Mindfulness Based Cognitive Therapy (MBCT) for Primary Care Patients

Not Applicable

Completed

• Conditions: Depression, Anxiety
• Interventions: Other: Treatment as usual (TAU); Behavioral: Mindfulness based cognitive therapy (MBCT)

• Registration Number: NCT03272516
• Lead Sponsor: University of Iceland

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.

Study Timeline

• Study First Submitted: 2017-08-31
• Study First Submitted QC: 2017-09-01
• Study First Posted: 2017-09-05
• Study Start: 2017-09-12
• Primary Completion: 2019-11-10
• Study Completion: 2020-10-21
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Treatment as usual (TAU)	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.
Intervention group	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 group	Treatment as usual (TAU)	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..

Primary Outcome Measures

Name	Time	Method
Symptoms of depression measured with the PHQ-9 questionnaire	up to 18 months	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	up to 18 months	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

Name	Time	Method
Subjective well-being measured with the SWEMWBS questionnaire	up to 18 months	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	up to 18 months	Self reported use of antidepressants in a questionnaire sent out by the study organization
Change in use of anxiolytics	up to 18 months	Self reported use of antidepressants in a questionnaire sent out by the study organization

Trial Locations

Locations (2)

Heilsugæslan Grafarvogi; 🇮🇸 Reykjavík, Grafarvogur, Iceland

Heilsugæslan Miðbæ; 🇮🇸 Reykjavík, Iceland