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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

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

Публикации

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• 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

Идентификаторы

NCT: NCT05509166 · 2000033355 · 1R01AA029088-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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