Affirmative Psychotherapy for Sexual Minority Women's Mental and Behavioral Health

Mental Health Issue Clinical Trial

— EQuIP  

Official title:

A Unified Protocol to Address Sexual Minority Women's Minority Stress, Mental Health and Hazardous Drinking

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05509166
• Other study ID #: 2000033355
• Secondary ID: 1R01AA029088-01A
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: August 1, 2027

Study information

• Verified date: January 2024
• Source: Yale University
• Contact: John E Pachankis, PhD
• Phone: 646-429-9407
• Email: John.Pachankis[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 and New Jersey. 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.

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 and New Jersey. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: August 1, 2027
• Est. primary completion date: February 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. be fluent in English

2. self-identify as lesbian, bisexual, queer, pansexual, or other non-heterosexual identity

3. report at least medium risk drinking level according to World Health Organization (WHO) (= 10 standard drinks/week, on average, in the past 30 days)

4. report at least 1 heavy drinking day (=4 drinks) at least once per week, on average, in the past 30 days

5. currently experience a Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 depression or anxiety disorder (screened initially using a cutoff of = 2 on the Brief Symptom Inventory-4 and further confirmed by diagnostic interview via the MINI)

6. report at least minimum motivation to reduce drinking (measured by the Readiness Ruler)

7. live in New York or New Jersey

Exclusion Criteria:

1. report current mental health treatment =1 day/mo

2. report having received any CBT in the past 12 months

3. report current alcohol or drug abuse treatment, except mutual self-help (e.g., Alcoholics Anonymous)

4. need alcohol detoxification indicated by =9 on Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar)

5. exhibit active psychosis or active mania, as assessed by the Structured Clinical Interviews for DSM-5 Disorders (SCID) Psych Screen

6. exhibit active suicidality or active homicidality, as assessed by the SCID-Psych Screen

7. be currently legally mandated to attend treatment

8. demonstrate gross cognitive impairment, as assessed with the Telephone Interview for Cognitive Status

Related Conditions & MeSH terms

• Heavy Drinking
• Mental Health Issue

Intervention

Behavioral:
• LGBTQ-affirmative Cognitive Behavioral Therapy
10-session LGBTQ-affirmative psychotherapy using CBT techniques
• LGBTQ-affirmative Treatment-As-Usual
10-session LGBTQ-affirmative psychotherapy

Locations

Country	Name	City	State
United States	Yale LGBTQ Mental Health Initiative with the Yale School of Public Office	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (10)

Bjureberg J, Ljotsson B, Tull MT, Hedman E, Sahlin H, Lundh LG, Bjarehed 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. doi: 10.1007/s10862-015-9514-x. Epub 2015 Sep 14. — View Citation

Fong TG, Inouye SK. The Telephone Interview for Cognitive Status. Cogn Behav Neurol. 2018 Sep;31(3):156-157. doi: 10.1097/WNN.0000000000000165. No abstract available. — View Citation

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. — View Citation

Maisto SA, Krenek M, Chung T, Martin CS, Clark D, Cornelius J. A comparison of the concurrent and predictive validity of three measures of readiness to change alcohol use in a clinical sample of adolescents. Psychol Assess. 2011 Dec;23(4):983-94. doi: 10.1037/a0024136. Epub 2011 Jul 18. — View Citation

Radloff LS. The CES-D scale: A self-report depression scale for research in the general population. Appl Psychol Meas. 1977;1(3):385-401.

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):e1590. doi: 10.1002/mpr.1590. Epub 2017 Oct 16. — View Citation

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. — View Citation

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. doi: 10.1016/0376-8716(96)01263-x. — View Citation

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. doi: 10.1111/j.1360-0443.1989.tb00737.x. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in heavy drinking	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.	Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Secondary	Change in Depression Symptom Severity	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.	Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Secondary	Change in Emotion Regulation	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.	Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up