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Sexual Minority StressEQuIPNCT03721276

Project EQuIP: Empowering Queer Identities in Psychotherapy

A study testing EQuIP (Empowering Queer Identities in Psychotherapy) in people with Sexual Minority Stress, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 35 years
Conditions the study is for
Sexual Minority Stress
What is being tested?
EQuIP (Empowering Queer Identities in Psychotherapy)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
18 Jul 2018to 18 Jul 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Yale LGBTQ+ Mental Health Initiative - Research Lab

    New York, New York, 10010

Other trials in United States

About this study

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).

Read the 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.

Being tested
EQuIP (Empowering Queer Identities in Psychotherapy)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EQuIP (Empowering Queer Identities in Psychotherapy)Behavioural

    Also called 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.

Study groups in NCT03721276
Study groupRoleWhat they receive
TherapyExperimentalIndividuals 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.
Receives: Behavioral: EQuIP (Empowering Queer Identities in Psychotherapy)
WaitlistOtherIndividuals 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.
Receives: Behavioral: EQuIP (Empowering Queer Identities in Psychotherapy)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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).

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

  3. 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.

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

Secondary outcomes (4)
  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2018
  2. Study start18 Jul 2018
  3. Primary completion18 Jul 2019
  4. Study completion18 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03721276
Sponsor's protocol ID
2000020997
Other IDs
R01MH109413
Acronym
EQuIP
Status last verified
Jan 2022
First submitted
22 Oct 2018
Last updated
26 Jan 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

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

    PubMed 6622612
  • 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.

    PubMed 19261243
  • 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.

    PubMed 24708078
  • 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.

    PubMed 16688739
  • 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.

    PubMed 24612048
  • 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.

    PubMed 27752853
  • 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.

    PubMed 12476246
  • 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.

    PubMed 21319899
  • 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

  • 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.

    PubMed 2280326
  • 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

  • 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

  • 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.

    PubMed 32437174

Questions about this trial

What is this clinical trial studying?

A study testing EQuIP (Empowering Queer Identities in Psychotherapy) in people with Sexual Minority Stress, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depression (time frame: Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03721276, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2022.

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