Effects of Cognitive Behavioral Therapy on Pain and Sleep in Adults with Traumatic Brain Injury: A Systematic Review and Meta-Analysis

Table 1

Baseline demographic and clinical characteristics of study participants.

	Author (year)	Study type	No. of participants (% women)	Age (y): range/mean (SD)	Time since injury mean (SD)	Severity	Outcome measures	Adverse events	Time points	Dropout rate after intervention
1	McCarty et al., 2021 [33]	Randomized controlled trial	: 200 (62.0); : 101 (59.4); C:99 (69.6)	: 14.7 (1.7); 11 to 18; : 14.8 (1.7); : 14.7 (1.7)	: 0-30 days: 2; 31-60 days: 62; 61-90 days: 19; 91-120 days: 8; 121-180 days: 5; 181-270 days: 5; : 0-30 days: 4; 31-60 days: 55; 61-90 days: 17; 91-120 days: 13; 121-180 days: 5; 181-270 days: 5	: Mild:200	(1) Postconcussive symptoms (the Health Behavior Inventory); (2) Health-related quality of life (the Pediatric Quality of Life Inventory); (3) Psychological assessment: (the Patient Health Questionnaire–9, Generalized Anxiety Disorder-7 item scale, the 15-item anxiety subscale of the Revised Child Anxiety and Depression Scale-Short version); (4) Sleep quality (Adolescent Sleep Wake Scale); (5) Headache pain (Traumatic Brain Injury-Quality of Life headache pain)	None	: baseline; 6-month intervention; 6-month follow-ups; : baseline; 6 months; 6-month follow-ups	: 1.98%; : 4.04%; : 3.00%
2	Tomfohr-Madsen et al., 2019 [28]	Randomized controlled trial	: 24 (75.0); : 12 (75.0); : 12 (75.0)	: 15.0 (1.4); 12 to 18; : 15.2 (1.5); : 14.9 (1.3)	: 1 month to 12 months	: Mild: 24	(1) Sleep disturbance (Insomnia Severity Index, Pittsburgh Sleep Quality Index, Dysfunctional Beliefs and Attitudes about Sleep Scale, sleep diary); (2) Postconcussive symptoms (the Health Behavior Inventory); (3) Psychological assessment (Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depression)	None	: baseline; 6-week intervention; 4-week follow-ups; : baseline; 6 weeks; 4-week follow-ups	: 16.67%; : 8.33%; : 12.50%
3	Theadom et al., 2018 [26]	Randomized controlled trial	: 24 (62.5); : 12 (58.3); : 12 (66.7)	: 35.9 (11.8); 17 to 56	: 10.42 (7.32) months; : 15.09 (10.67) months	: Mild: 11; Moderate: 1; : Mild: 11; Moderate: 1	(1) Sleep disturbance (Pittsburgh Sleep Quality Index, actigraphy sleep onset); (2) Cognitive function: (CNS vital signs online neuropsychological assessment); (3) Quality of life: (Quality of Life after Brain Injury questionnaire)	None	: baseline; 6-week intervention; : baseline; 6-week intervention	: 16.67%; : 16.67%; : 16.67%
4	Nguyen et al., 2017 [34]	Randomized controlled trial	: 24 (33.3); : 13 (30.8); : 11 (36.4)	: 45.53 (13.87); : 41.90 (12.95); : 43.87 (12.95)	77 days to 20.47 years); : 759.15 (714.23) days; : 2093.36 (2192.62) days	: Mild: 4; Moderate: 1; Severe: 8; : Mild: 1; Moderate: 1; Severe: 9	(1) Sleep disturbance (Pittsburgh Sleep Quality Index, Insomnia Severity, Index, Epworth Sleepiness Scale); (2) Fatigue: (Brief Fatigue Inventory, Fatigue Severity Scale); (3) Psychological assessment: (Hospital Anxiety and Depression Scale, anxiety and depression)	None	: baseline; 2-month intervention; 2-month follow-ups; : baseline; 2 months; 2-month follow-ups	: 0%; : 0%; : 0%
5	Potter et al., 2016 [25]	Randomized controlled trial	: 46 (45.7); : 26 (42.3); : 20 (50.0)	: 40.1 (10.3); : 43.1 (13.1); : 41.4 (11.6)	: 6–12 months: 6; >12, ≤24 months: 6; >24 months: 14; : 6–12 months: 7; >12, ≤24 months: 3; >24 months: 10	: Mild: 12; Moderate: 7; Severe: 6; : Mild: 6; Moderate: 5; Severe: 14	(1) TBI symptom (Rivermead Post-Concussion Symptoms Questionnaire, Brain Injury Community Rehabilitation Outcome Scale, Impact of Event Scale); (2) Psychological assessment: (Hospital Anxiety and Depression Scale, Anxiety and Depression State-Trait Anger Expression Inventory-2); (3) Pain and fatigue (McGill Pain Questionnaire, Checklist of Individual Strength); (4) Quality of life: (Quality of Life Assessment Schedule, European Quality of Life)	None	: baseline; 12-week intervention; : baseline; 12-week intervention	: 3.85%; : 0%; : 2.17%
6	Kjeldgaard et al., 2014 [24]	Randomized controlled trial	: 90 (55.6); : 45; : 45	: 34 (11.3)	Not mentioned	: Mild: 90	(1) Pain and headache (basic headache diary, pressure pain thresholds); (2) TBI symptom (Rivermead Post-Concussion Symptoms Questionnaire); (3) Psychological assessment (Symptom Checklist); (4) Quality of life (36-item Short Form Health Survey)	None	: baseline; 16-week intervention; : baseline; 16-week intervention	: 22.22%; : 17.78%; : 20.00%
7	Lah et al., 2019 [32]	Case report	: 5 (20.0)	: 11.8 (0.8)	: 7.4 (2.9) years	Moderate: 2; Severe: 3	(1) Sleep quality (sleep diaries, actigraphy watches, Insomnia Severity Index, Pittsburgh Sleep Quality Index); (2) Fatigue (PedsQL Multidimensional Fatigue Scale)	None	Baseline; 4-week intervention; 1-week follow-up	After intervention; : 28.57%; After follow-up; : 42.86%
8	Baker et al., 2018 [35]	Case report	: 25 (32.0)	: 29	: 1 month-10 years (average 26 months)	Mild: 25	(1) Pain and headache (migraine frequency, duration, and severity); (2) Quality of life; (3) Occupational assessment (current deployment and duty status)	None	Baseline; 2-year follow-up	: 0%
9	Lu et al., 2016 [31]	Case report	: 3 (66.7)	: 53.7 (10.1); Case 1: 60; Case 2: 42; Case 3: 59	Case 1: 6 years; Case 2: 2 years; Case 3: 1 year	Case 1: Mild; Case 2: Moderate; Case 3: Severe	1. Sleep quality (Insomnia Severity Index, Pittsburgh Sleep Quality Index, Dysfunctional Beliefs and Attitudes about Sleep Scale–Brief Version); 2. Pain (Brief Pain Inventory); (3) Psychological assessment (the Hospital Anxiety and Depression Scale (HADS): anxiety; depression); (4) Fatigue (Multidimensional Assessment of Fatigue-Global Fatigue Index)	None	Baseline; 4-week intervention; 1-3-month follow-up	: 0%
10	Ouellet and Morin, 2007 [29]	Case report	: 11 (45.5)	: 27.3 (8.5)	: 27.5 (9.7) months	Mild: 1; Mild-moderate: 2; Moderate: 2; Moderate-severe: 3; Severe: 3	(1) Sleep quality (sleep diary, Insomnia Severity Index, Dysfunctional Beliefs and Attitudes about Sleep Scale); (2) Fatigue (Multidimensional Fatigue Inventory); (3) Psychological assessment (Beck Depression/Anxiety Inventory)	None	Baseline; 8-10-week intervention; 1-3-month follow-up	: 0%
11	Gurr and Coetzer, 2005 [27]	Case report	: 41 (31.7)	: 44.05; Range: 22-78	: 78.7 (108.3) months	Mild: 18; Moderate: 7; Severe: 16	(1) Pain and headache (Headache Disability Inventory, Headache Needs Assessment, Chronic Pain Index); (2) Quality of life (Nottingham Health Profile); (3) Psychological assessment (Hospital Anxiety and Depression Scale)	None	Baseline; 14-15-week interventions; 12-13-week follow-up	: 51.2%
12	Ouellet and Morin, 2004 [30]	Single-case study	: 1 (0)	: late thirties	1 year	Moderate	(1) Sleep disturbance (sleep diary, polysomnography data, Insomnia Severity Index, Dysfunctional Beliefs and Attitudes about Sleep Scale); (2) Psychological assessment (Beck Anxiety Inventory, Beck Depression Inventory)	None	Baseline; 8 weeks of CBT; 1-month follow-up; 3-month follow-up	: 0