NCT06951555

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 7, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 30, 2025

Completed
Last Updated

June 6, 2025

Status Verified

June 1, 2025

Enrollment Period

9.1 years

First QC Date

March 7, 2025

Last Update Submit

June 2, 2025

Conditions

Keywords

Cybersex addictionpsychological treatmente-healthsexual compulsivityeffectivenessonline sex addiction

Outcome Measures

Primary Outcomes (6)

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

    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).

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

  • Internet Sex Screening Test (ISST) Delmonico (1997)

    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

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

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

    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.

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

  • Sexual Compulsivity Scale (Kalichman & Rompa, 1995)

    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.

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

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

    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).

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

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

    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.

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

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

12 session CBT treament

Behavioral: Online Individual Cognitive-Behavioral Therapy (CBT)

Wait List Control

NO INTERVENTION

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

Interventions

12-session individual and online CBT treatment for online sexual compulsivity/cybersex addiction Cognitive-behavioral psychological treatment program applied online and individually. The program consists of twelve sessions of approximately one hour's duration and weekly frequency 1. Psychoeducational module and motivational interviewing. 2. Environmental planning 3. Beginning of training in emotional self-regulation techniques. 4. Cognitive errors and cognitive discussion. 5. Self-talk, thought traps, responsibility vs. guilt and "backpack" of coping resources. 6. Self-esteem, stigma and life goals 7. "Backpack" of coping resources, mindfulness and slow breathing training for anxiety 8. Stress coping techniques 9. Lifestyle 10. and 11. Reduction of stimulus control and addressing previously unaddressed relevant issues. 12\. Relapse prevention

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Jaume I

Castellon, Castellón, Spain

Location

MeSH Terms

Conditions

Compulsive Sexual Behavior Disorder

Condition Hierarchy (Ancestors)

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

Study Officials

  • Rafael Ballester-Arnal, PhD

    University Jaume I

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Individual psychological intervention administered online with wait list control condition
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2025

First Posted

April 30, 2025

Study Start

January 1, 2016

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

June 6, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations