Compulsive Sexual BehaviorNCT05572372
Effects of an ACT-based Psychological Treatment in Patients With Hypersexuality
A study testing Acceptance and Commitment Therapy in people with Compulsive Sexual Behavior and Hypersexuality, 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 hypersexuality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Compulsive Sexual Behavior, Hypersexuality
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jan 2022to 31 Dec 2022
- 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 had a sexual relationship in the last year
- significant score on the HBI Inventory (of 53 or more)
- at least 6 months of problematic pornography use or sexual practices
- clinically significant discomfort related to sexual practices
Show all 9Show fewer
- degree of interference in his/her life of sexual practices greater than or equal to 5 out of 10
- at least one failure in his attempts to change his sexual life
- desire to improve/reduce excessive sexual behaviour
Who cannot join
- practicing meditation at least once a week in the last three months
- 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: Psychological Treatment of Hypersexuality: a Clinical Trial With Acceptance and Commitment Therapy
Investigation of the efficacy of Acceptance and Commitment Therapy (ACT) for the psychological treatment of hypersexuality.
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 clinical trial will not include a control group.
- Conditions
- Compulsive Sexual Behavior, Hypersexuality
- Being tested
- Acceptance and Commitment Therapy
- Medical subject headings
- Compulsive Sexual Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
The aim of the intervention was to increase psychological flexibility. Therapeutic methods focused on values clarification, cognitive defusion, self-as-context, acceptance, commited action and flexible attention to present moment.
| Study group | Role | What they receive |
|---|---|---|
| ACT group | Experimental | Psychological intervention will consist in an 8-session individual on line-delivered ACT-based treatment. Receives: Behavioral: Acceptance and Commitment Therapy |
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. García-Barba et al. (2020) consider the presence of a problem of hypersexuality when the score is equal or higher than 53.
Measured: Change from Baseline Hypersexuality at 5 months
Secondary outcomes (11)
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.
Measured: Change from Baseline psychological inflexibilty at 5 months
Change in Cognitive Fusion Questionnaire (CFQ)
Cognitive Fusion Questionnaire assesses cognitive fusion. It is a 7-item, seven-point Likert-type scale. Scores range between 7 and 49. Higher the score in the questionnaire, the higher the tendency to believe the literal content of private events (higher levels of cognitive fusion and worse outcome).
Measured: Change from Baseline cognitive fusion at 5 months
Change in Scale of Body Connection (SBC)
Scale of Body Connection assesses Body Awareness (the capacity to be aware of body states, processes and actions, paying attention to the internal experience of the body) and Bodily Dissociation (avoidance of body experiences). It is a 20-item, 7-point Likert-type scale. Scores in Body Awareness scale range between 0 and 48. Higher scores indicate higher levels of body awareness and better outcome. Scores in Bodily Dissociation scale range between 0 and 32. Higher scores indicate higher levels of bodily dissociation and worse outcome.
Measured: Change from Baseline body awareness at 5 months
Change in Mindful Attention Awareness Scale (MAAS)
Mindful Attention Awareness Scale assesses mindfulness skills. It is a 15-item 6-point scale. Scores range between 1 and 6. Higher scores indicate a higher degree of attention to the present moment and a better outcome.
Measured: Change from Baseline mindufullness skills at 5 months
Change in The New Sexual Satisfaction Scale-short form (NSSS-S)
he New Sexual Satisfaction Scale assesses sexual satisfaction. It is a 12-item, 7-point Likert-type scale. Scores range between 12 and 60. Higher scores indicate a higher degree of sexual satisfaction and a better outcome.
Measured: Change from Baseline sexual satisfaction at 5 months
Change in Intensity of cravings subjective scale
Global self-assessment of intensity of cravings VAS-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 VAS-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 Time spent planning or practicing sex per week
Self-monitoring: 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 number of sexual encounters per week
Self-monitoring: Number of sexual encounters during last week. Higher number of sexual encounters 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start8 Jan 2022
- Primary completion31 Jul 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compulsive Sexual BehaviorStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- apoyopositivo.org
- Responsible party
- Sponsor
- Investigators
- Francisco Montesinos, Ph.D., Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572372
- Sponsor's protocol ID
- CIPI/21/003
- Status last verified
- May 2023
- First submitted
- 12 Sep 2022
- Last updated
- 11 May 2023
- 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 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Treatment of Hypersexuality: a Clinical Trial With Acceptance and Commitment Therapy
- ClinicalTrials.gov ID
- NCT05572372
- Acronym / sponsor ID
- CIPI/21/003
- Conditions
- Compulsive Sexual Behavior, Hypersexuality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Collaborators
- apoyopositivo.org
- Study start
- 8 Jan 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 7 Oct 2022 (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 hypersexuality.
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 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 TherapyPsychological intervention will consist in an 8-session individual on line-delivered ACT-based treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- older than 18 years-old
- Spanish speaking
- having had a sexual relationship in the last year
- significant score on the HBI Inventory (of 53 or more)
- at least 6 months of problematic pornography use or sexual practices
Key exclusion criteria (5 listed)
- practicing meditation at least once a week in the last three months
- 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 TherapyThe aim of the intervention was to increase psychological flexibility. Therapeutic methods focused on values clarification, cognitive defusion, self-as-context, acceptance, commited action and flexible attention to present moment. | 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. García-Barba et al. (2020) consider the presence of a problem of hypersexuality when the score is equal or higher than 53.
11 secondary outcomes
Change in Acceptance and Action Questionnaire (AAQ-II)
Time frame: Change from Baseline psychological inflexibilty at 5 months
Change in Cognitive Fusion Questionnaire (CFQ)
Time frame: Change from Baseline cognitive fusion at 5 months
Change in Scale of Body Connection (SBC)
Time frame: Change from Baseline body awareness at 5 months
Change in Mindful Attention Awareness Scale (MAAS)
Time frame: Change from Baseline mindufullness skills at 5 months
Change in The New Sexual Satisfaction Scale-short form (NSSS-S)
Time frame: Change from Baseline sexual satisfaction at 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 Time spent planning or practicing sex per week
Time frame: Through study completion, an average of 5 months
Change in number of sexual encounters 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
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 11 May 2023.
- 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 in people with Compulsive Sexual Behavior and Hypersexuality, 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 9 inclusion and 5 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 11 May 2023. 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 11 May 2023.