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临床试验/NCT07102303
NCT07102303已完成不适用

Controlled Study on the Effectiveness of an Online Group Treatment Intervention Program for Cybersex Addiction / Online Sexual Compulsivity: Comparison With an Individual Program and a Wait List Control

Universitat Jaume I4 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2018年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
86
试验地点
4
主要终点
Semi-Structured Clinical Interview for the assessment of Compulsive Sexual Behavior (SSCI-CSB) (Castro-Calvo et al., in review)

研究概览

简要总结

The goal of this clinical trial is to study the effectiveness of an online group therapy to treat people with cybersex addiction or online sexual compulsivity. It will compare group therapy to individual therapy. It uses cognitive behavioral therapy, a therapy that aims to change thoughts and behaviors. In this case, the therapy will train participants in coping strategies that allow them to control their sexual impulses. The main questions it aims to answer are:

Is online group therapy effective to treat cybersex addiction/online sexual compulsivity? How does group therapy compare to individual therapy?

Researchers will compare the results of participants in group therapy to those in individual therapy and those who receive no treatment.

Participants will:

Attend evaluation sessions Attend therapy sessions once per week for 12 weeks Keep a weekly diary of their sexual behavior Complete follow-up surveys 1 week, 3 months, 6 months, 9 months, and 12 months after treatment

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

性别
All
接受健康志愿者

入选标准

  • online sexual compulsive behaviors, and may or may not also have other offline sexual compulsive behaviors
  • any gender or sexual orientation
  • minimum score of 9-18 points on the Internet Sex Screening Test (ISST) of Delmonico (1997) in the Spanish adaptation of Ballester, Gil, Gómez and Gil (2010)

排除标准

  • coocurrence of psychotic symptoms, cognitive impairment, or other serious mental conditions

研究组 & 干预措施

Group Intervention

Experimental

12 session group CBT treament

干预措施: Online Group Cognitive-Behavioral Therapy (CBT) (Behavioral)

Wait List Control

No Intervention

Wait list control, 3 months on wait list with no treatment

Individual Intervention

Active Comparator

12 session CBT treament

干预措施: Online Individual Cognitive-Behavioral Therapy (CBT) (Behavioral)

结局指标

主要结局

Semi-Structured Clinical Interview for the assessment of Compulsive Sexual Behavior (SSCI-CSB) (Castro-Calvo et al., in review)

时间窗: Baseline; Upon treatment completion, an average of 12 weeks; Follow-up at 1, 3, 6, and 12 months

This is a pioneering interview that allows a criterial evaluation of the patient. It asks about the different types of online and offline sexual behavior, both in terms of whether or not they are performed, as well as the percentage of sexual behavior they represent, the weekly time spent, the weekly orgasms obtained through this behavior, the discomfort it produces and the degree of control over it. From there, a series of questions related to 16 symptoms grouped around 9 criteria are developed. Then the onset, evolution, clinical course and search for therapeutic help are explored, and on the final sheet all the information can be summarized with the novelty that the diagnosis can be established according to the criteria of three classifications of three different authors (Carnes, Goodman and Kafka).

Internet Sex Screening Test (ISST) Delmonico (1997)

时间窗: Baseline; Upon treatment completion, an average of 12 weeks; Follow-up at 1, 3, 6, and 12 months

Spanish adaptation by Ballester, Gil, Gómez and Gil (2010). The original version includes 25 true/false items and measures online sexual behavior. Validating the original instrument with general population (through online self-administration), exploratory factor analysis revealed five factors (Delmonico and Miller, 2003): Online Sexual Compulsivity, Online Social Sexual Behavior, Online Solitary Sexual Behavior; Online Sexual Expense; and Online Sexual Behavior Interest. In addition, it includes two single-item scales. The first assesses the use of a computer outside the home for sexual purposes and the second explores access to illegal sexual material. The remaining items do not form part of any single factor. Their reliability ranged from 0.51 to 0.86. After a process of translation and adaptation of the questionnaire following the international guidelines established for this purpose (Balluerka et al., 2007; Hambleton et al., 2005)

Hypersexual Behavior Inventory (Reid, Garos & Carpenter, 2011)

时间窗: Baseline; Upon treatment completion, an average of 12 weeks; Follow-up at 1, 3, 6, and 12 months

This 19-item instrument with Likert-type response format (1=Never / 5=Many times) was designed to assess the three basic dimensions of hypersexuality. As noted in the introduction, the HI has been validated only in a male clinical population. In this sample, the resulting factor structure replicated the criteria under which the HI was designed. First, a factor called "Coping" (items 1, 3, 6, 8, 13, 16 and 18), which would reflect the use of sex as a means of controlling negative emotional states; secondly, another factor, "Control" (items 2, 4, 7, 10, 11, 12, 15 and 17), whose content would denote deficits in controlling sexual thoughts, impulses or behaviors; and the last factor, "Consequences" (items 5, 9, 14 and 19), which would explore persistence in sexual behavior despite the negative consequences derived. The authors obtained a high correlation between them. Reliability for each scale ranged from 0.89 to 0.95.

Sexual Compulsivity Scale (Kalichman & Rompa, 1995)

时间窗: Baseline; Upon treatment completion, an average of 12 weeks; Follow-up at 1, 3, 6, and 12 months

Spanish version adapted and validated for application in Spain (in preparation). This questionnaire will be used as a screening instrument from which a group of participants with sexual compulsivity problems and another group of similar number, sex, age and sexual orientation without this type of problem will be selected. The cut-off point to be used will be the same as that used by the author of the scale, the 80th percentile. Internal consistency of 0.84.

Compulsive Sexual Behavior Inventory (CSBI) (Coleman, Miner, Ohlerking & Raymond, 2001)

时间窗: Baseline; Upon treatment completion, an average of 12 weeks; Follow-up at 1, 3, 6, and 12 months

28-item self-report scale that assesses the severity of symptoms of sexual compulsivity. This questionnaire is of interest because it not only includes a global measure of sexual compulsivity but also the type of compulsive paraphilic behavior (exhibitionism, sadism, phone calls, fetishism...) or non-paraphilic behavior (compulsive cruising, compulsive fixation on an unattainable partner, compulsive search for new experiences and partners, multiple sexual partners, sexual compulsivity within a specific relationship and compulsive autoeroticism).

Cognitive and Behavioral Outcomes of Sexual Behavior Scale (CBOSB) (McBride, Reece & Perera, 2006)

时间窗: Baseline; Upon treatment completion, an average of 12 weeks; Follow-up at 1, 3, 6, and 12 months

Following the list of consequences that may result from sexual compulsivity identified by the Society for the Advancement of the Sexual Health and classified into six domains, the authors developed this scale that records both the individual's concern about the consequences that may result from his or her sexual behavior and the fact that he or she is actually experiencing such consequences. The six domains (economic, legal, physical, psychological, spiritual and social) were identified by the National Council on Sexual Addiction and Compulsivity, NCSAC (2004) and are translated into a total of 20 items referring to cognitive aspects evaluated on a scale of 0 to 4 (never to always) and another 16 dichotomous response items that evaluate the behavioral consequences.

次要结局

  • Internet Addiction Diagnostic Questionnaire (IADQ; Young, 1998)(Baseline; Upon treatment completion, an average of 12 weeks; Follow-up at 1, 3, 6, and 12 months)
  • Adapted Structured Clinical Interview for DSM, Patient Version) & SCID-II (Structured Clinical Interview for Axis II Disorders) (First, Gibbon, Spitzer, Williams & Smith)(Baseline; Upon treatment completion, an average of 12 weeks; Follow-up at 1, 3, 6, and 12 months)
  • Revised Sexual Sensation Seeking Scale (Kalichman & Rompa, 1995)(Baseline; Upon treatment completion, an average of 12 weeks; Follow-up at 1, 3, 6, and 12 months)
  • Psychological Wellbeing Scale (Ryff, 1989)(Baseline; Upon treatment completion, an average of 12 weeks; Follow-up at 1, 3, 6, and 12 months)
  • Rosenberg Self-Esteem Scale (1979)(Baseline; Upon treatment completion, an average of 12 weeks; Follow-up at 1, 3, 6, and 12 months)
  • Hospital Anxiety and Depresión Scale (Zigmond & Snaith, 1983)(Baseline; Upon treatment completion, an average of 12 weeks; Follow-up at 1, 3, 6, and 12 months)
  • Quality of Life Index (Mezzich, Cohen & Ruiperez, 1999)(Baseline; Upon treatment completion, an average of 12 weeks; Follow-up at 1, 3, 6, and 12 months)
  • Expectations of Change Scale (adapted from the Borkovec and Nau Inventory, 1972)(Baseline)
  • Program Satisfaction Scale (adapted from the Borkovec and Nau Inventory, 1972)(Upon treatment completion, an average of 12 weeks)

研究者

发起方
Universitat Jaume I
申办方类型
Other
责任方
Sponsor

研究点 (4)

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