CBT Versus a Return to Work Intervention for Patients With Common Mental Illness in Primary Care

Phase 3

Completed

• Conditions: Major Depression; Stress Disorders; Primary Insomnia; Anxiety Disorders

• Registration Number: NCT01636791
• Lead Sponsor: Karolinska Institutet

Brief Summary

Background: Common mental illness, such as anxiety disorders and depression, is the main cause for sick leave in Sweden. Cognitive behavior therapy (CBT) has been shown to be effective in alleviating target symptoms of these disorders, but its effect on sick leave rates has not been sufficiently addressed. The investigators have developed an intervention called return to work (RTW), which is based in cognitive behavioral theory, that has a primary aim of helping sick-listed patients with common mental illness return to work. This new treatment has not been evaluated in a randomized controlled trial.

Aims: The aim of this study is to investigate the effect of CBT and RTW for common mental illness in a randomized controlled trial conducted in primary care. Participants will be randomized to diagnosis specific CBT (n=70), RTW (n=70), or a combination of the two treatments (n=70). Main outcomes are days of sick leave and clinician severity rating of psychiatric symptoms. This study could contribute to new knowledge regarding how to best treat patients on sick leave with common mental illness.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-05
• Study First Submitted QC: 2012-07-09
• Study First Posted: 2012-07-10
• Study Start: 2012-09
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-02
• Last Update Posted: 2016-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

Inclusion Criteria

• Have been on sick leave (at least 50%) for at least 1 month and not more than 6 months
• Have an anxiety disorder diagnosis (obsessive compulsive disorder, social phobia, panic disorder, generalized anxiety disorder, post-traumatic stress disorder, specific phobia), or/and major depression, or/and maladaptive stress reaction, or/and primary insomnia

Exclusion Criteria

• A lower score than 4 on the Clinician severity rating scale
• A higher score than 6 on the Clinician severity rating scale

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinician Severity Rating (CSR)	Baseine, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up	Change in CSR at post-treatment, 26 week follow-up, and 52 week follow-up compared to baseline.
Sick leave	1 year	Number of days on sick leave

Secondary Outcome Measures

Name	Time	Method
Work ability index (WAI)	Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up	Change in WAI at post-treatment, 26 week follow-up, 52 week follow-up
Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)	Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up	Change in TIC-P at post-treatment, 26 week follow-up, and 52 week follow-up
Quality of Life Inventory (QOLI)	Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up	Change in QOLI at post-treatment, 26 week follow-up, and 52 week follow-up
Sheehan Disability Scales (SDS)	Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up	Change in SDS at post-treatment, 26 week follow-up, and 52 week follow-up
Liebowitz Social Anxiety Scale Self-report (LSAS-SR)	Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up	Change in LSAS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
Insomnia Severity Index (ISI)	Baseline, post-treatment (variable depending on disorder, 26 week follow-up, 52 week follow-up	Change in ISI at post-treatment, 26 week follow-up, and 52 week follow-up
Perceived Stress Scale (PSS)	Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up	Change in PSS at post-treatment, 26 week follow-up, and 52 week follow-up
EuroQol-5 dimension (EQ5D)	Baseline, post-treatment (variable depending on disorder), 26 feel follow-up, 52 week follow-up	Change in EQ5D at post-treatment, 26 week follow-up, and 52 week follow-up
Self-rated health 5 (SRH-5)	Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up	Change in SRH-5 at post-treatment, 26 week follow-up and 52 week follow-up
Panic Disorder Severity Scale Self-rated (PDSS-SR)	Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up	Change in PDSS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
Health Anxiety Inventory (HAI)	Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up	Change in HAI at post-treatment, 26 week follow-up, and 52 week follow-up
Obsessive Compulsive Inventory-Revised (OCI-R)	Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up	Change in OCI-R at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
Penn-State Worry Questionnaire (PSWQ)	Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up	Change in PSWQ at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
Post Traumatic Stress Disorder Symptom Scale-Self report (PTSDSS)	Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up	Change in PTSDSS at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
Montgomery-Åsberg Depression Rating Scale-Self-report (MADRS-S)	Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up	Change in MADRS-S at post-treatment, 26 week follow-up, and 52 week follow-up

Trial Locations

Locations (1)

Karolinska Institutet and Gustavsberg primary care center; 🇸🇪 Stockholm, Sweden