Study of Mindfulness-based Group Treatment in Patients With Depression and Anxiety
This study is ongoing, but not recruiting participants.
Sponsor:
Lund University
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
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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 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 May 21, 2013