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Mindfulness for Antidepressant-induced Sexual Symptoms

NCT02768012 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-10-26

No results posted yet for this study

Summary

Antidepressant-induced sexual dysfunction (AISD) affects the majority of women taking antidepressants and reduces medication compliance: however there is a paucity of evidence-based strategies for the management of this condition. Mindfulness-based cognitive therapy (MBCT) has been shown to be effective in the treatment of non-antidepressant-induced sexual dysfunction and may be beneficial in the treatment of AISD. The investigators propose a randomized, controlled, proof-of-principle trial to establish preliminary evidence of efficacy of MBCT in AISD and to inform the design of a larger trial to evaluate its effectiveness

Conditions

  • Other Substance Induced Sexual Dysfunction

Interventions

BEHAVIORAL

mindfulness-based cognitive therapy

Six two-hour small group sessions (6-9 participants) will be administered over 8 weeks focusing on MBCT. The intervention follows a written protocol to ensure fidelity of delivery. Participants will receive detailed manuals summarizing session content and home assignments (HAs), including mindfulness practices, audio versions of which will be available on an internet link.

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-12-31
Completion
2018-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02768012 on ClinicalTrials.gov