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

Primary Purpose

Anxiety Disorders, Depressive Disorders, Stress Disorders

Status

Completed

Phase

Phase 3

Locations

Sweden

Study Type

Interventional

Intervention

CBT

MMI

CAU

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring primary health care,common mental disorders,, group therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Center for Family and Community Medicine, Karolinska Institutet,

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Other

Arm Label

CBT cognitive behavioral therapy

MMI Multimodal group intervention

CAU

Arm Description

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

group multimodal intervention

Care as usual given by the GPs

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Psychopathology as measured by the Comprehensive Psychopathological Rating Scale Self-asssessmen (CPRS-S-A)

Full Information

NCT ID

NCT01565213

First Posted

March 19, 2012

Last Updated

March 26, 2012

Sponsor

Karolinska Institutet

1. Study Identification

Unique Protocol Identification Number

NCT01565213

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska Institutet

4. Oversight

Data Monitoring Committee

5. 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.

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety Disorders, Depressive Disorders, Stress Disorders

Keywords

primary health care,common mental disorders,, group therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

245 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CBT cognitive behavioral therapy

Arm Type

Active Comparator

Arm Description

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

Arm Title

MMI Multimodal group intervention

Arm Type

Active Comparator

Arm Description

group multimodal intervention

Arm Title

CAU

Arm Type

Other

Arm Description

Care as usual given by the GPs

Intervention Type

Behavioral

Intervention Name(s)

CBT

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

MMI

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

CAU

Intervention Description

Care as usual by the GPs

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Change in Psychopathology as measured by the Comprehensive Psychopathological Rating Scale Self-asssessmen (CPRS-S-A)

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Center for Family and Community Medicine, Karolinska Institutet,

City

Huddinge

ZIP/Postal Code

141 83

Country

Sweden

12. IPD Sharing Statement

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

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