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

March 28, 2023 updated by: Julia Velten, Ruhr University of Bochum

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?

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
266

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
    • NRW
      • Bochum, NRW, Germany, 44787
        • Ruhr University Bochum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: 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.
Experimental: 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).
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).
No Intervention: Waitlist
Participants will receive no immediate treatment but will be able to choose either MIND or COPE after a six months waiting period.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sexual Interest and Desire Inventory Female (SIDI-F)
Time Frame: at baseline, 5 weeks after baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Female Sexual Distress Scale Revised (FSDS-R)
Time Frame: at baseline, 5 weeks after baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Desire subscale of the Female Sexual Function Index
Time Frame: at baseline, 5 weeks after baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
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)
Time Frame: at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
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)
Time Frame: at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
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)
Time Frame: at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
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)
Time Frame: at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
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
Time Frame: at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
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)
Time Frame: at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
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)
Time Frame: at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
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)
Time Frame: at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
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
Time Frame: 3 months after baseline, 6 months after baseline
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)
Time Frame: 3 months after baseline, 6 months after baseline
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)
Time Frame: 3 months after baseline, 6 months after baseline, 12 months after baseline
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)
Time Frame: at baseline, 3 months after baseline
An experimental paradigm used to assess implicit cognitive biases towards sexual stimuli
at baseline, 3 months after baseline
Scrambled-sentences task
Time Frame: at baseline, 3 months after baseline
An experimental paradigm used to assess implicit cognitive biases towards sexual stimuli
at baseline, 3 months after baseline
Qualitative evaluation of COPE and MIND
Time Frame: 12 weeks after baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ruhr University of Bochum

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of British Columbia
Friedrich-Alexander-Universität Erlangen-Nürnberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 16, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 16, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VE 1083/2-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD data of accepted publications will be published open access on the respective Journal's website or on the Open Science Framework.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypoactive Sexual Desire Disorder

Clinical Trials on Cognitive-behavioral treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings