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AntidepressantsNCT03361514

Discontinuation of Antidepressant Medication in Primary Care.

A study testing Supported Protocolized Discontinuation (SPD) and Mindfulness Based Cognitive Therapy (MBCT) in people with Antidepressants, run by Radboud University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Antidepressants
What is being tested?
Supported Protocolized Discontinuation (SPD) and Mindfulness Based Cognitive Therapy (MBCT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
119 participants
Where
1 siteNetherlands
Study dates
20 Feb 2017to 1 Aug 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Netherlands1 site

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

    Nijmegen, Gelderland, 6500HB

Other trials in Netherlands

About this study

Official title: Discontinuation of Antidepressant Medication in Primary Care Supported by Monitoring Plus Mindfulness-based Cognitive Therapy Versus Monitoring Alone.

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.

Read the 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.

Conditions
Antidepressants
Being tested
Supported Protocolized Discontinuation (SPD), Mindfulness Based Cognitive Therapy (MBCT)
Keywords
antidepressants, discontinuation, primary care, MBCT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supported Protocolized Discontinuation (SPD)Behavioural

    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.

  • Mindfulness Based Cognitive Therapy (MBCT)Behavioural

    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.

Study groups in NCT03361514
Study groupRoleWhat they receive
Supported Protocolized DiscontinuationActive comparatorSupported Protocolized Discontinuation (SPD) Patients will receive guidance of their GP and can have supportive meetings with the mental health assistant.
Receives: Behavioral: Supported Protocolized Discontinuation (SPD)
SPD + Mindfulness (MBCT)ExperimentalIn addition to the SPD (as mentioned above) patients are offered Mindfulness Based Cognitive Therapy (MBCT)
Receives: Behavioral: Supported Protocolized Discontinuation (SPD); Behavioral: Mindfulness Based Cognitive Therapy (MBCT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (8)

  1. Structured Clinical Interview for DSM-IV-TR Disorders

    Diagnostic instrument to assess relapse of depressive episode

    Measured: baseline and 6, 9 and 12 months

  2. Discontinuation-Emergent Signs and Symptoms

    Self-report measure for assessing signs and symptoms associated with discontinuation or interruption of SSRI treatment.

    Measured: baseline and 6, 9 and 12 months

  3. Inventory of Depressive Symptomatology

    A clinican-administered interview assessing the severity of depressive symptoms

    Measured: baseline and 6, 9 and 12 months

  4. State/Trait Anxiety Inventory

    Self-report measure for assessing both state and trait levels of anxiety

    Measured: baseline and 6, 9 and 12 months

  5. Module Suicide Cognitions of the Mini International Neuropsychiatric Interview

    A clinican-administered interview assessing the suicidal cognitions and to specify suicidal risk

    Measured: baseline and 6, 9 and 12 months

  6. Mental Health Continuum - short form

    Self-report questionnaire that assesses emotional, psychological and social well-being

    Measured: baseline and 6, 9 and 12 months

  7. Five Facet Mindfulness Questionnaire

    Self-report measure assessing mindfulness skills

    Measured: baseline and 6, 9 and 12 months

  8. Self-Compassion Scale

    Self-report measure consisting of 12 items addressing six components: self-kindness, self-judgment, common humanity, isolation, mindfulness and over-identification

    Measured: baseline and 6, 9 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2017
  2. Study start20 Feb 2017
  3. Primary completion1 Aug 2019
  4. Study completion1 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03361514
Sponsor's protocol ID
MFN-ADM-2015-2019
Other IDs
NL56937.091.16
Status last verified
Jan 2020
First submitted
30 Oct 2017
Last updated
5 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We intend to comply with guidelines for open access as much as possible.

Publications

  • 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.

    PubMed 37669281

  • 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.

    PubMed 31349796

Questions about this trial

What is this clinical trial studying?

A study testing Supported Protocolized Discontinuation (SPD) and Mindfulness Based Cognitive Therapy (MBCT) in people with Antidepressants, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients who fully discontinued their antidepressant medication after 6 months. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03361514, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.

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