Clinical trial NCT06625437: ACT for HIV-Positive Men
Official title: Evaluation of the Effectiveness of Acceptance and Commitment Therapy for General Mental Health Concerns in HIV-Positive Men
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress
Anxiety
Mental Disorder
Distress-based Psychopathology
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-post design with single group of participants who will each receive the treatment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Patient Health Questionnaire-9 Screener
timeFrame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
measure: PTSD Checklist-5
timeFrame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
measure: Yale-Brown Obsessive Compulsive Scale
timeFrame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
measure: Alcohol Use Disorders Identification Test
timeFrame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
measure: HIV stigma scale
timeFrame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
measure: Internalized homophobia scale
timeFrame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
measure: Brief pornography screen
timeFrame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
measure: Life Quality Scale
timeFrame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
measure: Experiential Avoidance Rating Scale
timeFrame: 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: National Institute of Drug Abuse Modified Alcohol, Smoking, and Substance Involvement Screening Test
timeFrame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
measure: High risk sexual behaviors
timeFrame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
measure: Generalized Anxiety Disorder-7 Screener
timeFrame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
measure: PSYFLEX
timeFrame: 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)
Secondary outcomes:
measure: Therapeutic Alliance Scale
timeFrame: Administered immediately after final intervention session (8th/final session; each session is 1 hour)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Nicholas Borgogna, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Drew Whittington, MS, MA
role: PRINCIPAL_INVESTIGATOR
References: