NCT05572372

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

7 months

First QC Date

September 12, 2022

Last Update Submit

May 10, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from Baseline Hypersexuality at 5 months

Secondary Outcomes (11)

  • Change in Acceptance and Action Questionnaire (AAQ-II)

    Change from Baseline psychological inflexibilty at 5 months

  • Change in Cognitive Fusion Questionnaire (CFQ)

    Change from Baseline cognitive fusion at 5 months

  • Change in Scale of Body Connection (SBC)

    Change from Baseline body awareness at 5 months

  • Change in Mindful Attention Awareness Scale (MAAS)

    Change from Baseline mindufullness skills at 5 months

  • Change in The New Sexual Satisfaction Scale-short form (NSSS-S)

    Change from Baseline sexual satisfaction at 5 months

  • +6 more secondary outcomes

Study Arms (1)

ACT group

EXPERIMENTAL

Psychological intervention will consist in an 8-session individual on line-delivered ACT-based treatment.

Behavioral: Acceptance and Commitment Therapy

Interventions

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.

ACT group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Europea de Madrid

Villaviciosa de Odón, Madrid, 28670, Spain

Location

MeSH Terms

Conditions

Compulsive Sexual Behavior Disorder

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Behavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehaviorSexual and Gender DisordersSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Francisco Montesinos, Ph.D.

    Universidad Europea de Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2022

First Posted

October 7, 2022

Study Start

January 8, 2022

Primary Completion

July 31, 2022

Study Completion

December 31, 2022

Last Updated

May 11, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations