Clinical trial · Interventional
Combined Cognitive and Vocational Interventions After Mild-to-moderate TBI: a Randomized Controlled Trial
The Effect Evaluation of Combined Cognitive and Vocational Interventions After Mild-to-moderate Traumatic Brain Injury: a Randomized Controlled Trial and Qualitative Process Evaluation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Injuries, Traumatic | — | UNRESOLVED | — |
| Cognitive Impairment | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combined cognitive (Compensatory Cognitive Training - CCT) and vocational rehabilitation (Supported Employment) | Behavioral | — | UNRESOLVED |
| Control Group | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Cognitive Intervention and Supported Employment (CCI-SE)
- description
- Combined cognitive and vocational rehabilitation in a mixed design.
- interventionNames
- Behavioral: Combined cognitive (Compensatory Cognitive Training - CCT) and vocational rehabilitation (Supported Employment)
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- Usual follow-up assessment and treatment provided by the multidisciplinary TBI rehabilitation team.
- interventionNames
- Behavioral: Control Group
Primary outcomes (2)
- measure
- Return to work
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * reside in Oslo and Akershus counties in Norway * mild-to-moderate TBI (Glasgow Coma scale score 10-15 at injury site). Confirmation of diagnosis of mild TBI will be done through documenting that acute symptoms adhere to the American Congress of Rehabilitation Medicine's (ACRM) definition of mild TBI. * loss of consciousness \<24 hours * posttraumatic amnesia (PTA) \<7 days * employed in a minimum 50% position at the time of injury * sick listed at the 50% or higher level due to post-concussive symptoms 2 months post-injury Exclusion Criteria: * history of severe psychiatric or neurological illness * active substance abuse * inability to speak and read Norwegian
References
Publications (3)
- DERIVEDHowe 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. PMID 35151285
- DERIVEDHowe 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. PMID 33240196
- DERIVEDHowe 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. PMID 29041954