Affirmative Psychotherapy for Mental Health Issues

(EQuIP Trial)

Overseen By Danielle M Chiaramonte, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Current mental health treatment, CBT, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 14

Duration: 10 weeks

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of LGBTQ-affirmative cognitive-behavioral therapy (CBT) for sexual minority women dealing with heavy drinking and mental health issues like depression. Delivered through telehealth, the therapy aims to determine if it can more effectively reduce these problems compared to standard LGBTQ-affirmative therapy. Women who identify as lesbian, bisexual, queer, or other non-heterosexual identities and have experienced heavy drinking and mental health symptoms may be suitable participants, especially if they reside in New York, New Jersey, or Pennsylvania. As an unphased trial, this study provides a unique opportunity to contribute to innovative research tailored to the community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude those currently receiving mental health treatment or alcohol/drug abuse treatment, except for mutual self-help groups.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that LGBTQ-affirmative cognitive-behavioral therapy (CBT) is generally safe and well-tolerated. Past studies have demonstrated its effectiveness in reducing substance use and mental health issues without serious side effects. No evidence of harmful outcomes exists, and it has successfully helped LGBTQ individuals with challenges like depression and anxiety. Conducted through telehealth, this trial allows participants to receive therapy from home, enhancing convenience and comfort. Overall, existing research supports the safety of LGBTQ-affirmative CBT. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about LGBTQ-affirmative Cognitive Behavioral Therapy because it specifically targets the unique stressors faced by sexual minority women, such as minority stress. Unlike traditional therapies that may not address these specific issues, this therapy is tailored to help with depression, anxiety, and alcohol abuse stemming from discrimination and stigma. Additionally, its delivery via telehealth makes it more accessible to people who might not have easy access to in-person therapy, allowing for a more inclusive approach to mental health care.

What evidence suggests that this trial's treatments could be effective for mental health issues?

Research has shown that LGBTQ-affirmative cognitive-behavioral therapy (CBT), which participants in this trial may receive, can reduce mental health issues like depression and anxiety in sexual minority women. This therapy addresses stressors specific to LGBTQ individuals, leading to improved mental health. For those dealing with alcohol use, LGBTQ-affirmative CBT has reduced heavy drinking by focusing on the unique challenges faced by sexual minorities. Early results also suggest it can help with other substance use problems. Overall, this therapy empowers individuals by affirming their identities and reducing harmful stress. Another treatment option in this trial is LGBTQ-affirmative Treatment-as-Usual, which provides supportive therapy tailored to LGBTQ individuals. ^{2 6 7 8 9}

Who Is on the Research Team?

John E Pachankis, PhD

Principal Investigator

Yale University

Tonda Hughes, PhD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for sexual minority women in New York who speak English, drink heavily according to WHO standards, and have depression or anxiety. They must want to reduce drinking but not be in mental health treatment more than once a month or need detoxification.

Inclusion Criteria

Live in New York or New Jersey

Be fluent in English

Report at least medium risk drinking level according to World Health Organization (WHO) (≥ 10 standard drinks/week, on average, in the past 30 days)

Exclusion Criteria

Exhibit active suicidality or active homicidality, as assessed by the SCID-Psych Screen

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10 weekly sessions of LGBTQ-affirmative cognitive behavioral therapy delivered via telehealth

10 weeks

10 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up assessments at 4, 8, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• LGBTQ-affirmative Cognitive Behavioral Therapy
• LGBTQ-affirmative Treatment-As-Usual

Trial Overview

The study tests a special 10-session LGBTQ-affirmative cognitive-behavioral therapy (CBT) via telehealth against usual LGBTQ-affirmative treatments. It aims to see if this new CBT can better reduce heavy drinking and improve mental health symptoms.

How Is the Trial Designed?

Group I: LGBTQ-affirmative Cognitive Behavioral Therapy Experimental Treatment 1 Intervention

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.

Group II: LGBTQ-affirmative Treatment-as-Usual Active Control 1 Intervention

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.

LGBTQ-affirmative Cognitive Behavioral Therapy is already approved in United States for the following indications:

Approved in United States as LGBTQ-affirmative CBT for:

• Depression
• Anxiety
• Heavy drinking

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

LGBQ+ affirmative psychotherapies are essential for addressing the unique needs of sexual minority clients, but there is a lack of empirical research on their effectiveness and specific practices.

The authors propose that these therapies should not be limited to sexual orientation-specific approaches but can be beneficial for all clients, emphasizing the need for further research and diverse therapeutic practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging in LGBQ+ affirmative psychotherapies with all clients: Defining themes and practices. Moradi, B., Budge, SL.[2019]

Training in LGBT-affirmative psychotherapy significantly improved the knowledge and skills of 96 mental health professionals, regardless of their years of experience or personal characteristics.

The training also led to notable reductions in negative attitudes towards LGBTQ+ individuals, indicating that such educational programs can effectively enhance therapists' cultural competence and affirming practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Affirmative LGBT psychotherapy: Outcomes of a therapist training protocol. Pepping, CA., Lyons, A., Morris, EMJ.[2020]

An 11-week online training program significantly improved mental health providers' self-reported LGBTQ-affirmative competencies and skills, with effects lasting up to 8 months after training, indicating its efficacy in enhancing care for LGBTQ individuals.

Participants who received immediate training demonstrated a greater uptake of LGBTQ-affirmative CBT skills in simulated practice compared to those who waited, suggesting that online training is an effective method for disseminating evidence-based mental health practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training in LGBTQ-affirmative cognitive behavioral therapy: A randomized controlled trial across LGBTQ community centers. Pachankis, JE., Soulliard, ZA., Seager van Dyk, I., et al.[2023]

LGBTQ-affirmative internet-based cognitive-behavioral therapy (ICBT) was found to be feasible and acceptable for 120 LGBTQ youth, with participants completing an average of 6.08 sessions and reporting positive engagement with the treatment.

While overall outcomes showed small and non-significant differences, ICBT was particularly effective in reducing psychological distress for participants living in areas with high anti-LGBTQ bias, suggesting that the therapy may be especially beneficial for those facing greater stigma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided LGBTQ-affirmative internet cognitive-behavioral therapy for sexual minority youth's mental health: A randomized controlled trial of a minority stress treatment approach. Pachankis, JE., Soulliard, ZA., Layland, EK., et al.[2023]

The AFFIRM intervention, an evidence-based cognitive behavioral therapy for LGBTQ+ individuals, demonstrated high adherence among clinicians, with an average fidelity score of 84.13 from 151 coded group sessions.

The study identified key factors affecting implementation, such as deviations from the manual and facilitation challenges, which were used to enhance clinical training and improve the delivery of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Fidelity of an Affirmative Cognitive Behavioral Group Intervention. Craig, SL., Pascoe, RV., Iacono, G., et al.[2023]

There is currently no clear definition or theoretical framework for gay affirmative therapy, which leaves therapists uncertain about its implementation and researchers lacking a basis for investigation.

The article suggests that gay affirmative therapy should be recognized as a culturally competent approach for working with LGBTQ+ clients and recommends future research on integrating the 'coming out' narrative into therapeutic practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gay affirmative psychotherapy with lesbian, gay, and bisexual individuals: implications for contemporary psychotherapy research. Johnson, SD.[2012]

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S0005789424001552

A Pilot Trial of an LGBTQ-Affirmative Cognitive-Behavioral ...

... effective brief screening test for problem drinking. ... Physical and/or sexual abuse are associated with negative health outcomes among transgender women of ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40032395/

Randomised controlled trial of LGBTQ-affirmative cognitive ...

Introduction: Sexual minority women represent one of the highest-risk groups for hazardous drinking and comorbid mental health problems (eg, ...

3.

bmjopen.bmj.com

bmjopen.bmj.com/content/15/3/e086738

Randomised controlled trial of LGBTQ-affirmative cognitive ...

. The Influence of Gender and Sexual Orientation on Alcohol Use and Alcohol-Related Problems: Toward a Global Perspective. Alcohol Res 2016 ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05509166

Affirmative Psychotherapy for Sexual Minority Women's ...

Participants rate 10 items on varying scales, with a higher sum indicating higher cannabis use and related problems. Baseline, 4-month follow-up, 8-month follow ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11539333/

Implementing LGBTQ-affirmative cognitive-behavioral therapy

In a pre-registered follow-up study, moderation findings indicated that the efficacy of LGBTQ-affirmative CBT on comorbid substance use, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11877267/

Randomised controlled trial of LGBTQ-affirmative cognitive ...

Behavioral couple therapy for gay and lesbian couples with alcohol use disorders. J Subst Abuse Treat. 2009;37:379–87. doi: 10.1016/j.jsat ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05408858

NCT05408858 | LGBTQ-affirmative CBT for Youth

Lesbian, gay, bisexual, transgender, and queer (LGBTQ) youth experience more mental health problems than their heterosexual and cisgender peers. The purpose ...

8.

implementationsciencecomms.biomedcentral.com

implementationsciencecomms.biomedcentral.com/articles/10.1186/s43058-024-00657-x

Implementing LGBTQ-affirmative cognitive-behavioral therapy

... LGBTQ-affirmative CBT was efficacious in reducing substance use and comorbid mental health concerns, compared to the control conditions [9] ...

9.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0005789424000352

State of the Science: LGBTQ-Affirmative Psychotherapy

LGBTQ-affirmative psychotherapy is effective in addressing mental health problems ... use of Acceptance and Commitment Therapy (ACT) with LGBTQI+ individuals.