Study of Mindfulness-based Group Treatment in Patients With Depression and Anxiety
Condition: Mental Disorders
MeSH terms: Mental Disorders; Psychotic Disorders
Study type: Interventional

Summary: 
      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.
    

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.

      Study design:

      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.
    

Intervention name(s): Mindfulness-based group treatment
Intervention type(s): Behavioral
Intervention description(s): 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 intervention name(s): Mindfulness
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Group treatment; Mindfulness; Minor mental disorders; Inflammation