Discontinuation of Antidepressant Medication in Primary Care.

NCT03361514 | Completed

• 2 other identifiers: MFN-ADM-2015-2019NL56937.091.16
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Antidepressants

Keywords

antidepressants, discontinuation, primary care, MBCT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Structured Clinical Interview for DSM-IV-TR Disorders

  baseline and 6, 9 and 12 months

• Discontinuation-Emergent Signs and Symptoms

  baseline and 6, 9 and 12 months

• Inventory of Depressive Symptomatology

  baseline and 6, 9 and 12 months

• State/Trait Anxiety Inventory

  baseline and 6, 9 and 12 months

• Module Suicide Cognitions of the Mini International Neuropsychiatric Interview

  baseline and 6, 9 and 12 months

Other Outcomes (2)

• Trimbos/iMTA Questionnaire on Costs associated with Psychiatric illness

  baseline and 6, 9 and 12 months

• Euro-Quality of Life 5D-5L

  baseline and 6, 9 and 12 months

Study Arms (2)

Supported Protocolized Discontinuation

ACTIVE COMPARATOR

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)

SPD + Mindfulness (MBCT)

EXPERIMENTAL

In addition to the SPD (as mentioned above) patients are offered Mindfulness Based Cognitive Therapy (MBCT)

Behavioral: Supported Protocolized Discontinuation (SPD); Behavioral: Mindfulness Based Cognitive Therapy (MBCT)

Interventions

Supported Protocolized Discontinuation (SPD) BEHAVIORAL

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.

SPD + Mindfulness (MBCT); Supported Protocolized Discontinuation

Mindfulness Based Cognitive Therapy (MBCT) BEHAVIORAL

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.

SPD + Mindfulness (MBCT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Pro Persona Mental Health Care Foundation: collaborator
• Innovatiefonds Zorgverzekeraars: collaborator

Study Sites (1)

Radboud University Medical Centre for Mindfulness, Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500HB, Netherlands

Location

Related Publications (2)

• Huijbers MJ, Wentink C, Lucassen PLBJ, Kramers C, Akkermans R, Spijker J, Speckens AEM. Supporting antidepressant discontinuation using mindfulness plus monitoring versus monitoring alone: A cluster randomized trial in general practice. PLoS One. 2023 Sep 5;18(9):e0290965. doi: 10.1371/journal.pone.0290965. eCollection 2023.

  PMID: 37669281 DERIVED

• 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.

  PMID: 31349796 DERIVED

MeSH Terms

Interventions

Mindfulness-Based Cognitive Therapy

Intervention Hierarchy (Ancestors)

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

Study Officials

• Anne EM Speckens, prof. dr.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is designed as a cluster-randomized controlled trial conducted in primary care, randomizing General Practitioners over a.) Supported Protocolized Discontinuation (SPD) alone or b.) SPD with additional Mindfulness-Based Cognitive Therapy (MBCT). Both the patient, GP and the research team will be aware of the allocated condition.

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: December 5, 2017
• Study Start: February 20, 2017
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After publication of the main trial papers including embargo period.
• Access Criteria: To be decided in a later stage.

Locations

NL (1)