Discontinuation of Antidepressant Medication in Primary Care.

Overview

To investigate the effectiveness of the combination of Supported Protocolized Discontinuation (SPD) and Mindfulness-Based Cognitive Therapy (MBCT) in comparison with SPD alone in successful discontinuation of long-term use of antidepressants in primary care.

Full Title of Study: “Discontinuation of Antidepressant Medication in Primary Care Supported by Monitoring Plus Mindfulness-based Cognitive Therapy Versus Monitoring Alone.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 1, 2019

Detailed Description

Antidepressant use continues to rise, mainly explained by an increase in the proportion of patients receiving long term treatment. Although treatment guidelines recommend discontinuation after sustained remission, discontinuing antidepressants appears to be challenging for both patients and general practitioners. Mindfulness-Based Cognitive Therapy (MBCT) is an effective intervention that reduces the risk of relapse in recurrent depression and might facilitate discontinuation by teaching patients to cope with withdrawal symptoms and fear of relapse. The current study aims to investigate the effectiveness of the combination of Supported Protocolized Discontinuation (SPD) and MBCT in comparison with SPD alone in successful discontinuation of long-term use of antidepressants in primary care. Methods/Design This study involves a cluster-randomized controlled trial conducted in primary care patients with long-term use antidepressants with baseline and 6, 9 and 12 months follow-up assessments. Patients choosing to discontinue their medication will be offered a combination of supported protocolized discontinuation (SPD) and MBCT or SPD alone. Our primary outcome will be full discontinuation of antidepressant medication (= 0 mg) within 6 months after baseline assessment. Secondary outcome measures will be the severity of withdrawal symptoms, symptoms of depression and anxiety, psychological well-being, quality of life and medical and societal costs.

Interventions

  • Behavioral: Supported Protocolized Discontinuation (SPD)
    • Patients who choose to discontinue their medication will make a personal tapering schedule with their GP based upon a discontinuation protocol with tapering suggestions. The protocol offers suggestions to taper within a maximum of 6 months describing all types of available dosages per antidepressant so individualized schedules can be constructed. In addition, they will be offered supportive meetings with the GP’s mental health assistant. The assistant will receive basic information about discontinuation guidance, i.e. the information brochure, decision aid, discontinuation protocol and a short guideline how to organise consultations.
  • Behavioral: Mindfulness Based Cognitive Therapy (MBCT)
    • In addition to the SPD patients are offered Mindfulness Based Cognitive Therapy (MBCT) in homogeneous groups of patients willing to withdraw from their medication. MBCT will be offered according to the treatment protocol developed for recurrent depression, adaptated to the specific needs of patients discontinuing their antidepressant medication. The mindfulness courses will be provided by teachers qualifying the advanced criteria of the Association of Mindfulness Based Teachers in the Netherlands and Flanders. All teachers will receive additional training in using the specific study protocol at the start of the project.

Arms, Groups and Cohorts

  • Active Comparator: Supported Protocolized Discontinuation
    • Supported Protocolized Discontinuation (SPD) Patients will receive guidance of their GP and can have supportive meetings with the mental health assistant.
  • Experimental: SPD + Mindfulness (MBCT)
    • In addition to the SPD (as mentioned above) patients are offered Mindfulness Based Cognitive Therapy (MBCT)

Clinical Trial Outcome Measures

Primary Measures

  • Number of patients who fully discontinued their antidepressant medication after 6 months.
    • Time Frame: 6 months
    • Our primary outcome will be full discontinuation of antidepressant medication (= 0 mg) within 6 months after baseline assessment. Use of medication will be measured with daily calendars. Patients daily fill out paper calendars describing their daily milligrams of their antidepressant use.

Secondary Measures

  • Structured Clinical Interview for DSM-IV-TR Disorders
    • Time Frame: baseline and 6, 9 and 12 months
    • Diagnostic instrument to assess relapse of depressive episode
  • Discontinuation-Emergent Signs and Symptoms
    • Time Frame: baseline and 6, 9 and 12 months
    • Self-report measure for assessing signs and symptoms associated with discontinuation or interruption of SSRI treatment.
  • Inventory of Depressive Symptomatology
    • Time Frame: baseline and 6, 9 and 12 months
    • A clinican-administered interview assessing the severity of depressive symptoms
  • State/Trait Anxiety Inventory
    • Time Frame: baseline and 6, 9 and 12 months
    • Self-report measure for assessing both state and trait levels of anxiety
  • Module Suicide Cognitions of the Mini International Neuropsychiatric Interview
    • Time Frame: baseline and 6, 9 and 12 months
    • A clinican-administered interview assessing the suicidal cognitions and to specify suicidal risk
  • Mental Health Continuum – short form
    • Time Frame: baseline and 6, 9 and 12 months
    • Self-report questionnaire that assesses emotional, psychological and social well-being
  • Five Facet Mindfulness Questionnaire
    • Time Frame: baseline and 6, 9 and 12 months
    • Self-report measure assessing mindfulness skills
  • Self-Compassion Scale
    • Time Frame: baseline and 6, 9 and 12 months
    • Self-report measure consisting of 12 items addressing six components: self-kindness, self-judgment, common humanity, isolation, mindfulness and over-identification

Participating in This Clinical Trial

Inclusion Criteria

• Having received prescriptions for antidepressants in primary care for at least the past nine months Exclusion Criteria:

  • Current treatment by a psychiatrist – Current diagnosis of substance use disorder – Non-psychiatric indication for long-term antidepressant usage (i.e. neuropathic pain) – Having participated in a mindfulness training (> 3 sessions) within the last 5 years – Inability to perform the assessments due to cognitive or language difficulties – Younger than 18 years

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Radboud University Medical Center
  • Collaborator
    • Pro Persona
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Anne EM Speckens, prof. dr., Principal Investigator, Radboud University Medical Center

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