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HypersexualityNCT06408545

Acceptance and Commitment Therapy for Problematic Chemsex

A study testing Acceptance and Commitment Therapy (ACT) in people with Hypersexuality and Compulsive Sexual Behavior, run by Universidad Europea de Madrid at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Acceptance and Commitment Therapy (ACT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteSpain
Study dates
1 Mar 2024to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Universidad Europea de Madrid

    Villaviciosa de Odón, Madrid, 28670

Other trials in Spain

About this study

Official title: Acceptance and Commitment Therapy for Problematic Chemsex: a Pilot Study

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.

Read the 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 pilot study will not include a control group.

Being tested
Acceptance and Commitment Therapy (ACT)
Keywords
Sexuality, Risky sexual behavior
Medical subject headings
Compulsive Sexual Behavior Disorder, Chemsex, Sexuality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acceptance and Commitment Therapy (ACT)Behavioural

    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.

Study groups in NCT06408545
Study groupRoleWhat they receive
ACT groupExperimental8 individual weekly sessions including ACT methods
Receives: Behavioral: Acceptance and Commitment Therapy (ACT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from Baseline Hypersexuality at 5 months

Secondary outcomes (17)
  1. 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.

    Measured: Change from Baseline Drug Abuse at 5 months

  2. 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.

    Measured: Change from Baseline Anxiety and Depression at 5 months

  3. 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.

    Measured: Change from Baseline psychological inflexibility at 5 months

  4. 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.

    Measured: Change from Baseline Internalized Homonegativity at 5 months

  5. 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.

    Measured: Change from Baseline Emotional Loneliness at 5 months

  6. 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.

    Measured: Change from Baseline Awareness, Courage and Responsiveness at 5 months

  7. 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.

    Measured: Change from Baseline psychological flexibility at 5 months

  8. 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.

    Measured: Change from Baseline value consistency living at 5 months

  9. 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.

    Measured: Through study completion, an average of 5 months

  10. 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.

    Measured: Through study completion, an average of 5 months

  11. 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.

    Measured: Through study completion, an average of 5 months

  12. 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.

    Measured: Through study completion, an average of 5 months

  13. 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.

    Measured: Through study completion, an average of 5 months

  14. 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.

    Measured: Through study completion, an average of 5 months

  15. 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

    Measured: Through study completion, an average of 5 months

  16. 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.

    Measured: Through study completion, an average of 5 months

  17. 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.

    Measured: Through study completion, an average of 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2024
  2. Study start1 Mar 2024
  3. Primary completion30 Sep 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06408545
Sponsor's protocol ID
2023-324
Status last verified
Apr 2024
First submitted
22 Apr 2024
Last updated
23 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Acceptance and Commitment Therapy (ACT) in people with Hypersexuality and Compulsive Sexual Behavior, run by Universidad Europea de Madrid at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hypersexual Behavior Inventory (HBI) (time frame: Change from Baseline Hypersexuality at 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.

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