Acceptance and Commitment Therapy for Mental Health in HIV-Positive Men

(ACT for HIV Trial)

Overseen By Drew Whittington, MS, MA

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Narcotics

Disqualifiers: Self-harm, Suicide attempt, Eating disorder, others

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

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether acceptance and commitment therapy, a form of talk therapy, can improve mental health for men living with HIV. The therapy emphasizes accepting thoughts and feelings rather than fighting them and committing to personal values. Men diagnosed with HIV who have not recently experienced issues with self-harm or substance use might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance mental health support for men living with HIV.

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 mention that participants should not have used narcotics like heroin, meth, crack cocaine, or opioids in the last 7 days.

What prior data suggests that acceptance and commitment therapy is safe for mental health in HIV-positive men?

Research has shown that Acceptance and Commitment Therapy (ACT) is safe and well-tolerated for people living with HIV. Studies involving HIV-positive individuals, particularly those who might drink heavily, have found ACT to be practical and acceptable. Participants could continue with the therapy and generally responded well.

In another study, researchers developed a four-session ACT program for hospitalized patients. Therapists and HIV care experts found it useful for these patients, and no major safety issues were reported.

Overall, while specific details on side effects aren't mentioned, the available evidence suggests that ACT is a safe option for improving mental health in HIV-positive men. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Acceptance and Commitment Therapy (ACT) for mental health in HIV-positive men is unique because it focuses on enhancing psychological flexibility rather than merely reducing symptoms. Unlike standard treatments, which often rely on medications or traditional talk therapy to manage mental health in HIV-positive individuals, ACT encourages patients to accept their thoughts and feelings while committing to personal values and behavior changes. Researchers are excited about this approach because it empowers individuals to live more meaningful lives, even in the face of challenging emotions and circumstances, potentially leading to improved mental health and overall well-being.

What evidence suggests that acceptance and commitment therapy is effective for mental health in HIV-positive men?

Research has shown that Acceptance and Commitment Therapy (ACT), the focus of this trial, can effectively improve mental health conditions like anxiety and depression. This therapy encourages individuals to focus on the present moment and take actions aligned with their personal values, aiding in the management of various psychological symptoms. Studies indicate that ACT is practical and well-received by people living with HIV, particularly those facing stigma or engaging in risky behaviors. Specifically, ACT has been helpful in reducing self-stigma among gay men living with HIV. These findings suggest that ACT could improve overall mental health in HIV-positive men. ^{2 4 6 7 8}

Who Is on the Research Team?

Nicholas Borgogna, PhD

Principal Investigator

University of Alabama at Birmingham

Drew Whittington, MS, MA

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for men who are at least 18 years old and have been diagnosed with HIV. It's specifically aimed at those experiencing mental health issues such as anxiety, stress, or other psychiatric disorders.

Inclusion Criteria

I have been diagnosed with HIV.

I identify as a man.

Exclusion Criteria

Has engaged in self-harm within the last three months

Has attempted suicide within the last year

Has had an active plan to attempt suicide within the last 30 days

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive acceptance and commitment therapy for general mental health concerns

8 weeks

8 sessions (in-person, 1 hour each)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acceptance and Commitment Therapy

Trial Overview The study is testing the effectiveness of acceptance and commitment therapy (ACT), a type of cognitive-behavioral therapy, in improving mental health among HIV-positive men who engage in sexual activity with other men.

How Is the Trial Designed?

Group I: Acceptance and commitment therapy Experimental Treatment 1 Intervention

Trial of acceptance and commitment therapy for hiv-positive men.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

This study adapted an Acceptance and Commitment Therapy (ACT) intervention for people living with HIV who engage in hazardous drinking, using a systematic approach that included input from both patients (13 participants) and healthcare providers (10 participants).

The adaptation process followed the ADAPT-ITT model, which provides a structured framework for developing behavioral interventions, ensuring that the new ACT intervention is tailored to the specific needs of PWH and can be effectively implemented in future randomized clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Telephone-Delivered Acceptance and Commitment Therapy Intervention for People Living with HIV who are Hazardous Drinkers. Woolf-King, SE., Firkey, M., Foley, JD., et al.[2022]

In a study of 137 people living with HIV/AIDS, internalized HIV stigma was found to increase the severity of PTSD symptoms, particularly in areas of re-experiencing and hyper-arousal, suggesting it may be a vulnerability factor for these individuals.

Mindfulness skills, specifically acting with awareness, were associated with reduced severity of PTSD symptoms, indicating that enhancing mindfulness could serve as a protective factor in trauma-exposed individuals with HIV/AIDS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internalized HIV Stigma and Mindfulness: Associations With PTSD Symptom Severity in Trauma-Exposed Adults With HIV/AIDS. Gonzalez, A., Locicero, B., Mahaffey, B., et al.[2017]

A study involving 144 HIV-positive pregnant women in Nigeria showed that introducing acceptance and commitment therapy (ACT) with weekly mobile phone messages significantly improved mental health, as indicated by higher scores on the Action and Acceptance Questionnaire (AAQ-II).

The intervention, which lasted for three months, demonstrated that mobile phone-based ACT can enhance psychological flexibility in women diagnosed with HIV, suggesting a beneficial approach to mental health support in PMTCT programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of mobile phones to deliver acceptance and commitment therapy in the prevention of mother-child HIV transmission in Nigeria. Ishola, AG., Chipps, J.[2017]

Asymptomatic HIV antibody positive men exhibited higher levels of anxiety and hopelessness compared to male cancer patients, indicating a unique psychological adjustment pattern in this group.

The study found a positive correlation between depression and high-risk sexual practices among HIV-infected men, suggesting that mental health may influence behaviors related to HIV transmission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationships between mental adjustment to HIV diagnosis, psychological morbidity and sexual behaviour. Kelly, B., Dunne, M., Raphael, B., et al.[2019]

Acceptance and Commitment Therapy (ACT) was found to be perceived as appropriate and relevant for people living with HIV who also engage in hazardous drinking, suggesting its potential as a tailored intervention.

Participants expressed both satisfaction and dissatisfaction with ACT, highlighting the need to address specific positive and negative effects, as well as identifying facilitators and barriers to effectively implementing this therapy in HIV care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and Commitment Therapy (ACT) for HIV-infected Hazardous Drinkers: A Qualitative Study of Acceptability. Woolf-King, SE., Sheinfil, AZ., Babowich, JD., et al.[2023]

Acceptance and Commitment Therapy (ACT) has been shown to be more effective than waitlist conditions and standard treatment for depression and anxiety, based on a systematic review of 36 randomized controlled trials.

The effectiveness of ACT is linked to its ability to enhance psychological flexibility, which is a key mechanism in its approach to treating mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and Commitment Therapy as a Treatment for Anxiety and Depression: A Review. Twohig, MP., Levin, ME.[2018]

About 50% of HIV patients experience mental disorders, which can significantly interfere with their treatment and health outcomes, as seen in two case studies of patients with severe depression and posttraumatic stress disorder.

After receiving psychiatric treatment, both patients improved their adherence to antiretroviral therapy and made safer choices regarding sexual behavior, highlighting the importance of addressing mental health in the management of HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[HIV infection and psychiatric symptoms: a common and important combination]. Schadé, A., Bierman, WF.[2010]

HIV-infected men who have sex with men (MSM) often face mental health and substance abuse issues that significantly hinder their ability to stick to antiretroviral therapy (ART), which is crucial for managing their health and preventing HIV transmission.

Recent intervention trials have shown promise in improving ART adherence by simultaneously addressing these mental health and substance abuse problems, highlighting the need for integrated approaches to support this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Substance Use and Mental Health Problems in Medication Adherence Among HIV-Infected MSM. White, JM., Gordon, JR., Mimiaga, MJ.[2016]

In a study of 456 HIV-positive men who have sex with men, 71% were on antiretroviral treatment, primarily using a combination of protease inhibitors and nucleoside reverse transcriptase inhibitors, highlighting the widespread use of effective treatment regimens.

However, 51% of those on treatment reported missing at least one dose in the past month, with factors like avoidant coping strategies and alcohol use linked to poorer adherence, indicating a need for targeted support to improve medication compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of HIV antiretroviral treatments, access and adherence in an ethnically diverse sample of men who have sex with men. Halkitis, PN., Parsons, JT., Wolitski, RJ., et al.[2022]

Acceptance-based behavior therapy (ABBT) may be more effective than traditional cognitive behavioral interventions in improving adherence to highly active antiretroviral therapy (HAART) among adults with HIV, particularly by addressing avoidance behaviors related to stigma and denial.

The study outlines an ABBT approach tailored for urban, minority, low socioeconomic patients, and preliminary observations suggest that this treatment is feasible and acceptable for promoting HAART adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance-based behavior therapy to promote HIV medication adherence. Moitra, E., Herbert, JD., Forman, EM.[2011]

A new Acceptance and Commitment Therapy (ACT)-based intervention was developed for hospitalized patients with HIV who are not consistently engaged in care, showing high acceptability among participants.

Of the patients who attended at least three sessions, half followed up with HIV care and achieved a viral load of less than 20 copies/mL two months after the intervention, indicating potential efficacy in improving treatment engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Initial Feasibility of a Hospital-Based Acceptance and Commitment Therapy Intervention to Improve Retention in Care for Out-of-Care Persons with HIV: Lessons Learned from an Open Pilot Trial. Dindo, L., Moitra, E., Roddy, MK., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6764523/

Acceptance and Commitment Therapy (ACT) for HIV ... The qualitative data from this study indicate that ACT is a feasible and acceptable transdiagnostic approach for PLWH who are at-risk drinkers.

2. withpower.com withpower.com/trial/phase-mental-disorders-2025-8bba7

Acceptance and Commitment Therapy for Mental Health in ... Research shows that Acceptance and Commitment Therapy (ACT) is effective for improving mental health conditions like anxiety and depression, and it has been ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1077722914000935

Acceptance and Compassion-Based Group Therapy to ... ACT, combined with CFT techniques, appeared to reduce the experience of self-stigma among these gay men living with HIV.

4. elsevier.es elsevier.es/es-revista-enfermeria-clinica-35-articulo-effect-logo-therapy-acceptance-commitment-therapy-S1130862118300469

Effect of logo-therapy, acceptance, commitment ... Research has shown that the psychological welfare of people living with HIV can be improved through social support. Family psychoeducation (FPE) is a mental ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03974061

Brief Acceptance and Commitment Therapy for HIV ... ACT is a transdiagnostic treatment that uses mindfulness skills and values-guided behavioral action plans to impact a broad array of psychological symptoms. ACT ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06625437

Study Details | NCT06625437 | ACT for HIV-Positive Men The purpose of the current study is to examine the feasibility and effectiveness of acceptance and commitment therapy, a specific form of cognitive-behavioral ...

7. researchprotocols.org researchprotocols.org/2025/1/e65921

Protocol for a Pilot Randomized Controlled Trial This study aims to develop and test an intervention, ACTPrEP, to increase PrEP use among young Black men who have sex with men.

8. mdpi.com mdpi.com/2077-0383/11/10/2827

Development and Initial Feasibility of a Hospital-Based ... Therapists and HIV care experts developed a four-session ACT-based intervention to be delivered during hospitalization. Fifteen hospitalized patients with ...