Clinical trial NCT03272516: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of Iceland
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2017-09-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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:

1. Increasing subjective wellbeing
2. Reducing antidepressant/anxiolytica use for primary care patients, with mild to moderate symptoms of depression and/or anxiety.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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:

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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Primary outcomes:
measure: Symptoms of depression measured with the PHQ-9 questionnaire
timeFrame: up to 18 months
measure: Symptoms of anxiety measured with the GAD-7 questionnaire
timeFrame: up to 18 months
Secondary outcomes:
measure: Subjective well-being measured with the SWEMWBS questionnaire
timeFrame: up to 18 months
measure: Change in use of antidepressants
timeFrame: up to 18 months
measure: Change in use of anxiolytics
timeFrame: up to 18 months
Other outcomes:
Locations:
city: Reykjavík
country: Iceland
facility: Heilsugæslan Grafarvogi
state: Grafarvogur
city: Reykjavík
country: Iceland
facility: Heilsugæslan Miðbæ
Study officials:
affiliation: Directorate of Health, Iceland
name: Dóra G Gudmundsdóttir, PhD
role: STUDY_CHAIR
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