Affirmative Psychotherapy for Sexual Minority Women's Mental and Behavioral Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
be 18 years of age or older
be fluent in English
self-identify as lesbian, bisexual, queer, pansexual, or other non-heterosexual identity
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
LGBTQ-affirmative Cognitive Behavioral Therapy
Behavioral10-session LGBTQ-affirmative psychotherapy using CBT techniques
LGBTQ-affirmative Treatment-As-Usual
Behavioral10-session LGBTQ-affirmative psychotherapy
Treatment groups
274 Participants
are divided into 2 treatment groupsGroup A: LGBTQ-affirmative Cognitive Behavioral TherapyExperimental treatment 1 intervention
Group B: LGBTQ-affirmative Treatment-as-UsualActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in heavy drinking
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-upSecondary outcomes
1
Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)
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-up2
Depression Symptom Severity
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-up3
Anxiety Symptom Severity
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-up4
Overall Depression Severity and Impairment Scale (ODSIS)
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-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov