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

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ClinicalTrials.gov Identifier: NCT01565213
Recruitment Status : Completed
First Posted : March 28, 2012
Last Update Posted : March 28, 2012
Sponsor:
Information provided by (Responsible Party):
Kersti Ejeby, Karolinska Institutet

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)

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Study Type : Interventional  (Clinical Trial)
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 : January 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine


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.

CAU
Care as usual given by the GPs
Behavioral: CAU
Care as usual by the GPs




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01565213


Locations
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Sweden
Center for Family and Community Medicine, Karolinska Institutet,
Huddinge, Sweden, 141 83
Sponsors and Collaborators
Karolinska Institutet
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Responsible Party: Kersti Ejeby, MD Head GP, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01565213    
Other Study ID Numbers: LS 0506-1010
First Posted: March 28, 2012    Key Record Dates
Last Update Posted: March 28, 2012
Last Verified: March 2012
Keywords provided by Kersti Ejeby, Karolinska Institutet:
primary health care,common mental disorders,
group therapy
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Anxiety Disorders
Mental Disorders
Psychotic Disorders
Pathologic Processes
Mood Disorders
Schizophrenia Spectrum and Other Psychotic Disorders