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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Karolinska Institutet
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Erik Hedman, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01636791
First received: July 5, 2012
Last updated: September 21, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Anxiety Disorders
Major Depression
Stress Disorders
Primary Insomnia
Behavioral: Cognitive behavior therapy
Behavioral: Return to work
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Sick leave [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number of days on sick leave

  • Clinician Severity Rating (CSR) [ Time Frame: Baseine, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in CSR at post-treatment, 26 week follow-up, and 52 week follow-up compared to baseline.


Secondary Outcome Measures:
  • Montgomery-Åsberg Depression Rating Scale-Self-report (MADRS-S) [ Time Frame: Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in MADRS-S at post-treatment, 26 week follow-up, and 52 week follow-up

  • Work ability index (WAI) [ Time Frame: Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in WAI at post-treatment, 26 week follow-up, 52 week follow-up

  • Insomnia Severity Index (ISI) [ Time Frame: Baseline, post-treatment (variable depending on disorder, 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in ISI at post-treatment, 26 week follow-up, and 52 week follow-up

  • Health Anxiety Inventory (HAI) [ Time Frame: Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in HAI at post-treatment, 26 week follow-up, and 52 week follow-up

  • Perceived Stress Scale (PSS) [ Time Frame: Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in PSS at post-treatment, 26 week follow-up, and 52 week follow-up

  • Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P) [ Time Frame: Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in TIC-P at post-treatment, 26 week follow-up, and 52 week follow-up

  • Quality of Life Inventory (QOLI) [ Time Frame: Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in QOLI at post-treatment, 26 week follow-up, and 52 week follow-up

  • EuroQol-5 dimension (EQ5D) [ Time Frame: Baseline, post-treatment (variable depending on disorder), 26 feel follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in EQ5D at post-treatment, 26 week follow-up, and 52 week follow-up

  • Sheehan Disability Scales (SDS) [ Time Frame: Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in SDS at post-treatment, 26 week follow-up, and 52 week follow-up

  • Self-rated health 5 (SRH-5) [ Time Frame: Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in SRH-5 at post-treatment, 26 week follow-up and 52 week follow-up

  • Obsessive Compulsive Inventory-Revised (OCI-R) [ Time Frame: Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in OCI-R at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.

  • Liebowitz Social Anxiety Scale Self-report (LSAS-SR) [ Time Frame: Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in LSAS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.

  • Panic Disorder Severity Scale Self-rated (PDSS-SR) [ Time Frame: Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in PDSS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.

  • Penn-State Worry Questionnaire (PSWQ) [ Time Frame: Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in PSWQ at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.

  • Post Traumatic Stress Disorder Symptom Scale-Self report (PTSDSS) [ Time Frame: Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in PTSDSS at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.


Estimated Enrollment: 210
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01636791

Contacts
Contact: Erik Hedman, PhD 123 40 000 ext +468 kire.hedman@ki.se
Contact: Sigrid Salomonsson, MSc 7186883 ext +468 sigrid.salomonsson@sll.se

Locations
Sweden
Karolinska Institutet and Gustavsberg primary care center Recruiting
Stockholm, Sweden, 13440
Principal Investigator: Erik Hedman, PhD         
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
  More Information

No publications provided

Responsible Party: Erik Hedman, Principal investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01636791     History of Changes
Other Study ID Numbers: GVC CBT vs RTW
Study First Received: July 5, 2012
Last Updated: September 21, 2013
Health Authority: Sweden: The National Board of Health and Welfare

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Depression
Depressive Disorder
Sleep Initiation and Maintenance Disorders
Stress Disorders, Traumatic
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014