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

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: Anxiety Disorders; Stress Disorders; Depressive Disorders
• Intervention / Treatment: Behavioral: CBT; Behavioral: MMI; Behavioral: CAU

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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)	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)	Change from baseline in CPRS-S-A at weeks 52

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Study record dates

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: group therapy; primary health care,common mental disorders,
• Additional Relevant MeSH Terms: Pathologic Processes; Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Depressive Disorder; Disease; Psychotic Disorders; Anxiety Disorders; Mental Disorders
• Other Study ID Numbers: LS 0506-1010