Study of Mindfulness-based Group Treatment in Patients With Depression and Anxiety
The purpose of this study is to determine the effectiveness, with respect to symptoms and systemic inflammatory level, of mindfulness-based group treatment compared with normal treatment in patients diagnosed with minor to moderate mental disorders. The hypothesis is that mindfulness group-treatment 1) will be at least as effective as normal treatment in reducing psychiatric symptoms; 2) will increase quality of life compared with normal treatment; 3) will be costeffective compared with normal treatment; and 4) will reduce inflammation-related markers. The study will be conducted at primary care centers in Skåne, Sweden. We will assess the effect of mindfulness-based group treatment on psychiatric symptoms, quality of life, and health (as rated by the patients themselves) as well as inflammatory markers.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Mindfulness-based Group Treatment of Patients With Depression and Anxiety: Effects on Symptoms and Inflammatory Markers in a Randomized Controlled Multicenter Study in Primary Care|
- Depression symptoms [ Time Frame: Week 8 ] [ Designated as safety issue: No ]MADRS-S total score after treatment
- Depression symptoms [ Time Frame: 1 week after treatment, and 6, 12, and 24 months after completion of the treatment ] [ Designated as safety issue: No ]PHQ-9 score after treatment and after 6, 12, and 24 months after completion of treatment
- Anxiety and depression symptoms [ Time Frame: 1 week after treatment and 6, 12, and 24 months after completion of the treatment ] [ Designated as safety issue: No ]HAD score after treatment and after 6, 12, and 24 months
- Self-rated health [ Time Frame: 8 weeks, 6, 12 and 25 months ] [ Designated as safety issue: No ]SCL-90 score after treatment and 6, 12, and 24 months after treatment
- Systemic inflammation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Serum levels of the following inflammatory factors will be measured by enzyme-linked immunosorbent assay (ELISA): epidermal growth factors, adiponectin, high-sensitivity C-reactive protein (hs-CRP), interferon (IFN)-γ, interleukin (IL)-1β, IL-6, IL-10 and tumor necrosis factor (TNF)-α. Serum levels of microRNA and telomere length will be measured by RT-PCR.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||June 2014|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Experimental: Mindfulness-based group treatment
8 group mindfulness sessions (1 per week), complemented by home mindfulness exercises
Behavioral: Mindfulness-based group treatment
An 8-week course of mindfulness-based group treatment (one 2-hour session per week; 10 patients per group). Each group session will be led by two mindfulness instructors, who will lead the patients through the Here & Now mindfulness program. Between sessions, patients will perform additional mindfulness practice at home via the Internet.
Other Name: Mindfulness
No Intervention: Treatment as usual
Treatment as usual (including individual CBT and medication)
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