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Completed

NCT Number: NCT03780751

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

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.

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Key information

Conditions

Hypoactive Sexual Desire Disorder Genital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ruhr University Bochum

Bochum, North Rhine-Westphalia, 44787, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cognitive-behavioral treatment

Behavioral

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

Behavioral

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).

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Collaborators

  • Friedrich-Alexander-Universität Erlangen-Nürnberg
  • University of British Columbia

Registry information

Official study 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?

Acronym: MiSELF

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Dec 19, 2018
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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