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

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01565213
• Other study ID #: LS 0506-1010
• Status: Completed
• Phase: Phase 3
• First received: March 19, 2012
• Last updated: March 26, 2012
• Start date: January 2006
• Est. completion date: September 2010

Study information

• Verified date: March 2012
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: September 2010
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Disorders
• Disease
• Mental Disorders
• Psychotic Disorders
• Stress Disorders
• Stress Disorders, Traumatic

Intervention

Behavioral:
• CBT
group cognitive behavioural based therapy (CBT) administered by psychologists once a week for 12 weeks,
• 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 by the GPs

Locations

Country	Name	City	State
Sweden	Center for Family and Community Medicine, Karolinska Institutet,	Huddinge

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Quality of life as measured by the SF-36 (Mental Component Score)		Change from baseline in SF-36 at 52 weeks	Yes
Secondary	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	Yes