Waitlist Controlled Comparison of Cognitive-behavioral vs. Mindfulness-based Online-treatments for Women With Low Sexual Desire

Not Applicable

Completed

• Conditions: Hypoactive Sexual Desire Disorder
• Interventions: Behavioral: Cognitive-behavioral treatment; Behavioral: Mindfulness-based treatment

• Registration Number: NCT03780751
• Lead Sponsor: Ruhr University of Bochum

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-18
• Study First Submitted: 2018-12-18
• Study First Submitted QC: 2018-12-18
• Study First Posted: 2018-12-19
• Primary Completion: 2022-09-16
• Study Completion: 2022-09-16
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 266

Inclusion Criteria

• 18 years or older
• female gender
• able to read, write and speak German
• Meet criteria of ICD-10 criteria of Hypoactive Sexual Desire Disorder (established via online-screening and telephone interview)
• Experience significant sexuality-related personal distress (established via online-screening and telephone interview)

Exclusion Criteria

• currently pregnant
• 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
• suicide ideation (established via telephone interview)
• 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
• currently experiencing significant symptoms of a physical condition that might interfere with study participation (e.g., cancer, multiple sclerosis) as established via telephone interview
• current Substance-Abuse Disorder
• current or lifetime Psychotic Disorder
• significant relationship discord or violence

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive-behavioral treatment	Cognitive-behavioral treatment	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.
Mindfulness-based treatment	Mindfulness-based treatment	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).

Primary Outcome Measures

Name	Time	Method
Sexual Interest and Desire Inventory Female (SIDI-F)	at baseline, 5 weeks after baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline	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.

Secondary Outcome Measures

Name	Time	Method
Female Sexual Distress Scale Revised (FSDS-R)	at baseline, 5 weeks after baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline	The Female Sexual Distress Scale (FSDS) is a 13-item self- assessment questionnaire for the evaluation of sexually related personal distress.

Trial Locations

Locations (1)

Ruhr University Bochum; 🇩🇪 Bochum, NRW, Germany