Effects of an ACT-based Psychological Treatment in Patients With Hypersexuality

May 10, 2023 updated by: Universidad Europea de Madrid

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.

Study Overview

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

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Madrid
      • Villaviciosa de Odón, Madrid, Spain, 28670
        • Universidad Europea de Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.

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
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.
Change from Baseline Hypersexuality at 5 months

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
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.
Change from Baseline psychological inflexibilty at 5 months
Change in Cognitive Fusion Questionnaire (CFQ)
Time Frame: Change from Baseline cognitive fusion at 5 months
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).
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
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.
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
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.
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
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.
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
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.
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
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.
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
Self-monitoring: 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
Change in number of sexual encounters per week
Time Frame: Through study completion, an average of 5 months
Self-monitoring: Number of sexual encounters during last week. Higher number of sexual encounters indicate worse outcome.
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
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
Change in number of different sexual partners per week
Time Frame: Through study completion, an average of 5 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Francisco Montesinos, Ph.D., Universidad Europea de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2022

Primary Completion (Actual)

July 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

September 12, 2022

First Submitted That Met QC Criteria

October 6, 2022

First Posted (Actual)

October 7, 2022

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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