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.
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
- Conditions the study is for
- Hypersexuality, Compulsive Sexual Behavior, Sexualized Drug Use (Chemsex)
- What is being tested?
- Acceptance and Commitment Therapy (ACT)
- Type of treatment
- Lifestyle or therapy programme
- 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.
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 group | Role | What they receive |
|---|---|---|
| ACT group | Experimental | 8 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.
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted10 May 2024
- Study start1 Mar 2024
- Primary completion30 Sep 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypersexualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Apoyo Positivo
- Responsible party
- Sponsor
- Investigators
- Francisco Montesinos, Ph.D., Principal investigator, Universidad Europea de Madrid
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Therapy for Problematic Chemsex: a Pilot Study
- ClinicalTrials.gov ID
- NCT06408545
- Acronym / sponsor ID
- 2023-324
- Keywords
- Sexuality, Risky sexual behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Collaborators
- Apoyo Positivo
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACT group | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT)8 individual weekly sessions including ACT methods |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- receiving psychological or psychopharmacological treatment
- intellectual disability
- substance dependence (use not associated with sex)
- personality disorder or other serious or chronic mental disorder diagnosed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | ACT group |
Primary outcome
Change in Hypersexual Behavior Inventory (HBI)
Time frame: Change from Baseline Hypersexuality at 5 months
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.
17 secondary outcomes
Change in Drug Abuse Screening Test (Dast-10)
Time frame: Change from Baseline Drug Abuse at 5 months
Change in Brief Symptom Inventory (BSI)
Time frame: Change from Baseline Anxiety and Depression at 5 months
Change in Acceptance and Action Questionnaire (AAQ-II)
Time frame: Change from Baseline psychological inflexibility at 5 months
Change in Short Internalized Homonegativity Scale (SIHS)
Time frame: Change from Baseline Internalized Homonegativity at 5 months
Change in Social and Emotional Loneliness in Adults (SESLA)
Time frame: Change from Baseline Emotional Loneliness at 5 months
Change in Awareness, Courage and Responsiveness Scale (ACRS)
Time frame: Change from Baseline Awareness, Courage and Responsiveness at 5 months
Change in The Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT)
Time frame: Change from Baseline psychological flexibility at 5 months
Change in the Life Values Questionnaire (VLQ)
Time frame: Change from Baseline value consistency living at 5 months
Change in Time spent planning or practicing sex per week
Time frame: Through study completion, an average of 5 months
Change in Frequency of chemsex encounters per week
Time frame: Through study completion, an average of 5 months
Change in number of different sexual partners per week
Time frame: Through study completion, an average of 5 months
Change in Frequency of substance consumption per week
Time frame: Through study completion, an average of 5 months
Change in Frequency of risky sexual practices per week
Time frame: Through study completion, an average of 5 months
Change in number of new diagnoses of sexually transmitted infections per week
Time frame: Through study completion, an average of 5 months
Change in Intensity of cravings subjective scale
Time frame: Through study completion, an average of 5 months
Change in Interference of cravings subjective scale
Time frame: Through study completion, an average of 5 months
Change in Frequency of value committed actions per week
Time frame: Through study completion, an average of 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco Montesinos, Ph.D. principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
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.