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

Primary Purpose

Anxiety Disorders, Major Depression, Stress Disorders

Status
Completed
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
Cognitive behavior therapy
Return to work
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska Institutet and Gustavsberg primary care center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Cognitive Behavior Therapy

Return to work

CBT and Return to work

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Sick leave
Number of days on sick leave
Clinician Severity Rating (CSR)
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)
Change in MADRS-S at post-treatment, 26 week follow-up, and 52 week follow-up
Work ability index (WAI)
Change in WAI at post-treatment, 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
Health Anxiety Inventory (HAI)
Change in HAI at post-treatment, 26 week follow-up, and 52 week follow-up
Perceived Stress Scale (PSS)
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)
Change in TIC-P at post-treatment, 26 week follow-up, and 52 week follow-up
Quality of Life Inventory (QOLI)
Change in QOLI at post-treatment, 26 week follow-up, and 52 week follow-up
EuroQol-5 dimension (EQ5D)
Change in EQ5D at post-treatment, 26 week follow-up, and 52 week follow-up
Sheehan Disability Scales (SDS)
Change in SDS at post-treatment, 26 week follow-up, and 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
Obsessive Compulsive Inventory-Revised (OCI-R)
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)
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)
Change in PDSS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
Penn-State Worry Questionnaire (PSWQ)
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)
Change in PTSDSS at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.

Full Information

First Posted
July 5, 2012
Last Updated
March 2, 2016
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
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1. Study Identification

Unique Protocol Identification Number
NCT01636791
Brief Title
CBT Versus a Return to Work Intervention for Patients With Common Mental Illness in Primary Care
Acronym
CBT vs RTW I
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Major Depression, Stress Disorders, Primary Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavior Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Return to work
Arm Type
Experimental
Arm Description
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.
Arm Title
CBT and Return to work
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavior therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Return to work
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sick leave
Description
Number of days on sick leave
Time Frame
1 year
Title
Clinician Severity Rating (CSR)
Description
Change in CSR at post-treatment, 26 week follow-up, and 52 week follow-up compared to baseline.
Time Frame
Baseine, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
Secondary Outcome Measure Information:
Title
Montgomery-Åsberg Depression Rating Scale-Self-report (MADRS-S)
Description
Change in MADRS-S at post-treatment, 26 week follow-up, and 52 week follow-up
Time Frame
Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
Title
Work ability index (WAI)
Description
Change in WAI at post-treatment, 26 week follow-up, 52 week follow-up
Time Frame
Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
Title
Insomnia Severity Index (ISI)
Description
Change in ISI at post-treatment, 26 week follow-up, and 52 week follow-up
Time Frame
Baseline, post-treatment (variable depending on disorder, 26 week follow-up, 52 week follow-up
Title
Health Anxiety Inventory (HAI)
Description
Change in HAI at post-treatment, 26 week follow-up, and 52 week follow-up
Time Frame
Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
Title
Perceived Stress Scale (PSS)
Description
Change in PSS at post-treatment, 26 week follow-up, and 52 week follow-up
Time Frame
Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
Title
Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)
Description
Change in TIC-P at post-treatment, 26 week follow-up, and 52 week follow-up
Time Frame
Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
Title
Quality of Life Inventory (QOLI)
Description
Change in QOLI at post-treatment, 26 week follow-up, and 52 week follow-up
Time Frame
Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
Title
EuroQol-5 dimension (EQ5D)
Description
Change in EQ5D at post-treatment, 26 week follow-up, and 52 week follow-up
Time Frame
Baseline, post-treatment (variable depending on disorder), 26 feel follow-up, 52 week follow-up
Title
Sheehan Disability Scales (SDS)
Description
Change in SDS at post-treatment, 26 week follow-up, and 52 week follow-up
Time Frame
Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
Title
Self-rated health 5 (SRH-5)
Description
Change in SRH-5 at post-treatment, 26 week follow-up and 52 week follow-up
Time Frame
Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
Title
Obsessive Compulsive Inventory-Revised (OCI-R)
Description
Change in OCI-R at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
Time Frame
Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
Title
Liebowitz Social Anxiety Scale Self-report (LSAS-SR)
Description
Change in LSAS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
Time Frame
Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
Title
Panic Disorder Severity Scale Self-rated (PDSS-SR)
Description
Change in PDSS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
Time Frame
Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
Title
Penn-State Worry Questionnaire (PSWQ)
Description
Change in PSWQ at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
Time Frame
Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
Title
Post Traumatic Stress Disorder Symptom Scale-Self report (PTSDSS)
Description
Change in PTSDSS at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
Time Frame
Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
Other Pre-specified Outcome Measures:
Title
Inflammatory cytokines
Description
Change in inflammatory cytokines at post-treatment
Time Frame
Baseline, post-treatment (variable depending on disorder)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Karolinska Institutet and Gustavsberg primary care center
City
Stockholm
ZIP/Postal Code
13440
Country
Sweden

12. IPD Sharing Statement

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CBT Versus a Return to Work Intervention for Patients With Common Mental Illness in Primary Care

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