Process evaluation of a complex intervention evaluating the effectiveness of home-based rehabilitation in the chronic phase of traumatic brain injury

To perform a process evaluation of a randomized controlled trial (RCT) evaluating a manualized intervention aiming to ameliorate long-term symptoms of traumatic brain injury (TBI) by assessing implementation fidelity, delivery context and acceptability of the intervention. Data from 60 participants were collected during recruitment, intervention delivery and outcome data collection in the RCT. Enrollment records, logs and checklists documented the delivery of the intervention (implementation fidelity) and the collaboration with family members and outside collaborators (delivery context). Attendance-rate, self-reported acceptability and willingness to participate in future studies were used to assess the acceptability of the intervention. The main elements and dose of the intervention were delivered as intended with an excellent adherence to the manual items. Family members co-participated in the intervention for 39 (65%) of the participants. Outside collaborators were contacted for 32 (53%) of the participants. Acceptability scores were high for participants, family members and therapists. The intervention was successfully delivered with high acceptability. This process evaluation informs researchers, clinicians and stakeholders about important factors influencing the outcomes of the intervention that should be considered in clinical implementation of rehabilitation interventions. Pre-registered 4th of June 2018 at clinicaltrials.gov (NCT03545594).</p

A pilot study of cognitive remediation in remitted major depressive disorder patients

Major depressive disorder (MDD) is associated with working memory (WM) impairments. These deficits often persist following remission and are associated with rumination, a recognized risk factor for depression relapse. The efficacy of WM-targeted cognitive remediation as a potential relapse prevention tool has not been investigated. The present pilot study aimed to investigate the feasibility, acceptability, and cognitive benefits of a WM-targeted cognitive remediation program in remitted depression. Twenty-eight MDD participants in remission were recruited. The intervention consisted of twenty-five 30–40-minute training sessions, coupled with weekly coaching, administered over a 5-week period. Before and after the intervention, a battery of objective neuropsychological tests and self-report measures was administered. Key outcomes were WM, inhibition and rumination. Acceptability of the intervention was observed, with 83% showing high motivation, along with WM gains for all completers (n =18, 64% of recruited participants). The cognitive remediation selectively improved targeted WM functions, as measured by objective tests. This did not translate into self-reported improvements in everyday WM or inhibition. However, all but one completer achieved at least one personal goal related to WM and 44% achieved two or, the maximum possible, three such goals. For remitters whose WM was significantly enhanced after the intervention, the cognitive remediation also decreased dysphoric-mood related rumination. The successful pilot testing of the WM-targeted intervention supports the conduct of a fully powered randomized controlled trial as a relapse prevention approach in remitted MDD

The Participation Assessment with Recombined Tools-Objective (PART-O): measurement properties of the Norwegian version after traumatic brain injury

To translate and evaluate the validity of the Participation Assessment with Recombined Tools-Objective (PART-O) in a Norwegian context. One hundred and twenty persons with TBI with verified intracranial lesions and persistent symptoms lasting more than 2 years, included in a randomized controlled trial, rated their participation using the PART-O at baseline. The PART-O with its three subscales (Productivity, Out and About, and Social Relations) was translated to Norwegian. Descriptive statistics, Cronbach's alpha, Rasch analysis, and correlation analysis were applied. The Rasch analysis indicated a unidimensional construct of PART-O and its subscales (χ2 p > 0.28). The internal consistency was moderate (Cronbach's alpha 0.48–0.52) and there was a need to reduce scaling options for most of the items. The Out and About and Productivity subscales had considerable floor effects. PART-O showed moderate positive correlation to TBI-related quality of life and global functioning. PART-O and its subscales reflect unidimensional aspects of participation. In the present Norwegian TBI population the original scaling of PART-O was too detailed for all subscales. The floor effects and suboptimal targeting between items and subjects participation level of the Out and About subscale is a matter of concern.</p