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Potential participants to date all had etiological factors for their sexual dysfunction additional to the antidepressant. Thus they all had exclusion criterior
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mindfulness-based cognitive therapy | Active Comparator | The practice of mindfulness will be followed plus the basics of cognitive therapy given in small group format. |
|
| waitlist | No Intervention | Women diagnosed with AISD randomised to wait list will receive no active treatment during the trial period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Estimation of the minimal clinically important improvement | At treatment completion (8 weeks) patients will be asked to assess their response to MBCT treatment on a five-point descriptive scale (none = no good at all, treatment was ineffective; poor = some effect but unsatisfactory; fair = reasonable effect but could be better; good = satisfactory effect but still some problems; excellent = ideal response, sexual dysfunction gone). The minimal clinically important improvement for the CSFQ-14 and the FSFI will be determined from the group reporting a "good" response following established methods. |
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Inclusion Criteria:
participants need to be:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000099025 | Mindfulness-Based Cognitive Therapy |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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|
| 18 months |
| D004191 |
| Behavioral Disciplines and Activities |