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Completed

NCT Number: NCT01565213

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Center for Family and Community Medicine, Karolinska Institutet,

Huddinge, 141 83, Sweden

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CBT

Behavioral

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

MMI

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

Behavioral

Care as usual by the GPs

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2010
First posted
Mar 28, 2012
Registry last updated
Mar 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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