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

NCT03780751 | Completed

• 1 other identifier: VE 1083/2-1
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoactive Sexual Desire Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Female Sexual Distress Scale Revised (FSDS-R)

  at baseline, 5 weeks after baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline

Other Outcomes (15)

• Desire subscale of the Female Sexual Function Index

  at baseline, 5 weeks after baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline

• Patient Health Questionnaire 9 (PHQ-9)

  at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline

• Generalized Anxiety Disorder 7 (GAD-7)

  at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline

Study Arms (3)

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.

Behavioral: Cognitive-behavioral treatment

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).

Behavioral: Mindfulness-based treatment

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.

Interventions

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.

Cognitive-behavioral treatment

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).

Mindfulness-based treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruhr University of Bochum: lead
• Friedrich-Alexander-Universität Erlangen-Nürnberg: collaborator
• University of British Columbia: collaborator

Study Sites (1)

Ruhr University Bochum

Bochum, North Rhine-Westphalia, 44787, Germany

Location

Related Publications (2)

• 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.

  PMID: 39446648 DERIVED

• 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.

  PMID: 32990248 DERIVED

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Mental Disorders; Genital Diseases; Urogenital Diseases

Study Officials

• Julia Velten, PhD

  Ruhr University Bochum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Research Associate

Model Details: 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.

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 19, 2018
• Study Start: December 18, 2018
• Primary Completion: September 16, 2022
• Study Completion: September 16, 2022
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

DE (1)