Study of Mindfulness-based Group Treatment in Patients With Depression and Anxiety
|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|
|Study Completion Date:||April 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)
Hide Detailed Description
Modern cognitive behavioral therapy (CBT) has since the 1990s involved mindfulness, a meditation-based technique that teaches patients to manage their thoughts and feelings. A problem with individual-based psychotherapies is that they are costly, and therapists educated in mindfulness are scarce. Here, we are seeking basis for healthcare providers in primary care to recommend group-based mindfulness training to patients with minor to moderate mental disorders.
Aims of the study:
The primary aim of this study is to assess the effectiveness of mindfulness-based group treatment of patients with minor to moderate mental disorders in primary care through comparison with patients who receive treatment as usual (controls). The cost-effectiveness of mindfulness-based group treatment as an alternative to individual CBT will also be studied. In addition, since increased systemic inflammation has been linked to mental disorders, the effects of the intervention on systemic inflammation—as measured by serum levels of well-established inflammatory and inflammation-related markers (proteins, miRNAs, SNPs, telomere length)—will also be evaluated. Finally, we intend to analyze gene-environment interactions to see if we can find characteristics in the neighbourhood environment that may predict the development of mental disorders in genetically susceptible individuals.
Parameters evaluated in the study:
Parameters assessed at baseline, before the intervention starts: Blood sampling (level of inflammation and inflammation-related markers); Daily functioning (the Global Assessment of Functioning (GAF) scale); Quality of life (the EQ-5D instrument); Symptom Checklist (SCL-90) instrument; self-rated health (a Swedish Survey of Living Conditions (ULF) question with 5 alternative answers); and mindfulness ability (the Mindfulness Attention Awareness Scale (MAAS)). Post-intervention: Blood sampling, Level of depression (as assessed using the Montgomery-Asberg Depression Rating Scale (MADRS-S); the Patient Health Questionnaire (PHQ-9); Anxiety level and stress reactions (the Hospital Anxiety and Depression (HAD) scale); as well as the above described GAF, EQ-5D, SCL-90, ULF and MAAS. Follow-up: the patients will be assessed by the PHQ-9, HAD, MADRS-S, EQ-5D, GAF, SCL-90, ULF and MAAS questionnaires 6, 12 and 24 months after the end of intervention. As a co-variate to the above described parameters, we will analyze Geographic Information System (GIS)-coordinates for neighbourhood social and physical characteristics.
Patients seeking treatment for minor to moderate mental disorders at one of 17 primary care centers in Skåne County, Sweden, and satisfying the inclusion criteria listed below, will be invited to enroll in the study. A total of 30 health care providers (1-2 per primary care center) will be trained as mindfulness instructors. The recruited patients (estimated total 300) will be randomly assigned to one of two groups: the first will receive mindfulness-based group treatment and the second treatment as usual. Patients in both groups will be invited for an initial consultation, during which they will be asked to provide blood samples for analysis of inflammation-related markers, and to complete the questionnaires listed above. Details of the medications the patients are currently taking will be recorded. These consultations will take place before the intervention begins.
The intervention will consist of 8-weeks 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. A mindfulness instructor will complete a case report form (CRF) for each patient. This CRF will include records of attendance at the group sessions and details of any medications taken (patients in both the control and intervention groups will be prescribed drugs for their mental disorders as their GPs deem appropriate). The patients will themselves keep a record of the mindfulness practice they perform at home.
Patients in the control group will receive treatment as usual, which may consist of CBT, counseling, or other forms of therapy that are provided in primary care. Full details of the treatment each patient in the control group receives will be recorded in the CRF.
Follow-up will be performed 1 week after the end of the intervention in the intervention group, and after 8 weeks of treatment as usual in the control group. All patients will be asked to fill in the questionnaires listed above and to provide blood samples for analysis of inflammation-related marker levels. Patients will be asked to complete further questionnaires at 6, 12, and 24 months after completion of the intervention.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01476371
|Principal Investigator:||Jan Sundquist, M.D., Ph.D.||Lund University|