Cognitive Behavior Therapy Versus a Return to Work Intervention for Sick-listed Patients With Common Mental Illness in Primary Care: a Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 1
- 主要终点
- Clinician Severity Rating (CSR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •A lower score than 4 on the Clinician severity rating scale
- •A higher score than 6 on the Clinician severity rating scale
研究组 & 干预措施
Cognitive Behavior Therapy
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.
干预措施: Cognitive behavior therapy (Behavioral)
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.
干预措施: Return to work (Behavioral)
CBT and Return to work
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.
干预措施: Cognitive behavior therapy (Behavioral)
CBT and Return to work
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.
干预措施: Return to work (Behavioral)
结局指标
主要结局
Clinician Severity Rating (CSR)
时间窗: 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.
Sick leave
时间窗: 1 year
Number of days on sick leave
次要结局
- Panic Disorder Severity Scale Self-rated (PDSS-SR)(Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up)
- Work ability index (WAI)(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)(Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up)
- Quality of Life Inventory (QOLI)(Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up)
- Sheehan Disability Scales (SDS)(Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up)
- Liebowitz Social Anxiety Scale Self-report (LSAS-SR)(Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up)
- Insomnia Severity Index (ISI)(Baseline, post-treatment (variable depending on disorder, 26 week follow-up, 52 week follow-up)
- Perceived Stress Scale (PSS)(Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up)
- EuroQol-5 dimension (EQ5D)(Baseline, post-treatment (variable depending on disorder), 26 feel follow-up, 52 week follow-up)
- Self-rated health 5 (SRH-5)(Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up)
- Montgomery-Åsberg Depression Rating Scale-Self-report (MADRS-S)(Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up)
- Health Anxiety Inventory (HAI)(Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up)
- Obsessive Compulsive Inventory-Revised (OCI-R)(Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up)
- Penn-State Worry Questionnaire (PSWQ)(Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up)
- Post Traumatic Stress Disorder Symptom Scale-Self report (PTSDSS)(Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up)
研究者
Erik Hedman
Principal investigator
Karolinska Institutet