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

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?

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.

Study Overview

• Status: Completed
• Conditions: Hypoactive Sexual Desire Disorder
• Intervention / Treatment: Behavioral: Cognitive-behavioral treatment; Behavioral: Mindfulness-based treatment

• Study Type: Interventional
• Enrollment (Actual): 266
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Bochum, NRW, Germany, 44787
      • Ruhr University Bochum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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).	Behavioral: 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).
No Intervention: Waitlist; Participants will receive no immediate treatment but will be able to choose either MIND or COPE after a six months waiting period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
Working alliance inventory (WAI) adapted for online treatments	Measures working alliance with eCoaches and online-program	3 months after baseline, 6 months after baseline
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
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
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
Scrambled-sentences task	An experimental paradigm used to assess implicit cognitive biases towards sexual stimuli	at baseline, 3 months after baseline
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

Collaborators and Investigators

• Sponsor: Ruhr University of Bochum
• Collaborators: University of British Columbia; Friedrich-Alexander-Universität Erlangen-Nürnberg

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2018
• Primary Completion (Actual): September 16, 2022
• Study Completion (Actual): September 16, 2022

Study Registration Dates

• First Submitted: December 18, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Mindfulness; Cognitive-behavioral therapy; Internet-based intervention; Sexual dysfunction; Female Sexual Interest/Arousal Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Hypokinesia; Sexual Dysfunctions, Psychological
• Other Study ID Numbers: VE 1083/2-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD data of accepted publications will be published open access on the respective Journal's website or on the Open Science Framework.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No