Mindfulness Based Cognitive Therapy (MBCT) for Primary Care Patients

University of Iceland

Status: Completed

Conditions: Depression, Anxiety

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03272516

UI-2017-MBCT.

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 67 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Control group

Active Comparator group

Description:

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.

Treatment:

Other: Treatment as usual (TAU)

Intervention group

Experimental group

Description:

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:

Other: Treatment as usual (TAU)

Behavioral: Mindfulness based cognitive therapy (MBCT)