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

Overseen By Drew Whittington, MS, MA

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Alabama at Birmingham

Must not be taking: Narcotics

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of the current study is to examine the feasibility and effectiveness of acceptance and commitment therapy, a specific form of cognitive-behavioral therapy, for treating general mental health concerns among HIV-positive men who have sex with men.

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 data supports the effectiveness of the treatment Acceptance and Commitment Therapy for mental health in HIV-positive men?

Research shows that Acceptance and Commitment Therapy (ACT) is effective for improving mental health conditions like anxiety and depression, and it has been adapted for people living with HIV to address issues like alcohol use and medication adherence. ACT helps by increasing psychological flexibility, which is the ability to adapt to difficult thoughts and feelings without being overwhelmed by them. ^{1 2 3 4 5}

Is Acceptance and Commitment Therapy safe for humans?

Acceptance and Commitment Therapy (ACT) is generally considered safe for humans. It is a type of talk therapy that has been used for various mental health conditions, and there are no known significant safety concerns associated with its use. ^{6 7 8 9 10}

How is Acceptance and Commitment Therapy (ACT) unique for mental health in HIV-positive men?

Acceptance and Commitment Therapy (ACT) is unique because it focuses on promoting psychological flexibility and acceptance, helping individuals live in accordance with their values despite the challenges of living with HIV. Unlike traditional therapies that may focus on changing thoughts, ACT encourages acceptance of difficult thoughts and feelings, which can be particularly beneficial for managing the mental health challenges associated with HIV. ^{1 2 3 4 11}

Research Team

Nicholas Borgogna, PhD

Principal Investigator

University of Alabama at Birmingham

Drew Whittington, MS, MA

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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 am 18 years old or older.

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

Trial Timeline

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

Treatment Details

Interventions

• Acceptance and Commitment Therapy (Behavioral Intervention)

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.

Participant Groups

Group I: Acceptance and commitment therapy Experimental Treatment 1 Intervention

Trial of acceptance and commitment therapy for hiv-positive men who have sex with men

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

References

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

Acceptance and Commitment Therapy (ACT) for HIV-infected Hazardous Drinkers: A Qualitative Study of Acceptability. [2023]

2. Switzerland 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Acceptance-based behavior therapy to promote HIV medication adherence. [2011]

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

Development of a Telephone-Delivered Acceptance and Commitment Therapy Intervention for People Living with HIV who are Hazardous Drinkers. [2022]

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

Acceptance and Commitment Therapy as a Treatment for Anxiety and Depression: A Review. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

[HIV infection and psychiatric symptoms: a common and important combination]. [2010]

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

The Role of Substance Use and Mental Health Problems in Medication Adherence Among HIV-Infected MSM. [2016]

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

Internalized HIV Stigma and Mindfulness: Associations With PTSD Symptom Severity in Trauma-Exposed Adults With HIV/AIDS. [2017]

9. England pubmed.ncbi.nlm.nih.gov

Relationships between mental adjustment to HIV diagnosis, psychological morbidity and sexual behaviour. [2019]

10. England 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. [2022]

11. England 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. [2017]