Mindfulness for Antidepressant-induced Sexual Symptoms

NCT02768012 | Withdrawn

• 1 other identifier: H15-02707
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• group difference on change in CSFQ-14 score after intervention

  The researchers will calculate an 80% confidence interval for the between group difference on change in CSFQ-14 score pre to post intervention using a linear mixed model that includes treatment, time and time-by-treatment as fixed effects and patient as a random effect. If the confidence interval excludes 0 the researchers will consider this preliminary evidence of efficacy.

  18 months

Secondary Outcomes (1)

• Estimation of the minimal clinically important improvement

  18 months

Study Arms (2)

mindfulness-based cognitive therapy

ACTIVE COMPARATOR

The practice of mindfulness will be followed plus the basics of cognitive therapy given in small group format.

Behavioral: mindfulness-based cognitive therapy

waitlist

NO INTERVENTION

Women diagnosed with AISD randomised to wait list will receive no active treatment during the trial period.

Interventions

mindfulness-based cognitive therapy BEHAVIORAL

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.

mindfulness-based cognitive therapy

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• participants need to be:
• referred to the Sexual Medicine Clinic
• women 19 years of age or older
• fulfilling the DSM-5 criteria for clinical diagnosis of AISD for at least 4 weeks, confirmed by Changes in Sexual Functioning Questionnaire (CSFQ-14) total score of 41 or below
• on a therapeutic dose of antidepressant for at least 8 weeks and on a stable dose for at least 4 weeks
• in clinical remission from depression and/or anxiety, confirmed by a Patient Health Questionnaire (PHQ-9) score of less than 5, and a Generalized Anxiety Disorder-7 (GAD-7) score of less than 10, respectively
• willing to commit to adhere to their antidepressant regimen for the duration of the trial (20 weeks) unless medically contraindicated
• willing to commit to attend to all group sessions, homework assignments, and questionnaires
• the referring physician commits to continued provision of mental health care throughout the study

You may not qualify if:

• history of SD prior to being started on current antidepressant except SD secondary to clinical depression, or AISD
• chronic pain with intercourse not relieved with lubricants
• primary psychiatric disorder other than a depressive or anxiety disorder
• alcohol/substance abuse
• general medical illnesses known to impair sexual function including but not limited to cancer, neurological, endocrine, renal, and cardiovascular conditions
• non-antidepressant medication induced SD (70)
• receiving other concurrent pharmacological or psychological interventions for SD
• positive screen for borderline personality disorder, due to the high prevalence of sexual difficulties (70, 71), and the potential destabilizing effect of mindfulness meditation in those affected (72)
• previous formal practice of mindfulness meditation.

Sponsors & Collaborators

• University of British Columbia: lead

MeSH Terms

Interventions

Mindfulness-Based Cognitive Therapy

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 11, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: July 1, 2018
• Last Updated: October 26, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share