EQuIP: Affirmative Psychotherapy for Sexual Minority Women's Mental and Behavioral Health
Study Details
Study Description
Brief Summary
The purpose of this 2-arm randomized controlled trial is to assess the efficacy of a 10-session lesbian, gay, bisexual, transgender, and queer (LGBTQ)-affirmative cognitive-behavioral psychotherapy (CBT) delivered via telehealth in a large sample of sexual minority women (SMW) in New York State. The investigators will assess whether the EQuIP(Empowering Queer Identities in Psychotherapy) treatment demonstrates significant reductions in heavy drinking (HD) and mental health symptoms (e.g., depression) compared to LGBTQ-affirmative treatment-as-usual.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Detailed Description
The purpose of this study is to assess the efficacy of a 10-session LGBTQ-affirmative cognitive behavioral psychotherapy (CBT) delivered via telehealth in a large sample of sexual minority women (SMW) in New York State. The treatment, EQuIP (Empowering Queer Identities in Psychotherapy), uses a CBT-based transdiagnostic approach to target the common cognitive, affective, and behavioral responses to minority stress that lead to mental and behavioral health disparities for sexual minority women. We will assess in a 2-arm randomized controlled trial (RCT) whether the EQuIP treatment demonstrates significant reductions in heavy drinking (HD) and mental health symptoms (e.g., depression) compared to LGBTQ-affirmative Treatment-As-Usual. The investigators will assess whether psychosocial mechanisms (e.g., emotion dysregulation) mediate reductions in heavy drinking and separately and identify whether EQuIP is differentially efficacious across key demographic factors.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LGBTQ-affirmative Cognitive Behavioral Therapy Individuals assigned to LGBTQ-affirmative cognitive behavioral therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, delivered via telehealth. Based on the Unified Protocol, sessions will address minority stress mechanisms underlying sexual minority women's depression, anxiety, and alcohol abuse. |
Behavioral: LGBTQ-affirmative Cognitive Behavioral Therapy
10-session LGBTQ-affirmative psychotherapy using CBT techniques
|
| Active Comparator: LGBTQ-affirmative Treatment-as-Usual Individuals assigned to LGBTQ-affirmative Treatment-as-Usual will receive 10 weekly sessions from a therapist at the Institute for Human Identity who will provide their LGBTQ-affirmative therapy services via telehealth. |
Behavioral: LGBTQ-affirmative Treatment-As-Usual
10-session LGBTQ-affirmative psychotherapy
|
Outcome Measures
Primary Outcome Measures
- Change in heavy drinking [Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up]
The proportion of heavy drinking days will be assessed using a 30-day Timeline Followback. The Timeline Followback is a structured interview that will assess alcohol use over the past 30 days. Heavy drinking days are defined as those in which more than four drinks were consumed within a two-hour period.
Secondary Outcome Measures
- Change in Depression Symptom Severity [Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up]
The Center for Epidemiological Studies - Depression Scale (CES-D) will be used to compute an overall depression score (sum of the 20 items, with Items 3, 11, 14, and 16 reverse-scored). A higher score will indicate more depressive symptomatology during the past week. The range of scores for this outcome is 0-60.
- Change in Emotion Regulation [Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up]
Emotion regulation will be measured using a validated abbreviated version of the Difficulties in Emotion Regulation Scale. A sum score of 18 items will result in a range of scores from 18-90, with higher scores indicating more difficulty in emotion regulation.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
be fluent in English
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self-identify as lesbian, bisexual, queer, pansexual, or other non-heterosexual identity
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report at least medium risk drinking level according to World Health Organization (WHO) (≥ 10 standard drinks/week, on average, in the past 30 days)
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report at least 1 heavy drinking day (≥4 drinks) at least once per week, on average, in the past 30 days
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currently experience a Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 depression or anxiety disorder (screened initially using a cutoff of ≥ 2.5 on the Brief Symptom Inventory-4 and further confirmed by diagnostic interview via the MINI)
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report at least minimum motivation to reduce drinking (measured by the Readiness Ruler)
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live in New York State
Exclusion Criteria:
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report current mental health treatment ≥1 day/mo
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report having received any CBT in the past 12 months
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report current alcohol or drug abuse treatment, except mutual self-help (e.g., Alcoholics Anonymous)
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need alcohol detoxification indicated by ≥9 on Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar)
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exhibit active psychosis or active mania, as assessed by the Structured Clinical Interviews for DSM-5 Disorders (SCID) Psych Screen
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exhibit active suicidality or active homicidality, as assessed by the SCID-Psych Screen
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be currently legally mandated to attend treatment
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demonstrate gross cognitive impairment, as assessed with the Telephone Interview for Cognitive Status
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yale LGBTQ Mental Health Initiative with the Yale School of Public Office | New York | New York | United States | 10001 |
Sponsors and Collaborators
- Yale University
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
- Principal Investigator: John E Pachankis, PhD, Yale University
- Principal Investigator: Tonda Hughes, PhD, Columbia University
Study Documents (Full-Text)
None provided.More Information
Publications
- Bjureberg J, Ljótsson B, Tull MT, Hedman E, Sahlin H, Lundh LG, Bjärehed J, DiLillo D, Messman-Moore T, Gumpert CH, Gratz KL. Development and Validation of a Brief Version of the Difficulties in Emotion Regulation Scale: The DERS-16. J Psychopathol Behav Assess. 2016 Jun;38(2):284-296. Epub 2015 Sep 14.
- Fong TG, Inouye SK. The Telephone Interview for Cognitive Status. Cogn Behav Neurol. 2018 Sep;31(3):156-157. doi: 10.1097/WNN.0000000000000165.
- Lang AJ, Norman SB, Means-Christensen A, Stein MB. Abbreviated brief symptom inventory for use as an anxiety and depression screening instrument in primary care. Depress Anxiety. 2009;26(6):537-43. doi: 10.1002/da.20471.
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- Shankman SA, Funkhouser CJ, Klein DN, Davila J, Lerner D, Hee D. Reliability and validity of severity dimensions of psychopathology assessed using the Structured Clinical Interview for DSM-5 (SCID). Int J Methods Psychiatr Res. 2018 Mar;27(1). doi: 10.1002/mpr.1590. Epub 2017 Oct 16.
- Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57. Review.
- Sobell LC, Brown J, Leo GI, Sobell MB. The reliability of the Alcohol Timeline Followback when administered by telephone and by computer. Drug Alcohol Depend. 1996 Sep;42(1):49-54.
- Sullivan JT, Sykora K, Schneiderman J, Naranjo CA, Sellers EM. Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar). Br J Addict. 1989 Nov;84(11):1353-7.
- Witkiewitz K, Hallgren KA, Kranzler HR, Mann KF, Hasin DS, Falk DE, Litten RZ, O'Malley SS, Anton RF. Clinical Validation of Reduced Alcohol Consumption After Treatment for Alcohol Dependence Using the World Health Organization Risk Drinking Levels. Alcohol Clin Exp Res. 2017 Jan;41(1):179-186. doi: 10.1111/acer.13272. Epub 2016 Dec 26.
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