Acceptance and Commitment Therapy for Problematic Chemsex

Compulsive Sexual Behavior Clinical Trial

Official title:

Acceptance and Commitment Therapy for Problematic Chemsex: a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06408545
• Other study ID #: 2023-324
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Universidad Europea de Madrid
• Contact: Francisco M Montesinos, Ph.D.
• Phone: +34647413773
• Email: francisco.montesinos[@]universidadeuropea.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigation of the efficacy of Acceptance and Commitment Therapy (ACT) for the psychological treatment of problematic chemsex. As a pilot study, the intervention will be tested in a small group.

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 pilot study will not include a control group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Compulsive Sexual Behavior
• Hypersexuality

Intervention

Behavioral:
• Acceptance and Commitment Therapy (ACT)
Acceptance and Commitment Therapy methods were focused on promoting Values clarification, Acceptance, Cognitive defusion, Committed action and Flexible attention to the present moment, and included methods such as the Garden Metaphor, Funeral exercise or Mindfulness training.

Locations

Country	Name	City	State
Spain	Universidad Europea de Madrid	Villaviciosa de Odón	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Europea de Madrid	Apoyo Positivo

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hypersexual Behavior Inventory (HBI)	The Hypersexual Behavior Inventory is a 19-item, seven-point Likert-type scale. Scores range between 19 and 95. Higher scores indicate higher levels of Hypersexuality and worse outcome. The presence of a problem of hypersexuality is considered when the score is equal or higher than 53.	Change from Baseline Hypersexuality at 5 months
Secondary	Change in Drug Abuse Screening Test (Dast-10)	Drug Abuse Screening Test is a self-administered 10-item questionnaire with dichotomous (Yes/No) responses designed to identify individuals with problematic drug use. Scores range between 0 and 10. Different cutoff points are established regarding problematic substance use, as follows: 0 = low risk or abstinence, 1-2 = risk, 3-5 = harmful, > 6 = substance dependence. The presence of a problem of substance abuse is considered when the score is equal or higher than 3.	Change from Baseline Drug Abuse at 5 months
Secondary	Change in Brief Symptom Inventory (BSI)	Anxiety and Depression subscales of The Brief Symptom Inventory (BSI) include 15 items, each item is rated on a 5-point scale (0 to 4) according to manifestations of anxiety and depression symptoms in the last 30 days (ranging from ''not at-all'' to ''extremely''). Higher scores indicate higher levels of anxiety and depression and worse outcome.	Change from Baseline Anxiety and Depression at 5 months
Secondary	Change in Acceptance and Action Questionnaire (AAQ-II)	Acceptance and Action Questionnaire assesses psychological inflexibility. It is a 7-item, seven-point Likert-type scale. Scores range between 7 and 49. Higher scores indicate higher levels of psychological inflexibility and worse outcome. The presence of a problem of psychological inflexibility is considered when the score is equal or higher than 27.	Change from Baseline psychological inflexibility at 5 months
Secondary	Change in Short Internalized Homonegativity Scale (SIHS)	Internalized homophobia has been defined as "the internalization of society's homophobic attitudes within a lesbian, gay, or bisexual individual". The Short Internalized Homonegativity Scale measures this phenomenon through a 13-item, five-point Likert-type scale ranging from strongly disagree to strongly agree. Scores range between 13 and 65. Higher scores indicate higher levels of internalized homonegativity and worse outcome. For men, the mean total score is 28.16 (SD = 8.23). The questionnaire includes three sub-scales: public identification as homosexual, sexual comfort with homosexual and social comfort with homosexual people.	Change from Baseline Internalized Homonegativity at 5 months
Secondary	Change in Social and Emotional Loneliness in Adults (SESLA)	The Scale of Evaluation of Social and Emotional Loneliness in Adults evaluates loneliness. The scale is comprised of 3 factors: social loneliness, which reflects the lack of friends and social relationships, family loneliness, which reflects the lack of a supportive family environment for the person, and romantic loneliness, which reflects the lack of an intimate romantic relationship. The scale consists of 15 items with which agreement or disagreement is shown according to a 7-point Likert-type scale. Scores range between 15 and 105. Higher scores indicate higher levels of loneliness and worse outcome.	Change from Baseline Emotional Loneliness at 5 months
Secondary	Change in Awareness, Courage and Responsiveness Scale (ACRS)	The Awareness, Courage and Responsiveness Scale is the first measure created to assess a contextual-behavioral model of Intimacy, rooted in the Functional Analytic Psychotherapy. It is a 24-item self-report assessment to evaluate the components of the ACR model, using a 7-point Likert-type scale from 1 (never true) to 7 (always true). The scale is comprised of 4 subscales: Others-Awareness (OA), 5 items; Self-Awareness (SA), 6 items; Courage (C), 6 items; and Responsiveness (R), 7 items. The total sum of the items of the scale is considered a global measure of Intimacy (ACRS-T). Scores range between 24 and 168. Higher scores indicate higher levels of skills to generate intimacy and better outcome.	Change from Baseline Awareness, Courage and Responsiveness at 5 months
Secondary	Change in The Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT)	The Comprehensive Assessment of Acceptance and Commitment Therapy Processes Change is a 23-item, seven-point Likert-type scale. Scores range between 0 and 138. Higher scores indicate higher levels of psychological flexibility and better outcome. This scale provides more accurate information about each of the psychological processes underlying psychological flexibility. Specifically, it consists of 3 subscales: openness, awareness, and action.	Change from Baseline psychological flexibility at 5 months
Secondary	Change in the Life Values Questionnaire (VLQ)	The Life Values Questionnaire relates to 10 domains of different life values, which include: family, marriage/intimate partner relationships, parenthood, friendship, work, education, leisure, spirituality, citizenship, and physical self-care. Participants are asked to evaluate on a Likert scale from 0 to 10 the degree of importance they give to these values, where 0 is of little importance and 10 is of great importance. Additionally, they are asked to rate the degree of consistency with which they engage in actions committed to these values, ranging from 0 to 10. Scores are obtained for different sub-scales: importance, consistency, and discrepancy. As a global score for the questionnaire, the composite score is obtained by subtracting the consistency score from the importance score. Higher scores in discrepancy indicates lower levels of value consistency living and worse outcome.	Change from Baseline value consistency living at 5 months
Secondary	Change in Time spent planning or practicing sex per week	Time spent (hours) planning or practicing sex during last week. Higher number of hours indicate worse outcome.	Through study completion, an average of 5 months
Secondary	Change in Frequency of chemsex encounters per week	Self-monitoring: Frequency of practicing chemsex during last week. Higher number of chemsex encounters indicate worse outcome.	Through study completion, an average of 5 months
Secondary	Change in number of different sexual partners per week	Self-monitoring: Number of different sexual partners during last week. Higher number of different sexual partners indicate worse outcome.	Through study completion, an average of 5 months
Secondary	Change in Frequency of substance consumption per week	Self-monitoring: Frequency of consuming substances during last week. Higher number of substances consumed indicate worse outcome.	Through study completion, an average of 5 months
Secondary	Change in Frequency of risky sexual practices per week	Self-monitoring: Frequency of risky sexual practices during the last week. Higher number of risky sexual practices indicate worse outcome.	Through study completion, an average of 5 months
Secondary	Change in number of new diagnoses of sexually transmitted infections per week	Self-monitoring: Number of new diagnoses of sexually transmitted infections. Higher number of new diagnoses indicate worse outcome.	Through study completion, an average of 5 months
Secondary	Change in Intensity of cravings subjective scale	Global self-assessment of intensity of cravings Visual Analogue Scale-ratings. Scores range from 0 = very low intensity to 10 = very high intensity. Higher scores indicate higher levels of intensity of cravings and worse outcome	Through study completion, an average of 5 months
Secondary	Change in Interference of cravings subjective scale	Global self-assessment of interference of cravings Visual Analogue Scale-ratings. Scores range from 0 = very low interference to 10 = very high interference. Higher scores indicate higher levels of interference of cravings and worse outcome.	Through study completion, an average of 5 months
Secondary	Change in Frequency of value committed actions per week	Self-monitoring: Frequency of value committed actions in presence of craving during last week. Higher number of value committed actions indicate better outcome.	Through study completion, an average of 5 months