Clinical trial NCT03780751: Waitlist Controlled Comparison of Cognitive-behavioral vs. Mindfulness-based Online-treatments for Women With Low Sexual Desire
Official title: 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?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoactive Sexual Desire Disorder
Keywords: Sexual dysfunction
Female Sexual Interest/Arousal Disorder
Internet-based intervention
Mindfulness
Cognitive-behavioral therapy
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
Collaborators: name: Friedrich-Alexander-Universität Erlangen-Nürnberg
name: University of British Columbia
First posted: 2018-12-19
Enrollment: 266
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
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
Secondary outcomes:
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
Other outcomes:
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
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
measure: Generalized Anxiety Disorder 7 (GAD-7)
timeFrame: at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
measure: Scale of Body Connection (SBC)
timeFrame: at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
measure: Mindful Attention and Awareness Scale (MAAS)
timeFrame: at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
measure: Body Image Self-Consciousness Scale
timeFrame: at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
measure: Self-Compassion Scale (SCS)
timeFrame: at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
measure: Rumination-Reflection Questionnaire - Adapted Rumination Subscale (RRQ)
timeFrame: at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
measure: Health Action Process Approach (HAPA)
timeFrame: at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
measure: Working alliance inventory (WAI) adapted for online treatments
timeFrame: 3 months after baseline, 6 months after baseline
measure: Inventory for the Assessment of Negative Effects of Psychotherapy (INEP)
timeFrame: 3 months after baseline, 6 months after baseline
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: 3 months after baseline, 6 months after baseline, 12 months after baseline
measure: Single target implicit association task (ST-IAT)
timeFrame: at baseline, 3 months after baseline
measure: Scrambled-sentences task
timeFrame: at baseline, 3 months after baseline
measure: Qualitative evaluation of COPE and MIND
timeFrame: 12 weeks after baseline
Locations:
city: Bochum
country: Germany
facility: Ruhr University Bochum
state: NRW
Study officials:
affiliation: Ruhr University Bochum
name: Julia Velten, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.