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临床试验/NCT06406296
NCT06406296
已完成
不适用

Effectiveness of a Group Intervention Based on Acceptance and Commitment Therapy to Address Problematic Chemsex Through a Randomized Clinical Trial

Universidad Europea de Madrid2 个研究点 分布在 1 个国家目标入组 36 人2024年6月1日

概览

阶段
不适用
干预措施
Acceptance and Commitment Therapy (ACT)
疾病 / 适应症
Hypersexuality
发起方
Universidad Europea de Madrid
入组人数
36
试验地点
2
主要终点
Change in Hypersexual Behavior Inventory (HBI)
状态
已完成
最后更新
19天前

概览

简要总结

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

详细描述

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 include a control group.

注册库
clinicaltrials.gov
开始日期
2024年6月1日
结束日期
2025年9月30日
最后更新
19天前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Universidad Europea de Madrid
责任方
Sponsor

入排标准

入选标准

  • 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

排除标准

  • receiving psychological or psychopharmacological treatment
  • intellectual disability
  • substance dependence (use not associated with sex)
  • personality disorder or other serious or chronic mental disorder diagnosed

研究组 & 干预措施

ACT group

8 individual weekly sessions which included ACT methods

干预措施: Acceptance and Commitment Therapy (ACT)

Waiting list

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

结局指标

主要结局

Change in Hypersexual Behavior Inventory (HBI)

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

次要结局

  • 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)
  • Change in The Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT)(Change from Baseline psychological flexibility at 5 months)
  • Change in the Life Values Questionnaire (VLQ)(Change from Baseline value consistency living at 5 months)
  • Change in Time spent planning or practicing sex per week(Through study completion, an average of 5 months)
  • Change in number of different sexual partners per week(Through study completion, an average of 5 months)
  • Change in Frequency of value committed actions per week(Through study completion, an average of 5 months)
  • Change in Brief Symptom Inventory (BSI)(Change from Baseline Anxiety and Depression at 5 months)
  • Change in Drug Abuse Screening Test (Dast-10)(Change from Baseline Drug Abuse at 5 months)
  • Change in Acceptance and Action Questionnaire (AAQ-II)(Change from Baseline psychological inflexibility at 5 months)
  • Change in Awareness, Courage and Responsiveness Scale (ACRS)(Change from Baseline Awareness, Courage and Responsiveness at 5 months)
  • Change in Frequency of chemsex encounters per week(Through study completion, an average of 5 months)
  • Change in Interference of cravings subjective scale(Through study completion, an average of 5 months)
  • Change in Frequency of substance consumption per week(Through study completion, an average of 5 months)
  • Change in Frequency of risky sexual practices per week(Through study completion, an average of 5 months)
  • Change in number of new diagnoses of sexually transmitted infections per week(Through study completion, an average of 5 months)
  • Change in Intensity of cravings subjective scale(Through study completion, an average of 5 months)

研究点 (2)

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