Discontinuation of Antidepressant Medication in Primary Care.

Radboud University Medical Center

Status: Completed

Conditions: Antidepressants

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03361514

MFN-ADM-2015-2019

NL56937.091.16 (Registry Identifier)

Details and patient eligibility

About

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 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.

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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119 participants in 2 patient groups

Supported Protocolized Discontinuation

Active Comparator group

Description:

Supported Protocolized Discontinuation (SPD) Patients will receive guidance of their GP and can have supportive meetings with the mental health assistant.

Treatment:

Behavioral: Supported Protocolized Discontinuation (SPD)

SPD + Mindfulness (MBCT)

Experimental group

Description:

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

Treatment:

Behavioral: Supported Protocolized Discontinuation (SPD)

Behavioral: Mindfulness Based Cognitive Therapy (MBCT)