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

Ruhr University of Bochum

Status: Completed

Conditions: Hypoactive Sexual Desire Disorder

Treatments: Behavioral: Cognitive-behavioral treatment; Behavioral: Mindfulness-based treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03780751

VE 1083/2-1

Details and patient eligibility

About

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.

Enrollment: 266 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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266 participants in 3 patient groups

Cognitive-behavioral treatment

Experimental group

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.

Treatment:

Behavioral: Cognitive-behavioral treatment

Mindfulness-based treatment

Experimental group

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).

Treatment:

Behavioral: Mindfulness-based treatment

Waitlist

No Intervention group

Description:

Participants will receive no immediate treatment but will be able to choose either MIND or COPE after a six months waiting period.