NCT06980974WithdrawnNot Applicable
Quasi-Randomized Controlled Trial of Acceptance and Commitment Therapy for Chemsex
University of Alabama at Birmingham2 sites in 1 country100 target enrollmentStarted: December 1, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Chemsex frequency
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Arms & Interventions
ACT-for-chemsex
Experimental
16 weeks of ACT to reduce chemsex
Intervention: ACT-for-chemsex (Behavioral)
Treatment as usual
Active Comparator
Treatment as usual
Intervention: Treatment as Usual (TAU) (Other)
Outcomes
Primary Outcomes
Chemsex frequency
Time Frame: Baseline, 16 week post-treatment, six month follow-up
Self-reported chemsex frequency in the past six months
Secondary Outcomes
- Modified NIDA ASSIST(Baseline, 16 week post-treatment, six month follow-up)
- Quality of Life Scale(Baseline, 16 week post-treatment, six month follow-up)
- Sexual Health History(Baseline)
- Center for epidemiologic studies depression scale(Baseline, 16 week post-treatment, six month follow-up, every two weeks.)
- generalized anxiety disorder-7(Baseline, 16 week post-treatment, six month follow-up, every two weeks)
- Experiential Avoidance Rating Scale(Baseline, 16 week post-treatment, six month follow-up)
- Patient Checklist-5(Baseline, 16 week post-treatment, six month follow-up)
- PSY Flex(Through study completion, an average of one a week")
- Multidimensional Psychological Flexibility Inventory(Baseline, 16 week post-treatment, six month follow-up)
Investigators
Nicholas C. Borgogna
Assistant Professor
University of Alabama at Birmingham
Study Sites (2)
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