Yale LGBTQ Mental Health Initiative with the Yale School of Public Office
New York, 10001, United States
Location status: Recruiting
NCT Number: NCT05509166
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
New York, 10001, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
10-session LGBTQ-affirmative psychotherapy using CBT techniques
10-session LGBTQ-affirmative psychotherapy
Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
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.
Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
The (DIAMOND) is a semi-structured diagnostic interview based on the DSM-5 that enables non-clinicians to determine the presence and severity of mood, anxiety, and stress-/trauma-related disorders.
Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
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.
Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
The Beck Anxiety Inventory (BAI) will be used to compute an overall anxiety score. Total score is calculated by finding the sum of the 21 items. Score of 0-21 = low anxiety; score of 22-36 = moderate anxiety; score of 36 and above = high anxiety. A higher score will indicate more depressive symptomatology during the past week. The range of scores for this outcome is 0-63.
Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
The Overall Depression Severity and Impairment Scale (ODSIS) will be used to compute an overall depression severity and impairment score. Total score is calculated using the sum of the 5 items. The range of scores for this outcome is 0-20.
Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
The Overall Anxiety Severity and Impairment Scale (OASIS) will be used to compute an overall anxiety severity and impairment score. Total score is calculated using the sum of the 5 items. The range of scores for this outcome is 0-20.
Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD to monitor symptom change during and after treatment
Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
The Suicidal Ideation Attributes Scale (SIDAS) is a 5-item self-report measure that assesses suicidal ideation with response options from 0 to 10. Total SIDAS scores are calculated as the sum of the five items, with controllability reverse scored. Total scores range from 0 to 50.
Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
The Brief Symptom Inventory (BSI) measures current or past presence and severity of mental health symptoms. The self-report measure is rated on a scale of 0 (not at all) to 4 (extremely), with higher scores indicating more severe symptomatology.
Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
The Patient Reported Outcomes Measurement Information System (PROMIS) Alcohol Use Short Form is a self-report questionnaire designed to measure alcohol use in the past 30 days. Participants respond to 7 questions on a scale of 1 (Never) to 5 (Almost Always), and the sum of the responses are converted to a t-score, with a higher score representing higher alcohol use
Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
The Brief Comprehensive Effects of Alcohol Scale evaluates participants' outcome expectancy when drinking. The measure contains 38 items that are rated on a scale of 1 (Disagree) to 4 (Agree), with a higher sum indicating a higher level of effect in certain alcohol use domains.
Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
The Daily Drinking Questionnaire assesses the amount of drinks a participant consumes on a daily basis throughout the course of a week.
Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
The Alcohol Abstinence Self-Efficacy Scale measures a participant's confidence in being able to avoid or abstain from alcohol. Participants rate 20 items on a scale of 1 (Not at all confident) to 5 (Extremely confident), with a higher score indicating higher confidence in being able to abstain from alcohol.
Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
The Drug Use Disorders Identification Test (DUDIT) is a self-report measure designed to assess drug-related problems and drug use. Participants rate 11 items that can be scored on a scale of 0 to 4, with a higher sum representing more drug-related problems and dependency.
Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
The Cannabis Use Disorder Identification Test (CUDIT) assesses self-reported cannabis use and problems related to cannabis use. Participants rate 10 items on varying scales, with a higher sum indicating higher cannabis use and related problems.
Interested in participating?
Request InfoYale University
Other
A Unified Protocol to Address Sexual Minority Women's Minority Stress, Mental Health and Hazardous Drinking
Acronym: EQuIP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07591428
Alcohol Drinking, Alcohol-Related Disorders
Tulsa, Oklahoma, United States
View Trial DetailsNCT07516873
Heavy Drinking
Malden, Massachusetts, United States
View Trial DetailsNCT05491551
Alcohol Drinking, Alcohol-Related Disorders
Berkeley, California, United States
View Trial DetailsNCT07277673
Erectile Dysfunction, Genital Diseases
Giza, Dokki, Egypt
View Trial Details