A manual-based family intervention for families living with the consequences of traumatic injury to the brain or spinal cord: a study protocol of a randomized controlled trial

Abstract

BackgroundAcquiring a traumatic injury constitutes a severe life change for the survivor, but also for the surrounding family. The paradigm of helping the family has primarily been on psychosocial interventions targeting caregivers. However, interventions including both survivor and caregivers should be an essential part of treatment, as the whole family’s functional level and mental health can be affected. The current study protocol presents a manualized family intervention for families living with traumatic injury to the brain (TBI) or spinal cord (tSCI). The objectives are to investigate if the intervention improves quality of life (QoL) and decreases burden. It is hypothesized that the family intervention improves problem-solving strategies and family dynamics, which will reduce the burden. This may improve the caregivers’ mental health, which will improve the support to the survivor and QoL.MethodsThe study is an interventional, two-arm, randomized controlled trial. During a 2-year period, a total of 132 families will be included. Participants will be recruited from East-Denmark. Inclusion criteria are (1) TBI or tSCI, (2) ≥ 18 years of age, (3) ≥ 6 months to ≤ 2 years since discharge from hospital, (4) ability to understand and read Danish, (5) cognitive abilities that enable participation, and (6) a minimum of one family member actively involved in the survivor’s life. Exclusion criteria are (1) active substance abuse, (2) aphasia, (3) prior neurologic or psychiatric diagnose, and (4) history of violence. Within each disease group, families will be allocated randomly to participate in an intervention or a control group with a ratio 1:1. The intervention groups receive the family intervention consisting of eight sessions of 90 min duration. Families in the control groups receive 2 h of psychoeducation. All participants complete questionnaires on QoL, self-perceived burden, family dynamics, problem-solving strategies, mental health, and resilience at pre-intervention, post-intervention, and 6-month follow up.ConclusionIf the intervention is found to have effect, the study will contribute with novel knowledge on the use of a manual-based intervention including the entire family. This would be of clinical interest and would help families living with the consequences of TBI or tSCI.Trials registrationClinicalTrials.gov, NCT03814876. Retrospectively registered on 24 January 2019.

Resilience-Oriented Interventions for Patients With Traumatic Brain Injury: Prototypes Analysis and New Program Development

“…After analyzing the content and rejection of articles that did not meet the inclusion criteria, the review included 6 original articles, that describe 5 resilience-oriented interventions. Four studies were conducted in the United States (Donnelly, K., et al, 2019b;Kreutzer, J., et al, 2018;Church, D., et al, 2016;Vranceanu, A., et al, 2020), one -in Denmark (Soendergaard, P., et al, 2019). Four studies were conducted involving a civilian sample (Donnelly, K., et al, 2019b;Kreutzer, J., et al, 2018;Vranceanu, A., et al, 2020;Soendergaard, P., et al, 2019), one -involving war veterans (Church, D., et al, 2016.…”

“…Four studies were conducted in the United States (Donnelly, K., et al, 2019b;Kreutzer, J., et al, 2018;Church, D., et al, 2016;Vranceanu, A., et al, 2020), one -in Denmark (Soendergaard, P., et al, 2019). Four studies were conducted involving a civilian sample (Donnelly, K., et al, 2019b;Kreutzer, J., et al, 2018;Vranceanu, A., et al, 2020;Soendergaard, P., et al, 2019), one -involving war veterans (Church, D., et al, 2016. All studies have a randomized controlled trial design.…”

“…All studies have a randomized controlled trial design. Two studies had the wait-list control group (Kreutzer, J., et al, 2018;Soendergaard, P., et al, 2019), three studies -had treatment as usual (TAU) group as a control (Donnelly, K., et al, 2019b;Church, D., et al, 2016;Vranceanu, A., et al, 2020). Among all studies 3 were pilot (Donnelly, K., et al, 2019b;Church, D., et al, 2016;Vranceanu, A., et al, 2020).…”

“…Family resilience-oriented intervention. Soendergaard et al described a resilience-oriented intervention for families of persons with TBI and spinal cord injury, which consists of 8 90 minutes sessions with a frequency of 1 session / week (Soendergaard, P., et al, 2019):…”

Correction to: A manual-based family intervention for families living with the consequences of traumatic injury to the brain or spinal cord: a study protocol of a randomized controlled trial

“…After publication of our article [1] we were notified that a few duplicate sentences were included on page 7 of the manuscript.…”