Heavy DrinkingEQuIPNCT05509166
Affirmative Psychotherapy for Sexual Minority Women's Mental and Behavioral Health
A study testing LGBTQ-affirmative Cognitive Behavioral Therapy and LGBTQ-affirmative Treatment-As-Usual in people with Heavy Drinking and Mental Health Issue, run by Yale University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heavy Drinking, Mental Health Issue
- What is being tested?
- LGBTQ-affirmative Cognitive Behavioral Therapy and LGBTQ-affirmative Treatment-As-Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be 18 years of age or older
- be fluent in English
- self-identify as lesbian, bisexual, queer, pansexual, or other non-heterosexual identity
- 3) report at ≥ 8 standard drinks/week, on average, in the past 30 days, OR report at least 2 heavy drinking days ( ≥ 4 drinks in one day) in the past 30 days 4) currently experience a Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 depression or anxiety disorder (screened initially using a cutoff of ≥ 2 on the Brief Symptom Inventory-4 and further confirmed by diagnostic interview via the DIAMOND) 5) report at least minimum motivation to reduce drinking (measured by the Readiness Ruler) 6) live in New York, New Jersey, and Pennsylvania and planning to stay for at least the next 4 months
Who cannot join
- 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)
- exhibit active psychosis or active mania, as assessed by the Structured Clinical Interviews for DSM-5 Disorders (SCID) Psych Screen
- exhibit active suicidality or active homicidality, as assessed by the SCID-Psych Screen
- be currently legally mandated to attend treatment
- demonstrate gross cognitive impairment, as assessed with the Telephone Interview for Cognitive Status
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale LGBTQ Mental Health Initiative with the Yale School of Public Office
New York, New York, 10001
Danielle M Chiaramonte, PhD, 708-334-8331, Danielle.Chiaramonte@yale.edu
Ben E Eisenstadt, BA, 347-633-0610, Ben.Eisenstadt@yale.edu
About this study
Official title: A Unified Protocol to Address Sexual Minority Women's Minority Stress, Mental Health and Hazardous Drinking
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.
Read the detailed description
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.
- Conditions
- Heavy Drinking, Mental Health Issue
- Being tested
- LGBTQ-affirmative Cognitive Behavioral Therapy, LGBTQ-affirmative Treatment-As-Usual
- Keywords
- LGBTQ, Cognitive Behavioral Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LGBTQ-affirmative Cognitive Behavioral TherapyBehavioural
10-session LGBTQ-affirmative psychotherapy using CBT techniques
LGBTQ-affirmative Treatment-As-UsualBehavioural
10-session LGBTQ-affirmative psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| LGBTQ-affirmative Cognitive Behavioral Therapy | Experimental | Individuals assigned to LGBTQ-affirmative cognitive behavioral therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, delivered via telehealth. Based on the Unified Protocol, sessions will address minority stress mechanisms underlying sexual minority women's depression, anxiety, and alcohol abuse. Receives: Behavioral: LGBTQ-affirmative Cognitive Behavioral Therapy |
| LGBTQ-affirmative Treatment-as-Usual | Active comparator | Individuals assigned to LGBTQ-affirmative Treatment-as-Usual will receive 10 weekly sessions from a therapist at the Institute for Human Identity who will provide their LGBTQ-affirmative therapy services via telehealth. Receives: Behavioral: LGBTQ-affirmative Treatment-As-Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Secondary outcomes (14)
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.
Measured: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
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.
Measured: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
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.
Measured: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
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.
Measured: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Overall Anxiety Severity and Impairment Scale (OASIS)
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.
Measured: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
PTSD symptoms
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
Measured: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Suicidal Ideation
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.
Measured: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Mental Health Symptom Presence and Severity
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.
Measured: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Alcohol Use
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
Measured: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Effects of Alcohol Use
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.
Measured: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Frequency of Alcohol Use
The Daily Drinking Questionnaire assesses the amount of drinks a participant consumes on a daily basis throughout the course of a week.
Measured: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Alcohol Self-Efficacy
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.
Measured: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Drug Use and Drug-Related Problems
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.
Measured: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Cannabis Use and Cannabis-Related Problems
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.
Measured: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Feb 2023
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Heavy DrinkingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- John E Pachankis, PhD, Principal investigator, Yale UniversityTonda Hughes, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509166
- Sponsor's protocol ID
- 2000033355
- Other IDs
- 1R01AA029088-01A1
- Acronym
- EQuIP
- Status last verified
- Jul 2026
- First submitted
- 17 Aug 2022
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following study conclusion, De-identified individual participant data will be made available to qualified researchers upon request to the PIs
Publications
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.
PubMed 27239096Sobell 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.
PubMed 8889403Radloff LS. The CES-D scale: A self-report depression scale for research in the general population. Appl Psychol Meas. 1977;1(3):385-401.
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.
PubMed 30239466Lang AJ, Norman SB, Means-Christensen A, Stein MB. Abbreviated brief symptom inventory for use as an anxiety and depression screening instrument in primary care. Depress Anxiety. 2009;26(6):537-43. doi: 10.1002/da.20471.
PubMed 19016462Sheehan 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.
PubMed 9881538Shankman 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.
PubMed 29034525Sullivan 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.
PubMed 2597811Maisto SA, Krenek M, Chung T, Martin CS, Clark D, Cornelius J. A comparison of the concurrent and predictive validity of three measures of readiness to change alcohol use in a clinical sample of adolescents. Psychol Assess. 2011 Dec;23(4):983-94. doi: 10.1037/a0024136. Epub 2011 Jul 18.
PubMed 21767028Witkiewitz K, Hallgren KA, Kranzler HR, Mann KF, Hasin DS, Falk DE, Litten RZ, O'Malley SS, Anton RF. Clinical Validation of Reduced Alcohol Consumption After Treatment for Alcohol Dependence Using the World Health Organization Risk Drinking Levels. Alcohol Clin Exp Res. 2017 Jan;41(1):179-186. doi: 10.1111/acer.13272. Epub 2016 Dec 26.
PubMed 28019652Pachankis J, Chiaramonte D, Scheer JR, Ankrum H, Eisenstadt B, Hobbs R, Baldwin H, Kidd JD, Witkiewitz K, Esserman DA, Plourde K, Drabble L, Hughes T. Randomised controlled trial of LGBTQ-affirmative cognitive-behavioural therapy for sexual minority women's minority stress, mental health and hazardous drinking: Project EQuIP protocol. BMJ Open. 2025 Mar 3;15(3):e086738. doi: 10.1136/bmjopen-2024-086738.
PubMed 40032395
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Unified Protocol to Address Sexual Minority Women's Minority Stress, Mental Health and Hazardous Drinking
- ClinicalTrials.gov ID
- NCT05509166
- Acronym / sponsor ID
- EQuIP / 2000033355
- Conditions
- Heavy Drinking, Mental Health Issue
- Keywords
- LGBTQ, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LGBTQ-affirmative Cognitive Behavioral Therapy | Experimental | Behavioral: LGBTQ-affirmative Cognitive Behavioral TherapyIndividuals assigned to LGBTQ-affirmative cognitive behavioral therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, delivered via telehealth. Based on the Unified Protocol, sessions will address minority stress mechanisms underlying sexual minority women's depression, anxiety, and alcohol abuse. |
| LGBTQ-affirmative Treatment-as-Usual | Active comparator | Behavioral: LGBTQ-affirmative Treatment-As-UsualIndividuals assigned to LGBTQ-affirmative Treatment-as-Usual will receive 10 weekly sessions from a therapist at the Institute for Human Identity who will provide their LGBTQ-affirmative therapy services via telehealth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- be 18 years of age or older
- be fluent in English
- self-identify as lesbian, bisexual, queer, pansexual, or other non-heterosexual identity
- 3) report at ≥ 8 standard drinks/week, on average, in the past 30 days, OR report at least 2 heavy drinking days ( ≥ 4 drinks in one day) in the past 30 days 4) currently experience a Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 depression or anxiety disorder (screened initially using a cutoff of ≥ 2 on the Brief Symptom Inventory-4 and further confirmed by diagnostic interview via the DIAMOND) 5) report at least minimum motivation to reduce drinking (measured by the Readiness Ruler) 6) live in New York, New Jersey, and Pennsylvania and planning to stay for at least the next 4 months
Key exclusion criteria (8 listed)
- 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)
- exhibit active psychosis or active mania, as assessed by the Structured Clinical Interviews for DSM-5 Disorders (SCID) Psych Screen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LGBTQ-affirmative Cognitive Behavioral Therapy10-session LGBTQ-affirmative psychotherapy using CBT techniques | Behavioural | LGBTQ-affirmative Cognitive Behavioral Therapy |
| LGBTQ-affirmative Treatment-As-Usual10-session LGBTQ-affirmative psychotherapy | Behavioural | LGBTQ-affirmative Treatment-as-Usual |
Primary outcome
Change in heavy drinking
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.
14 secondary outcomes
Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)
Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Depression Symptom Severity
Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Anxiety Symptom Severity
Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Overall Depression Severity and Impairment Scale (ODSIS)
Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Overall Anxiety Severity and Impairment Scale (OASIS)
Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
PTSD symptoms
Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Suicidal Ideation
Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Mental Health Symptom Presence and Severity
Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Alcohol Use
Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Effects of Alcohol Use
Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Frequency of Alcohol Use
Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Alcohol Self-Efficacy
Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Drug Use and Drug-Related Problems
Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Cannabis Use and Cannabis-Related Problems
Time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Background: PubMed 27239096Bjureberg 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.
- Background: PubMed 8889403Sobell 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.
- BackgroundRadloff LS. The CES-D scale: A self-report depression scale for research in the general population. Appl Psychol Meas. 1977;1(3):385-401.
- Background: PubMed 30239466Fong 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.
- Background: PubMed 19016462Lang AJ, Norman SB, Means-Christensen A, Stein MB. Abbreviated brief symptom inventory for use as an anxiety and depression screening instrument in primary care. Depress Anxiety. 2009;26(6):537-43. doi: 10.1002/da.20471.
- Background: PubMed 9881538Sheehan 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.
- Background: PubMed 29034525Shankman 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.
- Background: PubMed 2597811Sullivan 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.
- Background: PubMed 21767028Maisto SA, Krenek M, Chung T, Martin CS, Clark D, Cornelius J. A comparison of the concurrent and predictive validity of three measures of readiness to change alcohol use in a clinical sample of adolescents. Psychol Assess. 2011 Dec;23(4):983-94. doi: 10.1037/a0024136. Epub 2011 Jul 18.
- Background: PubMed 28019652Witkiewitz K, Hallgren KA, Kranzler HR, Mann KF, Hasin DS, Falk DE, Litten RZ, O'Malley SS, Anton RF. Clinical Validation of Reduced Alcohol Consumption After Treatment for Alcohol Dependence Using the World Health Organization Risk Drinking Levels. Alcohol Clin Exp Res. 2017 Jan;41(1):179-186. doi: 10.1111/acer.13272. Epub 2016 Dec 26.
- Derived from this study: PubMed 40032395Pachankis J, Chiaramonte D, Scheer JR, Ankrum H, Eisenstadt B, Hobbs R, Baldwin H, Kidd JD, Witkiewitz K, Esserman DA, Plourde K, Drabble L, Hughes T. Randomised controlled trial of LGBTQ-affirmative cognitive-behavioural therapy for sexual minority women's minority stress, mental health and hazardous drinking: Project EQuIP protocol. BMJ Open. 2025 Mar 3;15(3):e086738. doi: 10.1136/bmjopen-2024-086738.
- Individual participant dataSharing planned: Yes. Following study conclusion, De-identified individual participant data will be made available to qualified researchers upon request to the PIs
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John E Pachankis, PhD principal investigator
Yale University
Tonda Hughes, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LGBTQ-affirmative Cognitive Behavioral Therapy and LGBTQ-affirmative Treatment-As-Usual in people with Heavy Drinking and Mental Health Issue, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John E Pachankis, PhD (646-429-9407, John.Pachankis@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in heavy drinking (time frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05509166, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.