (Post Intervention)	6.17 score on a scale Standard Error 0.68	—

SECONDARY outcome

Timeframe: Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)

Population: 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.

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.

Outcome measures

Measure	Therapy n=30 Participants 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.	Waitlist n=30 Participants 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.
Suicidal Ideation Attributes Scale Post-intervention	2.09 score on a scale Standard Error 1.04	2.73 score on a scale Standard Error 1.05
Suicidal Ideation Attributes Scale Three-month pre-intervention	—	5.03 score on a scale Standard Error 1.42
Suicidal Ideation Attributes Scale Immediate Pre-intervention	4.13 score on a scale Standard Error 1.51	5.59 score on a scale Standard Error 1.58
Suicidal Ideation Attributes Scale Three-month Follow-up (Post Intervention)	1.46 score on a scale Standard Error 0.75	—

SECONDARY outcome

Timeframe: Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)

Population: 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.

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.

Outcome measures

Measure	Therapy n=30 Participants 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.	Waitlist n=30 Participants 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.
Lesbian, Gay, and Bisexual Identity Scale-Internalized Homonegativity Subscale Three-month pre-intervention	—	1.49 score on a scale Standard Error 0.13
Lesbian, Gay, and Bisexual Identity Scale-Internalized Homonegativity Subscale Immediate Pre-intervention	1.72 score on a scale Standard Error 0.19	1.32 score on a scale Standard Error 0.10
Lesbian, Gay, and Bisexual Identity Scale-Internalized Homonegativity Subscale Post-intervention	1.63 score on a scale Standard Error 0.16	1.36 score on a scale Standard Error 0.12
Lesbian, Gay, and Bisexual Identity Scale-Internalized Homonegativity Subscale Three-month Follow-up (Post Intervention)	1.49 score on a scale Standard Error 0.13	—

POST_HOC outcome

Timeframe: Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)

Population: 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.

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.

Outcome measures

Measure	Therapy n=30 Participants 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.	Waitlist n=30 Participants 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.
Sexual Minority Women's Rejection Sensitivity Scale Three-month pre-intervention	—	24.98 score on a scale Standard Error 1.63
Sexual Minority Women's Rejection Sensitivity Scale Immediate Pre-intervention	25.19 score on a scale Standard Error 1.38	23.03 score on a scale Standard Error 1.58
Sexual Minority Women's Rejection Sensitivity Scale Post-intervention	22.10 score on a scale Standard Error 1.51	22.12 score on a scale Standard Error 1.76
Sexual Minority Women's Rejection Sensitivity Scale Three-month Follow-up (Post Intervention)	22.78 score on a scale Standard Error 1.72	—

POST_HOC outcome

Timeframe: Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)

Population: 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.

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.

Outcome measures

Measure	Therapy n=30 Participants 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.	Waitlist n=30 Participants 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.
Sexual Orientation Concealment Three-month pre-intervention	—	1.89 score on a scale Standard Error 0.12
Sexual Orientation Concealment Immediate Pre-intervention	1.87 score on a scale Standard Error 0.11	1.67 score on a scale Standard Error 0.12
Sexual Orientation Concealment Post-intervention	1.74 score on a scale Standard Error 0.12	1.77 score on a scale Standard Error 0.14
Sexual Orientation Concealment Three-month Follow-up (Post Intervention)	1.75 score on a scale Standard Error 0.13	—

POST_HOC outcome

Timeframe: Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)

Population: 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.

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.

Outcome measures

Measure	Therapy n=30 Participants 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.	Waitlist n=30 Participants 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.
Difficulties in Emotion Regulation Scale-Short Form Three-month pre-intervention	—	49.37 score on a scale Standard Error 1.92
Difficulties in Emotion Regulation Scale-Short Form Immediate Pre-intervention	47.50 score on a scale Standard Error 1.82	47.07 score on a scale Standard Error 1.74
Difficulties in Emotion Regulation Scale-Short Form Post-intervention	40.74 score on a scale Standard Error 1.89	45.85 score on a scale Standard Error 1.72
Difficulties in Emotion Regulation Scale-Short Form Three-month Follow-up (Post Intervention)	40.58 score on a scale Standard Error 1.64	—

POST_HOC outcome

Timeframe: Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)

Population: 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.

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.

Outcome measures

Measure	Therapy n=30 Participants 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.	Waitlist n=30 Participants 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.
Multidimensional Scale of Perceived Social Support Three-month pre-intervention	—	3.39 score on a scale Standard Error 0.25
Multidimensional Scale of Perceived Social Support Immediate Pre-intervention	3.72 score on a scale Standard Error 0.21	5.39 score on a scale Standard Error 0.14
Multidimensional Scale of Perceived Social Support Post-intervention	4.31 score on a scale Standard Error 0.28	5.35 score on a scale Standard Error 0.17
Multidimensional Scale of Perceived Social Support Three-month Follow-up (Post Intervention)	5.12 score on a scale Standard Error 0.24	—

POST_HOC outcome

Timeframe: Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)

Population: 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.

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.

Outcome measures

Measure	Therapy n=30 Participants 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.	Waitlist n=30 Participants 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.
Ruminative Responses Scale-Brooding Subscale Three-month pre-intervention	—	13.57 score on a scale Standard Error 0.55
Ruminative Responses Scale-Brooding Subscale Immediate Pre-intervention	13.80 score on a scale Standard Error 0.45	13.52 score on a scale Standard Error 0.54
Ruminative Responses Scale-Brooding Subscale Post-intervention	12.91 score on a scale Standard Error 0.57	12.04 score on a scale Standard Error 0.66
Ruminative Responses Scale-Brooding Subscale Three-month Follow-up (Post Intervention)	11.25 score on a scale Standard Error 0.48	—

POST_HOC outcome

Timeframe: Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)

Population: 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.

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).

Outcome measures

Measure	Therapy n=30 Participants 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.	Waitlist n=30 Participants 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.
Simple Rathus Assertiveness Schedule-Short Form Post-intervention	62.43 score on a scale Standard Error 3.05	59.42 score on a scale Standard Error 2.29
Simple Rathus Assertiveness Schedule-Short Form Three-month pre-intervention	—	62.80 score on a scale Standard Error 2.67
Simple Rathus Assertiveness Schedule-Short Form Immediate Pre-intervention	66.87 score on a scale Standard Error 3.10	57.86 score on a scale Standard Error 2.11
Simple Rathus Assertiveness Schedule-Short Form Three-month Follow-up (Post Intervention)	62.46 score on a scale Standard Error 3.13	—

Adverse Events

Therapy

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Waitlist

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Therapy n=60 participants at risk 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.	Waitlist n=30 participants at risk 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.
Psychiatric disorders Active suicidality	1.7% 1/60 • Number of events 1 • From baseline through study completion (up to 6 months). 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.	0.00% 0/30 • From baseline through study completion (up to 6 months). 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.

Other adverse events

Adverse event data not reported

Additional Information

Dr. John Pachankis

Yale University

Phone: 6463444060

Email: john.pachankis@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place