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.
Highlights
Information about the study; consent to participation; Nurse
If the family intervention turns out to be effective, all families allocated to the control groups will be offered the 8-week family intervention after the study completion
Intention-to treat (ITT) analyses will be performed to examine the effect of the family intervention using repeated measures analysis of variance (ANOVA), with “time” as the repeated measurement
Summary
Information about the study; consent to participation; Nurse. If the family is randomized to the completion of baseline questionnaires; randomization; intervention group at the end of theThe homework assignment is given (90 min) session, the neuropsychologist will present the homework assignment Making meaningPresentation of the study and the individual sessions; Neuropsychologist expectations to the participants and the facilitator; making meaning of TBI/tSCI and psychoeducation; the homework assignment is reviewed and a new given; session rating scale (90 min) Shifting focusThe relationship between thoughts, feelings, and behaviour; the homework assignment is reviewed and a new given; session rating scale (90 min)Managing emotionsLearning to identify signs indicating an escalation of emotions and techniques to handle emotions; strategies for overcoming negative emotions; the homework assignment is reviewed and a new given; session rating scale (90 min) CommunicatingTalk-listening techniques and communication improving effectively strategies; communication danger sings; the homework assignment is reviewed and a new given; session rating scale (90 min)Finding solutions. Presentation of the study and the individual sessions; Neuropsychologist expectations to the participants and the facilitator; making meaning of TBI/tSCI and psychoeducation; the homework assignment is reviewed and a new given; session rating scale (90 min) Shifting focus. The current study protocol presents a manualized family intervention for families living with traumatic injury to the brain (TBI) or spinal cord (tSCI). Background and objectives Each year traumatic injury to the brain (TBI) or spinal cord (tSCI) affects approximately 3000 individuals and their families in Denmark [1, 2]. About 43% of caregivers for TBI survivors report spending more than 5 h per week helping their injured family member, and of this group, 22% spend more than 16 h each week [11, 12]. It is important to help the family in coping with the changed life situation [26]
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