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

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?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03780751
Acronym
MiSELF
Enrollment
266
Registered
2018-12-19
Start date
2018-12-18
Completion date
2022-09-16
Last updated
2023-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoactive Sexual Desire Disorder

Keywords

Sexual dysfunction, Female Sexual Interest/Arousal Disorder, Internet-based intervention, Mindfulness, Cognitive-behavioral therapy

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.

Interventions

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.

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).

Sponsors

Friedrich-Alexander-Universität Erlangen-Nürnberg
CollaboratorOTHER
University of British Columbia
CollaboratorOTHER
Ruhr University of Bochum
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 baselineThe 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

MeasureTime frameDescription
Female Sexual Distress Scale Revised (FSDS-R)at baseline, 5 weeks after baseline, 3 months after baseline, 6 months after baseline, 12 months after baselineThe Female Sexual Distress Scale (FSDS) is a 13-item self- assessment questionnaire for the evaluation of sexually related personal distress.

Other

MeasureTime frameDescription
Patient Health Questionnaire 9 (PHQ-9)at baseline, 3 months after baseline, 6 months after baseline, 12 months after baselineA 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 baselineA 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 baselineA 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 baselineA 15-item self-report measure used to assess mindfulness
Body Image Self-Consciousness Scaleat baseline, 3 months after baseline, 6 months after baseline, 12 months after baselineA 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 baselineA 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 baselineA 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 baselineTreatment adherence as measured with the HAPA scales
Working alliance inventory (WAI) adapted for online treatments3 months after baseline, 6 months after baselineMeasures working alliance with eCoaches and online-program
Inventory for the Assessment of Negative Effects of Psychotherapy (INEP)3 months after baseline, 6 months after baseline15-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 baseline8-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 baselineAn experimental paradigm used to assess implicit cognitive biases towards sexual stimuli
Scrambled-sentences taskat baseline, 3 months after baselineAn experimental paradigm used to assess implicit cognitive biases towards sexual stimuli
Qualitative evaluation of COPE and MIND12 weeks after baselineQualitative telephone interviews with approx. 50 participants to assess perceived mechanisms of change as well as strengths and weaknesses of the programs
Desire subscale of the Female Sexual Function Indexat baseline, 5 weeks after baseline, 3 months after baseline, 6 months after baseline, 12 months after baselineThe Female Sexual Function Index measures women's sexual function with 19-items. Here, the two items assessing sexual desire will be used.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026