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

Anxiety Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01667809
• Other study ID #: GVC CBT vs RTW II
• Status: Completed
• Phase: Phase 3
• First received: August 10, 2012
• Last updated: March 2, 2016
• Start date: August 2012
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depressive Disorder, Major
• Disease
• Major Depression
• Mental Disorders
• Primary Insomnia
• Stress Disorders
• Stress Disorders, Traumatic

Intervention

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.
• 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.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet and Gustavsberg primary care center	Stockholm,	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sick leave	Number of days on sick leave	1 year	No
Primary	Clinician Severity Rating (CSR)	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	No
Secondary	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	Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up	No
Secondary	Insomnia Severity Index (ISI)	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	No
Secondary	Health Anxiety Inventory (HAI)	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	No
Secondary	Perceived Stress Scale (PSS)	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	No
Secondary	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	Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up	No
Secondary	Quality of Life Inventory (QOLI)	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	No
Secondary	EuroQol-5 dimension (EQ5D)	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	No
Secondary	Sheehan Disability Scales (SDS)	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	No
Secondary	Self-rated health 5 (SRH-5)	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	No
Secondary	Obsessive Compulsive Inventory-Revised (OCI-R)	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	No
Secondary	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.	Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up	No
Secondary	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.	Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up	No
Secondary	Penn-State Worry Questionnaire (PSWQ)	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	No
Secondary	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.	Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up	No