Mindfulness Based Cognitive Therapy (MBCT) for Primary Care Patients With Mild to Moderate Symptoms of Depression or Anxiety.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Iceland
- Enrollment
- 120
- Locations
- 4
- Primary Endpoint
- Symptoms of depression measured with the PHQ-9 questionnaire
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Investigator)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 67 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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-
- •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
Outcomes
Primary Outcomes
Symptoms of depression measured with the PHQ-9 questionnaire
Time Frame: 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
Time Frame: 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 Outcomes
- Subjective well-being measured with the SWEMWBS questionnaire(up to 18 months)
- Change in use of antidepressants(up to 18 months)
- Change in use of anxiolytics(up to 18 months)
Investigators
Svala Sigurdardottir
Principal Investigator
University of Iceland