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Mindfulness-Based Treatment for Women With Sexual Interest/Desire Concerns: The MIND Group

This study is currently recruiting participants.
Verified May 2017 by Lori Brotto, University of British Columbia
Sponsor:
ClinicalTrials.gov Identifier:
NCT01690897
First Posted: September 24, 2012
Last Update Posted: June 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Lori Brotto, University of British Columbia
  Purpose
The purpose of this study is to test and determine the efficacy of an 8-session mindfulness-based psychoeducational intervention for women with sexual interest/ desire concerns when compared to a wait-list control condition.

Condition Intervention
Low Female Sexual Desire Behavioral: Mindfulness-based treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Lori Brotto, University of British Columbia:

Primary Outcome Measures:
  • Sexual Distress [ Time Frame: up to 6 months post treatment ]
    Sexual distress will be measured with the revised version of the Female Sexual Distress Scale-R (Derogatis et al., 2008).


Secondary Outcome Measures:
  • Subjective sexual arousal [ Time Frame: pre-treatment, 2-4 weeks post treatment and 6 months post treatment ]
    Subjects will indicate their levels of subjective arousal while undergoing arousal testing. A device manufactured for the UBC Sexual Health Lab called the "arousometer"- a computer mouse mounted on a metal track divided into 10 equally spaced intervals corresponding to "sexually turned off" (-2) to "the most sexually aroused you have ever been or could imagine being" (7). This device allows continuous self-report measurement of subjective sexual arousal while viewing the erotic films.

  • Interoceptive Awareness [ Time Frame: 2-4 weeks post treatment and 6 months post treatment ]
    Interoceptive Awareness will be measured using the Heartbeat Perception task (Schandry, 1981).


Other Outcome Measures:
  • Physiological sexual arousal [ Time Frame: pre-treatment, 2-4 weeks post treatment and 6 months post treatment ]
    Physiological sexual arousal will be measured with a Vaginal Photoplethysmograph (VPP) during exposure to erotic films. The VPP measures vaginal pulse amplitude (VPA) which has been found to be a sensitive and specific measure of genital arousal (Laan & Everaerd, 1995).

  • Sexual Desire [ Time Frame: pre-treatment, 2-4 weeks post treatment and 6 months post treatment ]
    The Sexual Interest and Desire Inventory (SIDI; Clayton et al. 2006) will be used to measure sexual desire.

  • Depression [ Time Frame: pre-treatment, 2-4 weeks post treatment and 6 months post treatment ]
    Depression will be measured with the Beck Depression Inventory (Beck & Beamesderfer,1974).

  • Mindfulness [ Time Frame: pre-treatment, 2-4 weeks post treatment and 6 months post treatment ]
    Mindfulness will be measured with the Five Factor Mindfulness questionnaire (Baer, Smith, Hopkins, Krietemeyer & Tony, 2006)


Estimated Enrollment: 64
Study Start Date: January 2013
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immediate treatment
Women randomized into the "immediate treatment" group will undergo pre-treatment testing (questionnaires and physiological assessment)within 14 days of beginning treatment
Behavioral: Mindfulness-based treatment
The MIND Study treatment consists of eight 2-hour long weekly group psychoeducational sessions combining education, cognitive and behavioural theory, and mindfulness skills.
Waitlist control
Women randomized to the "waitlist" group will undergo initial testing (questionnaires and physiological testing) and receive no treatment until the next scheduled group (8 weeks). They will undergo pretreatment testing and treatment on the same schedule as women in the "immediate treatment" group.
Behavioral: Mindfulness-based treatment
The MIND Study treatment consists of eight 2-hour long weekly group psychoeducational sessions combining education, cognitive and behavioural theory, and mindfulness skills.

Detailed Description:

HYPOTHESES:

  1. Compared to baseline, the MIND group will have significantly greater improvements in self-report measures of: (a) subjective sexual arousal; (b) perception of genital arousal; (c) sexual desire; (e) sexual distress; (f) depressive symptoms; (g) mindfulness, and (h) genital sexual response as measured by a vaginal photoplethysmograph.
  2. We hypothesize no significant change in any of the endpoints listed in #1 from the first to the second wait-list (pre-treatment) conditions.
  3. We are interested in concordance between genital and subjective sexual arousal as another endpoint. It is unknown if participation in the MIND group will significantly increase concordance
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • must be a patient at the British Columbia Centre for Sexual Medicine
  • must be experiencing distressing sexual interest/desire and/or sexual arousal concerns
  • must between the ages of 19 - 65
  • must be fluent in English

Exclusion Criteria:

  • not a patient at the BC Centre for Sexual Medicine
  • not experiencing distressing sexual interest/desire and/or sexual arousal concerns
  • not between the ages of 19-65
  • unable to read, write, speak and understand English
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01690897


Contacts
Contact: Yvonne Erskine, M.Ed 604-875-4111 ext 69801 yvonne.erskine@vch.ca
Contact: Lori Brotto, Ph.D 604-875-4111 ext 68898 lori.brotto@vch.ca

Locations
Canada, British Columbia
Department of Gynaecology Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Laurel Paterson, PhD    604-875-4111 ext 68901    laurel.paterson@vch.ca   
Sponsors and Collaborators
University of British Columbia
  More Information

Responsible Party: Lori Brotto, Associate professor, UBC Department of Gynaecology, University of British Columbia
ClinicalTrials.gov Identifier: NCT01690897     History of Changes
Other Study ID Numbers: H12-01659
First Submitted: August 22, 2012
First Posted: September 24, 2012
Last Update Posted: June 1, 2017
Last Verified: May 2017

Keywords provided by Lori Brotto, University of British Columbia:
Female sexual desire
Psychoeducational intervention
Mindfulness