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

Sponsor

Ruhr University of Bochum (Other)

Overall Status

Recruiting

CT.gov ID

NCT03780751

Collaborator

Friedrich-Alexander-Universität Erlangen-Nürnberg (Other), University of British Columbia (Other)

266

Enrollment

Location

Arms

36.5

Anticipated Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypoactive Sexual Desire Disorder	Behavioral: Cognitive-behavioral treatment Behavioral: Mindfulness-based treatment	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

266 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

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?

Actual Study Start Date :

Dec 18, 2018

Anticipated Primary Completion Date :

Jul 1, 2021

Anticipated Study Completion Date :

Jan 1, 2022

Arms and Interventions

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.

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

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

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.

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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