Brain Injuries, TraumaticNCT03092713
Combined Cognitive and Vocational Interventions After Mild-to-moderate TBI: a Randomized Controlled Trial
A study testing Combined cognitive (Compensatory Cognitive Training - CCT) and vocational rehabilitation (Supported Employment) in people with Brain Injuries, Traumatic and Cognitive Impairment, run by Oslo University Hospital at 1 site in Norway.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Brain Injuries, Traumatic, Cognitive Impairment
- What is being tested?
- Combined cognitive (Compensatory Cognitive Training - CCT) and vocational rehabilitation (Supported Employment)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteNorway
- Study dates
- 2 Jan 2017to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- history of severe psychiatric or neurological illness
- active substance abuse
- inability to speak and read Norwegian
Trial locations and contacts
1 site in 1 country.
Norway1 site
Oslo University Hospital, Dept. of physical medicine and rehabilitation
Oslo, 0424
About this study
Official title: The Effect Evaluation of Combined Cognitive and Vocational Interventions After Mild-to-moderate Traumatic Brain Injury: a Randomized Controlled Trial and Qualitative Process Evaluation
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.
Read the detailed description
Please, see protocol article: https://www.ncbi.nlm.nih.gov/pubmed/29041954
- Conditions
- Brain Injuries, Traumatic, Cognitive Impairment
- Being tested
- Combined cognitive (Compensatory Cognitive Training - CCT) and vocational rehabilitation (Supported Employment), Control Group
- Keywords
- Cognitive Rehabilitation, Supported employment, Mild and moderate TBI, Return to work, Randomized Controlled Trial
- Medical subject headings
- Brain Injuries, Traumatic, Cognitive Dysfunction, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined cognitive (Compensatory Cognitive Training - CCT) and vocational rehabilitation (Supported Employment)Behavioural
The CCI-SE Group receives a manualized Group-based cognitive psycho-educational intervention (10 sessions), combined with supported employment at their work-place.
Control GroupBehavioural
The Control Group receives usual assessment and treatment at Oslo University Hospital.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Intervention and Supported Employment (CCI-SE) | Active comparator | Combined cognitive and vocational rehabilitation in a mixed design. Receives: Behavioral: Combined cognitive (Compensatory Cognitive Training - CCT) and vocational rehabilitation (Supported Employment) |
| Control group | Active comparator | Usual follow-up assessment and treatment provided by the multidisciplinary TBI rehabilitation team. Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to work
The effect of the intervention on return to work rates throughout the follow-up period
Measured: 18 months post injury
Work stability
The effect of the intervention on work stability rates throughout the follow-up period
Measured: 18 months post injury
Secondary outcomes (3)
Rivermead post-concussion questionnaire
Questionnaire; The effect of the study intervention on post concussive symptoms
Measured: 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
Measured: 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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start2 Jan 2017
- Primary completion31 Dec 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with active treatment group compared to treatment as usual
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway, Sunnaas Rehabilitation Hospital, Oslo Metropolitan University, Norwegian Labour and Welfare Administration
- Responsible party
- Principal investigator, Nada Andelic, Oslo University Hospital
- Investigators
- Nada Andelic, MD; PhD, Principal investigator, Oslo University Hospital/University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092713
- Sponsor's protocol ID
- 2016/2038
- Status last verified
- Oct 2021
- First submitted
- 10 Mar 2017
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35151285Howe 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.
PubMed 33240196Howe 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.
PubMed 29041954
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Evaluation of Combined Cognitive and Vocational Interventions After Mild-to-moderate Traumatic Brain Injury: a Randomized Controlled Trial and Qualitative Process Evaluation
- ClinicalTrials.gov ID
- NCT03092713
- Acronym / sponsor ID
- 2016/2038
- Conditions
- Brain Injuries, Traumatic, Cognitive Impairment
- Keywords
- Cognitive Rehabilitation, Supported employment, Mild and moderate TBI, Return to work, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- The Research Council of Norway, Sunnaas Rehabilitation Hospital, Oslo Metropolitan University, Norwegian Labour and Welfare Administration
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 28 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Please, see protocol article: https://www.ncbi.nlm.nih.gov/pubmed/29041954
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial with active treatment group compared to treatment as usual
| Arm | Type | Receives |
|---|---|---|
| Cognitive Intervention and Supported Employment (CCI-SE) | Active comparator | Behavioral: Combined cognitive (Compensatory Cognitive Training - CCT) and vocational rehabilitation (Supported Employment)Combined cognitive and vocational rehabilitation in a mixed design. |
| Control group | Active comparator | Behavioral: Control GroupUsual follow-up assessment and treatment provided by the multidisciplinary TBI rehabilitation team. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- history of severe psychiatric or neurological illness
- active substance abuse
- inability to speak and read Norwegian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined cognitive (Compensatory Cognitive Training - CCT) and vocational rehabilitation (Supported Employment)The CCI-SE Group receives a manualized Group-based cognitive psycho-educational intervention (10 sessions), combined with supported employment at their work-place. | Behavioural | Cognitive Intervention and Supported Employment (CCI-SE) |
| Control GroupThe Control Group receives usual assessment and treatment at Oslo University Hospital. | Behavioural | Control group |
Primary outcome
Return to work
Time frame: 18 months post injury
The effect of the intervention on return to work rates throughout the follow-up period
Work stability
Time frame: 18 months post injury
The effect of the intervention on work stability rates throughout the follow-up period
3 secondary outcomes
Rivermead post-concussion questionnaire
Time frame: 18 months
Euro-Qol - 5D (EQ-5D)
Time frame: 18 months
Quality of life after brain injury (Qolibri)
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Derived from this study: PubMed 35151285Howe 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.
- Derived from this study: PubMed 33240196Howe 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.
- Derived from this study: PubMed 29041954Howe 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.
- Protocol paperLink provided by the sponsor.
- Baseline paperLink provided by the sponsor.
- The interim analysis paperLink provided by the sponsor.
- The intervention effect paperLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nada Andelic, MD; PhD principal investigator
Oslo University Hospital/University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined cognitive (Compensatory Cognitive Training - CCT) and vocational rehabilitation (Supported Employment) in people with Brain Injuries, Traumatic and Cognitive Impairment, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to work (time frame: 18 months post injury). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03092713, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.