NCT03272516

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

September 12, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

2.2 years

First QC Date

August 31, 2017

Last Update Submit

November 3, 2020

Conditions

Depression, Anxiety

Keywords

Mild to moderate DepressionMild to moderate AnxietyMindfulness based cognitive therapyPrimary carePHQ-9GAD-7AntidepressantsAnxiolyticaSubjective wellbeing

Outcome Measures

Primary Outcomes (2)

  • 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)

    up to 18 months

  • 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)

    up to 18 months

Secondary Outcomes (3)

  • Subjective well-being measured with the SWEMWBS questionnaire

    up to 18 months

  • Change in use of antidepressants

    up to 18 months

  • Change in use of anxiolytics

    up to 18 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

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)

Intervention group

EXPERIMENTAL

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..

Behavioral: Mindfulness based cognitive therapy (MBCT)Other: Treatment as usual (TAU)

Interventions

Mindfulness based cognitive therapy (MBCT)BEHAVIORAL

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 group
Treatment as usual (TAU)OTHER

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.

Control groupIntervention group

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Heilsugæslan Grafarvogi

Reykjavik, Grafarvogur, 112, Iceland

Location

Heilsugæslan Miðbæ

Reykjavik, 101, Iceland

Location

Related Publications (45)

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MeSH Terms

Conditions

DepressionAnxiety Disorders

Interventions

Mindfulness-Based Cognitive TherapyTherapeutics

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Dóra G Gudmundsdóttir, PhD

    Directorate of Health, Iceland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
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.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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: 1. Increasing subjective wellbeing 2. Reducing antidepressant/anxiolytica use for primary care patients, with mild to moderate symptoms of depression and/or anxiety.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 31, 2017

First Posted

September 5, 2017

Study Start

September 12, 2017

Primary Completion

November 10, 2019

Study Completion

October 21, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
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.
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.

Locations

IC(2)