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

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ClinicalTrials.gov Identifier: NCT03780751
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : October 8, 2020
Sponsor:
Collaborators:
Friedrich-Alexander-Universität Erlangen-Nürnberg
University of British Columbia
Information provided by (Responsible Party):
Julia Velten, Ruhr University of Bochum

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : December 18, 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : January 2022

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.



Primary Outcome Measures :
  1. Sexual Interest and Desire Inventory Female (SIDI-F) [ Time Frame: 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 :
  1. Female Sexual Distress Scale Revised (FSDS-R) [ Time Frame: 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:
  1. Desire subscale of the Female Sexual Function Index [ Time Frame: 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.

  2. Patient Health Questionnaire 9 (PHQ-9) [ Time Frame: 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.

  3. Generalized Anxiety Disorder 7 (GAD-7) [ Time Frame: 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.

  4. Scale of Body Connection (SBC) [ Time Frame: 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

  5. Mindful Attention and Awareness Scale (MAAS) [ Time Frame: at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline ]
    A 15-item self-report measure used to assess mindfulness

  6. Body Image Self-Consciousness Scale [ Time Frame: 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

  7. Self-Compassion Scale (SCS) [ Time Frame: 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.

  8. Rumination-Reflection Questionnaire - Adapted Rumination Subscale (RRQ) [ Time Frame: at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline ]
    A 12-item scale that assess rumination about sexual issues

  9. Health Action Process Approach (HAPA) [ Time Frame: at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline ]
    Treatment adherence as measured with the HAPA scales

  10. Working alliance inventory (WAI) adapted for online treatments [ Time Frame: 3 months after baseline, 6 months after baseline ]
    Measures working alliance with eCoaches and online-program

  11. Inventory for the Assessment of Negative Effects of Psychotherapy (INEP) [ Time Frame: 3 months after baseline, 6 months after baseline ]
    15-item self-report measure that assesses side-effects of psychological treatments

  12. Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: 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

  13. Single target implicit association task (ST-IAT) [ Time Frame: at baseline, 3 months after baseline ]
    An experimental paradigm used to assess implicit cognitive biases towards sexual stimuli

  14. Scrambled-sentences task [ Time Frame: at baseline, 3 months after baseline ]
    An experimental paradigm used to assess implicit cognitive biases towards sexual stimuli

  15. Qualitative evaluation of COPE and MIND [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03780751


Contacts
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Contact: Milena Meyers, MSc 0049-234-3227939 milena.meyers@rub.de
Contact: Anna Lutz, MA 0049-234-3223169 anna.lutz@rub.de

Locations
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Germany
Ruhr University Bochum Recruiting
Bochum, NRW, Germany, 44787
Contact: Milena Meyers, MSc    0049234 ext 3222159    milena.meyers@rub.de   
Contact: Julia Velten, PhD    0049234 ext 3222159    julia.velten@rub.de   
Sponsors and Collaborators
Ruhr University of Bochum
Friedrich-Alexander-Universität Erlangen-Nürnberg
University of British Columbia
Investigators
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Principal Investigator: Julia Velten, PhD Ruhr University Bochum
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Julia Velten, Postdoctoral Research Associate, Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT03780751    
Other Study ID Numbers: VE 1083/2-1
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD data of accepted publications will be published open access on the respective Journal's website or on the Open Science Framework.
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Julia Velten, Ruhr University of Bochum:
Sexual dysfunction
Female Sexual Interest/Arousal Disorder
Internet-based intervention
Mindfulness
Cognitive-behavioral therapy
Additional relevant MeSH terms:
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Hypokinesia
Sexual Dysfunctions, Psychological
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Mental Disorders