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Mindfulness Based Cognitive Therapy (MBCT) for Primary Care Patients

Primary Purpose

Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Iceland
Study Type
Interventional
Intervention
Mindfulness based cognitive therapy (MBCT)
Treatment as usual (TAU)
Sponsored by
University of Iceland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression, Anxiety focused on measuring Mild to moderate Depression, Mild to moderate Anxiety, Mindfulness based cognitive therapy, Primary care, PHQ-9, GAD-7, Antidepressants, Anxiolytica, Subjective wellbeing

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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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Sites / Locations

  • Heilsugæslan Grafarvogi
  • Heilsugæslan Miðbæ

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Intervention group

Arm Description

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.

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..

Outcomes

Primary Outcome Measures

Symptoms of depression measured with the PHQ-9 questionnaire
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)
Symptoms of anxiety measured with the GAD-7 questionnaire
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)

Secondary Outcome Measures

Subjective well-being measured with the SWEMWBS questionnaire
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)
Change in use of antidepressants
Self reported use of antidepressants in a questionnaire sent out by the study organization
Change in use of anxiolytics
Self reported use of antidepressants in a questionnaire sent out by the study organization

Full Information

First Posted
August 31, 2017
Last Updated
November 3, 2020
Sponsor
University of Iceland
Collaborators
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT03272516
Brief Title
Mindfulness Based Cognitive Therapy (MBCT) for Primary Care Patients
Official Title
Mindfulness Based Cognitive Therapy (MBCT) for Primary Care Patients With Mild to Moderate Symptoms of Depression or Anxiety.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 12, 2017 (Actual)
Primary Completion Date
November 10, 2019 (Actual)
Study Completion Date
October 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iceland
Collaborators
University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
Keywords
Mild to moderate Depression, Mild to moderate Anxiety, Mindfulness based cognitive therapy, Primary care, PHQ-9, GAD-7, Antidepressants, Anxiolytica, Subjective wellbeing

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial, where patients are randomized to two groups. Group 1 receives treatment as usual, group 2 receives treatment as usual plus Mindfulness Based Cognitive Therapy (MBCT) for symptoms of mild to moderate depression or anxiety. Our primary aim is to investigate whether MBCT added to TAU is more effective than TAU alone in reducing mild to moderate symptoms of depression and/or anxiety among primary care patients. Our secondary aim is to investigate whether MBCT added to TAU is more effective than TAU alone in: Increasing subjective wellbeing Reducing antidepressant/anxiolytica use for primary care patients, with mild to moderate symptoms of depression and/or anxiety.
Masking
Investigator
Masking Description
The investigator will contact all participants in both groups via email or telephone to ask them to answer questionnaires.The investigator will not have information about which group which participant is. Participants will be contacted and invited to answer a questionnaire before, after, 6 and 18 months after 8 weeks of TAU and TAU plus MBCT.
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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..
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness based cognitive therapy (MBCT)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as usual (TAU)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Symptoms of depression measured with the PHQ-9 questionnaire
Description
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)
Time Frame
up to 18 months
Title
Symptoms of anxiety measured with the GAD-7 questionnaire
Description
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)
Time Frame
up to 18 months
Secondary Outcome Measure Information:
Title
Subjective well-being measured with the SWEMWBS questionnaire
Description
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)
Time Frame
up to 18 months
Title
Change in use of antidepressants
Description
Self reported use of antidepressants in a questionnaire sent out by the study organization
Time Frame
up to 18 months
Title
Change in use of anxiolytics
Description
Self reported use of antidepressants in a questionnaire sent out by the study organization
Time Frame
up to 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Age: <18 and >67 years old. Severe psychiatric symptoms requiring psychiatric care Risk of suicide Inability to participate in group sessions because of severe substance misuse; Inability to speak and understand Icelandic Pregnancy; Current psychotherapy of any kind; Participation in any other psychiatric intervention study; Thyroid disease (if newly diagnosed by the doctor). Score under 5 on both GAD7 and PHQ-9 and score over 14 on either GAD7 or PHQ-9. 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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dóra G Gudmundsdóttir, PhD
Organizational Affiliation
Directorate of Health, Iceland
Official's Role
Study Chair
Facility Information:
Facility Name
Heilsugæslan Grafarvogi
City
Reykjavík
State/Province
Grafarvogur
ZIP/Postal Code
112
Country
Iceland
Facility Name
Heilsugæslan Miðbæ
City
Reykjavík
ZIP/Postal Code
101
Country
Iceland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
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Mindfulness Based Cognitive Therapy (MBCT) for Primary Care Patients

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