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

NCT ID: NCT03780751

Last Updated: 2023-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

266 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-18

Study Completion Date

2022-09-16

Brief Summary

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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.

Detailed Description

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Conditions

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Hypoactive Sexual Desire Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cognitive-behavioral treatment

Intervention Type 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

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).

Group Type EXPERIMENTAL

Mindfulness-based treatment

Intervention Type 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).

Waitlist

Participants will receive no immediate treatment but will be able to choose either MIND or COPE after a six months waiting period.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Friedrich-Alexander-Universität Erlangen-Nürnberg

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role collaborator

Ruhr University of Bochum

OTHER

Sponsor Role lead

Responsible Party

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Julia Velten

Postdoctoral Research Associate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julia Velten, PhD

Role: PRINCIPAL_INVESTIGATOR

Ruhr University Bochum

Locations

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Ruhr University Bochum

Bochum, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 39446648 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32990248 (View on PubMed)

Other Identifiers

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VE 1083/2-1

Identifier Type: -

Identifier Source: org_study_id

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