Clinical trial NCT01636791: CBT Versus a Return to Work Intervention for Patients With Common Mental Illness in Primary Care
Official title: Cognitive Behavior Therapy Versus a Return to Work Intervention for Sick-listed Patients With Common Mental Illness in Primary Care: a Randomized Clinical 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: 2012-07-10
Enrollment: 211
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 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.


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

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