Cognitive Behavior Therapy Versus a Return to Work Intervention for Sick-listed Patients With Common Mental Illness in Primary Care: a Randomized Clinical Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Anxiety Disorders
- Sponsor
- Karolinska Institutet
- Enrollment
- 211
- Locations
- 1
- Primary Endpoint
- Clinician Severity Rating (CSR)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Erik Hedman
Principal investigator
Karolinska Institutet
Eligibility Criteria
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
Outcomes
Primary Outcomes
Clinician Severity Rating (CSR)
Time Frame: 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
Time Frame: 1 year
Number of days on sick leave
Secondary Outcomes
- Work ability index (WAI)(Baseline, post-treatment (variable depending on disorder), 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)
- Quality of Life Inventory (QOLI)(Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up)
- Sheehan Disability Scales (SDS)(Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 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)
- Insomnia Severity Index (ISI)(Baseline, post-treatment (variable depending on disorder, 26 week follow-up, 52 week follow-up)
- Perceived Stress Scale (PSS)(Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up)
- EuroQol-5 dimension (EQ5D)(Baseline, post-treatment (variable depending on disorder), 26 feel follow-up, 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)
- Panic Disorder Severity Scale Self-rated (PDSS-SR)(Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up)
- Montgomery-Åsberg Depression Rating Scale-Self-report (MADRS-S)(Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up)
- Health Anxiety Inventory (HAI)(Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 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)
- Penn-State Worry Questionnaire (PSWQ)(Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up)
- Post Traumatic Stress Disorder Symptom Scale-Self report (PTSDSS)(Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up)