Development and Validation of a Brief Version of the Difficulties in Emotion Regulation Scale: The DERS-16.
Johan Bjureberg, Brjánn Ljótsson, Matthew T Tull...
https://pubmed.ncbi.nlm.nih.gov/27239096Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID05509166
A Unified Protocol to Address Sexual Minority Women's Minority Stress, Mental Health and Hazardous Drinking
Led by Yale University · Updated on 2025-07-28
450
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a 10-session LGBTQ-affirmative cognitive behavioral psychotherapy (CBT) delivered via telehealth for sexual minority women experiencing heavy drinking and mental health issues such as depression and anxiety. This randomized controlled trial compares the EQuIP treatment, which targets minority stress responses contributing to these health disparities, to LGBTQ-affirmative treatment-as-usual. The study aims to identify whether EQuIP reduces heavy drinking and mental health symptoms more effectively and examines psychosocial factors that may influence outcomes across different demographic groups. Participants are randomly assigned to one of two groups: the experimental group receives 10 weekly individual CBT sessions focused on minority stress mechanisms related to depression, anxiety, and alcohol abuse, delivered remotely. The comparator group receives 10 weekly LGBTQ-affirmative therapy sessions via telehealth from therapists at the Institute for Human Identity. Both groups complete sessions over a similar time frame following an initial baseline assessment. During the study, participants undergo assessments at baseline and at 4, 8, and 12 months afterward. These evaluations include measures of heavy drinking, depression and anxiety symptom severity, PTSD symptoms, suicidal ideation, alcohol and drug use, and related problems. Researchers also monitor mental health symptom presence and impairment. The total participation includes these follow-up periods to track changes over time and assess the sustained impact of the treatments.
CONDITIONS
Brief Title
Affirmative Psychotherapy for Sexual Minority Women's Mental and Behavioral Health
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Be 18 years of age or older
- Be fluent in English
- Self-identify as lesbian, bisexual, queer, pansexual, or another non-heterosexual identity
- Report at least 8 standard drinks per week on average in the past 30 days or have at least 2 heavy drinking days (4 or more drinks in one day) in the past 30 days
- Currently experience a DSM-5 depression or anxiety disorder confirmed by diagnostic interview
- Report at least minimum motivation to reduce drinking
- Live in New York, New Jersey, or Pennsylvania and plan to stay for at least the next 4 months
You will not qualify if you...
- Receive current mental health treatment 1 day or more per month
- Have received any cognitive behavioral therapy in the past 3 months
- Receive current alcohol or drug abuse treatment, except mutual self-help groups
- Require alcohol detoxification as indicated by a CIWA-Ar score of 9 or higher
- Exhibit active psychosis or mania
- Exhibit active suicidality or homicidality
- Be legally mandated to attend treatment
- Demonstrate gross cognitive impairment assessed by Telephone Interview for Cognitive Status
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Treatment
Duration - 10 weeks
Participants receive 10 weekly sessions of LGBTQ-affirmative psychotherapy delivered via telehealth, either using cognitive behavioral therapy techniques or treatment-as-usual.
Weekly sessions delivered remotely via telehealth
Follow-up
Duration - Up to 8 months after treatment
Participants are monitored for mental health and drinking outcomes after completion of therapy.
3 follow-up visits at 4, 8, and 12 months after baseline assessment
Trial Site Locations
Total: 1 location
1
Yale LGBTQ Mental Health Initiative with the Yale School of Public Office
New York, New York, United States, 10001
Actively Recruiting
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Research Team
J
John E Pachankis, PhD
D
Danielle M Chiaramonte, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
The reliability of the Alcohol Timeline Followback when administered by telephone and by computer.
L C Sobell, J Brown, G I Leo...
https://pubmed.ncbi.nlm.nih.gov/8889403The Telephone Interview for Cognitive Status.
Tamara G Fong, Sharon K Inouye
https://pubmed.ncbi.nlm.nih.gov/30239466Abbreviated brief symptom inventory for use as an anxiety and depression screening instrument in primary care.
Ariel J Lang, Sonya B Norman, Adrienne Means-Christensen...
https://pubmed.ncbi.nlm.nih.gov/19016462The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10.
D V Sheehan, Y Lecrubier, K H Sheehan...
https://pubmed.ncbi.nlm.nih.gov/9881538Reliability and validity of severity dimensions of psychopathology assessed using the Structured Clinical Interview for DSM-5 (SCID).
Stewart A Shankman, Carter J Funkhouser, Daniel N Klein...
https://pubmed.ncbi.nlm.nih.gov/29034525Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar).
J T Sullivan, K Sykora, J Schneiderman...
https://pubmed.ncbi.nlm.nih.gov/2597811A comparison of the concurrent and predictive validity of three measures of readiness to change alcohol use in a clinical sample of adolescents.
Stephen A Maisto, Marketa Krenek, Tammy Chung...
https://pubmed.ncbi.nlm.nih.gov/21767028Clinical Validation of Reduced Alcohol Consumption After Treatment for Alcohol Dependence Using the World Health Organization Risk Drinking Levels.
Katie Witkiewitz, Kevin A Hallgren, Henry R Kranzler...
https://pubmed.ncbi.nlm.nih.gov/28019652Randomised controlled trial of LGBTQ-affirmative cognitive-behavioural therapy for sexual minority women's minority stress, mental health and hazardous drinking: Project EQuIP protocol.
John Pachankis, Danielle Chiaramonte, Jillian R Scheer...
https://pubmed.ncbi.nlm.nih.gov/40032395