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Project EQuIP: Empowering Queer Identities in Psychotherapy (EQuIP)

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ClinicalTrials.gov Identifier: NCT03721276
Recruitment Status : Recruiting
First Posted : October 26, 2018
Last Update Posted : October 26, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Yale University

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

Condition or disease Intervention/treatment Phase
Sexual Minority Stress Behavioral: ESTEEM (Effective Skills to Empower Effective Men) for Women Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Patients will either be immediately enrolled or wait listed for the intervention.
Primary Purpose: Treatment
Official Title: Project EQuIP: Empowering Queer Identities in Psychotherapy
Actual Study Start Date : July 18, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Therapy
Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse.
Behavioral: ESTEEM (Effective Skills to Empower Effective Men) for Women
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.

No Intervention: 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.



Primary Outcome Measures :
  1. Depression [ Time Frame: 3 Months ]
    Depression will be measured using the Center for Epidemiologic Studies Depression Scale (CES-D). It is a 20 item scale with a range of 0-60, where 60 is the highest measure of depression.

  2. Anxiety [ Time Frame: 3 Months ]
    Anxiety will be measured using the Brief Symptom Inventory (BSI). The BSI is an 18 item inventory with a range of scores from 0 to 4, where 4 is the highest amount of the construct under measure.

  3. Alcohol Use [ Time Frame: 3 Months ]
    Alcohol use will be measured using the Short Index of Problems for Alcohol (SIP-A). The SIP-A is a 15 item measure that has a range of scores from 0-15. The highest score of 15 is an indicator of the greatest amount of alcohol use related problems.


Secondary Outcome Measures :
  1. Depression [ Time Frame: Baseline ]
    Depression will be measured using the Center for Epidemiologic Studies Depression Scale (CES-D). It is a 20 item scale with a range of 0-60, where 60 is the highest measure of depression.

  2. Depression [ Time Frame: 6 Months ]
    Depression will be measured using the Center for Epidemiologic Studies Depression Scale (CES-D). It is a 20 item scale with a range of 0-60, where 60 is the highest measure of depression.

  3. Anxiety [ Time Frame: Baseline ]
    Anxiety will be measured using the Brief Symptom Inventory (BSI). The BSI is an 18 item inventory with a range of scores from 0 to 4, where 4 is the highest amount of the construct under measure.

  4. Anxiety [ Time Frame: 6 Months ]
    Anxiety will be measured using the Brief Symptom Inventory (BSI). The BSI is an 18 item inventory with a range of scores from 0 to 4, where 4 is the highest amount of the construct under measure.

  5. Alcohol Use [ Time Frame: Baseline ]
    Alcohol use will be measured using the Short Index of Problems for Alcohol (SIP-A). The SIP-A is a 15 item 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.

  6. Alcohol Use [ Time Frame: 6 Months ]
    Alcohol use will be measured using the Short Index of Problems for Alcohol (SIP-A). The SIP-A is a 15 item 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.

  7. Internalized Homophobia [ Time Frame: Baseline ]
    Internalized homophobia (IH) using the IH measure that consists of 9 items that are scored to create a score ranging from 1-4. The score of 4 is the highest measure of IH.

  8. Internalized Homophobia [ Time Frame: 3 Months ]
    Internalized homophobia (IH) using the IH measure that consists of 9 items that are scored to create a score ranging from 1-4. The score of 4 is the highest measure of IH.

  9. Internalized Homophobia [ Time Frame: 6 Months ]
    Internalized homophobia (IH) using the IH measure that consists of 9 items that are scored to create a score ranging from 1-4. The score of 4 is the highest measure of IH.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

For Phase 3

Inclusion Criteria:

  • self-identification as queer, lesbian, or bisexual
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03721276


Contacts
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Contact: John Pachankis, PhD 646-347-4060 john.pachankis@yale.edu
Contact: Erin McConocha, MPH 646-344-4060 erin.mcconocha@yale.edu

Locations
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United States, New York
ESTEEM Labratory Recruiting
New York, New York, United States, 10010
Contact: John Pachankis, PhD    646-344-4060    john.pachankis@yale.edu   
Contact: Erin McConocha, MPH    646-344-4060    erin.mcconocha@yale.edu   
Sponsors and Collaborators
Yale University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: John Pachankis, PhD Associate Professor of Public Health (Social and Behavioral Sciences)

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03721276     History of Changes
Other Study ID Numbers: 2000020997
R01MH109413 ( U.S. NIH Grant/Contract )
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No