Mindfulness Based Cognitive Therapy (MBCT) for Primary Care Patients

November 3, 2020 updated by: Svala Sigurdardottir, University of Iceland

Mindfulness Based Cognitive Therapy (MBCT) for Primary Care Patients With Mild to Moderate Symptoms of Depression or Anxiety.

This study is done to evaluate the effects of Mindfulness Based Cognitive Therapy (MBCT) for primary care patients that have mild to moderate symptoms of depression and anxiety. Half of the study participants will receive treatment as usual (TAU), and the other half will receive TAU plus MBCT. The investigators will be comparing changes in symptoms of depression and anxiety between the groups, and hypothesize that the TAU plus MBCT group will have significantly lower symptoms of depression and anxiety compared to TAU group post-intervention

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients that show mild to moderate symptoms of depression and anxiety are common in the primary care setting. These patients are often treated with antidepressant or anxiolytic medication instead of cognitive therapy, which is the first choice of treatment according to clinical guidelines in Iceland. Although these patients are often referred to cognitive therapy, there are long waiting lists for group therapy and personal therapy is expensive. MBCT has been shown to have good effects on people with recurrent depression and on patients suffering from anxiety. Therefore, the investigators main objective is to assess whether MBCT is effective in the primary care setting for patients with mild symptoms of anxiety and depression and compare its effect to TAU.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iceland
      • Reykjavík, Iceland, 101
        • Heilsugæslan Miðbæ
    • Grafarvogur
      • Reykjavík, Grafarvogur, Iceland, 112
        • Heilsugæslan Grafarvogi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • PHQ-9 and GAD-7 score 5-14 points
  • Age18 - 67
  • No current/recent psychotherapy of any kind other than his/hers physicians therapy( can be taking antidepressants but not in CBT)
  • No regular meditation or yoga practice
  • Not mentally retarded
  • Speaks and understands Icelandic
  • No current substance dependence
  • Not diagnosed with schizophrenic symptoms or bipolar disease that that currently requires treatment
  • Not participating in another mental health study

Exclusion Criteria:

  1. Age: <18 and >67 years old.
  2. Severe psychiatric symptoms requiring psychiatric care
  3. Risk of suicide
  4. Inability to participate in group sessions because of severe substance misuse;
  5. Inability to speak and understand Icelandic
  6. Pregnancy;
  7. Current psychotherapy of any kind;
  8. Participation in any other psychiatric intervention study;
  9. Thyroid disease (if newly diagnosed by the doctor).
  10. Score under 5 on both GAD7 and PHQ-9 and score over 14 on either GAD7 or PHQ-9.
  11. One or more of the following ICD-10 psychiatric diagnoses:

F00-F09 Organic, including symptomatic, mental disorders F10-F19 Mental and behavioural disorders due to psychoactive substance use F20-F29 Schizophrenia, schizotypal and delusional disorders F70-F79 Mental retardation

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
This group receives treatment as usual (TAU) from his/hers physician. This treatment is different for each physician, but mainly consists of cognitive therapy, personal interviews or antidepressants or anxiolytics.
Other: Treatment as usual (TAU)
Usual treatment prescribed by each physician, specifically interview therapy, cognitive therapy, antidepressants and/or anxiolytics as well as a mixture of all of the above.
Experimental: Intervention group
Mindfulness Based Cognitive Therapy (MBCT). This group receives 8 weeks of MBCT in addition to usual treatment (TAU). The MBCT consists of weekly group sessions of 2,5 hours, where participants receive cognitive therapy as well as mindfulness meditation. This group is also assigned homework, according to the MBCT protocol..
Other: Treatment as usual (TAU)
Usual treatment prescribed by each physician, specifically interview therapy, cognitive therapy, antidepressants and/or anxiolytics as well as a mixture of all of the above.
Behavioral: Mindfulness based cognitive therapy (MBCT)
Mindfulness Based Cognitive Therapy (MBCT). This group receives 8 weeks of MBCT in addition to usual treatment (TAU). The MBCT consists of weekly group sessions of 2,5 hours, where participants receive cognitive therapy as well as mindfulness meditation. This group is also assigned homework, according to the MBCT protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms of depression measured with the PHQ-9 questionnaire
Time Frame: up to 18 months
Comparing scores on the PHQ-9 before and after the intervention as well as, 6 and 18 months after the intervention for both the control group (TAU) and the intervention group (TAU plus MBCT)
up to 18 months
Symptoms of anxiety measured with the GAD-7 questionnaire
Time Frame: up to 18 months
Comparing scores on the GAD-7 before and after the intervention as well as 6 and 18 months after the intervention for both the control group (TAU) and the intervention group (TAU plus MBCT)
up to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective well-being measured with the SWEMWBS questionnaire
Time Frame: up to 18 months
Comparing overall score on the SWEMWBS before and after the intervention as well as 6 and 18 months after the intervention for both the control group (TAU) and the intervention group (TAU plus MBCT)
up to 18 months
Change in use of antidepressants
Time Frame: up to 18 months
Self reported use of antidepressants in a questionnaire sent out by the study organization
up to 18 months
Change in use of anxiolytics
Time Frame: up to 18 months
Self reported use of antidepressants in a questionnaire sent out by the study organization
up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Iceland

Collaborators

University of Aarhus

Investigators

  • Study Chair: Dóra G Gudmundsdóttir, PhD, Directorate of Health, Iceland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2017

Primary Completion (Actual)

November 10, 2019

Study Completion (Actual)

October 21, 2020

Study Registration Dates

First Submitted

August 31, 2017

First Submitted That Met QC Criteria

September 1, 2017

First Posted (Actual)

September 5, 2017

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UI-2017-MBCT.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

There is a plan to make IPD and related data dictionaries available to other researchers when requested. We will be willing to share the below mentioned IPD.

IPD Sharing Time Frame

The IPD and additional data will be shared at the time when the summary data are published or otherwise made available and will be available for 5 years after the end of the study.

IPD Sharing Access Criteria

The study protocol, SAP, ICF, CSR and analytic code can be available for relevant researches, working on similar studies or researchers who want to reproduce the protocol and set up of the study as well as for doing a meta-analysis on similar studies. This must be done in the timeframe mentioned above. The group working on this project (the PhD students consult group) will review the requests and make shared decision on that and as well as decide how it will be shared.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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