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CBT vs RTW Intervention for Patients With Common Subclinical Mental Illness in Primary Care

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Erik Hedman, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01667809
First received: August 10, 2012
Last updated: November 19, 2014
Last verified: November 2014
  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 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.


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 Subclinical Common Mental Illness in Primary Care: a Randomized Controlled 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 (12 weeks on average), 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 (12 weeks on average), 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

  • Insomnia Severity Index (ISI) [ Time Frame: Baseline, post-treatment (12 weeks on average) 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 (12 weeks on average), 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 (12 weeks on average), 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 (12 weeks on average), 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 (12 weeks on average) 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 (12 weeks on average) 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 (12 weeks on average), 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 (12 weeks on average), 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 (12 weeks on average), 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 (12 weeks on average), 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 (12 weeks on average), 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 (12 weeks on average), 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 (12 weeks on average), 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: 100
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
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.

  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 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
  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: NCT01667809

Locations
Sweden
Karolinska Institutet and Gustavsberg primary care center
Stockholm,, Stockholm, Sweden, 13440
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: NCT01667809     History of Changes
Other Study ID Numbers: GVC CBT vs RTW II
Study First Received: August 10, 2012
Last Updated: November 19, 2014
Health Authority: Sweden: The National Board of Health and Welfare

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder, Major
Disease
Mental Disorders
Stress Disorders, Traumatic
Behavioral Symptoms
Depressive Disorder
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 24, 2014