CBT Versus a Return to Work Intervention for Patients With Common Mental Illness in Primary Care (CBT vs RTW I)

Cognitive Behavior Therapy Versus a Return to Work Intervention for Sick-listed Patients With Common Mental Illness in Primary Care: a Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Anxiety Disorders; Major Depression; Primary Insomnia; Stress Disorders
• Intervention / Treatment: Behavioral: Cognitive behavior therapy; Behavioral: Return to work

• Study Type: Interventional
• Enrollment (Actual): 211
• Phase: Phase 3

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 13440
    • Karolinska Institutet and Gustavsberg primary care center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cognitive Behavior Therapy; As the trial will include several different common 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.	Behavioral: Cognitive behavior therapy; 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.
Experimental: 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.	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.
Experimental: CBT and Return to work; Participants randomized to this arm will receive a combination of cognitive behavior therapy and the return to work treatment. This arm is included in the study as the clinically most relevant therapy, would the return to work treatment be effective in reducing sick leave, is a treatment were patients are provided support to return to work but also is clinically effective in reducing psychiatric symptoms.	Behavioral: Cognitive behavior therapy; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sick leave	Number of days on sick leave	1 year
Clinician Severity Rating (CSR)	Change in CSR at post-treatment, 26 week follow-up, and 52 week follow-up compared to baseline.	Baseine, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery-Åsberg Depression Rating Scale-Self-report (MADRS-S)	Change in MADRS-S at post-treatment, 26 week follow-up, and 52 week follow-up	Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
Work ability index (WAI)	Change in WAI at post-treatment, 26 week follow-up, 52 week follow-up	Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
Insomnia Severity Index (ISI)	Change in ISI at post-treatment, 26 week follow-up, and 52 week follow-up	Baseline, post-treatment (variable depending on disorder, 26 week follow-up, 52 week follow-up
Health Anxiety Inventory (HAI)	Change in HAI at post-treatment, 26 week follow-up, and 52 week follow-up	Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
Perceived Stress Scale (PSS)	Change in PSS at post-treatment, 26 week follow-up, and 52 week follow-up	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)	Change in TIC-P at post-treatment, 26 week follow-up, and 52 week follow-up	Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
Quality of Life Inventory (QOLI)	Change in QOLI at post-treatment, 26 week follow-up, and 52 week follow-up	Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
EuroQol-5 dimension (EQ5D)	Change in EQ5D at post-treatment, 26 week follow-up, and 52 week follow-up	Baseline, post-treatment (variable depending on disorder), 26 feel follow-up, 52 week follow-up
Sheehan Disability Scales (SDS)	Change in SDS at post-treatment, 26 week follow-up, and 52 week follow-up	Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
Self-rated health 5 (SRH-5)	Change in SRH-5 at post-treatment, 26 week follow-up and 52 week follow-up	Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
Obsessive Compulsive Inventory-Revised (OCI-R)	Change in OCI-R at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.	Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
Liebowitz Social Anxiety Scale Self-report (LSAS-SR)	Change in LSAS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.	Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
Panic Disorder Severity Scale Self-rated (PDSS-SR)	Change in PDSS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.	Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
Penn-State Worry Questionnaire (PSWQ)	Change in PSWQ at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.	Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
Post Traumatic Stress Disorder Symptom Scale-Self report (PTSDSS)	Change in PTSDSS at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.	Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory cytokines	Change in inflammatory cytokines at post-treatment	Baseline, post-treatment (variable depending on disorder)

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: July 5, 2012
• First Submitted That Met QC Criteria: July 9, 2012
• First Posted (Estimate): July 10, 2012

Study Record Updates

• Last Update Posted (Estimate): March 3, 2016
• Last Update Submitted That Met QC Criteria: March 2, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Mental Disorders
• Other Study ID Numbers: GVC CBT vs RTW

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No