Acceptance and Commitment Therapy for Chemsex

Not Applicable

Not yet recruiting

• Conditions: Chemsex

• Registration Number: NCT06980974
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

Quasi-randomized control trial of acceptance and commitment therapy (ACT) for chemsex.

Detailed Description

Intervention will entail a prescreening, intake session, 16 therapy sessions, and a six-month follow-up. Each session will be 45-55 minutes long. Participants in ACT-for-chemsex will be compared to participants in a treatment as usual condition.

Study Timeline

• Study First Submitted: 2025-04-21
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-12
• Last Update Submitted: 2025-05-12
• Study First Posted: 2025-05-20
• Last Update Posted: 2025-05-20
• Study Start: 2025-12-01
• Primary Completion: 2030-07-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

• Male
• age 18-65
• access to internet capable smart device
• documentation of Alabama residence
• access to a private area to attend tele ACT-for-chemsex sessions
• self-reported chemsex within six-months of intake
• English fluency.

Exclusion Criteria

• Psychotic disorder
• bipolar disorder
• eating disorder
• major neurocognitive disorder diagnosis
• self-harm or suicide attempt within 12 months of screener
• suicide plan/intention at time of screening
• ongoing treatment for a complex medical comorbidity (e.g., in patient cancer treatment)
• current enrollment in an individual ACT-based psychotherapy intervention.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Chemsex frequency	Baseline, 16 week post-treatment, six month follow-up	Self-reported chemsex frequency in the past six months

Secondary Outcome Measures

Name	Time	Method
Modified NIDA ASSIST	Baseline, 16 week post-treatment, six month follow-up	Past six month substance use on the following scale 0=never; 1. Once or Twice; 2. Monthly; 3. Weekly; 4. Daily or Almost Daily
Sexual Health History	Baseline	Questions will inquire about STI status including a lifetime history and past 12-month diagnostic status for the following STIs: HIV, Gonorrhea, Syphilis, Chlamydia, Hepatitis C, and Genital Herpes. Participants will be asked "In the past year, have you taken PrEP (pre-exposure prophylaxis)?" ("0=No", "1=Yes, Daily PrEP", "2=Yes, On-Demand \[2-1-1\] PrEP", "3=Yes, Long-acting PrEP", "4=Not sure"). We will include ad-hoc measures commonly used in previous studies for single item assessments of lifetime, past year, past month, and past week number of partnered sexual experiences, sexual partners, and age of first partnered sexual experience. We will also include the ID Risk Behavior (BRAID) scale (e.g., "Had unprotected \[no condom\] sex with someone who was a one-night stand or someone you had just met?" "yes", "no"), sexual violence questions as recommended by the Centers for Disease Control and Prevention YRCSS standard national questionnaire.
Center for epidemiologic studies depression scale	Baseline, 16 week post-treatment, six month follow-up, every two weeks.	A series of questions asking about depression symptoms (e.g. " I was bothered by things that usually don't bother me "); On the following scale: 0=Rarely or none of the time (less than 1 day); 1. Some or a little of the time (1-2 days); 2. Occasionally or a moderate amount of the time (3-4 days); 3. Most or all of the time (5-7 days)
generalized anxiety disorder-7	Baseline, 16 week post-treatment, six month follow-up, every two weeks	Anxiety measure.; Over the last two weeks, how often have you been bothered by the following problems?; e.g. "Feeling nervous, anxious, or on edge"; 0=not at all; 1. several days; 2. more than half the days; 3. nearly every day
Quality of Life Scale	Baseline, 16 week post-treatment, six month follow-up	A series of questions asking about quality of life (e.g. " Relations with parents, siblings, other relatives")
Experiential Avoidance Rating Scale	Baseline, 16 week post-treatment, six month follow-up	A series of questions asking about experiential avoidance symptoms (e.g. "I have gone to extremes to get rid of thoughts I don't like.")
Patient Checklist-5	Baseline, 16 week post-treatment, six month follow-up	A series of questions asking about PTSD symptoms (e.g. " Repeated, disturbing, and unwanted memories of the stressful experience? ")
PSY Flex	Through study completion, an average of one a week"	A series of questions asking about psychological flexibility (e.g. "Even if I am somewhere else with my thoughts, I can focus on what's going on in important moments.")
Multidimensional Psychological Flexibility Inventory	Baseline, 16 week post-treatment, six month follow-up	A series of questions asking about psychological flexibility (e.g. " I was receptive to observing unpleasant thoughts and feelings without interfering with them.")

Trial Locations

Locations (1)

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