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

Study Overview
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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)

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

Conditions
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Anxiety Disorders, Depressive Disorders, Stress Disorders

Intervention / Treatment
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* Behavioral: CBT
* Behavioral: MMI
* Behavioral: CAU


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CBT cognitive behavioral therapy<br>group cognitive behavioural based therapy (CBT) administered by psychologists once a week for 12 weeks | Behavioral: CBT<br>* group cognitive behavioural based therapy (CBT) administered by psychologists once a week for 12 weeks,<br>|
| Active Comparator: MMI Multimodal group intervention<br>group multimodal intervention | Behavioral: MMI<br>* 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.<br>|
| Other: CAU<br>Care as usual given by the GPs | Behavioral: CAU<br>* Care as usual by the GPs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary health care,common mental disorders,, group therapy