Anxiety DisordersPhase 3CBT vs RTW INCT01636791

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

A Phase 3 study testing Cognitive behavior therapy and Return to work in people with Anxiety Disorders and Major Depression, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Anxiety Disorders, Major Depression, Stress Disorders
What is being tested?: Cognitive behavior therapy and Return to work
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 211 participants
Where: 1 siteSweden
Study dates: Sep 2012to Dec 2015
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

A lower score than 4 on the Clinician severity rating scale
A higher score than 6 on the Clinician severity rating scale

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Karolinska Institutet and Gustavsberg primary care center
Stockholm, Stockholm County, 13440

Other trials in Sweden

About this study

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

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.

Conditions: Anxiety Disorders, Major Depression, Stress Disorders, Primary Insomnia
Being tested: Cognitive behavior therapy, Return to work
Medical subject headings: Anxiety Disorders, Depressive Disorder, Major, Stress Disorders, Traumatic, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cognitive behavior therapyBehavioural
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.
Return to workBehavioural
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.

Study groups in NCT01636791
Study group	Role	What they receive
Cognitive Behavior Therapy	Active comparator	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. Receives: Behavioral: Cognitive behavior therapy
Return to work	Experimental	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. Receives: Behavioral: Return to work
CBT and Return to work	Experimental	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. Receives: Behavioral: Cognitive behavior therapy; Behavioral: Return to work

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (15)

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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2012Dec 2015

First posted10 Jul 2012 (estimated)
Study startSep 2012
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Anxiety DisordersStudies of the same condition, open and under way.
More trials run by Karolinska InstitutetThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 211 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01636791
Sponsor's protocol ID: GVC CBT vs RTW
Acronym: CBT vs RTW I
Status last verified: Mar 2016
First submitted: 5 Jul 2012
Last updated: 3 Mar 2016
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01636791
Acronym / sponsor ID: CBT vs RTW I / GVC CBT vs RTW
Conditions: Anxiety Disorders, Major Depression, Stress Disorders, Primary Insomnia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 211 participants (actual)
Lead sponsor: Karolinska InstitutetUniversity, hospital or other
Collaborators: Region Stockholm
Study start: Sep 2012
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 10 Jul 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Cognitive Behavior Therapy	Active comparator	Behavioral: Cognitive behavior therapyAs 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.
Return to work	Experimental	Behavioral: Return to workParticipants 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.
CBT and Return to work	Experimental	Behavioral: Cognitive behavior therapy, Behavioral: Return to workParticipants 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

A lower score than 4 on the Clinician severity rating scale
A higher score than 6 on the Clinician severity rating scale

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cognitive behavior therapyCognitive 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.	Behavioural	CBT and Return to work, Cognitive Behavior Therapy
Return to workParticipants 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.	Behavioural	CBT and Return to work, Return to work

Primary outcome

Sick leave
Time frame: 1 year
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
Change in CSR at post-treatment, 26 week follow-up, and 52 week follow-up compared to baseline.

15 secondary outcomes

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
Work ability index (WAI)
Time frame: Baseline, post-treatment (variable depending on disorder), 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
Health Anxiety Inventory (HAI)
Time frame: Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 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
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
Quality of Life Inventory (QOLI)
Time frame: Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 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
Sheehan Disability Scales (SDS)
Time frame: Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 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
Obsessive Compulsive Inventory-Revised (OCI-R)
Time frame: Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
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
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
Penn-State Worry Questionnaire (PSWQ)
Time frame: Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cognitive behavior therapy and Return to work in people with Anxiety Disorders and Major Depression, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sick leave (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01636791.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2016.