Study of Mindfulness-based Group Treatment in Patients With Depression and Anxiety

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jan Sundquist, Lund University
ClinicalTrials.gov Identifier:
NCT01476371
First received: November 11, 2011
Last updated: April 8, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Mental Disorders
Behavioral: Mindfulness-based group treatment

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Lund University:

Primary Outcome Measures:
  • Depression symptoms [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    MADRS-S total score after treatment


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 300
Study Start Date: January 2012
Estimated Study Completion Date: June 2014
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mental disorders: Mild depressive episode (ICD-10 code F32.0)
  • Moderate depressive episode (F32.1)
  • Depressive episode, unspecified (F32.9)
  • Recurrent depressive disorder, current episode mild (F33.0)
  • Recurrent depressive disorder, current episode moderate (F33.1)
  • Panic disorder (F41.0)
  • Generalized Anxiety Disorder (F41.1)
  • Mixed Anxiety and Depression Adjustment (F41.2)
  • Other mixed anxiety disorders (F41.3)
  • Other specified anxiety disorders (F41.8)
  • Anxiety disorders unspecified (F41.9)
  • Adjustment Disorder (F43.2)
  • Other reactions to severe stress (F43.8)
  • Reaction to severe stress, unspecified (F43.9)
  • Age: 20-64 years
  • Ability to speak Swedish
  • Daily access to the Internet
  • Score of ≥10 points on the PHQ-9 OR ≥7 points on the HAD scale OR between 13 and 34 points on the MADRS-S (mild to moderate depression)

Exclusion Criteria:

  • Serious depression/anxiety that needs psychiatric care
  • Personality disorders
  • Suicide risk (score of >4 on item 9 of the MADRS-S)
  • Ongoing treatment at a psychiatric clinic at the time of recruitment
  • Ongoing psychotherapy (e.g., CBT) at the time of recruitment
  • Current alcohol, prescription medicine or narcotic abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01476371

Sponsors and Collaborators
Lund University
Investigators
Principal Investigator: Jan Sundquist, M.D., Ph.D. Lund University
  More Information

Additional Information:
No publications provided

Responsible Party: Jan Sundquist, Professor Jan Sundquist, Lund University
ClinicalTrials.gov Identifier: NCT01476371     History of Changes
Other Study ID Numbers: CPF-0001
Study First Received: November 11, 2011
Last Updated: April 8, 2013
Health Authority: Sweden: Swedish Data Inspection Board

Keywords provided by Lund University:
Group treatment
Mindfulness
Minor mental disorders
Inflammation

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Depression
Depressive Disorder
Schizophrenia and Disorders with Psychotic Features
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on April 17, 2014