Internet-Guided Cognitive Behavioral Therapy for Insomnia Among Patients With Traumatic Brain Injury: A Randomized Clinical Trial

Abstract

Importance: Many military service members and veterans report insomnia after sustaining traumatic brain injury (TBI). Limitations of first-line treatment, cognitive-behavioral therapy for insomnia (CBT-I), include availability of qualified clinicians, low completion rates, and cost.

Objective: To investigate the feasibility and efficacy of internet-guided CBT-I (eCBT-I) in military service members and veterans with insomnia and a history of TBI.

Design, setting, and participants: This randomized clinical trial of fully remote internet-based interventions and evaluations was conducted from September 1, 2020, to June 30, 2021, with 3 months of follow-up. Participants included a volunteer sample of military service members and veterans aged 18 to 64 years with a history of mild TBI/concussion and at least moderately severe insomnia defined as an insomnia severity index (ISI) score of greater than 14 and Pittsburgh Sleep Quality Index of greater than 4. Self-reported race, ethnicity, and educational level were generally representative of the US military. Data were analyzed from October 21, 2021, to April 29, 2024.

Intervention: Internet-based CBT-I delivered over 6 weekly lesson modules with assigned homework activities.

Main outcomes and measures: The prespecified primary outcome measure was change in ISI score over time. Prespecified secondary outcome measures included self-reported measures of depression symptoms, posttraumatic stress disorder (PTSD) symptoms, sleep quality, migraine impact, and fatigue.

Results: Of 204 people screened, 125 were randomized 3:1 to eCBT-I vs online sleep education, and 106 completed baseline evaluations (83 men [78.3%]; mean [SD] age, 42 [12] years). Of these, 22 participants (20.8%) were Hispanic or Latino and 78 (73.6%) were White. Fifty participants completed postintervention evaluations, and 41 completed the 3-month follow-up. Baseline mean (SD) ISI scores were 19.7 (4.0) in those randomized to eCBT-I and 18.9 (5.0) in those randomized to sleep education. After intervention, mean (SD) ISI scores were 13.7 (5.6) in those randomized to eCBT-I and 16.6 (5.7) in those randomized to sleep education. The difference in the extent of reduction in ISI scores between groups was 3.5 (95% CI,-6.5 to -0.4 [P = .03]; Cohen d, -0.32 [95% CI, -0.70 to -0.04]). In the eCBT-I group, the extent of insomnia improvement correlated with the extent of depressive symptom improvement (Spearman ρ = 0.68 [P < .001]), PTSD symptoms (ρ = 0.36 [P = .04]), sleep quality (ρ = 0.54 [P = .001]), and fatigue impact (ρ = -0.58 [P < .001]) but not migraine-related disability.

Conclusions and relevance: The findings of this randomized clinical trial suggest that fully remote eCBT-I was moderately feasible and effective for self-reported insomnia and depression symptoms in military service members and veterans with a history of TBI. There is great potential benefit for eCBT-I due to low availability and cost of qualified CBT-I clinicians, although optimization of completion rates remains a challenge. Future studies may use home-based objective sleep assessments and should increase study retention.

Trial registration: ClinicalTrials.gov Identifier: NCT04377009.

Figure 1.. Study Flow Diagram

CBT indicates cognitive behavioral therapy; TBI, traumatic brain injury. ISI indicates insomnia severity index.

Figure 2.. Modified Intention-to-Treat Analyses of Primary and Key Secondary Outcome Measures Including All Available Data

A, The Insomnia Severity Index (ISI) scores range from 0 to 28, with scores greater than 14 indicating moderate to severe insomnia. Self-reported insomnia severity constituted the primary outcome measure. B, Depression symptom severity was measured using the Patient Health Questionnaire 9 for depression symptoms. Scores range from 0 to 27, with higher scores indicating more severe depression symptoms. C, Posttraumatic stress disorder (PTSD) symptom severity was measured using the PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition). Scores range from 0 to 80, with higher scores indicating more severe PTSD symptoms. D. Self-reported sleep quality was measured with the Pittsburgh Sleep Quality Index (PSQI). Scores range from 0 to 21, with scores of 4 or greater indicating moderately severe insomnia. E, Migraine-related disability was measured using the Migraine Disability Assessment (MIDAS). Scores range from 0 to 60, with higher scores indicating more severe migraine disability. F, Fatigue impact was measured using the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F). Scores range from 0 to 140, with higher scores indicating less severe fatigue. Data were reported as a function of group (internet-based cognitive behavioral therapy for insomnia [eCBT-I] vs education control) and assessment point. Sample sizes were 82 participants for eCBT-I and 24 for the control groups at baseline, 33 for eCBT-I and 17 for control groups after intervention, and 29 for eCBT-I and 12 for control groups at 3-month follow-up. Error bars indicate SD. ^aP = .03 for difference between groups.

Figure 3.. Correlation Between Changes in Self-Reported Insomnia and Changes in Depression Symptom Severity

Correlations for the group with internet-based cognitive behavioral therapy for insomnia (eCBT-I) (blue squares) are plotted separately from correlations for control group (orange circles). Spearman nonparametric correlation coefficients are reported. ISI indicates Insomnia Severity Index; PHQ-9, Patient Health Questionnaire 9.