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

NCT ID: NCT01565213

Last Updated: 2012-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2010-09-30

Brief Summary

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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

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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)

Conditions

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Anxiety Disorders Depressive Disorders Stress Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CBT cognitive behavioral therapy

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

Group Type ACTIVE_COMPARATOR

CBT

Intervention Type BEHAVIORAL

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

MMI Multimodal group intervention

group multimodal intervention

Group Type ACTIVE_COMPARATOR

MMI

Intervention Type 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.

CAU

Care as usual given by the GPs

Group Type OTHER

CAU

Intervention Type BEHAVIORAL

Care as usual by the GPs

Interventions

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CBT

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

Intervention Type 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.

Intervention Type BEHAVIORAL

CAU

Care as usual by the GPs

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Kersti Ejeby

MD Head GP

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Center for Family and Community Medicine, Karolinska Institutet,

Huddinge, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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LS 0506-1010

Identifier Type: -

Identifier Source: org_study_id

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