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

Primary Purpose

Hypoactive Sexual Desire Disorder

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cognitive-behavioral treatment
Mindfulness-based treatment
Sponsored by
Ruhr University of Bochum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoactive Sexual Desire Disorder focused on measuring Sexual dysfunction, Female Sexual Interest/Arousal Disorder, Internet-based intervention, Mindfulness, Cognitive-behavioral therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ruhr University Bochum

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Cognitive-behavioral treatment

Mindfulness-based treatment

Waitlist

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 18, 2018
Last Updated
March 28, 2023
Sponsor
Ruhr University of Bochum
Collaborators
Friedrich-Alexander-Universität Erlangen-Nürnberg, University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT03780751
Brief Title
Waitlist Controlled Comparison of Cognitive-behavioral vs. Mindfulness-based Online-treatments for Women With Low Sexual Desire
Acronym
MiSELF
Official 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?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 18, 2018 (Actual)
Primary Completion Date
September 16, 2022 (Actual)
Study Completion Date
September 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruhr University of Bochum
Collaborators
Friedrich-Alexander-Universität Erlangen-Nürnberg, University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoactive Sexual Desire Disorder
Keywords
Sexual dysfunction, Female Sexual Interest/Arousal Disorder, Internet-based intervention, Mindfulness, Cognitive-behavioral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
266 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive-behavioral treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Mindfulness-based treatment
Arm Type
Experimental
Arm Description
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).
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
Participants will receive no immediate treatment but will be able to choose either MIND or COPE after a six months waiting period.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral treatment
Intervention Description
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
Intervention Name(s)
Mindfulness-based treatment
Intervention Description
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 Outcome Measure Information:
Title
Sexual Interest and Desire Inventory Female (SIDI-F)
Description
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.
Time Frame
at baseline, 5 weeks after baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Secondary Outcome Measure Information:
Title
Female Sexual Distress Scale Revised (FSDS-R)
Description
The Female Sexual Distress Scale (FSDS) is a 13-item self- assessment questionnaire for the evaluation of sexually related personal distress.
Time Frame
at baseline, 5 weeks after baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Other Pre-specified Outcome Measures:
Title
Desire subscale of the Female Sexual Function Index
Description
The Female Sexual Function Index measures women's sexual function with 19-items. Here, the two items assessing sexual desire will be used.
Time Frame
at baseline, 5 weeks after baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Title
Patient Health Questionnaire 9 (PHQ-9)
Description
A 9-item self-report measure used to assess symptoms of depression.
Time Frame
at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Title
Generalized Anxiety Disorder 7 (GAD-7)
Description
A 7-item self-report measure used to assess symptoms of anxiety.
Time Frame
at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Title
Scale of Body Connection (SBC)
Description
A 20-item self-report measure used to assess body awareness
Time Frame
at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Title
Mindful Attention and Awareness Scale (MAAS)
Description
A 15-item self-report measure used to assess mindfulness
Time Frame
at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Title
Body Image Self-Consciousness Scale
Description
A 15-item self-report measure used to assess body-related self-consciousness
Time Frame
at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Title
Self-Compassion Scale (SCS)
Description
A 12-item self-report scale used to assess self-compassion.
Time Frame
at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Title
Rumination-Reflection Questionnaire - Adapted Rumination Subscale (RRQ)
Description
A 12-item scale that assess rumination about sexual issues
Time Frame
at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Title
Health Action Process Approach (HAPA)
Description
Treatment adherence as measured with the HAPA scales
Time Frame
at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Title
Working alliance inventory (WAI) adapted for online treatments
Description
Measures working alliance with eCoaches and online-program
Time Frame
3 months after baseline, 6 months after baseline
Title
Inventory for the Assessment of Negative Effects of Psychotherapy (INEP)
Description
15-item self-report measure that assesses side-effects of psychological treatments
Time Frame
3 months after baseline, 6 months after baseline
Title
Client Satisfaction Questionnaire (CSQ-8)
Description
8-item self-report measure that assesses women's satisfaction with the online treatment they received
Time Frame
3 months after baseline, 6 months after baseline, 12 months after baseline
Title
Single target implicit association task (ST-IAT)
Description
An experimental paradigm used to assess implicit cognitive biases towards sexual stimuli
Time Frame
at baseline, 3 months after baseline
Title
Scrambled-sentences task
Description
An experimental paradigm used to assess implicit cognitive biases towards sexual stimuli
Time Frame
at baseline, 3 months after baseline
Title
Qualitative evaluation of COPE and MIND
Description
Qualitative telephone interviews with approx. 50 participants to assess perceived mechanisms of change as well as strengths and weaknesses of the programs
Time Frame
12 weeks after baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Velten, PhD
Organizational Affiliation
Ruhr University Bochum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruhr University Bochum
City
Bochum
State/Province
NRW
ZIP/Postal Code
44787
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD data of accepted publications will be published open access on the respective Journal's website or on the Open Science Framework.
Citations:
PubMed Identifier
32990248
Citation
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.
Results Reference
derived

Learn more about this trial

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

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