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Project EQuIP: Empowering Queer Identities in Psychotherapy

Project EQuIP: Empowering Queer Identities in Psychotherapy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03721276
Acronym
EQuIP
Enrollment
60
Registered
2018-10-26
Start date
2018-07-18
Completion date
2019-07-18
Last updated
2022-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sexual Minority Stress

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).

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.

Interventions

BEHAVIORALEQuIP (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.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

Patients will either be immediately enrolled or wait listed for the intervention.

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
DepressionThree-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.
Brief Symptom InventoryThree-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).
Alcohol UseThree-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

MeasureTime frameDescription
Overall Depression Severity and Impairment ScaleThree-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.
Lesbian, Gay, and Bisexual Identity Scale-Internalized Homonegativity SubscaleThree-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.
Overall Anxiety Severity and Impairment ScaleThree-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.
Suicidal Ideation Attributes ScaleThree-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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
30
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.
30
Total60

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event01
Overall StudyLost to Follow-up53

Baseline characteristics

CharacteristicTherapyWaitlistTotal
Age, Continuous25.27 years
STANDARD_DEVIATION 3.35
25.90 years
STANDARD_DEVIATION 3.2
25.58 years
STANDARD_DEVIATION 3.26
Education level
4-year college degree
17 Participants17 Participants34 Participants
Education level
Not reported
3 Participants1 Participants4 Participants
Education level
Some college/currently in college
5 Participants8 Participants13 Participants
Education level
Some graduate school or higher
5 Participants4 Participants9 Participants
Employment status
Full-time (40+ hours per week)
18 Participants15 Participants33 Participants
Employment status
Part-time employment (<40 hours per week)
8 Participants8 Participants16 Participants
Employment status
Student
3 Participants4 Participants7 Participants
Employment status
Unemployed
1 Participants3 Participants4 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants5 Participants10 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
25 Participants25 Participants50 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Personal Income, annually
$30,000-49,999
10 Participants2 Participants12 Participants
Personal Income, annually
Less than $29,000
15 Participants17 Participants32 Participants
Personal Income, annually
More than $50,000
5 Participants11 Participants16 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
2 Participants2 Participants4 Participants
Race (NIH/OMB)
Black or African American
3 Participants3 Participants6 Participants
Race (NIH/OMB)
More than one race
2 Participants6 Participants8 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
22 Participants19 Participants41 Participants
Region of Enrollment
United States
30 Participants30 Participants60 Participants
Relationship status
Not reported
1 Participants0 Participants1 Participants
Relationship status
Partnered
13 Participants17 Participants30 Participants
Relationship status
Single or casually dating
16 Participants13 Participants29 Participants
Sex/Gender, Customized
Cisgender women
13 Participants21 Participants34 Participants
Sex/Gender, Customized
Gender diverse (transgender, gender queer, nonbinary, gender fluid)
17 Participants9 Participants26 Participants
Sexual Orientation
Lesbian
6 Participants3 Participants9 Participants
Sexual Orientation
Other (asexual, bisexual, pansexual, uncertain)
9 Participants9 Participants18 Participants
Sexual Orientation
Queer
15 Participants18 Participants33 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 600 / 30
other
Total, other adverse events
0 / 600 / 30
serious
Total, serious adverse events
1 / 600 / 30

Outcome results

Primary

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)

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.

ArmMeasureGroupValue (MEAN)Dispersion
TherapyAlcohol UseImmediate Pre-intervention3.63 score on a scaleStandard Error 0.57
TherapyAlcohol UsePost-intervention2.16 score on a scaleStandard Error 0.37
TherapyAlcohol UseThree-month Follow-up (Post Intervention)1.92 score on a scaleStandard Error 0.44
WaitlistAlcohol UseThree-month pre-intervention3.93 score on a scaleStandard Error 0.54
WaitlistAlcohol UseImmediate Pre-intervention3.34 score on a scaleStandard Error 0.6
WaitlistAlcohol UsePost-intervention2.80 score on a scaleStandard Error 0.64
Primary

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)

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.

ArmMeasureGroupValue (MEAN)Dispersion
TherapyBrief Symptom InventoryImmediate Pre-intervention1.74 units on a scaleStandard Error 0.14
TherapyBrief Symptom InventoryPost-intervention1.38 units on a scaleStandard Error 0.11
TherapyBrief Symptom InventoryThree-month Follow-up (Post Intervention)1.16 units on a scaleStandard Error 0.14
WaitlistBrief Symptom InventoryThree-month pre-intervention1.80 units on a scaleStandard Error 0.1
WaitlistBrief Symptom InventoryImmediate Pre-intervention1.85 units on a scaleStandard Error 0.09
WaitlistBrief Symptom InventoryPost-intervention1.64 units on a scaleStandard Error 0.11
Primary

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)

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.

ArmMeasureGroupValue (MEAN)Dispersion
TherapyDepressionImmediate Pre-intervention29.70 score on a scaleStandard Error 1.84
TherapyDepressionPost-intervention20.44 score on a scaleStandard Error 1.8
TherapyDepressionThree-month Follow-up (Post Intervention)19.00 score on a scaleStandard Error 2.18
WaitlistDepressionThree-month pre-intervention27.57 score on a scaleStandard Error 1.8
WaitlistDepressionImmediate Pre-intervention26.86 score on a scaleStandard Error 1.91
WaitlistDepressionPost-intervention24.83 score on a scaleStandard Error 2.44
Secondary

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)

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.

ArmMeasureGroupValue (MEAN)Dispersion
TherapyLesbian, Gay, and Bisexual Identity Scale-Internalized Homonegativity SubscaleImmediate Pre-intervention1.72 score on a scaleStandard Error 0.19
TherapyLesbian, Gay, and Bisexual Identity Scale-Internalized Homonegativity SubscalePost-intervention1.63 score on a scaleStandard Error 0.16
TherapyLesbian, Gay, and Bisexual Identity Scale-Internalized Homonegativity SubscaleThree-month Follow-up (Post Intervention)1.49 score on a scaleStandard Error 0.13
WaitlistLesbian, Gay, and Bisexual Identity Scale-Internalized Homonegativity SubscaleThree-month pre-intervention1.49 score on a scaleStandard Error 0.13
WaitlistLesbian, Gay, and Bisexual Identity Scale-Internalized Homonegativity SubscaleImmediate Pre-intervention1.32 score on a scaleStandard Error 0.1
WaitlistLesbian, Gay, and Bisexual Identity Scale-Internalized Homonegativity SubscalePost-intervention1.36 score on a scaleStandard Error 0.12
Secondary

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)

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.

ArmMeasureGroupValue (MEAN)Dispersion
TherapyOverall Anxiety Severity and Impairment ScaleImmediate Pre-intervention8.80 score on a scaleStandard Error 0.64
TherapyOverall Anxiety Severity and Impairment ScalePost-intervention6.00 score on a scaleStandard Error 0.7
TherapyOverall Anxiety Severity and Impairment ScaleThree-month Follow-up (Post Intervention)6.17 score on a scaleStandard Error 0.68
WaitlistOverall Anxiety Severity and Impairment ScaleThree-month pre-intervention8.20 score on a scaleStandard Error 0.46
WaitlistOverall Anxiety Severity and Impairment ScaleImmediate Pre-intervention8.03 score on a scaleStandard Error 0.46
WaitlistOverall Anxiety Severity and Impairment ScalePost-intervention6.08 score on a scaleStandard Error 0.6
Secondary

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)

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.

ArmMeasureGroupValue (MEAN)Dispersion
TherapyOverall Depression Severity and Impairment ScaleImmediate Pre-intervention6.30 score on a scaleStandard Error 0.83
TherapyOverall Depression Severity and Impairment ScalePost-intervention4.09 score on a scaleStandard Error 0.71
TherapyOverall Depression Severity and Impairment ScaleThree-month Follow-up (Post Intervention)3.88 score on a scaleStandard Error 0.69
WaitlistOverall Depression Severity and Impairment ScaleThree-month pre-intervention6.17 score on a scaleStandard Error 0.78
WaitlistOverall Depression Severity and Impairment ScaleImmediate Pre-intervention7.69 score on a scaleStandard Error 0.73
WaitlistOverall Depression Severity and Impairment ScalePost-intervention5.85 score on a scaleStandard Error 0.82
Secondary

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)

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.

ArmMeasureGroupValue (MEAN)Dispersion
TherapySuicidal Ideation Attributes ScaleImmediate Pre-intervention4.13 score on a scaleStandard Error 1.51
TherapySuicidal Ideation Attributes ScalePost-intervention2.09 score on a scaleStandard Error 1.04
TherapySuicidal Ideation Attributes ScaleThree-month Follow-up (Post Intervention)1.46 score on a scaleStandard Error 0.75
WaitlistSuicidal Ideation Attributes ScaleThree-month pre-intervention5.03 score on a scaleStandard Error 1.42
WaitlistSuicidal Ideation Attributes ScaleImmediate Pre-intervention5.59 score on a scaleStandard Error 1.58
WaitlistSuicidal Ideation Attributes ScalePost-intervention2.73 score on a scaleStandard Error 1.05
Post Hoc

Difficulties in Emotion Regulation Scale-Short Form

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)

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.

ArmMeasureGroupValue (MEAN)Dispersion
TherapyDifficulties in Emotion Regulation Scale-Short FormImmediate Pre-intervention47.50 score on a scaleStandard Error 1.82
TherapyDifficulties in Emotion Regulation Scale-Short FormPost-intervention40.74 score on a scaleStandard Error 1.89
TherapyDifficulties in Emotion Regulation Scale-Short FormThree-month Follow-up (Post Intervention)40.58 score on a scaleStandard Error 1.64
WaitlistDifficulties in Emotion Regulation Scale-Short FormThree-month pre-intervention49.37 score on a scaleStandard Error 1.92
WaitlistDifficulties in Emotion Regulation Scale-Short FormImmediate Pre-intervention47.07 score on a scaleStandard Error 1.74
WaitlistDifficulties in Emotion Regulation Scale-Short FormPost-intervention45.85 score on a scaleStandard Error 1.72
Post Hoc

Multidimensional Scale of Perceived Social Support

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)

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.

ArmMeasureGroupValue (MEAN)Dispersion
TherapyMultidimensional Scale of Perceived Social SupportImmediate Pre-intervention3.72 score on a scaleStandard Error 0.21
TherapyMultidimensional Scale of Perceived Social SupportPost-intervention4.31 score on a scaleStandard Error 0.28
TherapyMultidimensional Scale of Perceived Social SupportThree-month Follow-up (Post Intervention)5.12 score on a scaleStandard Error 0.24
WaitlistMultidimensional Scale of Perceived Social SupportThree-month pre-intervention3.39 score on a scaleStandard Error 0.25
WaitlistMultidimensional Scale of Perceived Social SupportImmediate Pre-intervention5.39 score on a scaleStandard Error 0.14
WaitlistMultidimensional Scale of Perceived Social SupportPost-intervention5.35 score on a scaleStandard Error 0.17
Post Hoc

Ruminative Responses Scale-Brooding Subscale

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)

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.

ArmMeasureGroupValue (MEAN)Dispersion
TherapyRuminative Responses Scale-Brooding SubscaleImmediate Pre-intervention13.80 score on a scaleStandard Error 0.45
TherapyRuminative Responses Scale-Brooding SubscalePost-intervention12.91 score on a scaleStandard Error 0.57
TherapyRuminative Responses Scale-Brooding SubscaleThree-month Follow-up (Post Intervention)11.25 score on a scaleStandard Error 0.48
WaitlistRuminative Responses Scale-Brooding SubscaleThree-month pre-intervention13.57 score on a scaleStandard Error 0.55
WaitlistRuminative Responses Scale-Brooding SubscaleImmediate Pre-intervention13.52 score on a scaleStandard Error 0.54
WaitlistRuminative Responses Scale-Brooding SubscalePost-intervention12.04 score on a scaleStandard Error 0.66
Post Hoc

Sexual Minority Women's Rejection Sensitivity Scale

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)

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.

ArmMeasureGroupValue (MEAN)Dispersion
TherapySexual Minority Women's Rejection Sensitivity ScaleImmediate Pre-intervention25.19 score on a scaleStandard Error 1.38
TherapySexual Minority Women's Rejection Sensitivity ScalePost-intervention22.10 score on a scaleStandard Error 1.51
TherapySexual Minority Women's Rejection Sensitivity ScaleThree-month Follow-up (Post Intervention)22.78 score on a scaleStandard Error 1.72
WaitlistSexual Minority Women's Rejection Sensitivity ScaleThree-month pre-intervention24.98 score on a scaleStandard Error 1.63
WaitlistSexual Minority Women's Rejection Sensitivity ScaleImmediate Pre-intervention23.03 score on a scaleStandard Error 1.58
WaitlistSexual Minority Women's Rejection Sensitivity ScalePost-intervention22.12 score on a scaleStandard Error 1.76
Post Hoc

Sexual Orientation Concealment

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)

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.

ArmMeasureGroupValue (MEAN)Dispersion
TherapySexual Orientation ConcealmentImmediate Pre-intervention1.87 score on a scaleStandard Error 0.11
TherapySexual Orientation ConcealmentPost-intervention1.74 score on a scaleStandard Error 0.12
TherapySexual Orientation ConcealmentThree-month Follow-up (Post Intervention)1.75 score on a scaleStandard Error 0.13
WaitlistSexual Orientation ConcealmentThree-month pre-intervention1.89 score on a scaleStandard Error 0.12
WaitlistSexual Orientation ConcealmentImmediate Pre-intervention1.67 score on a scaleStandard Error 0.12
WaitlistSexual Orientation ConcealmentPost-intervention1.77 score on a scaleStandard Error 0.14
Post Hoc

Simple Rathus Assertiveness Schedule-Short Form

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)

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.

ArmMeasureGroupValue (MEAN)Dispersion
TherapySimple Rathus Assertiveness Schedule-Short FormImmediate Pre-intervention66.87 score on a scaleStandard Error 3.1
TherapySimple Rathus Assertiveness Schedule-Short FormPost-intervention62.43 score on a scaleStandard Error 3.05
TherapySimple Rathus Assertiveness Schedule-Short FormThree-month Follow-up (Post Intervention)62.46 score on a scaleStandard Error 3.13
WaitlistSimple Rathus Assertiveness Schedule-Short FormThree-month pre-intervention62.80 score on a scaleStandard Error 2.67
WaitlistSimple Rathus Assertiveness Schedule-Short FormImmediate Pre-intervention57.86 score on a scaleStandard Error 2.11
WaitlistSimple Rathus Assertiveness Schedule-Short FormPost-intervention59.42 score on a scaleStandard Error 2.29

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026