Clinical trial NCT01667809: CBT vs RTW Intervention for Patients With Common Subclinical Mental Illness in Primary Care
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anxiety Disorders
Major Depression
Stress Disorders
Primary Insomnia
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2012-08-17
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sick leave
timeFrame: 1 year
measure: Clinician Severity Rating (CSR)
timeFrame: Baseine, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up
Secondary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale-Self-report (MADRS-S)
timeFrame: Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline, post-treatment (12 weeks on average) 26 week follow-up, 52 week follow-up
measure: Health Anxiety Inventory (HAI)
timeFrame: Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up
measure: Perceived Stress Scale (PSS)
timeFrame: Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up
measure: Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)
timeFrame: Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up
measure: Quality of Life Inventory (QOLI)
timeFrame: Baseline, post-treatment (12 weeks on average) 26 week follow-up, 52 week follow-up
measure: EuroQol-5 dimension (EQ5D)
timeFrame: Baseline, post-treatment (12 weeks on average) 26 feel follow-up, 52 week follow-up
measure: Sheehan Disability Scales (SDS)
timeFrame: Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up
measure: Self-rated health 5 (SRH-5)
timeFrame: Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up
measure: Obsessive Compulsive Inventory-Revised (OCI-R)
timeFrame: Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up
measure: Liebowitz Social Anxiety Scale Self-report (LSAS-SR)
timeFrame: Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up
measure: Panic Disorder Severity Scale Self-rated (PDSS-SR)
timeFrame: Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up
measure: Penn-State Worry Questionnaire (PSWQ)
timeFrame: Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up
measure: Post Traumatic Stress Disorder Symptom Scale-Self report (PTSDSS)
timeFrame: Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up
Other outcomes:
Locations:
city: Stockholm,
country: Sweden
facility: Karolinska Institutet and Gustavsberg primary care center
state: Stockholm
Study officials:
References: