Multidimensional Psychoeducative and Counseling Intervention (SAAM) for Symptomatic Patients with Mild Traumatic Brain Injury: A Pilot Randomized Controlled Trial.

OBJECTIVE:To estimate feasibility and explore the treatment effect of a psychoeducative and counseling intervention program targeting 4 postconcussion symptoms (SAAM: Sleep/fatigue, Attention, Anxiety/mood, Memory).SETTING:Level 1 trauma center.PARTICIPANTS:Twenty-five patients with postconcussion symptoms enrolled 1 to 3 months post-accident.DESIGN:Parallel-group (experimental and wait-list control), randomized controlled trial, with masked outcome assessment the week following the last intervention session. The Experimental group received the SAAM intervention (1 session/week during 4 weeks); care as usual was maintained for both groups.MAIN MEASURE:Rivermead Post-concussion Symptoms Questionnaire (RPQ).SECONDARY MEASURES:Hospital Anxiety and Depression Scale (HADS-A/-D); Pittsburgh Sleep Quality Index (PSQI); Multidimensional Fatigue Inventory (MFI); attention and memory neuropsychological battery; Community Integration Questionnaire (CIQ).TOLERABILITY MEASURE:A 10-item satisfaction questionnaire for the experimental group.RESULTS:15.67% of the participants evaluated for eligibility were randomized and completed the evaluation at T0. High rates of satisfaction regarding the SAAM intervention were found in the experimental group (n = 10). One participant (experimental group) withdrew after T0. Exploratory results showed that the group × time interaction was not significant, but had a large effect size for the RPQ (P = .051, η2 = .16) and HADS-D (P = .052, η2 = 0.17), and a significant interaction was found with a large effect size for the PSQI (P = .017, η2 = .24) and MFI (P = .041, η2 = .18). Post-hoc analyses revealed a significant reduction of these variables post-intervention. No significant group × time interaction was observed for cognitive measures and CIQ.CONCLUSION:The pilot study demonstrates the feasibility and tolerability of the SAAM intervention. Preliminary data suggest that SAAM intervention delivered post-acutely might reduce postconcussion symptoms, depression symptoms, fatigue, and sleep difficulties. A larger scale randomized control trial is warranted to confirm these promising results.