NCT01476371

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
215

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

March 7, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

November 11, 2011

Last Update Submit

March 4, 2025

Conditions

Mental Disorders

Keywords

Group treatmentMindfulnessMinor mental disordersInflammation

Outcome Measures

Primary Outcomes (1)

  • Depression symptoms

    MADRS-S total score after treatment

    Week 8

Secondary Outcomes (4)

  • Depression symptoms

    1 week after treatment, and 6, 12, and 24 months after completion of the treatment

  • Anxiety and depression symptoms

    1 week after treatment and 6, 12, and 24 months after completion of the treatment

  • Self-rated health

    8 weeks, 6, 12 and 25 months

  • Systemic inflammation

    8 weeks

Study Arms (2)

Mindfulness-based group treatment

EXPERIMENTAL

8 group mindfulness sessions (1 per week), complemented by home mindfulness exercises

Behavioral: Mindfulness-based group treatment

Treatment as usual

NO INTERVENTION

Treatment as usual (including individual CBT and medication)

Interventions

Mindfulness-based group treatmentBEHAVIORAL

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.

Also known as: Mindfulness
Mindfulness-based group treatment

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • +3 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Saha S, Jarl J, Gerdtham UG, Sundquist K, Sundquist J. Economic evaluation of mindfulness group therapy for patients with depression, anxiety, stress and adjustment disorders compared with treatment as usual. Br J Psychiatry. 2020 Apr;216(4):197-203. doi: 10.1192/bjp.2018.247.

    PMID: 30468136DERIVED

  • Sundquist J, Palmer K, Memon AA, Wang X, Johansson LM, Sundquist K. Long-term improvements after mindfulness-based group therapy of depression, anxiety and stress and adjustment disorders: A randomized controlled trial. Early Interv Psychiatry. 2019 Aug;13(4):943-952. doi: 10.1111/eip.12715. Epub 2018 Jul 3.

    PMID: 29968371DERIVED

  • Wang X, Sundquist K, Hedelius A, Palmer K, Memon AA, Sundquist J. Leukocyte telomere length and depression, anxiety and stress and adjustment disorders in primary health care patients. BMC Psychiatry. 2017 Apr 24;17(1):148. doi: 10.1186/s12888-017-1308-0.

    PMID: 28438147DERIVED

  • Sundquist J, Palmer K, Johansson LM, Sundquist K. The effect of mindfulness group therapy on a broad range of psychiatric symptoms: A randomised controlled trial in primary health care. Eur Psychiatry. 2017 Jun;43:19-27. doi: 10.1016/j.eurpsy.2017.01.328. Epub 2017 Feb 8.

    PMID: 28365464DERIVED

  • Sundquist J, Lilja A, Palmer K, Memon AA, Wang X, Johansson LM, Sundquist K. Mindfulness group therapy in primary care patients with depression, anxiety and stress and adjustment disorders: randomised controlled trial. Br J Psychiatry. 2015 Feb;206(2):128-35. doi: 10.1192/bjp.bp.114.150243. Epub 2014 Nov 27.

    PMID: 25431430DERIVED

Related Links

MeSH Terms

Conditions

Mental DisordersInflammation

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jan Sundquist, M.D., Ph.D.

    Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Jan Sundquist

Study Record Dates

First Submitted

November 11, 2011

First Posted

November 22, 2011

Study Start

January 1, 2012

Primary Completion

June 1, 2012

Study Completion

April 1, 2014

Last Updated

March 7, 2025

Record last verified: 2025-03