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

Hypoactive Sexual Desire Disorder Clinical Trial

— MiSELF  

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03780751
• Other study ID #: VE 1083/2-1
• Status: Completed
• Phase: N/A
• Start date: December 18, 2018
• Est. completion date: September 16, 2022

Study information

• Verified date: March 2023
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: September 16, 2022
• Est. primary completion date: September 16, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoactive Sexual Desire Disorder
• Hypokinesia
• Sexual Dysfunctions, Psychological

Intervention

Behavioral:
• 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
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).

Locations

Country	Name	City	State
Germany	Ruhr University Bochum	Bochum	NRW

Sponsors (3)

Lead Sponsor	Collaborator
Ruhr University of Bochum	Friedrich-Alexander-Universität Erlangen-Nürnberg, University of British Columbia

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Desire subscale of the Female Sexual Function Index	The Female Sexual Function Index measures women's sexual function with 19-items. Here, the two items assessing sexual desire will be used.	at baseline, 5 weeks after baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Other	Patient Health Questionnaire 9 (PHQ-9)	A 9-item self-report measure used to assess symptoms of depression.	at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Other	Generalized Anxiety Disorder 7 (GAD-7)	A 7-item self-report measure used to assess symptoms of anxiety.	at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Other	Scale of Body Connection (SBC)	A 20-item self-report measure used to assess body awareness	at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Other	Mindful Attention and Awareness Scale (MAAS)	A 15-item self-report measure used to assess mindfulness	at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Other	Body Image Self-Consciousness Scale	A 15-item self-report measure used to assess body-related self-consciousness	at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Other	Self-Compassion Scale (SCS)	A 12-item self-report scale used to assess self-compassion.	at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Other	Rumination-Reflection Questionnaire - Adapted Rumination Subscale (RRQ)	A 12-item scale that assess rumination about sexual issues	at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Other	Health Action Process Approach (HAPA)	Treatment adherence as measured with the HAPA scales	at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Other	Working alliance inventory (WAI) adapted for online treatments	Measures working alliance with eCoaches and online-program	3 months after baseline, 6 months after baseline
Other	Inventory for the Assessment of Negative Effects of Psychotherapy (INEP)	15-item self-report measure that assesses side-effects of psychological treatments	3 months after baseline, 6 months after baseline
Other	Client Satisfaction Questionnaire (CSQ-8)	8-item self-report measure that assesses women's satisfaction with the online treatment they received	3 months after baseline, 6 months after baseline, 12 months after baseline
Other	Single target implicit association task (ST-IAT)	An experimental paradigm used to assess implicit cognitive biases towards sexual stimuli	at baseline, 3 months after baseline
Other	Scrambled-sentences task	An experimental paradigm used to assess implicit cognitive biases towards sexual stimuli	at baseline, 3 months after baseline
Other	Qualitative evaluation of COPE and MIND	Qualitative telephone interviews with approx. 50 participants to assess perceived mechanisms of change as well as strengths and weaknesses of the programs	12 weeks after baseline
Primary	Sexual Interest and Desire Inventory Female (SIDI-F)	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.	at baseline, 5 weeks after baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Secondary	Female Sexual Distress Scale Revised (FSDS-R)	The Female Sexual Distress Scale (FSDS) is a 13-item self- assessment questionnaire for the evaluation of sexually related personal distress.	at baseline, 5 weeks after baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline