Treatment of Insomnia for Adolescents With Mild Traumatic Brain Injury

NCT03688984 | Completed

• 1 other identifier: REB16-1166
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A substantial number of children and adolescents sustain a mild traumatic brain injury (mTBI) each year. Although research supports that the vast majority of youth will recover quickly and return to normal functioning, some adolescents continue to report problems long after the injury. Disturbed sleep, notably trouble with sleep onset and sleep maintenance, is a frequently reported problem in those with slow recovery from a mTBI. Poor sleep is also associated with cognitive complaints, mood disturbance, and lower quality of life. Despite the identification of sleep disturbance as a problem associated with slow recovery, there are very few treatment options. Cognitive-behavioural therapy for insomnia (CBT-I) has shown promise in children and adolescents as an effective treatment for sleep disturbance, although it has yet to be applied to the adolescent mTBI population who also present with sleep problems. The objective of this study is to examine the treatment of sleep disturbance using cognitive-behavioural therapy for insomnia (CBT-I) in those adolescents who have a protracted recovery from their mTBI. This represents a novel treatment option for this patient population and is anticipated to improve outcomes and quality of life.

Conditions

Mild Traumatic Brain Injury; Post-Concussion Syndrome; Insomnia

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index (ISI) total score.

  The ISI is a seven-item self-report questionnaire that assesses sleep onset latency, sleep efficiency, and functional impact from sleep issues. The sleep latency and efficiency items are rated on a 5-point Likert scale from 0 (none) to 4 (very severe). The remaining four items measure dissatisfaction, how noticeable sleep problems are to others, distress from sleep problems, and interference with daily functioning (all rated on 5-point Likert scales). Total scores on the ISI range from 0-28 with higher scores indicating more insomnia symptoms.

  Baseline to post-treatment (7-weeks later)

Secondary Outcomes (10)

• Insomnia Severity Index (ISI) total score.

  Baseline to follow-up (4-weeks later)

• Pittsburgh Sleep Quality Index (PSQI) Global Score

  Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later)

• Dysfunctional Beliefs about Sleep (DBAS-16) total score

  Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later)

• Total sleep time (TST) as assessed via 7-night sleep diary.

  Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later)

• Wake after sleep onset (WASO) as assessed via 7-night sleep diary

  Baseline to post-treatment (7-weeks later) and a follow-up (4-weeks later)

Study Arms (2)

Cognitive Behavioural Therapy for Insomnia

EXPERIMENTAL

Six sessions of in person Cognitive Behavioural Therapy for Insomnia (CBT-I)

Behavioral: Cognitive Behavioural Therapy for Insomnia

Treatment As Usual

NO INTERVENTION

Participants will receive regular care in the Treatment As Usual (TAU) condition. Participants will be offered CBT-I at the completion of the trial.

Interventions

Cognitive Behavioural Therapy for Insomnia BEHAVIORAL

Cognitive Behavioural Therapy for Insomnia (CBT-I) consists of six individual therapy sessions that last approximately one hour each. The sessions include psychoeducation about insomnia, goal setting, relaxation training, stimulus control, sleep consolidation and medication review. Additional components include cognitive therapy, sleep hygiene and mindfulness and relapse prevention.

Cognitive Behavioural Therapy for Insomnia

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years of age
• diagnosed with a concussion by a nurse practitioner or physician at the ACH Complex Concussion Clinic (i.e., concussion was defined as an traumatic injury to the head, at least one reported symptom \[e.g., dizziness, headache, nausea\] at the time of the injury, and a Glasgow Coma Scale rating of ≥13/15 at 30 minutes after injury, or loss of consciousness \<30 minutes, or post-traumatic amnesia \<24 hours)
• being at least 2 months but no more than 12 months post-injury to ensure symptoms were no longer acute, yet current and persistent
• reporting elevated symptoms of insomnia measured by an Insomnia Severity Index score of ≥12
• ability to attend in-person treatment sessions.

You may not qualify if:

• moderate or severe TBI (i.e., Glasgow Coma scale rating of ≤12, loss of consciousness exceeding 30 minutes, and/or post-traumatic amnesia exceeding 24 hours)
• visual, hearing, motor, and/or language deficits that would hinder the completion of questionnaires or engagement in CBT-I.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Related Publications (1)

• Tomfohr-Madsen L, Madsen JW, Bonneville D, Virani S, Plourde V, Barlow KM, Yeates KO, Brooks BL. A Pilot Randomized Controlled Trial of Cognitive-Behavioral Therapy for Insomnia in Adolescents With Persistent Postconcussion Symptoms. J Head Trauma Rehabil. 2020 Mar/Apr;35(2):E103-E112. doi: 10.1097/HTR.0000000000000504.

  PMID: 31246882 DERIVED

MeSH Terms

Conditions

Brain Concussion; Post-Concussion Syndrome; Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Brian Brooks, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be blind to randomization condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 28, 2018
• Study Start: September 1, 2016
• Primary Completion: January 17, 2018
• Study Completion: January 17, 2018
• Last Updated: September 28, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)