- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05572372
Effects of an ACT-based Psychological Treatment in Patients With Hypersexuality
Psychological Treatment of Hypersexuality: a Clinical Trial With Acceptance and Commitment Therapy
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Madrid
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Villaviciosa de Odón, Madrid, Spain, 28670
- Universidad Europea de Madrid
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ACT group
Psychological intervention will consist in an 8-session individual on line-delivered ACT-based treatment.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Hypersexual Behavior Inventory (HBI)
Time Frame: Change from Baseline Hypersexuality at 5 months
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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.
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Change from Baseline Hypersexuality at 5 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Acceptance and Action Questionnaire (AAQ-II)
Time Frame: Change from Baseline psychological inflexibilty at 5 months
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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.
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Change from Baseline psychological inflexibilty at 5 months
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Change in Cognitive Fusion Questionnaire (CFQ)
Time Frame: Change from Baseline cognitive fusion at 5 months
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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).
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Change from Baseline cognitive fusion at 5 months
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Change in Scale of Body Connection (SBC)
Time Frame: Change from Baseline body awareness at 5 months
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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.
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Change from Baseline body awareness at 5 months
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Change in Mindful Attention Awareness Scale (MAAS)
Time Frame: Change from Baseline mindufullness skills at 5 months
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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.
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Change from Baseline mindufullness skills at 5 months
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Change in The New Sexual Satisfaction Scale-short form (NSSS-S)
Time Frame: Change from Baseline sexual satisfaction at 5 months
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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.
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Change from Baseline sexual satisfaction at 5 months
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Change in Intensity of cravings subjective scale
Time Frame: Through study completion, an average of 5 months
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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.
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Through study completion, an average of 5 months
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Change in Interference of cravings subjective scale
Time Frame: Through study completion, an average of 5 months
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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.
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Through study completion, an average of 5 months
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Change in Time spent planning or practicing sex per week
Time Frame: Through study completion, an average of 5 months
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Self-monitoring: Time spent (hours) planning or practicing sex during last week.
Higher number of hours indicate worse outcome.
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Through study completion, an average of 5 months
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Change in number of sexual encounters per week
Time Frame: Through study completion, an average of 5 months
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Self-monitoring: Number of sexual encounters during last week.
Higher number of sexual encounters indicate worse outcome.
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Through study completion, an average of 5 months
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Change in Frequency of chemsex encounters per week
Time Frame: Through study completion, an average of 5 months
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Self-monitoring: Frequency of practicing chemsex during last week.
Higher number of chemsex encounters indicate worse outcome.
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Through study completion, an average of 5 months
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Change in number of different sexual partners per week
Time Frame: Through study completion, an average of 5 months
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Self-monitoring: Number of different sexual partners during last week.
Higher number of different sexual partners indicate worse outcome.
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Through study completion, an average of 5 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Francisco Montesinos, Ph.D., Universidad Europea de Madrid
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CIPI/21/003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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