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

Trial Summary

What is the purpose of 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.

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.

What data supports the effectiveness of the treatment Affirmative Psychotherapy for Mental Health Issues?

Research indicates that LGBTQ-affirmative cognitive-behavioral therapy (CBT) can be effective in addressing mental health issues related to minority stress, as shown in a study on internet-based CBT for LGBTQ youth. Additionally, the development of fidelity processes for affirmative CBT interventions suggests a structured approach to ensuring effective implementation for LGBTQ+ populations. ^{1 2 3 4 5}

Is LGBTQ-affirmative psychotherapy safe for humans?

The available research does not specifically address safety concerns, but LGBTQ-affirmative psychotherapy is generally considered safe as it focuses on providing supportive and culturally appropriate care for LGBTQ individuals. ^{1 2 3 4 5}

How is LGBTQ-affirmative CBT different from other treatments for mental health issues?

LGBTQ-affirmative CBT is unique because it specifically incorporates cultural competence and affirmative practices to support LGBTQ+ individuals, addressing their unique experiences and challenges. This approach is not limited to sexual orientation-specific issues but is designed to be inclusive and applicable to all clients, enhancing the therapeutic process by acknowledging and affirming diverse identities. ^{2 3 4 5 6}

Research Team

John E Pachankis, PhD

Principal Investigator

Yale University

Tonda Hughes, PhD

Principal Investigator

Columbia University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Affirmative LGBT psychotherapy: Outcomes of a therapist training protocol. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Engaging in LGBQ+ affirmative psychotherapies with all clients: Defining themes and practices. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Training in LGBTQ-affirmative cognitive behavioral therapy: A randomized controlled trial across LGBTQ community centers. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Assessing the Fidelity of an Affirmative Cognitive Behavioral Group Intervention. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

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