Acceptance and Commitment Therapy for Chemsex

(ACT-for-chemse Trial)

Overseen By Nicholas C Borgogna, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Psychotic, Bipolar, Eating, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 17

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether Acceptance and Commitment Therapy (ACT), a type of counseling, helps reduce chemsex, which involves using drugs during sexual activities. Participants will either receive ACT or continue their usual treatment to determine which is more effective. It is ideal for men living in Alabama who have engaged in chemsex in the last six months and can attend online sessions. As an unphased trial, this study offers a unique opportunity to explore new therapeutic approaches in a flexible, online setting.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this therapy is safe for chemsex?

Research has shown that Acceptance and Commitment Therapy (ACT) is generally well-received by individuals using it for issues related to chemsex. Studies have found that participants often feel supported and notice improvements in their well-being. This suggests that the therapy can be safe and helpful for those facing chemsex challenges. Although specific information on side effects is lacking, positive feedback from participants suggests that negative reactions are rare. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Acceptance and Commitment Therapy (ACT) for chemsex because it offers a fresh approach to tackling the psychological aspects of chemsex, focusing on mindfulness and acceptance strategies. Unlike standard treatments, which may focus on abstinence or harm reduction alone, ACT aims to help individuals manage their thoughts and emotions related to drug use and sexual behavior. This therapy emphasizes personal values and committed action, potentially leading to more sustainable behavior change and improved mental health outcomes.

What evidence suggests that ACT-for-chemsex might be an effective treatment for chemsex?

Research shows that Acceptance and Commitment Therapy (ACT) can assist people involved in chemsex. Past studies have demonstrated significant improvements in stress management and reductions in anxiety and depression through ACT. In this trial, participants will receive either ACT-for-chemsex or treatment as usual. For Spanish-speaking adults who engage in chemsex, ACT has improved their management of sexual and drug use urges. It also aids LGBTQI+ individuals by enhancing their ability to cope with mental health challenges. These findings suggest that ACT could effectively address issues related to chemsex. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for males aged 18-65 living in Alabama who have engaged in chemsex within the last six months, can speak English fluently, and have access to a smart device and private space for therapy sessions. It excludes those with recent self-harm or suicide attempts, severe mental health conditions like psychosis or bipolar disorder, major neurocognitive disorders, eating disorders, or those currently receiving similar ACT-based therapy.

Inclusion Criteria

Access to internet capable smart device

I am male.

I have a private space for telehealth sessions.

Exclusion Criteria

Self-harm or suicide attempt within 12 months of screener

Suicide plan/intention at time of screening

I am currently receiving treatment for a serious health condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intake Session

Participants undergo an intake session before starting therapy

1 week

1 visit (in-person)

Treatment

Participants receive 16 weeks of Acceptance and Commitment Therapy (ACT) to reduce chemsex

16 weeks

16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Multiple assessments (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• ACT-for-chemsex

Trial Overview The study tests acceptance and commitment therapy (ACT) specifically designed for individuals engaging in chemsex compared to the usual treatment methods. Participants are quasi-randomly assigned to receive either specialized ACT sessions via telehealth or continue with their standard care.

How Is the Trial Designed?

Group I: ACT-for-chemsex Experimental Treatment 1 Intervention

16 weeks of ACT to reduce chemsex

Group II: Treatment as usual Active Control 1 Intervention

Treatment as usual

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1077722923000603

Acceptance and Commitment Therapy Approach for ... Results on outcome measures showed clinically notable and statistically significative improvements in psychological flexibility, anxiety and depression symptoms ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/96/NCT06406296/ICF_001.pdf

Effectiveness of a Group Intervention Based on Acceptance ... The study is aimed at Spanish-speaking adults who engage in chemsex and wish to improve control over their sexual and substance use impulses. The study has been ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11275498/

Effectiveness of Harm Reduction Interventions in Chemsex Of the participants' responses, 26.1% felt supported, another 26.1% mentioned that it helped them a lot, 21.7% said they felt better, 13.0% felt ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06408545

Acceptance and Commitment Therapy for Problematic ... Scores range between 0 and 138. Higher scores indicate higher levels of psychological flexibility and better outcome.

5. researchgate.net researchgate.net/publication/361726335_A_call_for_ACTion_A_systematic_review_of_empirical_evidence_for_the_use_of_Acceptance_and_Commitment_Therapy_ACT_with_LGBTQI_individuals

A systematic review of empirical evidence for the use of ... Results suggested that ACT can promote PF for LGBTQI+ individuals, consequentially leading to symptom reduction for a variety of mental health problems. ACT has ...

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06408545

Acceptance and Commitment Therapy for Problematic ... Higher number of chemsex encounters indicate worse outcome. Through study completion, an average of 5 months. Change in number of different sexual partners per ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/capr.12728

A pilot RCT of an online mindfulness‐based cognitive ... Outcomes in this study suggested that MBCI helped reduce levels of chemsex and increased well-being. This cultivated a stronger understanding of ...