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

NCT01667809 | Completed Phase 3

• 1 other identifier: GVC CBT vs RTW II
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Anxiety Disorders; Major Depression; Stress Disorders; Primary Insomnia

Outcome Measures

Primary Outcomes (2)

• Sick leave

  Number of days on sick leave

  1 year

• 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

Secondary Outcomes (14)

• Montgomery-Åsberg Depression Rating Scale-Self-report (MADRS-S)

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

• Insomnia Severity Index (ISI)

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

• Health Anxiety Inventory (HAI)

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

• Perceived Stress Scale (PSS)

  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)

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

Study Arms (2)

Cognitive Behavior Therapy

ACTIVE COMPARATOR

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

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.

Behavioral: Return to work

Interventions

Cognitive behavior therapy BEHAVIORAL

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.

Cognitive Behavior Therapy

Return to work BEHAVIORAL

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.

Return to work

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• A higer score than 3 on the Clinician severity rating scale
• A lower score than 2 on the Clinician severity rating scale

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Karolinska Institutet and Gustavsberg primary care center

Stockholm, Stockholm County, 13440, Sweden

Location

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder, Major; Stress Disorders, Traumatic; Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy; Return to Work

Condition Hierarchy (Ancestors)

Mental Disorders; Depressive Disorder; Mood Disorders; Trauma and Stressor Related Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Employment; Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 10, 2012
• First Posted: August 17, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 3, 2016

Record last verified: 2016-03

Locations

SE (1)