Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-29 @ 4:16 PM
Study NCT ID:
NCT07102303
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-03
First Post:
2025-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness Controlled Study of an Online Group Treatment Program for Cybersex Addiction /Online Sexual Compulsivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000096583', 'term': 'Compulsive Sexual Behavior Disorder'}], 'ancestors': [{'id': 'D016739', 'term': 'Behavior, Addictive'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019968', 'term': 'Sexual and Gender Disorders'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2025-07-21', 'studyFirstSubmitQcDate': '2025-07-28', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': '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).'}, {'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', 'description': '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)'}, {'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', 'description': '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.'}, {'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', 'description': '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.'}, {'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', 'description': '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).'}, {'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', 'description': "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."}], 'secondaryOutcomes': [{'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', 'description': "Questionnaire with 20 Likert-type items (rarely/occasionally/frequently/often/always). In its original version, self-administered online, it has six factors and the subscales have shown a Cronbach's alpha internal consistency between 0.54 and 0.82 (Widyanto and McMurran, 2004). Its reliability (internal consistency) in a Spanish sample of young university students is 0.910 (Salmerón, Ballester, Gómez and Gil, 2009). This questionnaire has also been recently validated by Puerta-Cortés et al. (2012) in a Colombian population."}, {'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', 'description': 'Adaptation of SCID-P (Structured Clinical Interview for DSM, Patient version) and SCID-II (Structured Clinical Interview for Axis II Disorders) interviews (First, Gibbon, Spitzer, Williams and Smith) in a reduced version to assess psychopathological comorbidity. Especially mood disorders, anxiety disorders especially obsessive-compulsive disorder, substance use disorder, non-toxic addictions, eating disorders, personality disorders especially borderline and obsessive-compulsive disorder, sexual dysfunctions, paraphilias and other impulse control disorders.'}, {'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', 'description': 'Scale evaluates one of the constructs most related to sexual compulsivity and sexual risk behaviors, sexual sensation seeking. It consists of 11 items that are answered following a 4-point Likert scale (not at all to strongly agree). Internal consistency of 0.87.'}, {'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', 'description': "This questionnaire contains 10 items and provides qualitative and quantitative information on self-esteem. The high levels of validity and reliability of this scale (Cronbach's Alpha of 0.87 and test-retest reliability of 0.85) have been widely documented (Martín-Albo, Núñez, Navarro, \\& Grijalvo, 2007; Vázquez, Jiménez, \\& Vázquez-Morejón, 2004)."}, {'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', 'description': 'Contains 14 statements referring to symptoms of depression and anxiety, whose frequency or intensity has to be evaluated by means of a 4-point Likert scale (scores range from 0 to 3). Of the 14 items that make up the scale, 7 evaluate depression, appearing intercalary. The assessment of depression is basically limited to symptoms of anhedonia, excluding the assessment of somatic symptoms. A score above 11 points is considered as indicative of anxious or depressive symptomatology, between 8 and 10 points the symptomatology is doubtful and between 0 and 7 is considered as absence of symptomatology.'}, {'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', 'description': 'The Ryff well-being scale assesses 6 dimensions of psychological well-being: autonomy, mastery of the environment, personal growth, positive relationships with others, purpose in life and self-acceptance. In the adaptation used, each dimension is evaluated with a thermometer, in which the patient must quantify (from 0 to 100) the extent to which they usually feel this way.'}, {'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', 'description': 'Assesses 10 important aspects for measuring quality of life: physical well-being, psychological well-being, self-care and independent functioning, occupational functioning, interpersonal functioning, social-emotional support, community and service support, personal fulfillment, spiritual fulfillment, global perception of quality of life.'}, {'measure': 'Expectations of Change Scale (adapted from the Borkovec and Nau Inventory, 1972)', 'timeFrame': 'Baseline', 'description': "The original scale was designed to assess patients' credibility and expectations of improvement in therapy. In the present adaptation, after having received information about the online treatment to be received, the aim is to measure the person's expectations of change with respect to this treatment. It consists of 7 items, rated on a scale of 0 - 10 (Not at all - Very much)."}, {'measure': 'Program Satisfaction Scale (adapted from the Borkovec and Nau Inventory, 1972)', 'timeFrame': 'Upon treatment completion, an average of 12 weeks', 'description': "After having received the treatment, it measures the person's satisfaction with the treatment in terms of liking, treatment logic, recommendation, usefulness and discomfort. It consists of seven items, rated on a scale of 0 - 10 (Not at all - Very much)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cybersex addiction', 'e-health', 'sexual compulsivity', 'effectiveness', 'online sex addiction', 'group therapy'], 'conditions': ['Sexual Compulsive Behavior Disorder', 'Cybersex Addiction', 'Online Compulsive Sexual Behavior']}, 'descriptionModule': {'briefSummary': '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:\n\nIs online group therapy effective to treat cybersex addiction/online sexual compulsivity? How does group therapy compare to individual therapy?\n\nResearchers will compare the results of participants in group therapy to those in individual therapy and those who receive no treatment.\n\nParticipants will:\n\nAttend 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* online sexual compulsive behaviors, and may or may not also have other offline sexual compulsive behaviors\n* any gender or sexual orientation\n* 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)\n\nExclusion Criteria:\n\n* coocurrence of psychotic symptoms, cognitive impairment, or other serious mental conditions'}, 'identificationModule': {'nctId': 'NCT07102303', 'acronym': 'ADISEX', 'briefTitle': 'Effectiveness Controlled Study of an Online Group Treatment Program for Cybersex Addiction /Online Sexual Compulsivity', 'organization': {'class': 'OTHER', 'fullName': 'Universitat Jaume I'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CD/13/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group Intervention', 'description': '12 session group CBT treament', 'interventionNames': ['Behavioral: Online Group Cognitive-Behavioral Therapy (CBT)']}, {'type': 'NO_INTERVENTION', 'label': 'Wait List Control', 'description': 'Wait list control, 3 months on wait list with no treatment'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Individual Intervention', 'description': '12 session CBT treament', 'interventionNames': ['Behavioral: Online Individual Cognitive-Behavioral Therapy (CBT)']}], 'interventions': [{'name': 'Online Group Cognitive-Behavioral Therapy (CBT)', 'type': 'BEHAVIORAL', 'description': '12-session group online CBT treatment for online sexual compulsivity/cybersex addiction. Cognitive-behavioral psychological treatment program applied online and in a group format. The program consists of twelve sessions of approximately 2,5 hour\'s duration and weekly frequency 1. Psychoeducational module and motivational interviewing. 2. Environmental planning, stimulus control 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', 'armGroupLabels': ['Group Intervention']}, {'name': 'Online Individual Cognitive-Behavioral Therapy (CBT)', 'type': 'BEHAVIORAL', 'description': '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, stimulus control 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', 'armGroupLabels': ['Individual Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12071', 'city': 'Castellon', 'state': 'Castellón', 'country': 'Spain', 'facility': 'Salusex center. University Jaume I of Castellón', 'geoPoint': {'lat': 39.98567, 'lon': -0.04935}}, {'city': 'Castellon', 'state': 'Castellón', 'country': 'Spain', 'facility': 'University Jaume I', 'geoPoint': {'lat': 39.98567, 'lon': -0.04935}}], 'overallOfficials': [{'name': 'Rafael Ballester-Arnal, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Jaume I'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data are subject to strict data protection measures by the sponsoring center and cannot be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitat Jaume I', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministerio de Ciencia e Innovación, Spain', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}