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

Overview

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.

Interventions

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

Primary outcome measures

• Change in heavy drinking [Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up]

Secondary outcome measures (12)

• Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND) [Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up]
• Depression Symptom Severity [Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up]
• Anxiety Symptom Severity [Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up]
• Overall Depression Severity and Impairment Scale (ODSIS) [Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up]
• Overall Anxiety Severity and Impairment Scale (OASIS) [Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up]
• PTSD symptoms [Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up]
• Suicidal Ideation [Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up]
• Mental Health Symptom Presence and Severity [Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up]
• Alcohol Use [Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up]
• Effects of Alcohol Use [Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up]
• Frequency of Alcohol Use [Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up]
• Alcohol Self-Efficacy [Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up]

Eligibility criteria

Inclusion criteria

• be 18 years of age or older
• be fluent in English
• 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

• report current mental health treatment ≥1 day/mo
• report having received any CBT in the past 3 months
• report current alcohol or drug abuse treatment, except mutual self-help (e.g., Alcoholics Anonymous)
• need alcohol detoxification indicated by ≥9 on Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar)
• exhibit active psychosis or active mania, as assessed by the Structured Clinical Interviews for DSM-5 Disorders (SCID) Psych Screen
• exhibit active suicidality or active homicidality, as assessed by the SCID-Psych Screen
• be currently legally mandated to attend treatment
• demonstrate gross cognitive impairment, as assessed with the Telephone Interview for Cognitive Status

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Yale LGBTQ Mental Health Initiative with the Yale School of Public Office — New York

Publications

• 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. PMID 27239096
• 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. PMID 8889403
• 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.
• 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. PMID 30239466
• 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. PMID 19016462
• 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. PMID 9881538
• 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. PMID 29034525
• 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. PMID 2597811

Identifiers

NCT: NCT05509166 · 2000033355 · 1R01AA029088-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗