CBT vs RTW Intervention for Patients With Common Subclinical Mental Illness in Primary Care

Phase 3

Completed

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

• Registration Number: NCT01667809
• 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 subclinical common mental illness in a randomized controlled trial conducted in primary care. Participants will be randomized to diagnosis specific CBT (n=50), RTW (n=50. 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 mild common mental illness.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-10
• Study First Submitted QC: 2012-08-14
• Study First Posted: 2012-08-17
• 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: 5

Inclusion Criteria

• Have been on sick leave (at least 50%) for at least 1 month and not more than 6 months
• Have subclinical levels of 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. Severity measured by clinical severity rating (CSR) 2-3 for mild subclinical level

Exclusion Criteria

• A higer score than 3 on the Clinician severity rating scale
• A lower score than 2 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 (12 weeks on average), 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
EuroQol-5 dimension (EQ5D)	Baseline, post-treatment (12 weeks on average) 26 feel follow-up, 52 week follow-up	Change in EQ5D at post-treatment, 26 week follow-up, and 52 week follow-up
Panic Disorder Severity Scale Self-rated (PDSS-SR)	Baseline, post-treatment (12 weeks on average), 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.
Insomnia Severity Index (ISI)	Baseline, post-treatment (12 weeks on average) 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 (12 weeks on average), 26 week follow-up, 52 week follow-up	Change in PSS at post-treatment, 26 week follow-up, and 52 week follow-up
Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)	Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up	Change in TIC-P at post-treatment, 26 week follow-up, and 52 week follow-up
Montgomery-Åsberg Depression Rating Scale-Self-report (MADRS-S)	Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up	Change in MADRS-S at post-treatment, 26 week follow-up, and 52 week follow-up
Health Anxiety Inventory (HAI)	Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up	Change in HAI at post-treatment, 26 week follow-up, and 52 week follow-up
Quality of Life Inventory (QOLI)	Baseline, post-treatment (12 weeks on average) 26 week follow-up, 52 week follow-up	Change in QOLI at post-treatment, 26 week follow-up, and 52 week follow-up
Obsessive Compulsive Inventory-Revised (OCI-R)	Baseline, post-treatment (12 weeks on average), 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.
Liebowitz Social Anxiety Scale Self-report (LSAS-SR)	Baseline, post-treatment (12 weeks on average), 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.
Sheehan Disability Scales (SDS)	Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up	Change in SDS at post-treatment, 26 week follow-up, and 52 week follow-up
Self-rated health 5 (SRH-5)	Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up	Change in SRH-5 at post-treatment, 26 week follow-up and 52 week follow-up
Post Traumatic Stress Disorder Symptom Scale-Self report (PTSDSS)	Baseline, post-treatment (12 weeks on average), 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.
Penn-State Worry Questionnaire (PSWQ)	Baseline, post-treatment (12 weeks on average), 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.

Trial Locations

Locations (1)

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