Discontinuation of Antidepressant Medication in Primary Care.

Not Applicable

Completed

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

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.

Recruitment & Eligibility

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

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of patients who fully discontinued their antidepressant medication after 6 months.	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 Outcome Measures

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

Locations (1): Radboud University Medical Centre for Mindfulness, Radboud University Nijmegen Medical Centre
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Nijmegen, Gelderland, Netherlands