Other Substance Induced Sexual Dysfunction Clinical Trial
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
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.
2. Objectives
1. To provide preliminary evidence of efficacy of MBCT in the management of AISD.
2. To establish the feasibility of conducting a larger RCT of MBCT in AISD by assessing
recruitment, attendance and retention rates.
3. To determine the minimal clinically important difference (MCID) for the Changes in
Sexual Functioning Questionnaire (CSFQ-14) and the Female Sexual Function Index (FSFI).
4. To gain initial estimates of variability for sample size calculation for future trials
of interventions in this patient population.
Study design: Randomized, controlled, parallel-group trial. There will be two treatments: a
mindfulness-based group intervention and a wait-list control. Randomization will be 2:1
(MBCT: WLC). This will be an open-label single center study.
Procedures: Ethics approval will be obtained from the University of British Columbia (UBC)
Clinical Research Ethics Board (CREB). Upon referral to the UBC sexual medicine clinic, women
are assessed by a clinician with expertise in sexual medicine. Those diagnosed with AISD, and
deemed as likely eligible, are informed about the study and invited to meet with the study
coordinator who will assess study criteria and provide more detail about the study
procedures. If the patient agrees to participation, she will first read the consent form and
accept it. The coordinator will then email her a direct link to the online survey. Upon
accessing the link, she will then be routed to the online questionnaire.
;