Mindfulness Based Cognitive Therapy (MBCT) for Primary Care Patients
NCT ID: NCT03272516
Last Updated: 2020-11-04
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
120 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-09-12
Study Completion Date
2020-10-21
Brief Summary
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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
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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.
Conditions
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Depression, Anxiety
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
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.
Primary Study Purpose
HEALTH_SERVICES_RESEARCH
Blinding Strategy
SINGLE
Investigators
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.
Study Groups
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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.
Group Type
ACTIVE_COMPARATOR
Treatment as usual (TAU)
Intervention Type
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.
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..
Group Type
EXPERIMENTAL
Mindfulness based cognitive therapy (MBCT)
Intervention Type
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.
Treatment as usual (TAU)
Intervention Type
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.
Interventions
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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.
Intervention Type
BEHAVIORAL
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.
Intervention Type
OTHER
Eligibility Criteria
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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
* 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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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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Minimum Eligible Age
18 Years
Maximum Eligible Age
67 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Aarhus
OTHER
Sponsor Role
collaborator
University of Iceland
OTHER
Sponsor Role
lead
Responsible Party
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Svala Sigurdardottir
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Dóra G Gudmundsdóttir, PhD
Role: STUDY_CHAIR
Directorate of Health, Iceland
Locations
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Heilsugæslan Grafarvogi
Reykjavik, Grafarvogur, Iceland
Site Status
Heilsugæslan Miðbæ
Reykjavik, , Iceland
Site Status
Countries
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Iceland
References
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RESULT
Other Identifiers
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UI-2017-MBCT.
Identifier Type: -
Identifier Source: org_study_id