Antidepressants
Conditions
Keywords
antidepressants, discontinuation, primary care, 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.
Interventions
BEHAVIORALSupported 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.
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.
Sponsors
Pro Persona Mental Health Care Foundation
Innovatiefonds Zorgverzekeraars
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Inventory of Depressive Symptomatology | baseline and 6, 9 and 12 months | A clinican-administered interview assessing the severity of depressive symptoms |
| State/Trait Anxiety Inventory | baseline and 6, 9 and 12 months | Self-report measure for assessing both state and trait levels of anxiety |
| 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 |
| Mental Health Continuum - short form | baseline and 6, 9 and 12 months | Self-report questionnaire that assesses emotional, psychological and social well-being |
| Five Facet Mindfulness Questionnaire | baseline and 6, 9 and 12 months | Self-report measure assessing mindfulness skills |
| 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 |
| Structured Clinical Interview for DSM-IV-TR Disorders | baseline and 6, 9 and 12 months | Diagnostic instrument to assess relapse of depressive episode |
Other
| Measure | Time frame | Description |
|---|---|---|
| Trimbos/iMTA Questionnaire on Costs associated with Psychiatric illness | baseline and 6, 9 and 12 months | Health service receipt self-report measure designed for economic evaluations in the Netherlands |
| Euro-Quality of Life 5D-5L | baseline and 6, 9 and 12 months | Short self-report instrument to assess quality adjusted life years |
Countries
Netherlands
Outcome results
None listed