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

NCT01565213 | Completed Phase 3

• 1 other identifier: LS 0506-1010
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders; Depressive Disorders; Stress Disorders

Keywords

primary health care,common mental disorders,; group therapy

Outcome Measures

Primary Outcomes (1)

• Change in Quality of life as measured by the SF-36 (Mental Component Score)

  Change from baseline in SF-36 at 52 weeks

Secondary Outcomes (1)

• 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 Arms (3)

CBT cognitive behavioral therapy

ACTIVE COMPARATOR

group cognitive behavioural based therapy (CBT) administered by psychologists once a week for 12 weeks

Behavioral: CBT

MMI Multimodal group intervention

ACTIVE COMPARATOR

group multimodal intervention

Behavioral: MMI

CAU

OTHER

Care as usual given by the GPs

Behavioral: CAU

Interventions

CBT BEHAVIORAL

group cognitive behavioural based therapy (CBT) administered by psychologists once a week for 12 weeks,

CBT cognitive behavioral therapy

MMI BEHAVIORAL

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.

MMI Multimodal group intervention

CAU BEHAVIORAL

Care as usual by the GPs

CAU

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with common mental disorders or problems

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Center for Family and Community Medicine, Karolinska Institutet,

Huddinge, 141 83, Sweden

Location

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder; Stress Disorders, Traumatic

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders; Trauma and Stressor Related Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Head GP

Study Record Dates

• First Submitted: March 19, 2012
• First Posted: March 28, 2012
• Study Start: January 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2010
• Last Updated: March 28, 2012

Record last verified: 2012-03

Locations

SE (1)