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| Name | Class |
|---|---|
| The Research Council of Norway | OTHER |
| Sunnaas Rehabilitation Hospital | OTHER |
| Oslo Metropolitan University | OTHER |
| Norwegian Labour and Welfare Administration |
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A considerable number of patients with mild and moderate traumatic brain injury (TBI) experience long-lasting somatic, cognitive, and emotional symptoms that may hamper their capacity to return to work (RTW). Although several studies have described medical, psychological and work-related factors that predict RTW after TBI, well-controlled intervention studies regarding RTW in this group are scarce. Furthermore, there have traditionally been weak collaborations among rehabilitation services in the health sector, the Labor and Welfare Administration (NAV), and the work-places.
The current project proposal describes an innovative randomized controlled trial (RCT) which will explore the effect of combined manualized cognitive rehabilitation efforts and supported employment in real-life competitive work settings for patients who have not returned to work 8 weeks post-injury. The project combines the rehabilitation and vocational science perspectives; it involves multidisciplinary collaboration, and explores the efficacy of increased cross-sectorial collaboration between specialized health care services and the welfare system. If the intervention proves efficient, the project will further describe the cost-effectiveness and utility of the program, and thereby provide important information of use for policy makers. In addition, the study aims at generating knowledge on the RTW-process both for the persons with TBI, and their workplaces, and to disseminate this knowledge in order to create new multidisciplinary and collaborative practices. The project has potential to generate knowledge of relevance for other patients with neurological deficit.
Please, see protocol article: https://www.ncbi.nlm.nih.gov/pubmed/29041954
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Intervention and Supported Employment (CCI-SE) | Active Comparator | Combined cognitive and vocational rehabilitation in a mixed design. |
|
| Control group | Active Comparator | Usual follow-up assessment and treatment provided by the multidisciplinary TBI rehabilitation team. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined cognitive (Compensatory Cognitive Training - CCT) and vocational rehabilitation (Supported Employment) | Behavioral | The CCI-SE Group receives a manualized Group-based cognitive psycho-educational intervention (10 sessions), combined with supported employment at their work-place. |
| Measure | Description | Time Frame |
|---|---|---|
| Return to work | The effect of the intervention on return to work rates throughout the follow-up period | 18 months post injury |
| Work stability | The effect of the intervention on work stability rates throughout the follow-up period | 18 months post injury |
| Measure | Description | Time Frame |
|---|---|---|
| Rivermead post-concussion questionnaire | Questionnaire; The effect of the study intervention on post concussive symptoms | 18 months |
| Euro-Qol - 5D (EQ-5D) | Questionnaire; The effect of the study intervention on health-related quality-of-life throughout the follow-up period |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Severity Scale | Questionnaire; The effect of the study intervention on fatigue throughout the follow-up period | 18 months |
| Insomnia Severity Index | Questionnaire; The effect of the study intervention on sleep throughout the follow-up period |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nada Andelic, MD; PhD | Oslo University Hospital/University of Oslo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital, Dept. of physical medicine and rehabilitation | Oslo | 0424 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35151285 | Derived | Howe EI, Andelic N, Fure SCR, Roe C, Soberg HL, Hellstrom T, Spjelkavik O, Enehaug H, Lu J, Ugelstad H, Lovstad M, Aas E. Cost-effectiveness analysis of combined cognitive and vocational rehabilitation in patients with mild-to-moderate TBI: results from a randomized controlled trial. BMC Health Serv Res. 2022 Feb 12;22(1):185. doi: 10.1186/s12913-022-07585-3. | |
| 33240196 |
| Label | URL |
|---|---|
| Protocol paper | View source |
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| OTHER |
Randomized controlled trial with active treatment group compared to treatment as usual
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Particpant are blinded to Group allocation, and all assessments are blinded to Group allocation.
|
| Control Group | Behavioral | The Control Group receives usual assessment and treatment at Oslo University Hospital. |
|
| 18 months |
| Quality of life after brain injury (Qolibri) | Questionnaire; The effect of the study intervention on disease-related quality-of-life throughout the follow-up period | 18 months |
| 18 months |
| Cognitive Failures Questionnaire | Questionnaire; The effect of the study intervention on self-reported cogntiive symptoms throughout the follow-up period | 18 months |
| Generalized Anxiety Disorder (GAD-7) | Questionnaire; The effect of the study intervention on anxiety throughout the follow-up period | 18 months |
| Patient Health Questionnaire (PHQ-9) | Questionnaire; The effect of the study intervention on depression throughout the follow-up period | 18 months |
| General Self-efficacy Scale | Questionnaire; The effect of the study intervention on self-efficacy throughout the follow-up period | 18 months |
| Neuropsychological functioning | Screening test battery including measures of general ability Level, attention, Processing speed, Learning and memory executive functioning, and performance validity | 18 months |
| Howe EI, Fure SCR, Lovstad M, Enehaug H, Sagstad K, Hellstrom T, Brunborg C, Roe C, Nordenmark TH, Soberg HL, Twamley E, Lu J, Andelic N. Effectiveness of Combining Compensatory Cognitive Training and Vocational Intervention vs. Treatment as Usual on Return to Work Following Mild-to-Moderate Traumatic Brain Injury: Interim Analysis at 3 and 6 Month Follow-Up. Front Neurol. 2020 Nov 10;11:561400. doi: 10.3389/fneur.2020.561400. eCollection 2020. |
| 29041954 | Derived | Howe EI, Langlo KS, Terjesen HCA, Roe C, Schanke AK, Soberg HL, Sveen U, Aas E, Enehaug H, Alves DE, Klethagen P, Sagstad K, Moen CM, Torsteinsbrend K, Linnestad AM, Nordenmark TH, Rismyhr BS, Wangen G, Lu J, Ponsford J, Twamley EW, Ugelstad H, Spjelkavik O, Lovstad M, Andelic N. Combined cognitive and vocational interventions after mild to moderate traumatic brain injury: study protocol for a randomized controlled trial. Trials. 2017 Oct 17;18(1):483. doi: 10.1186/s13063-017-2218-7. |
| Baseline paper | View source |
| The interim analysis paper | View source |
| The intervention effect paper | View source |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D060825 | Cognitive Dysfunction |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D012050 | Rehabilitation, Vocational |
| D016832 | Employment, Supported |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D004651 | Employment |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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