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| Name | Class |
|---|---|
| Friedrich-Alexander-Universität Erlangen-Nürnberg | OTHER |
| University of British Columbia | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive-behavioral treatment | Experimental | 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 | Experimental | 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). |
|
| Waitlist | No Intervention | Participants will receive no immediate treatment but will be able to choose either MIND or COPE after a six months waiting period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia Velten, PhD | Ruhr University Bochum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruhr University Bochum | Bochum | North Rhine-Westphalia | 44787 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39446648 | Derived | Velten J, Hirschfeld G, Meyers M, Margraf J. Results of a randomized waitlist-controlled trial of online cognitive behavioral sex therapy and online mindfulness-based sex therapy for hypoactive sexual desire dysfunction in women. J Consult Clin Psychol. 2024 Nov;92(11):742-755. doi: 10.1037/ccp0000922. Epub 2024 Oct 24. | |
| 32990248 |
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IPD data of accepted publications will be published open access on the respective Journal's website or on the Open Science Framework.
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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.
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|
| 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). |
|
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 |
| 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. |
| ID | Term |
|---|---|
| D020018 | Sexual Dysfunctions, Psychological |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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