Clinical trial NCT03361514: Discontinuation of Antidepressant Medication in Primary Care.
Official title: Discontinuation of Antidepressant Medication in Primary Care Supported by Monitoring Plus Mindfulness-based Cognitive Therapy Versus Monitoring Alone.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antidepressants
Keywords: antidepressants, discontinuation, primary care, MBCT
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Pro Persona Mental Health Care Foundation
name: Innovatiefonds Zorgverzekeraars
First posted: 2017-12-05
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients who fully discontinued their antidepressant medication after 6 months.
timeFrame: 6 months
Secondary outcomes:
measure: Structured Clinical Interview for DSM-IV-TR Disorders
timeFrame: baseline and 6, 9 and 12 months
measure: Discontinuation-Emergent Signs and Symptoms
timeFrame: baseline and 6, 9 and 12 months
measure: Inventory of Depressive Symptomatology
timeFrame: baseline and 6, 9 and 12 months
measure: State/Trait Anxiety Inventory
timeFrame: baseline and 6, 9 and 12 months
measure: Module Suicide Cognitions of the Mini International Neuropsychiatric Interview
timeFrame: baseline and 6, 9 and 12 months
measure: Mental Health Continuum - short form
timeFrame: baseline and 6, 9 and 12 months
measure: Five Facet Mindfulness Questionnaire
timeFrame: baseline and 6, 9 and 12 months
measure: Self-Compassion Scale
timeFrame: baseline and 6, 9 and 12 months
Other outcomes:
measure: Trimbos/iMTA Questionnaire on Costs associated with Psychiatric illness
timeFrame: baseline and 6, 9 and 12 months
measure: Euro-Quality of Life 5D-5L
timeFrame: baseline and 6, 9 and 12 months
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Centre for Mindfulness, Radboud University Nijmegen Medical Centre
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Anne EM Speckens, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.