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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2012 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
Lori Brotto, University of British Columbia
ClinicalTrials.gov Identifier:
NCT01690897
First received: August 22, 2012
Last updated: September 21, 2012
Last verified: August 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Sexual Distress [ Time Frame: up to 6 months post treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Mindfulness will be measured with the Five Factor Mindfulness questionnaire (Baer, Smith, Hopkins, Krietemeyer & Tony, 2006)


Estimated Enrollment: 64
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2012 (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

Ages Eligible for Study:   19 Years to 65 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
British Columbia Centre for Sexual Medicine Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1C6
Contact: Yvonne Erskine, M.Ed    604-875-4111 ext 68901    yvonne.erskine@vch.ca   
Contact: Lori Brotto, PhD    604-875-4111 ext 68898    lori.brotto@vch.ca   
Principal Investigator: Lori Brotto, PhD         
Sponsors and Collaborators
University of British Columbia
  More Information

No publications provided

Responsible Party: Lori Brotto, Assistant professor, UBC Department of Gynaecology, University of British Columbia
ClinicalTrials.gov Identifier: NCT01690897     History of Changes
Other Study ID Numbers: H12-01659
Study First Received: August 22, 2012
Last Updated: September 21, 2012
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on August 28, 2014