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      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Psychological Treatment of Low Sexual Desire in Women: Protocol for a Randomized, Waitlist-Controlled Trial of Internet-Based Cognitive Behavioral and Mindfulness-Based Treatments

      research-article
      Author(s): , MSc 1 , , Prof Dr 1 , , PD Dr 1 ,
      Editor(s):
      Other contributor(s): (Reviewer), (Reviewer)
      Publication date (Electronic):
      Journal: JMIR Research Protocols
      Publisher: JMIR Publications
      Keywords: sexual desire, sexual dysfunction, women’s sexual health, cognitive behavioral therapy

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          Abstract

          Background

          Psychological therapies are effective treatments for hypoactive sexual desire dysfunction (HSDD; formerly hypoactive sexual desire disorder), a common sexual dysfunction among women. Access to evidence-based treatments, however, remains difficult. Internet-based interventions are effective for a variety of psychological disorders and may be a promising means to close the treatment gap for HSDD.

          Objective

          This article describes the treatment protocol and study design of a randomized controlled trial, aiming to study the efficacy of cognitive behavioral and mindfulness-based interventions delivered via the internet for women with HSDD to a waitlist control group. Outcomes are sexual desire (primary) and sexual distress (secondary). Additional variables (eg, depression, mindfulness, rumination) will be assessed as potential moderators or mediators of treatment success.

          Methods

          A cognitive behavioral and a mindfulness-based self-help intervention for HSDD will be provided online. Overall, 266 women with HSDD will be recruited and assigned either to one of the intervention groups, or to a waitlist control group (2:2:1). Outcome data will be assessed at baseline, at 12 weeks, and at 6 and 12 months after randomization. Intention-to-treat and completer analyses will be conducted.

          Results

          We expect improvements in sexual desire and sexuality-related distress in both intervention groups compared to the waitlist control. Recruitment has begun in January 2019 and is expected to be completed in August 2021. Results will be published in 2022.

          Conclusions

          This study aims to contribute to the improvement and dissemination of psychological treatments for women with HSDD and to clarify whether cognitive behavioral and/or mindfulness-based treatments for HSDD are feasible and effective when delivered via the internet.

          Trial Registration

          ClinicalTrials.gov NCT03780751; https://clinicaltrials.gov/ct2/show/NCT03780751

          International Registered Report Identifier (IRRID)

          DERR1-10.2196/20326

          Related collections

          Most cited references67

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          The PHQ-9: A New Depression Diagnostic and Severity Measure

          Kurt Kroenke, Robert L Spitzer (2002)
          Article 0 comments Cited 963 times – based on 0 reviews     Review now
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            Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population.

            Bernd Löwe, Oliver Decker, Stefanie H. Müller … (2008)
            The 7-item Generalized Anxiety Disorder Scale (GAD-7) is a practical self-report anxiety questionnaire that proved valid in primary care. However, the GAD-7 was not yet validated in the general population and thus far, normative data are not available. To investigate reliability, construct validity, and factorial validity of the GAD-7 in the general population and to generate normative data. Nationally representative face-to-face household survey conducted in Germany between May 5 and June 8, 2006. Five thousand thirty subjects (53.6% female) with a mean age (SD) of 48.4 (18.0) years. The survey questionnaire included the GAD-7, the 2-item depression module from the Patient Health Questionnaire (PHQ-2), the Rosenberg Self-Esteem Scale, and demographic characteristics. Confirmatory factor analyses substantiated the 1-dimensional structure of the GAD-7 and its factorial invariance for gender and age. Internal consistency was identical across all subgroups (alpha = 0.89). Intercorrelations with the PHQ-2 and the Rosenberg Self-Esteem Scale were r = 0.64 (P < 0.001) and r = -0.43 (P < 0.001), respectively. As expected, women had significantly higher mean (SD) GAD-7 anxiety scores compared with men [3.2 (3.5) vs. 2.7 (3.2); P < 0.001]. Normative data for the GAD-7 were generated for both genders and different age levels. Approximately 5% of subjects had GAD-7 scores of 10 or greater, and 1% had GAD-7 scores of 15 or greater. Evidence supports reliability and validity of the GAD-7 as a measure of anxiety in the general population. The normative data provided in this study can be used to compare a subject's GAD-7 score with those determined from a general population reference group.
            Article 0 comments Cited 929 times – based on 0 reviews     Review now
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              Missing data: our view of the state of the art.

              Joseph Schafer, John W Graham (2002)
              Statistical procedures for missing data have vastly improved, yet misconception and unsound practice still abound. The authors frame the missing-data problem, review methods, offer advice, and raise issues that remain unresolved. They clear up common misunderstandings regarding the missing at random (MAR) concept. They summarize the evidence against older procedures and, with few exceptions, discourage their use. They present, in both technical and practical language, 2 general approaches that come highly recommended: maximum likelihood (ML) and Bayesian multiple imputation (MI). Newer developments are discussed, including some for dealing with missing data that are not MAR. Although not yet in the mainstream, these procedures may eventually extend the ML and MI methods that currently represent the state of the art.
              Article 0 comments Cited 910 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Julia Velten:
                ORCID: https://orcid.org/0000-0002-6822-767X
                Clinical Psychology and Psychotherapy, Mental Health Research and Treatment CenterFaculty of PsychologyRuhr University BochumMassenbergstr. 9-13Bochum, 44787Germany49 234 32 22159julia.velten@rub.de
                Journal
                Journal ID (nlm-ta): JMIR Res Protoc
                Journal ID (iso-abbrev): JMIR Res Protoc
                Journal ID (publisher-id): ResProt
                Title: JMIR Research Protocols
                Publisher: JMIR Publications (Toronto, Canada )
                ISSN (Electronic): 1929-0748
                Publication date Collection: September 2020
                Publication date (Electronic): 29 September 2020
                Volume: 9
                Issue: 9
                Electronic Location Identifier: e20326
                Affiliations
                [1 ] Clinical Psychology and Psychotherapy, Mental Health Research and Treatment Center Faculty of Psychology Ruhr University Bochum Bochum Germany
                Author notes
                Corresponding Author: Julia Velten julia.velten@ 123456rub.de
                Author information
                https://orcid.org/0000-0002-4207-4222
                https://orcid.org/0000-0001-5207-7016
                https://orcid.org/0000-0002-6822-767X
                Article
                Publisher ID: v9i9e20326
                DOI: 10.2196/20326
                PMC ID: 7556380
                PubMed ID: 32990248
                SO-VID: 53db9761-98df-4dca-9e11-7a014a7eae3f
                Copyright statement: ©Milena Meyers, Jürgen Margraf, Julia Velten. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 29.09.2020.
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                Date received : 10 June 2020
                Date revision requested : 21 July 2020
                Date revision received : 16 August 2020
                Date accepted : 16 August 2020
                Product
                Self URI: http://www.researchprotocols.org/2020/9/e20326/
                Categories
                Subject: Protocol
                Subject: Protocol

                Keywords: sexual desire,sexual dysfunction,women’s sexual health,cognitive behavioral therapy
                Data availability:
                Keywords: sexual desire, sexual dysfunction, women’s sexual health, cognitive behavioral therapy

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