Clinical trial NCT06951555: Effectiveness Study of Individual Online Treatment for Cybersex Addiction/Online Sexual Compulsive Behavior Disorder
Official title: Controlled Study of the Effectiveness of an Individual Online (E-Health) Psychological Intervention Program for Cybersex Addiction/Online Sexual Compulsive Behavior Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Compulsive Behavior Disorder
Cybersex Addiction
Online Compulsive Sexual Behavior
Keywords: Cybersex addiction
psychological treatment
e-health
sexual compulsivity
effectiveness
online sex addiction
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Individual psychological intervention administered online with wait list control condition
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

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

Primary outcomes:
measure: Semi-Structured Clinical Interview for the assessment of Compulsive Sexual Behavior (SSCI-CSB) (Castro-Calvo et al., in review)
timeFrame: Baseline; Upon treatment completion, an average of 12 weeks; Follow-up at 1, 3, 6, and 12 months
measure: Internet Sex Screening Test (ISST) Delmonico (1997)
timeFrame: Baseline; Upon treatment completion, an average of 12 weeks; Follow-up at 1, 3, 6, and 12 months
measure: Hypersexual Behavior Inventory (Reid, Garos & Carpenter, 2011)
timeFrame: Baseline; Upon treatment completion, an average of 12 weeks; Follow-up at 1, 3, 6, and 12 months
measure: Sexual Compulsivity Scale (Kalichman & Rompa, 1995)
timeFrame: Baseline; Upon treatment completion, an average of 12 weeks; Follow-up at 1, 3, 6, and 12 months
measure: Compulsive Sexual Behavior Inventory (CSBI) (Coleman, Miner, Ohlerking & Raymond, 2001)
timeFrame: Baseline; Upon treatment completion, an average of 12 weeks; Follow-up at 1, 3, 6, and 12 months
measure: Cognitive and Behavioral Outcomes of Sexual Behavior Scale (CBOSB) (McBride, Reece & Perera, 2006)
timeFrame: Baseline; Upon treatment completion, an average of 12 weeks; Follow-up at 1, 3, 6, and 12 months
Secondary outcomes:
measure: Internet Addiction Diagnostic Questionnaire (IADQ; Young, 1998)
timeFrame: Baseline; Upon treatment completion, an average of 12 weeks; Follow-up at 1, 3, 6, and 12 months
measure: Adapted Structured Clinical Interview for DSM, Patient Version) & SCID-II (Structured Clinical Interview for Axis II Disorders) (First, Gibbon, Spitzer, Williams & Smith)
timeFrame: Baseline; Upon treatment completion, an average of 12 weeks; Follow-up at 1, 3, 6, and 12 months
measure: Revised Sexual Sensation Seeking Scale (Kalichman & Rompa, 1995)
timeFrame: Baseline; Upon treatment completion, an average of 12 weeks; Follow-up at 1, 3, 6, and 12 months
measure: Rosenberg Self-Esteem Scale (1979)
timeFrame: Baseline; Upon treatment completion, an average of 12 weeks; Follow-up at 1, 3, 6, and 12 months
measure: Hospital Anxiety and Depresión Scale (Zigmond & Snaith, 1983)
timeFrame: Baseline; Upon treatment completion, an average of 12 weeks; Follow-up at 1, 3, 6, and 12 months
measure: Psychological Wellbeing Scale (Ryff, 1989)
timeFrame: Baseline; Upon treatment completion, an average of 12 weeks; Follow-up at 1, 3, 6, and 12 months
measure: Quality of Life Index (Mezzich, Cohen & Ruiperez, 1999)
timeFrame: Baseline; Upon treatment completion, an average of 12 weeks; Follow-up at 1, 3, 6, and 12 months
measure: Expectations of Change Scale (adapted from the Borkovec and Nau Inventory, 1972)
timeFrame: Baseline
measure: Program Satisfaction Scale (adapted from the Borkovec and Nau Inventory, 1972)
timeFrame: Upon treatment completion, an average of 12 weeks
Other outcomes:
Locations:
city: Castellón de la Plana
country: Spain
facility: University Jaume I
state: Castellón
Study officials:
affiliation: University Jaume I
name: Rafael Ballester-Arnal, PhD
role: PRINCIPAL_INVESTIGATOR
References: