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Clinical Trials/NCT01565213
NCT01565213
Completed
Phase 3

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

Karolinska Institutet1 site in 1 country245 target enrollmentJanuary 2006

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Anxiety Disorders
Sponsor
Karolinska Institutet
Enrollment
245
Locations
1
Primary Endpoint
Change in Quality of life as measured by the SF-36 (Mental Component Score)
Status
Completed
Last Updated
14 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
January 2006
End Date
September 2010
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kersti Ejeby

MD Head GP

Karolinska Institutet

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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)

Study Sites (1)

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