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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05572372
Other study ID # CIPI/21/003
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 8, 2022
Est. completion date December 31, 2022

Study information

Verified date May 2023
Source Universidad Europea de Madrid
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Investigation of the efficacy of Acceptance and Commitment Therapy (ACT) for the psychological treatment of hypersexuality.


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date December 31, 2022
Est. primary completion date July 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Acceptance and Commitment Therapy
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.

Locations

Country Name City State
Spain Universidad Europea de Madrid Villaviciosa de Odón Madrid

Sponsors (2)

Lead Sponsor Collaborator
Universidad Europea de Madrid apoyopositivo.org

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. GarcĂ­a-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 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. Change from Baseline psychological inflexibilty at 5 months
Secondary 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). Change from Baseline cognitive fusion at 5 months
Secondary 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. Change from Baseline body awareness at 5 months
Secondary 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. Change from Baseline mindufullness skills at 5 months
Secondary 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. Change from Baseline sexual satisfaction at 5 months
Secondary 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. Through study completion, an average of 5 months
Secondary 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. Through study completion, an average of 5 months
Secondary 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. Through study completion, an average of 5 months
Secondary 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. Through study completion, an average of 5 months
Secondary 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. Through study completion, an average of 5 months
Secondary 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. Through study completion, an average of 5 months
See also
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Enrolling by invitation NCT04634175 - Mind-body Intervention for Compulsive Sexual Behavior Disorder N/A
Completed NCT02300051 - Intervention Study for Individuals With Compulsive Sexual Behavior N/A
Completed NCT03495414 - Neurobiological Underpinnings to Hypersexual Disorder