ACT for HIV-Positive Men

Not Applicable

Recruiting

• Conditions: Stress; Anxiety; Mental Disorder; Distress-based Psychopathology
• Interventions: Behavioral: Acceptance and commitment therapy

• Registration Number: NCT06625437
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-09-26
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-02
• Study First Posted: 2024-10-03
• Study Start: 2025-01-15
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-18
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

• identify as a man
• be at least 18 years old
• has been diagnosed with HIV by a healthcare professional

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
• is currently diagnosed with any eating disorder
• has experienced hallucinations or delusions within the last 30 days
• has used narcotics within the last 7 days (heroin, meth, crack cocaine, opioids)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acceptance and commitment therapy	Acceptance and commitment therapy	Trial of acceptance and commitment therapy for hiv-positive men who have sex with men

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire-9 Screener	Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)	Measure of depressive symptoms
PTSD Checklist-5	Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)	Measure of post-traumatic stress symptoms
Yale-Brown Obsessive Compulsive Scale	Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)	Measure of obsessive-compulsive disorder symptoms
Alcohol Use Disorders Identification Test	Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)	Measure of alcohol use
HIV stigma scale	Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)	Measure of facets of stigma experienced by individuals with HIV
Internalized homophobia scale	Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)	Measure of internalized homophobia
Brief pornography screen	Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)	Measure of concerning pornography use
Life Quality Scale	Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)	Measure of life quality
Experiential Avoidance Rating Scale	Administered at baseline, every two weeks (every second therapy session) during intervention, and immediately after final intervention session (8th/final session; each session is 1 hour)	Measure of experiential avoidance
National Institute of Drug Abuse Modified Alcohol, Smoking, and Substance Involvement Screening Test	Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)	Measure of drug use
High risk sexual behaviors	Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)	* Frequency of sex with penetration; * Frequency of condom use; * Frequency of oral sex; * Frequency of sexual partners
Generalized Anxiety Disorder-7 Screener	Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)	Measure of anxiety symptoms
PSYFLEX	Administered at baseline, every two weeks (every second therapy session) during intervention, and immediately after final intervention session (8th/final session; each session is 1 hour)	Measure of psychological flexibility

Secondary Outcome Measures

Name	Time	Method
Therapeutic Alliance Scale	Administered immediately after final intervention session (8th/final session; each session is 1 hour)	Measure of patient and therapist alliance

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States