A pilot randomized controlled trial of on-line interventions to improve sleep quality in adults after mild or moderate traumatic brain injury

Theadom, Alice; Barker‐Collo, Suzanne; Jones, Kelly; Dudley, Margaret; Vincent, Norah; Feigin, Valery L.

doi:10.1177/0269215517736671

Cited by 41 publications

(69 citation statements)

References 29 publications

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“…The length of our eCBT-I protocol of 6 weeks is comparable with eCBT-I protocols in other studies. The CBT-I protocol in other studies examining e cacy in ABI consisted of 4 to 8 weekly session (12)(13)(14)(15)(16)(17), and 6-weeks for eCBT-I (18). In a review on the e cacy of eCBTI in the general population an average length of 5.5 weeks was found, with a range of 2-9 weeks (11).…”

Section: Interventionmentioning

confidence: 99%

“…Despite the high prevalence and serious consequences of insomnia in stroke patients or patients with TBI, studies examining CBT-I following acquired brain injury are scarce. To date, CBT-I was examined in two studies concerning stroke patients (12,13) and ve studies concerning patients with mild to severe TBI (14)(15)(16)(17)(18). The CBT-I protocol applied in the studies consisted of four to eight weekly sessions, combining cognitive and behavioral techniques including stimulus control, sleep restriction, cognitive therapy, and sleep hygiene education.…”

Section: Introductionmentioning

confidence: 99%

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A blended eHealth intervention for insomnia following acquired brain injury study protocol for a randomized controlled trial

Ford

Geurtsen

Groet

et al. 2020

Preprint

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Background: Up to a third of stroke patients and patients with traumatic brain injury suffer from insomnia, including problems to fall asleep or stay asleep at night. Insomnia may exacerbate other brain damage-related problems, for example regarding cognitive functioning and emotional well-being, may lead to poorer quality of life, and may complicate recovery processes. Cognitive behavioral therapy for insomnia, delivered face-to-face or online, is found to be effective in the general population. However, despite the high prevalence and serious consequences of insomnia following acquired brain injury, studies on the efficacy of face-to-face cognitive behavioral treatment in this population are scarce, and this applies even more for studies on online cognitive behavioral therapy. Therefore, this study aims to evaluate the efficacy of a newly developed guided online cognitive behavioral therapy for insomnia following acquired brain injury.Methods: A multicenter, prospective, randomized, open-label, blinded end point study (PROBE) will be conducted, in which 48 patients diagnosed with stroke or traumatic brain injury, and insomnia will be randomly allocated to the online cognitive behavioral therapy for insomnia treatment group or the treatment as usual group. The treatment consists of 6 online cognitive behavioral therapy sessions given on a weekly basis and personalized feedback after each session, combined with 2 face-to-face sessions. Outcomes will be assessed at baseline, immediately after the intervention period and at 6 weeks follow up. The primary outcome is the insomnia severity assessed with the insomnia severity index. Secondary outcome measures include sleep quality, sleep features derived from the sleep diary, fatigue, anxiety and depression, subjective cognitive functioning and societal participation.Discussion: This study will provide insight on the efficacy of online cognitive behavioral therapy for insomnia following stroke and traumatic brain injury.Trial Register: Netherlands Trial Register, NTR7082, 12 March 2018

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Section: Interventionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A blended eHealth intervention for insomnia following acquired brain injury study protocol for a randomized controlled trial

Ford

Geurtsen

Groet

et al. 2020

Preprint

View full text Add to dashboard Cite

show abstract

“…Despite the high prevalence and serious consequences of insomnia in stroke patients or patients with TBI, studies examining CBT-I following acquired brain injury are scarce. To date, CBT-I was examined in two studies concerning stroke patients (12,13) and ve studies concerning patients with mild to severe TBI (14)(15)(16)(17)(18). The CBT-I protocol applied in the studies consisted of four to eight weekly sessions, combining cognitive and behavioural techniques including stimulus control, sleep restriction, cognitive therapy, and sleep hygiene education.…”

Section: Introductionmentioning

confidence: 99%

“…CBT-I was adapted to brain injury patients by adding information on factors that could contribute to insomnia speci cally after brain injury. CBT-I was administered online in one study (18) and face-to-face in the other six studies. Six out of these seven studies found signi cant improvement on sleep outcomes (12)(13)(14)(16)(17)(18) and four of these studies found signi cant improvement on secondary outcomes as depression and fatigue (12,14,15,17).…”

Section: Introductionmentioning

confidence: 99%

“…Six out of these seven studies found signi cant improvement on sleep outcomes (12)(13)(14)(16)(17)(18) and four of these studies found signi cant improvement on secondary outcomes as depression and fatigue (12,14,15,17). Only three studies were randomized controlled trials, of which two compared CBT-I with treatment as usual (12,14) and one compared CBT-I with a placebo condition (online education only) (18). Furthermore, only three out of the seven studiesand none of the randomized controlled trials-formally assessed a diagnosis of ID as inclusion criterion (13,16,17).…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

A blended eHealth intervention for insomnia following acquired brain injury study protocol for a randomized controlled trial

Ford

Geurtsen

Groet

et al. 2020

Preprint

View full text Add to dashboard Cite

Background: Up to a third of stroke patients and patients with traumatic brain injury suffer from insomnia, including problems to fall asleep or stay asleep at night. Insomnia may exacerbate other brain damage-related problems, for example regarding cognitive functioning and emotional well-being, may lead to poorer quality of life, and may complicate recovery processes. Cognitive behavioural therapy for insomnia, delivered face-to-face or online, is found to be effective in the general population. However, despite the high prevalence and serious consequences of insomnia following acquired brain injury, studies on the efficacy of face-to-face cognitive behavioural treatment in this population are scarce, and this applies even more for studies on online cognitive behavioural therapy. Therefore, this study aims to evaluate the efficacy of a newly developed guided online cognitive behavioural therapy for insomnia following acquired brain injury.Methods: A multicenter randomized controlled trial will be conducted, in which 48 patients diagnosed with stroke or traumatic brain injury, and insomnia will be randomly allocated to the online cognitive behavioural therapy for insomnia treatment group or the treatment as usual group. The treatment consists of 6 online cognitive behavioural therapy sessions given on a weekly basis and personalized feedback after each session, combined with 2 face-to-face sessions. Outcomes will be assessed at baseline, immediately after the intervention period and at 6 weeks follow up. The primary outcome is the insomnia severity assessed with the insomnia severity index. Secondary outcome measures include sleep quality, sleep features derived from the sleep diary, fatigue, anxiety and depression, subjective cognitive functioning and societal participation.Discussion: This study will provide insight on the efficacy of online cognitive behavioural therapy for insomnia following stroke and traumatic brain injury.Trial Register: Netherlands Trial Register, NTR7082, 12 March 2018

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Internet-Guided Cognitive Behavioral Therapy for Insomnia Among Patients With Traumatic Brain Injury

Malarkey,

Fu,

Mannan

et al. 2024

JAMA Netw Open

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ImportanceMany 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.ObjectiveTo 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 ParticipantsThis 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.InterventionInternet-based CBT-I delivered over 6 weekly lesson modules with assigned homework activities.Main Outcomes and MeasuresThe 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.ResultsOf 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 &lt; .001]), PTSD symptoms (ρ = 0.36 [P = .04]), sleep quality (ρ = 0.54 [P = .001]), and fatigue impact (ρ = −0.58 [P &lt; .001]) but not migraine-related disability.Conclusions and RelevanceThe 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 RegistrationClinicalTrials.gov Identifier: NCT04377009

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A pilot randomized controlled trial of on-line interventions to improve sleep quality in adults after mild or moderate traumatic brain injury

Abstract: On-line programmes designed to improve sleep are feasible for use for adults following mild-to-moderate TBI. Based on the effect size identified in this pilot study, 128 people (64 per group) would be needed to determine clinical effectiveness.

Cited by 41 publications

References 29 publications

A blended eHealth intervention for insomnia following acquired brain injury study protocol for a randomized controlled trial

A blended eHealth intervention for insomnia following acquired brain injury study protocol for a randomized controlled trial

A blended eHealth intervention for insomnia following acquired brain injury study protocol for a randomized controlled trial

Internet-Guided Cognitive Behavioral Therapy for Insomnia Among Patients With Traumatic Brain Injury

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