Clinical trial NCT05509166: Affirmative Psychotherapy for Sexual Minority Women's Mental and Behavioral Health
Official title: A Unified Protocol to Address Sexual Minority Women's Minority Stress, Mental Health and Hazardous Drinking
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heavy Drinking
Mental Health Issue
Keywords: LGBTQ
Cognitive Behavioral Therapy
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-08-22
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, New Jersey and Pennsylvania. 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.

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, New Jersey and Pennsylvania. 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.

Eligibility criteria: Inclusion Criteria:

1. be 18 years of age or older
2. be fluent in English
3. self-identify as lesbian, bisexual, queer, pansexual, or other non-heterosexual identity

3) report at ≥ 8 standard drinks/week, on average, in the past 30 days, OR report at least 2 heavy drinking days ( ≥ 4 drinks in one day) in the past 30 days 4) 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 DIAMOND) 5) report at least minimum motivation to reduce drinking (measured by the Readiness Ruler) 6) live in New York, New Jersey, and Pennsylvania and planning to stay for at least the next 4 months

Exclusion Criteria:

1. report current mental health treatment ≥1 day/mo
2. report having received any CBT in the past 3 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

Primary outcomes:
measure: Change in heavy drinking
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Secondary outcomes:
measure: Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
measure: Depression Symptom Severity
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
measure: Anxiety Symptom Severity
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
measure: Overall Depression Severity and Impairment Scale (ODSIS)
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
measure: Overall Anxiety Severity and Impairment Scale (OASIS)
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
measure: PTSD symptoms
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
measure: Suicidal Ideation
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
measure: Mental Health Symptom Presence and Severity
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
measure: Alcohol Use
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
measure: Effects of Alcohol Use
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
measure: Frequency of Alcohol Use
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
measure: Alcohol Self-Efficacy
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
measure: Drug Use and Drug-Related Problems
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
measure: Cannabis Use and Cannabis-Related Problems
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Other outcomes:
Locations:
city: New York
country: United States
facility: Yale LGBTQ Mental Health Initiative with the Yale School of Public Office
state: New York
Study officials:
affiliation: Yale University
name: John E Pachankis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Tonda Hughes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.
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.
citation: 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.
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.
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.
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.