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

J Head Trauma Rehabil. 2021 Jul-Aug;36(4):E249-E261. doi: 10.1097/HTR.0000000000000653.

Abstract

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.

Trial registration: ClinicalTrials.gov NCT01947504.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Brain Concussion* / diagnosis
  • Brain Concussion* / therapy
  • Counseling
  • Humans
  • Pilot Projects
  • Post-Concussion Syndrome* / diagnosis
  • Post-Concussion Syndrome* / therapy
  • Sleep Initiation and Maintenance Disorders*

Associated data

  • ClinicalTrials.gov/NCT01947504