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

Sponsor

Karolinska Institutet (Other)

Overall Status

Completed

CT.gov ID

NCT01565213

Collaborator

(none)

245

Enrollment

Location

Arms

Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorders Depressive Disorders Stress Disorders	Behavioral: CBT Behavioral: MMI Behavioral: CAU	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

245 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.