NCT06406296

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

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

First Submitted

Initial submission to the registry

April 22, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
23 days until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

April 13, 2026

Status Verified

July 1, 2025

Enrollment Period

1.1 years

First QC Date

April 22, 2024

Last Update Submit

April 9, 2026

Conditions

Keywords

SexualityRisky sexual behavior

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. The presence of a problem of hypersexuality is considered when the score is equal or higher than 53.

    Change from Baseline Hypersexuality at 5 months

Secondary Outcomes (17)

  • Change in Drug Abuse Screening Test (Dast-10)

    Change from Baseline Drug Abuse at 5 months

  • Change in Brief Symptom Inventory (BSI)

    Change from Baseline Anxiety and Depression at 5 months

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

    Change from Baseline psychological inflexibility at 5 months

  • Change in Short Internalized Homonegativity Scale (SIHS)

    Change from Baseline Internalized Homonegativity at 5 months

  • Change in Social and Emotional Loneliness in Adults (SESLA)

    Change from Baseline Emotional Loneliness at 5 months

  • +12 more secondary outcomes

Study Arms (2)

ACT group

EXPERIMENTAL

8 individual weekly sessions which included ACT methods

Behavioral: Acceptance and Commitment Therapy (ACT)

Waiting list

NO INTERVENTION

Participants assigned to Waiting List arm waited for 5 months before receiving treatment

Interventions

Acceptance and Commitment Therapy methods were focused on promoting Values clarification, Acceptance, Cognitive defusion, Committed action and Flexible attention to the present moment, and included methods such as the Garden Metaphor, Funeral exercise or Mindfulness training.

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 used psychoactive substances to facilitate, maintain and/or improve sexual relations in the last year
  • significant score on the HBI Inventory (of 53 or more)
  • 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
  • desire to improve/reduce excessive sexual behaviour

You may not qualify if:

  • 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 DisorderChemsexSexuality

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

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

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
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomization assigned participants to 2 arms: ACT group Waiting list
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2024

First Posted

May 9, 2024

Study Start

June 1, 2024

Primary Completion

June 30, 2025

Study Completion

September 30, 2025

Last Updated

April 13, 2026

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations