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

Phase 3

Completed

• Conditions: Anxiety Disorders; Depressive Disorders; Stress Disorders
• Interventions: Behavioral: CBT; Behavioral: MMI; Behavioral: CAU

• Registration Number: NCT01565213
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

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 Timeline

• Study Start: 2006-01
• Primary Completion: 2008-09
• Study Completion: 2010-09
• Status Verified: 2012-03
• Study First Submitted: 2012-03-19
• Study First Submitted QC: 2012-03-26
• Last Update Submitted: 2012-03-26
• Study First Posted: 2012-03-28
• Last Update Posted: 2012-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT cognitive behavioral therapy	CBT	group cognitive behavioural based therapy (CBT) administered by psychologists once a week for 12 weeks
MMI Multimodal group intervention	MMI	group multimodal intervention
CAU	CAU	Care as usual given by the GPs

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Center for Family and Community Medicine, Karolinska Institutet,; 🇸🇪 Huddinge, Sweden