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

Karolinska Institutet5 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Anxiety Disorders Major Depression Stress Disorders

Interventions

Cognitive behavior therapyBEHAVIORAL

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 workBEHAVIORAL

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

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Karolinska Institutet and Gustavsberg primary care center

Stockholm, Stockholm County, Sweden

Outcomes

Primary Outcomes

Sick leave

Number of days on sick leave

Time frame: 1 year

Clinician Severity Rating (CSR)

Change in CSR at post-treatment, 26 week follow-up, and 52 week follow-up compared to baseline.

Time frame: Baseine, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up

Secondary Outcomes

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

Time frame: Baseline, post-treatment (12 weeks on average), 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

Time frame: Baseline, post-treatment (12 weeks on average) 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

Time frame: Baseline, post-treatment (12 weeks on average), 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

Time frame: 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)

Change in TIC-P at post-treatment, 26 week follow-up, and 52 week follow-up

Time frame: Baseline, post-treatment (12 weeks on average), 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

Time frame: Baseline, post-treatment (12 weeks on average) 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

Time frame: Baseline, post-treatment (12 weeks on average) 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

Time frame: Baseline, post-treatment (12 weeks on average), 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

Time frame: Baseline, post-treatment (12 weeks on average), 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.

Time frame: Baseline, post-treatment (12 weeks on average), 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.

Time frame: Baseline, post-treatment (12 weeks on average), 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.

Time frame: Baseline, post-treatment (12 weeks on average), 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.

Time frame: Baseline, post-treatment (12 weeks on average), 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.

Time frame: Baseline, post-treatment (12 weeks on average), 26 week follow-up, 52 week follow-up

Data from ClinicalTrials.gov

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