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

Karolinska Institute

Status and phase: Completed; Phase 3

Conditions: Depressive Disorders; Anxiety Disorders; Stress Disorders

Treatments: Behavioral: CAU; Behavioral: CBT; Behavioral: MMI

Study type: Interventional

Funder types: Other

Identifiers

NCT01565213

LS 0506-1010

Details and patient eligibility

About

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.

Full 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)

Enrollment: 245 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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245 participants in 3 patient groups

CBT cognitive behavioral therapy

Active Comparator group

Description:

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

Treatment:

Behavioral: CBT

MMI Multimodal group intervention

Active Comparator group

Description:

group multimodal intervention

Treatment:

Behavioral: MMI

CAU

Other group

Description:

Care as usual given by the GPs

Treatment:

Behavioral: CAU