Project EQuIP: Empowering Queer Identities in Psychotherapy

NCT03721276 | Completed Results

• 2 other identifiers: 2000020997R01MH109413
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Sexual Minority Stress

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  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.

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

Secondary Outcomes (4)

• Overall Depression Severity and Impairment Scale

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

• Overall Anxiety Severity and Impairment Scale

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

• Suicidal Ideation Attributes Scale

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

• Lesbian, Gay, and Bisexual Identity Scale-Internalized Homonegativity Subscale

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

Study Arms (2)

Therapy

EXPERIMENTAL

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)

Waitlist

OTHER

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)

Interventions

EQuIP (Empowering Queer Identities in Psychotherapy) BEHAVIORAL

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

Therapy; Waitlist

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Self- identification as a woman with the option of selecting multiple gender identities
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• month NYC residential stability and availability
• English fluency

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Yale LGBTQ+ Mental Health Initiative - Research Lab

New York, New York, 10010, United States

Location

Related Publications (14)

• Radloff, L. S. (1977). The CES-D Scale: A self-report depression scale for research in the general population. Applied Psychological Measurement, 1, 385-401. http://dx.doi.org/10.1177/014662167700100306

  BACKGROUND

• Derogatis LR, Melisaratos N. The Brief Symptom Inventory: an introductory report. Psychol Med. 1983 Aug;13(3):595-605.

  PMID: 6622612 BACKGROUND

• Alterman AI, Cacciola JS, Ivey MA, Habing B, Lynch KG. Reliability and validity of the alcohol short index of problems and a newly constructed drug short index of problems. J Stud Alcohol Drugs. 2009 Mar;70(2):304-7. doi: 10.15288/jsad.2009.70.304.

  PMID: 19261243 BACKGROUND

• Bentley KH, Gallagher MW, Carl JR, Barlow DH. Development and validation of the Overall Depression Severity and Impairment Scale. Psychol Assess. 2014 Sep;26(3):815-830. doi: 10.1037/a0036216. Epub 2014 Apr 7.

  PMID: 24708078 BACKGROUND

• Norman SB, Cissell SH, Means-Christensen AJ, Stein MB. Development and validation of an Overall Anxiety Severity And Impairment Scale (OASIS). Depress Anxiety. 2006;23(4):245-9. doi: 10.1002/da.20182.

  PMID: 16688739 BACKGROUND

• van Spijker BA, Batterham PJ, Calear AL, Farrer L, Christensen H, Reynolds J, Kerkhof AJ. The suicidal ideation attributes scale (SIDAS): Community-based validation study of a new scale for the measurement of suicidal ideation. Suicide Life Threat Behav. 2014 Aug;44(4):408-19. doi: 10.1111/sltb.12084. Epub 2014 Feb 24.

  PMID: 24612048 BACKGROUND

• Dyar C, Feinstein BA, Eaton NR, London B. The Mediating Roles of Rejection Sensitivity and Proximal Stress in the Association Between Discrimination and Internalizing Symptoms Among Sexual Minority Women. Arch Sex Behav. 2018 Jan;47(1):205-218. doi: 10.1007/s10508-016-0869-1. Epub 2016 Oct 17.

  PMID: 27752853 BACKGROUND

• Meyer IH, Rossano L, Ellis JM, Bradford J. A brief telephone interview to identify lesbian and bisexual women in random digit dialing sampling. J Sex Res. 2002 May;39(2):139-44. doi: 10.1080/00224490209552133.

  PMID: 12476246 BACKGROUND

• Mohr JJ, Kendra MS. Revision and extension of a multidimensional measure of sexual minority identity: the Lesbian, Gay, and Bisexual Identity Scale. J Couns Psychol. 2011 Apr;58(2):234-245. doi: 10.1037/a0022858.

  PMID: 21319899 BACKGROUND

• Gratz, K. L., & Roemer, L. (2004). Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the Difficulties in Emotion Regulation Scale. Journal of Psychopathology and Behavioral Assessment, 26, 41-54. http:// dx.doi.org/10.1023/B:JOBA.0000007455.08539.94

  BACKGROUND

• Zimet GD, Powell SS, Farley GK, Werkman S, Berkoff KA. Psychometric characteristics of the Multidimensional Scale of Perceived Social Support. J Pers Assess. 1990 Winter;55(3-4):610-7. doi: 10.1080/00223891.1990.9674095.

  PMID: 2280326 BACKGROUND

• Treynor, W., Gonzalez, R., & Nolen-Hoeksema, S. (2003). Rumination reconsidered: A psychometric analysis. Cognitive Therapy and Re- search, 27, 247-259. http://dx.doi.org/10.1023/A:1023910315561

  BACKGROUND

• Rathus, S. A. (1973). A 30-item schedule for assessing assertive behavior. Behavior Therapy, 4, 398-406. http://dx.doi.org/10.1016/S0005- 7894(73)80120-0

  BACKGROUND

• Pachankis JE, McConocha EM, Clark KA, Wang K, Behari K, Fetzner BK, Brisbin CD, Scheer JR, Lehavot K. A transdiagnostic minority stress intervention for gender diverse sexual minority women's depression, anxiety, and unhealthy alcohol use: A randomized controlled trial. J Consult Clin Psychol. 2020 Jul;88(7):613-630. doi: 10.1037/ccp0000508. Epub 2020 May 21.

  PMID: 32437174 RESULT

MeSH Terms

Interventions

Psychotherapy

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. John Pachankis
• Organization: Yale University

john.pachankis@yale.edu

6463444060

Study Officials

• John Pachankis, PhD

  Associate Professor of Public Health (Social and Behavioral Sciences)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients will either be immediately enrolled or wait listed for the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: October 26, 2018
• Study Start: July 18, 2018
• Primary Completion: July 18, 2019
• Study Completion: July 18, 2019
• Last Updated: January 26, 2022
• Results First Posted: October 20, 2021

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)