Cognitive Behavior Therapy Versus a Return to Work Intervention for Sick-listed Patients With Subclinical Common Mental Illness in Primary Care: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Clinician Severity Rating (CSR)
Study 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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Cognitive Behavior Therapy
As the trial will include several different common subclinical mental disorders, the cognitive behavior therapy used in the study will be based on the protocols with best empirical support. Cognitive behavior therapy entails psychoeducational components, i.e. the patient is learns about the disorder and how to view it from a cognitive behavioral perspective. The most important part of the treatment is systematic behavior changes often targeted at exposure to feared stimuli. This is combined with cognitive interventions targeted at challenging negative automatic thoughts. All treatments will be delivered by licensed psychologists.
Intervention: Cognitive behavior therapy (Behavioral)
Return to work
Participants randomized to this arm will receive an experimental treatment, based in cognitive behavioral therapy, with primary aim to help patients return to work. Interventions are aimed at solving work-related problems and comprises problem-solving training and systematic employer-patient meetings aimed at facilitating a gradual return to the workplace. Licensed psychologists deliver all treatments.
Intervention: Return to work (Behavioral)
Outcomes
Primary Outcomes
Clinician Severity Rating (CSR)
Time Frame: 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
Time Frame: 1 year
Number of days on sick leave
Secondary Outcomes
- EuroQol-5 dimension (EQ5D)(Baseline, post-treatment (12 weeks on average) 26 feel follow-up, 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)
- Insomnia Severity Index (ISI)(Baseline, post-treatment (12 weeks on average) 26 week follow-up, 52 week follow-up)
- Perceived Stress Scale (PSS)(Baseline, post-treatment (12 weeks on average), 26 week follow-up, 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)
- Montgomery-Åsberg Depression Rating Scale-Self-report (MADRS-S)(Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up)
- Health Anxiety Inventory (HAI)(Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up)
- Quality of Life Inventory (QOLI)(Baseline, post-treatment (12 weeks on average) 26 week follow-up, 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)
- Liebowitz Social Anxiety Scale Self-report (LSAS-SR)(Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up)
- Sheehan Disability Scales (SDS)(Baseline, post-treatment (12 weeks on average), 26 week follow-up, 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)
- Post Traumatic Stress Disorder Symptom Scale-Self report (PTSDSS)(Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up)
- Penn-State Worry Questionnaire (PSWQ)(Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up)
Investigators
Erik Hedman
Principal investigator
Karolinska Institutet