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临床试验/NCT06951555
NCT06951555已完成不适用

Controlled Study of the Effectiveness of an Individual Online (E-Health) Psychological Intervention Program for Cybersex Addiction/Online Sexual Compulsive Behavior Disorder

Universitat Jaume I1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年1月1日最近更新:
适应症
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
80
试验地点
1
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

Cybersex addiction, understood as a subtype of Internet addiction or a manifestation of Compulsive Sexual Behavior Disorder, is a growing phenomenon. Recent studies developed by our research group have revealed that about 10% of young people in Spain could be at risk of suffering or already suffer from this problem, which can lead to consequences beyond the addiction or compulsive behavior itself, such as low self-esteem, emotional problems, sexual dysfunction, infidelity, breakups, social isolation, development of paraphilias, increase of risky sexual behavior, problems with the law, etc.. Although some studies have been carried out so far, especially on the prevalence and characterization of the sociodemographic and psychological profile of people with this disorder, psychological intervention programs for this problem have hardly been developed, and studies on the effectiveness of such programs are very scarce. Furthermore, seeking psychological help for people with this type of problem is infrequent due in part to the stigma associated with sexual addictions. In this sense, e-health approaches can reach a potential audience of users who would not access treatment if they had to physically visit a clinic. For this reason, the present project seeks to evaluate the efficacy of an online intervention aimed at the treatment of cybersex addiction or online sexual compulsive behavior disorder in the general population. For this purpose, a sample of 100 patients with a risk or pathological profile will be randomly assigned to an experimental (n=50) or control group (n=50) with similar characteristics. All of them will undergo an online assessment. The experimental group will receive an individualized online program of twelve one-hour sessions. The study will be based on an experimental design of comparison between groups (experimental-control) with pretest-posttest-follow-up evaluation at 1 month, 3 months, 6 months and 12 months, to evaluate the efficacy of the intervention. For this purpose, descriptive and differential statistical analyses (t-tests and repeated measures ANOVA), Cohen's d test for effect size and regression analysis will be performed.

详细描述

Principal Investigator: Rafael Ballester-Arnal (Universitat Jaume I of Castellón, Spain)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者
否

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

Intervention

Experimental

12 session CBT treament

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

Wait List Control

No Intervention

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

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, Gorostiaga, Alonso-Arbiol and Haranburu, 2007; Hambleton, Merenda and Spielberger, 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

  • Expectations of Change Scale (adapted from the Borkovec and Nau Inventory, 1972)(Baseline)
  • 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)
  • 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)
  • Psychological Wellbeing Scale (Ryff, 1989)(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)
  • 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 (1)

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