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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01565213
Other study ID # LS 0506-1010
Secondary ID
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


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
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