Mindfulness Based Cognitive Therapy (MBCT) for Primary Care Patients

Study Overview
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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.

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

Conditions
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Depression, Anxiety

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


Participation Criteria
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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 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 -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 67 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>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)<br>* 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.<br>|
| Experimental: Intervention group<br>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)<br>* 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.<br>Other: Treatment as usual (TAU)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | up to 18 months | 
| Change in use of antidepressants | Self reported use of antidepressants in a questionnaire sent out by the study organization | up to 18 months | 
| Change in use of anxiolytics | Self reported use of antidepressants in a questionnaire sent out by the study organization | up to 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild to moderate Depression, Mild to moderate Anxiety, Mindfulness based cognitive therapy, Primary care, PHQ-9, GAD-7, Antidepressants, Anxiolytica, Subjective wellbeing