Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-02-23 @ 1:11 AM
Study NCT ID:
NCT03780751
Status:
COMPLETED
Last Update Posted:
2023-03-29
First Post:
2018-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Waitlist Controlled Comparison of Cognitive-behavioral vs. Mindfulness-based Online-treatments for Women With Low Sexual Desire
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are assigned to one of three groups parallel for the duration of the study. 40% of participants will be assigned to one of the two immediate treatment conditions, 20% of participants will be assigned to a waitlist and will begin active treatment after a six months waiting period.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 266}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-28', 'studyFirstSubmitDate': '2018-12-18', 'studyFirstSubmitQcDate': '2018-12-18', 'lastUpdatePostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Desire subscale of the Female Sexual Function Index', 'timeFrame': 'at baseline, 5 weeks after baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline', 'description': "The Female Sexual Function Index measures women's sexual function with 19-items. Here, the two items assessing sexual desire will be used."}, {'measure': 'Patient Health Questionnaire 9 (PHQ-9)', 'timeFrame': 'at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline', 'description': 'A 9-item self-report measure used to assess symptoms of depression.'}, {'measure': 'Generalized Anxiety Disorder 7 (GAD-7)', 'timeFrame': 'at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline', 'description': 'A 7-item self-report measure used to assess symptoms of anxiety.'}, {'measure': 'Scale of Body Connection (SBC)', 'timeFrame': 'at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline', 'description': 'A 20-item self-report measure used to assess body awareness'}, {'measure': 'Mindful Attention and Awareness Scale (MAAS)', 'timeFrame': 'at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline', 'description': 'A 15-item self-report measure used to assess mindfulness'}, {'measure': 'Body Image Self-Consciousness Scale', 'timeFrame': 'at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline', 'description': 'A 15-item self-report measure used to assess body-related self-consciousness'}, {'measure': 'Self-Compassion Scale (SCS)', 'timeFrame': 'at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline', 'description': 'A 12-item self-report scale used to assess self-compassion.'}, {'measure': 'Rumination-Reflection Questionnaire - Adapted Rumination Subscale (RRQ)', 'timeFrame': 'at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline', 'description': 'A 12-item scale that assess rumination about sexual issues'}, {'measure': 'Health Action Process Approach (HAPA)', 'timeFrame': 'at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline', 'description': 'Treatment adherence as measured with the HAPA scales'}, {'measure': 'Working alliance inventory (WAI) adapted for online treatments', 'timeFrame': '3 months after baseline, 6 months after baseline', 'description': 'Measures working alliance with eCoaches and online-program'}, {'measure': 'Inventory for the Assessment of Negative Effects of Psychotherapy (INEP)', 'timeFrame': '3 months after baseline, 6 months after baseline', 'description': '15-item self-report measure that assesses side-effects of psychological treatments'}, {'measure': 'Client Satisfaction Questionnaire (CSQ-8)', 'timeFrame': '3 months after baseline, 6 months after baseline, 12 months after baseline', 'description': "8-item self-report measure that assesses women's satisfaction with the online treatment they received"}, {'measure': 'Single target implicit association task (ST-IAT)', 'timeFrame': 'at baseline, 3 months after baseline', 'description': 'An experimental paradigm used to assess implicit cognitive biases towards sexual stimuli'}, {'measure': 'Scrambled-sentences task', 'timeFrame': 'at baseline, 3 months after baseline', 'description': 'An experimental paradigm used to assess implicit cognitive biases towards sexual stimuli'}, {'measure': 'Qualitative evaluation of COPE and MIND', 'timeFrame': '12 weeks after baseline', 'description': 'Qualitative telephone interviews with approx. 50 participants to assess perceived mechanisms of change as well as strengths and weaknesses of the programs'}], 'primaryOutcomes': [{'measure': 'Sexual Interest and Desire Inventory Female (SIDI-F)', 'timeFrame': 'at baseline, 5 weeks after baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline', 'description': 'The SIDI-F is a clinician-rated instrument consisting of 13 items designed to assess HSDD severity in women. A self-report version, modified for the use in partnered and unpartnered women will be applied.'}], 'secondaryOutcomes': [{'measure': 'Female Sexual Distress Scale Revised (FSDS-R)', 'timeFrame': 'at baseline, 5 weeks after baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline', 'description': 'The Female Sexual Distress Scale (FSDS) is a 13-item self- assessment questionnaire for the evaluation of sexually related personal distress.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sexual dysfunction', 'Female Sexual Interest/Arousal Disorder', 'Internet-based intervention', 'Mindfulness', 'Cognitive-behavioral therapy'], 'conditions': ['Hypoactive Sexual Desire Disorder']}, 'referencesModule': {'references': [{'pmid': '39446648', 'type': 'DERIVED', 'citation': 'Velten J, Hirschfeld G, Meyers M, Margraf J. Results of a randomized waitlist-controlled trial of online cognitive behavioral sex therapy and online mindfulness-based sex therapy for hypoactive sexual desire dysfunction in women. J Consult Clin Psychol. 2024 Nov;92(11):742-755. doi: 10.1037/ccp0000922. Epub 2024 Oct 24.'}, {'pmid': '32990248', 'type': 'DERIVED', 'citation': 'Meyers M, Margraf J, Velten J. Psychological Treatment of Low Sexual Desire in Women: Protocol for a Randomized, Waitlist-Controlled Trial of Internet-Based Cognitive Behavioral and Mindfulness-Based Treatments. JMIR Res Protoc. 2020 Sep 29;9(9):e20326. doi: 10.2196/20326.'}]}, 'descriptionModule': {'briefSummary': 'Problems with sexual function are common and distressing. The most frequent sexual difficulty in women is a lack of sexual desire with a prevalence of 20-30%. When low sexual desire is experienced over several months and causes significant personal distress, a sexual dysfunction can be diagnosed (ICD-10: Hypoactive Sexual Desire Disorder: HSDD). A distressing lack of desire is reported by 6% of sexually active women. Psychological interventions are the treatment of choice for women with HSDD. Promising treatment approaches include cognitive-behavioral and mindfulness-based interventions. A recent meta-analysis also showed that Internet-delivered programs are a valid alternative to face-to-face treatments. Aim of this project to assess the effectivity of two eight-week online-programs consisting of cognitive-behavioral (COPE) and mindfulness-based (MIND) interventions for women with HSDD. Both treatments will be compared to a waitlist-control group. For this project, two well-established group-treatment manuals will be translated into German and adapted to a multimedia online-environment. All participants will be guided through the programs by well-qualified eCoaches.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* female gender\n* able to read, write and speak German\n* Meet criteria of ICD-10 criteria of Hypoactive Sexual Desire Disorder (established via online-screening and telephone interview)\n* Experience significant sexuality-related personal distress (established via online-screening and telephone interview)\n\nExclusion Criteria:\n\n* currently pregnant\n* ongoing medical or psychological treatment for low desire or other sexual dysfunctions or plans to enter such treatment (e.g., in-person sexual therapy, couples therapy) during study participation\n* suicide ideation (established via telephone interview)\n* currently experiencing significant symptoms of a mental disorder that might interfere with study participation (e.g., Eating Disorders, Obsessive-Compulsive Disorder, Posttraumatic Stress Disorder, Major Depression, Bipolar Disorder) as established via telephone interview\n* currently experiencing significant symptoms of a physical condition that might interfere with study participation (e.g., cancer, multiple sclerosis) as established via telephone interview\n* current Substance-Abuse Disorder\n* current or lifetime Psychotic Disorder\n* significant relationship discord or violence'}, 'identificationModule': {'nctId': 'NCT03780751', 'acronym': 'MiSELF', 'briefTitle': 'Waitlist Controlled Comparison of Cognitive-behavioral vs. Mindfulness-based Online-treatments for Women With Low Sexual Desire', 'organization': {'class': 'OTHER', 'fullName': 'Ruhr University of Bochum'}, 'officialTitle': 'Randomized-controlled Comparison of Two Online-interventions: How Effective Are Cognitive-behavioral and Mindfulness-based Sexual Therapy in Improving Sexual Desire in Women With Hypoactive Sexual Desire Disorder?', 'orgStudyIdInfo': {'id': 'VE 1083/2-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive-behavioral treatment', 'description': 'COPE-program of 8 sessions (+ 1 booster session) of guided Internet-based treatment including psychoeducation, sexual education, guided masturbation, sensate focus and cognitive-behavioral interventions (e.g., thought diaries, challenging of maladaptive thought patterns, behavioral analysis). Participants are encouraged to practice exercises between sessions.', 'interventionNames': ['Behavioral: Cognitive-behavioral treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Mindfulness-based treatment', 'description': 'MIND-program of 8 sessions (+ 1 booster session) of guided Internet-based treatment including psychoeducation, sexual education, guided masturbation, sensate focus and mindfulness-based exercises (e.g., breathing meditation, body scan, sitting meditation).', 'interventionNames': ['Behavioral: Mindfulness-based treatment']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist', 'description': 'Participants will receive no immediate treatment but will be able to choose either MIND or COPE after a six months waiting period.'}], 'interventions': [{'name': 'Cognitive-behavioral treatment', 'type': 'BEHAVIORAL', 'description': 'COPE-program of 8 sessions (+ 1 booster session) of guided Internet-based treatment including psychoeducation, sexual education, guided masturbation, sensate focus and cognitive-behavioral interventions (e.g., thought diaries, challenging of maladaptive thought patterns, behavioral analysis). Participants are encouraged to practice exercises between sessions.', 'armGroupLabels': ['Cognitive-behavioral treatment']}, {'name': 'Mindfulness-based treatment', 'type': 'BEHAVIORAL', 'description': 'MIND-program of 8 sessions (+ 1 booster session) of guided Internet-based treatment including psychoeducation, sexual education, guided masturbation, sensate focus and mindfulness-based exercises (e.g., breathing meditation, body scan, sitting meditation).', 'armGroupLabels': ['Mindfulness-based treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44787', 'city': 'Bochum', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Ruhr University Bochum', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}], 'overallOfficials': [{'name': 'Julia Velten, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruhr University Bochum'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': "IPD data of accepted publications will be published open access on the respective Journal's website or on the Open Science Framework."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruhr University of Bochum', 'class': 'OTHER'}, 'collaborators': [{'name': 'Friedrich-Alexander-Universität Erlangen-Nürnberg', 'class': 'OTHER'}, {'name': 'University of British Columbia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postdoctoral Research Associate', 'investigatorFullName': 'Julia Velten', 'investigatorAffiliation': 'Ruhr University of Bochum'}}}}