Transdiagnostic Group Treatments for Patients With Common Mental Disorders in Primary Health Care

March 26, 2012 updated by: Kersti Ejeby, Karolinska Institutet

Transdiagnostic Group Treatments for Patients With Common Mental Disorders in Primary Health Care: A Randomized Controlled Trial

The purpose of this study is to compare the effects of CBT and MMI on the quality of life and relief of psychological symptoms of patients with common mental disorders or problems attending primary health care centre.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Design:

Clinical randomised non blinded controlled trial.

Setting:

The study was performed in an outpatient primary health care centre serving 36 000 inhabitants.

Participants:

Patients (n=278), aged 18-65 years, with common mental problems or disorders were referred to the study by the GPs and 245 were included in the study.

Interventions:

Participants were randomised to CAU or one of two group interventions in addition to CAU. These were: a) group cognitive behavioural based therapy (CBT) administered by psychologists once a week for 12 weeks, and b) group multimodal intervention (MMI) based on a protocol comprising a mix of existing group interventions and exercises borrowed from multiple techniques and therapeutic schools and administered by assistant nurses with brief training, including two sessions per week for 6 weeks.

Main outcome measures:

Primary outcome measure was the Mental Component Summary score of SF-36. Secondary outcome measures were perceived stress scale (PSS) and Self-Rating Scale for Affective Syndromes (CPRS-S-A)

Study Type

Interventional

Enrollment (Actual)

245

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Huddinge, Sweden, 141 83
        • Center for Family and Community Medicine, Karolinska Institutet,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with common mental disorders or problems

Exclusion Criteria:

patients were excluded if:

  • they met diagnostic criteria for bipolar or psychotic disorder or severe personality disorder,
  • were judged to be at risk of committing suicidal acts, and
  • if they had undergone MMI earlier. The investigators paid no consideration to whether patients were treated with SSRI medication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CBT cognitive behavioral therapy
group cognitive behavioural based therapy (CBT) administered by psychologists once a week for 12 weeks
Behavioral: CBT
group cognitive behavioural based therapy (CBT) administered by psychologists once a week for 12 weeks,
Active Comparator: MMI Multimodal group intervention
group multimodal intervention
Behavioral: MMI
group multimodal intervention (MMI) based on a protocol comprising a mix of existing group interventions and exercises borrowed from multiple techniques and therapeutic schools and administered by assistant nurses with brief training, including two sessions per week for 6 weeks.
Other: CAU
Care as usual given by the GPs
Behavioral: CAU
Care as usual by the GPs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Quality of life as measured by the SF-36 (Mental Component Score)
Time Frame: Change from baseline in SF-36 at 52 weeks
Change from baseline in SF-36 at 52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Psychopathology as measured by the Comprehensive Psychopathological Rating Scale Self-asssessmen (CPRS-S-A)
Time Frame: Change from baseline in CPRS-S-A at weeks 52
Change from baseline in CPRS-S-A at weeks 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

March 19, 2012

First Submitted That Met QC Criteria

March 26, 2012

First Posted (Estimate)

March 28, 2012

Study Record Updates

Last Update Posted (Estimate)

March 28, 2012

Last Update Submitted That Met QC Criteria

March 26, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LS 0506-1010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe