Discontinuation of Antidepressant Medication in Primary Care.

Discontinuation of Antidepressant Medication in Primary Care Supported by Monitoring Plus Mindfulness-based Cognitive Therapy Versus Monitoring Alone.

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.

Study Overview

• Status: Completed
• Conditions: Antidepressants
• Intervention / Treatment: Behavioral: Supported Protocolized Discontinuation (SPD); Behavioral: Mindfulness Based Cognitive Therapy (MBCT)

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.

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500HB
      • Radboud University Medical Centre for Mindfulness, Radboud University Nijmegen Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
Experimental: SPD + Mindfulness (MBCT); In addition to the SPD (as mentioned above) patients are offered Mindfulness Based Cognitive Therapy (MBCT)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients who fully discontinued their antidepressant medication after 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.	6 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trimbos/iMTA Questionnaire on Costs associated with Psychiatric illness	Health service receipt self-report measure designed for economic evaluations in the Netherlands	baseline and 6, 9 and 12 months
Euro-Quality of Life 5D-5L	Short self-report instrument to assess quality adjusted life years	baseline and 6, 9 and 12 months

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Innovatiefonds Zorgverzekeraars; Pro Persona
• Investigators: Principal Investigator: Anne EM Speckens, Prof. dr., Radboud University Medical Center

Publications and helpful links

General Publications

• Wentink C, Huijbers MJ, Lucassen P, Kramers C, Akkermans R, Adang E, Spijker J, Speckens AEM. Discontinuation of antidepressant medication in primary care supported by monitoring plus mindfulness-based cognitive therapy versus monitoring alone: design and protocol of a cluster randomized controlled trial. BMC Fam Pract. 2019 Jul 26;20(1):105. doi: 10.1186/s12875-019-0989-5.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2017
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: October 30, 2017
• First Submitted That Met QC Criteria: November 28, 2017
• First Posted (Actual): December 5, 2017

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 3, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: antidepressants, discontinuation, primary care, MBCT
• Other Study ID Numbers: MFN-ADM-2015-2019; NL56937.091.16 (Registry Identifier: CMO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We intend to comply with guidelines for open access as much as possible.
• IPD Sharing Time Frame: After publication of the main trial papers including embargo period.
• IPD Sharing Access Criteria: To be decided in a later stage.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No