Study Summary
This trial is testing whether a 10-session LGBTQ-affirmative cognitive-behavioral therapy delivered via telehealth can reduce heavy drinking and mental health symptoms in sexual minority women in New York State.
Eligible Conditions
- Alcohol Abuse
- Mental Health Issue
Treatment Effectiveness
Phase-Based Effectiveness
Phase 2 & 3
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Mental Depression
Change in Emotion Regulation
Drunk driving
Trial Safety
Phase-Based Safety
This is further along than 68% of similar trials
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
2 Treatment Groups
LGBTQ-affirmative Treatment-as-Usual
1 of 2
LGBTQ-affirmative Cognitive Behavioral Therapy
1 of 2
Active Control
Experimental Treatment
450 Total Participants · 2 Treatment Groups
Primary Treatment: LGBTQ-affirmative Cognitive Behavioral Therapy · No Placebo Group · Phase 2 & 3
LGBTQ-affirmative Cognitive Behavioral Therapy
Behavioral
Experimental Group · 1 Intervention: LGBTQ-affirmative Cognitive Behavioral Therapy · Intervention Types: BehavioralLGBTQ-affirmative Treatment-as-Usual
Behavioral
ActiveComparator Group · 1 Intervention: LGBTQ-affirmative Treatment-As-Usual · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,727 Previous Clinical Trials
20,519,138 Total Patients Enrolled
6 Trials studying Alcohol Abuse
1,178 Patients Enrolled for Alcohol Abuse
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
744 Previous Clinical Trials
1,343,815 Total Patients Enrolled
78 Trials studying Alcohol Abuse
27,350 Patients Enrolled for Alcohol Abuse
John E Pachankis, PhDPrincipal InvestigatorYale University
2 Previous Clinical Trials
450 Total Patients Enrolled
1 Trials studying Alcohol Abuse
326 Patients Enrolled for Alcohol Abuse
Tonda Hughes, PhDPrincipal InvestigatorColumbia University
Eligibility Criteria
Age 18+ · Female Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You must be able to speak English fluently.
You identify as something other than heterosexual, such as lesbian, bisexual, queer, or pansexual.
You must be willing to reduce your alcohol consumption as shown by the Readiness Ruler.
References
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- Sobell, Linda C., Joanne Brown, Gloria I. Leo, and Mark B. Sobell. 1996. “The Reliability of the Alcohol Timeline Followback When Administered by Telephone and by Computer”. Drug and Alcohol Dependence. Elsevier BV. doi:10.1016/0376-8716(96)01263-x.
- SULLIVAN, JOHN T., KATHY SYKORA, JOYCE SCHNEIDERMAN, CLAUDIO A. NARANJO, and EDWARD M. SELLERS. 1989. “Assessment of Alcohol Withdrawal: The Revised Clinical Institute Withdrawal Assessment for Alcohol Scale (ciwa-ar)”. Addiction. Wiley. doi:10.1111/j.1360-0443.1989.tb00737.x.
- Witkiewitz, Katie, Kevin A. Hallgren, Henry R. Kranzler, Karl F. Mann, Deborah S. Hasin, Daniel E. Falk, Raye Z. Litten, Stephanie S. O'Malley, and Raymond F. Anton. 2016. “Clinical Validation of Reduced Alcohol Consumption After Treatment for Alcohol Dependence Using the World Health Organization Risk Drinking Levels”. Alcoholism: Clinical and Experimental Research. Wiley. doi:10.1111/acer.13272.
- Lang, Ariel J., Sonya B. Norman, Adrienne Means-Christensen, and Murray B. Stein. 2008. “Abbreviated Brief Symptom Inventory for Use as an Anxiety and Depression Screening Instrument in Primary Care”. Depression and Anxiety. Wiley. doi:10.1002/da.20471.
- Shankman, Stewart A., Carter J. Funkhouser, Daniel N. Klein, Joanne Davila, Debra Lerner, and Danelle Hee. 2017. “Reliability and Validity of Severity Dimensions of Psychopathology Assessed Using the Structured Clinical Interview for DSM-5 (SCID)”. International Journal of Methods in Psychiatric Research. Wiley. doi:10.1002/mpr.1590.
- Maisto, Stephen A., Marketa Krenek, Tammy Chung, Christopher S. Martin, Duncan Clark, and Jack Cornelius. 2011. “A Comparison of the Concurrent and Predictive Validity of Three Measures of Readiness to Change Alcohol Use in a Clinical Sample of Adolescents.”. Psychological Assessment. American Psychological Association (APA). doi:10.1037/a0024136.
- 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.
- Bjureberg, Johan, Brjánn Ljótsson, Matthew T. Tull, Erik Hedman, Hanna Sahlin, Lars-Gunnar Lundh, Jonas Bjärehed, et al.. 2015. “Development and Validation of a Brief Version of the Difficulties in Emotion Regulation Scale: The DERS-16”. Journal of Psychopathology and Behavioral Assessment. Springer Science and Business Media LLC. doi:10.1007/s10862-015-9514-x.
- Fong, Tamara G., and Sharon K. Inouye. 2018. “The Telephone Interview for Cognitive Status”. Cognitive and Behavioral Neurology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/wnn.0000000000000165.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 2023. "Affirmative Psychotherapy for Sexual Minority Women's Mental and Behavioral Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05509166.
Frequently Asked Questions
Are recruitment efforts for this experiment still underway?
"The clinical trial in question was last updated 9/16/2022, over a year ago, meaning that it is no longer actively recruiting patients. This is corroborated by the information present on clinicaltrials.gov. There are, however, 60 other trials that are still looking for patients." - Anonymous Online Contributor
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