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

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ClinicalTrials.gov Identifier: NCT01476371
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : September 26, 2014
Sponsor:
Information provided by (Responsible Party):
Jan Sundquist, Lund University

Brief 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.

Condition or disease Intervention/treatment Phase
Mental Disorders Behavioral: Mindfulness-based group treatment Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. Depression symptoms [ Time Frame: Week 8 ]
    MADRS-S total score after treatment


Secondary Outcome Measures :
  1. Depression symptoms [ Time Frame: 1 week after treatment, and 6, 12, and 24 months after completion of the treatment ]
    PHQ-9 score after treatment and after 6, 12, and 24 months after completion of treatment

  2. Anxiety and depression symptoms [ Time Frame: 1 week after treatment and 6, 12, and 24 months after completion of the treatment ]
    HAD score after treatment and after 6, 12, and 24 months

  3. Self-rated health [ Time Frame: 8 weeks, 6, 12 and 25 months ]
    SCL-90 score after treatment and 6, 12, and 24 months after treatment

  4. Systemic inflammation [ Time Frame: 8 weeks ]
    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.



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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01476371


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jan Sundquist, Professor Jan Sundquist, Lund University
ClinicalTrials.gov Identifier: NCT01476371     History of Changes
Other Study ID Numbers: CPF-0001
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: September 26, 2014
Last Verified: September 2014

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

Additional relevant MeSH terms:
Depression
Mental Disorders
Psychotic Disorders
Behavioral Symptoms
Schizophrenia Spectrum and Other Psychotic Disorders