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Completed

NCT Number: NCT01667809

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

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.

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Key information

Conditions

Anxiety Disorders Depressive Disorder Depressive Disorder, Major Dyssomnias Major Depression Mental Disorders Mood Disorders Nervous System Diseases Primary Insomnia Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Stress Disorders Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Karolinska Institutet and Gustavsberg primary care center

Stockholm, Stockholm County, 13440, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Sick leave

    Time frame: 1 year

    Number of days on sick leave

  2. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 17, 2012
Registry last updated
Mar 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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