Reliability 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/29034525/Actively Recruiting
Led by Yale University · Updated on 2026-07-09
274
Participants Needed
1
Research Sites
17 weeks
Total Duration
Researchers are evaluating the effectiveness of a 10-session LGBTQ-affirmative cognitive-behavioral psychotherapy CBT called EQuIP Empowering Queer Identities in Psychotherapy delivered via telehealth for sexual minority women in New York, New Jersey, and Pennsylvania. This 2-arm randomized controlled trial compares EQuIP to LGBTQ-affirmative treatment-as-usual, aiming to reduce heavy drinking and mental health symptoms such as depression. The study also examines psychosocial factors like emotion regulation that may influence these outcomes and explores variation in treatment effects across demographic groups. Participants are randomly assigned to one of two groups one receiving 10 weekly individual sessions of LGBTQ-affirmative CBT based on the Unified Protocol targeting minority stress-related depression, anxiety, and alcohol use the other receiving 10 weekly sessions of LGBTQ-affirmative treatment-as-usual via telehealth from therapists at the Institute for Human Identity. Both treatments are delivered remotely, with sessions occurring weekly. During the study, participants undergo baseline assessments and follow-ups at 4, 8, and 12 months to measure changes in heavy drinking and mental health symptoms. Evaluations include diagnostic interviews, symptom severity scales for depression, anxiety, PTSD, suicidal ideation, and assessments of alcohol and drug use. The study monitors participant progress, mental health, and substance use over the course of the year-long follow-up, with all data collected remotely via telehealth.
CONDITIONS
Affirmative Psychotherapy for Sexual Minority Women's Mental and Behavioral Health
J
John E Pachankis, PhD
D
Danielle M Chiaramonte, PhD
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Yale University
Lead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Affirmative CBT (10 sessions) | Affirmative Treatment-as-Usual (10 sessions) |
|---|---|---|
| What it is | A structured 10-session LGBTQ-affirmative Cognitive Behavioral Therapy (CBT) program tailored for sexual minority women addressing both heavy drinking and co-occurring mood or anxiety disorders. | A 10-session LGBTQ-affirmative supportive psychotherapy program delivered as treatment-as-usual for sexual minority women with similar behavioral health needs. |
| Role in trial | Randomized intervention group: receives LGBTQ-affirmative CBT. | Randomized active control: receives LGBTQ-affirmative TAU. |
| Primary use | Aims to reduce hazardous alcohol use and improve depression and anxiety symptoms in sexual minority women. | Serves as the supportive care benchmark for reducing heavy drinking and improving mental health in this group. |
| How it is given or performed | Delivered as individual weekly sessions (10 total), each session using structured CBT techniques adapted for affirming sexual minority women’s identities. | Delivered as individual weekly sessions (10 total) using supportive psychotherapy methods consistent with established affirmative care. |
| Evidence status | Currently under active randomized evaluation with no published outcome results as of this trial registry. Project EQuIP protocol describes the rationale and the evidence base for using CBT techniques adapted for sexual minority stress. | Well-established as an affirmative supportive care approach, but direct evidence for its impact on both heavy drinking reduction and co-occurring depression/anxiety in this population is limited. |
| Important limitations | As an adapted intervention, effectiveness is not yet established for reducing both heavy drinking and mood/anxiety symptoms in sexual minority women. Requires participant motivation and attendance at all sessions. | Supportive psychotherapy may be less effective in addressing specific drinking behaviors and mental health symptoms than structured CBT. Published evidence in this precise population and setting is limited. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 10 weeks
Participants receive 10 weekly sessions of either LGBTQ-affirmative cognitive behavioral therapy or LGBTQ-affirmative treatment-as-usual delivered via telehealth.
Weekly sessions via telehealth
Duration - 12 months
Participants complete assessments at 4, 8, and 12 months after starting treatment to measure changes in heavy drinking and mental health symptoms.
3 assessment visits
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor