Clinical trial NCT06406296: Effectiveness of ACT for Problematic Chemsex
Official title: Effectiveness of a Group Intervention Based on Acceptance and Commitment Therapy to Address Problematic Chemsex Through a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypersexuality
Compulsive Sexual Behavior
Sexualized Drug Use (Chemsex)
Keywords: Sexuality
Risky sexual behavior
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
Collaborators: name: Apoyo Positivo
First posted: 2024-05-09
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization assigned participants to 2 arms:

ACT group Waiting list
Primary purpose: TREATMENT

Brief summary: Investigation of the efficacy of Acceptance and Commitment Therapy (ACT) for the psychological treatment of problematic chemsex.

Detailed description: After being informed about the study, all patients giving written informed consent will be assessed to determine eligibility for study entry.

Patients who meet eligibility requirements will receive psychological intervention consisting in an 8-session individual on line-delivered ACT-based treatment.

The participants will be assessed through self-report instruments before and after treatment and at 3 months follow-up.

The clinical trial will include a control group.

Eligibility criteria: Inclusion Criteria:

* older than 18 years-old
* Spanish speaking
* having used psychoactive substances to facilitate, maintain and/or improve sexual relations in the last year
* significant score on the HBI Inventory (of 53 or more)
* clinically significant discomfort related to sexual practices
* degree of interference in his/her life of sexual practices greater than or equal to 5 out of 10
* desire to improve/reduce excessive sexual behaviour

Exclusion Criteria:

* receiving psychological or psychopharmacological treatment
* intellectual disability
* substance dependence (use not associated with sex)
* personality disorder or other serious or chronic mental disorder diagnosed

Primary outcomes:
measure: Change in Hypersexual Behavior Inventory (HBI)
timeFrame: Change from Baseline Hypersexuality at 5 months
Secondary outcomes:
measure: Change in Drug Abuse Screening Test (Dast-10)
timeFrame: Change from Baseline Drug Abuse at 5 months
measure: Change in Brief Symptom Inventory (BSI)
timeFrame: Change from Baseline Anxiety and Depression at 5 months
measure: Change in Acceptance and Action Questionnaire (AAQ-II)
timeFrame: Change from Baseline psychological inflexibility at 5 months
measure: Change in Short Internalized Homonegativity Scale (SIHS)
timeFrame: Change from Baseline Internalized Homonegativity at 5 months
measure: Change in Social and Emotional Loneliness in Adults (SESLA)
timeFrame: Change from Baseline Emotional Loneliness at 5 months
measure: Change in Awareness, Courage and Responsiveness Scale (ACRS)
timeFrame: Change from Baseline Awareness, Courage and Responsiveness at 5 months
measure: Change in The Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT)
timeFrame: Change from Baseline psychological flexibility at 5 months
measure: Change in the Life Values Questionnaire (VLQ)
timeFrame: Change from Baseline value consistency living at 5 months
measure: Change in Time spent planning or practicing sex per week
timeFrame: Through study completion, an average of 5 months
measure: Change in Frequency of chemsex encounters per week
timeFrame: Through study completion, an average of 5 months
measure: Change in number of different sexual partners per week
timeFrame: Through study completion, an average of 5 months
measure: Change in Frequency of substance consumption per week
timeFrame: Through study completion, an average of 5 months
measure: Change in Frequency of risky sexual practices per week
timeFrame: Through study completion, an average of 5 months
measure: Change in number of new diagnoses of sexually transmitted infections per week
timeFrame: Through study completion, an average of 5 months
measure: Change in Intensity of cravings subjective scale
timeFrame: Through study completion, an average of 5 months
measure: Change in Interference of cravings subjective scale
timeFrame: Through study completion, an average of 5 months
measure: Change in Frequency of value committed actions per week
timeFrame: Through study completion, an average of 5 months
Other outcomes:
Locations:
city: Villaviciosa De Odón
country: Spain
facility: Universidad Europea de Madrid
state: Madrid
Study officials:
affiliation: Universidad Europea de Madrid
name: Francisco Montesinos, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: