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

March 2, 2016 updated by: Erik Hedman, Karolinska Institutet

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sick leave
Time Frame: 1 year
Number of days on sick leave
1 year
Clinician Severity Rating (CSR)
Time Frame: Baseine, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up
Change in CSR at post-treatment, 26 week follow-up, and 52 week follow-up compared to baseline.
Baseine, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Change in MADRS-S at post-treatment, 26 week follow-up, and 52 week follow-up
Baseline, post-treatment (12 weeks on average), 26 week follow-up, 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
Change in ISI at post-treatment, 26 week follow-up, and 52 week follow-up
Baseline, post-treatment (12 weeks on average) 26 week follow-up, 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
Change in HAI at post-treatment, 26 week follow-up, and 52 week follow-up
Baseline, post-treatment (12 weeks on average), 26 week follow-up, 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
Change in PSS at post-treatment, 26 week follow-up, and 52 week follow-up
Baseline, post-treatment (12 weeks on average), 26 week follow-up, 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
Change in TIC-P at post-treatment, 26 week follow-up, and 52 week follow-up
Baseline, post-treatment (12 weeks on average), 26 week follow-up, 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
Change in QOLI at post-treatment, 26 week follow-up, and 52 week follow-up
Baseline, post-treatment (12 weeks on average) 26 week follow-up, 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
Change in EQ5D at post-treatment, 26 week follow-up, and 52 week follow-up
Baseline, post-treatment (12 weeks on average) 26 feel follow-up, 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
Change in SDS at post-treatment, 26 week follow-up, and 52 week follow-up
Baseline, post-treatment (12 weeks on average), 26 week follow-up, 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
Change in SRH-5 at post-treatment, 26 week follow-up and 52 week follow-up
Baseline, post-treatment (12 weeks on average), 26 week follow-up, 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
Change in OCI-R at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up
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
Change in LSAS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up
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
Change in PDSS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up
Penn-State Worry Questionnaire (PSWQ)
Time Frame: Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up
Change in PSWQ at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up
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
Change in PTSDSS at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Region Stockholm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GVC CBT vs RTW II

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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