Table 1.
Characteristics of included RCTs of CBT-I.
| Study a | Subjects characteristics | BC Stages | Insomnia defined by | Insomnia duration | CBT-I group, nb | Comparison group, nb | Mean age (yrs) | Treatment components | Length/numbers of CBT-I sessions | Measures and Follow-up | Outcome measures | Sleep diary measures | Fatigue |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Savard J, 2005 [39] | BC survivors, completed radio-/ chemotherapy | I-III | DSM-IV, ICSD, IIS | Chronic | CBT-I (n = 27) | Waiting-list control (n = 30) | 54.1 | SC, SR, CR, SH/SE, fatigue and stress management | 8 weekly 90min sessions, one booster session, in groups of 4–6 patients. | pre, post, 3m, 6m, 12m | ISI | SE (%), TWT, TST, SOL, WASO | MFI |
| Dirksen SR, 2008 [40] | BC survivors, completed cancer treatment≥3m | I-III | DSM-IV-TR, ICSD | Chronic | CBT-I (n = 40) | Component control (n = 41) | 58.3 | CBT-I group: SC, SR, SH/SE Component control group: SH/SE | 6 weeks, in-person classes (~1 or 2 hours) or 15min by-phone sessions | pre, post | ISI | None | POMS-F |
| Berger AM, 2009 [41, 53] | BC patients, enrolled before initial chemotherapy. | I-IIIa | Self-reported history of diagnosis | Chronic | Behavioral therapy (n = 113) | Healthy eating (n = 106) | 52.1 | SC, SR, RT, SH | Plan: 90 min at randomization. Revising BT plan: 30 min, 2 days before each treatment and 30 days after the last treatment. 15 minute, in-person sessions 7 to 9 days after each revision. | pre, post, 1m, 3m, 12m | PSQI | TST, awakenings, WASO, SE (%) | PFS |
| Fiorentino L, 2010 [42] | BC survivors, completed BC treatment | I-IIIa | DSM-IV | Chronic | Individual CBT-I (n = 11) | Delayed treatment control condition (n = 10) | 61 | SR, SC, SH/SE, RT, CT | 6 weekly individual CBT-I sessions | pre, post, 6wk | ISI, PSQI | TST, WASO, awakenings, SE (%) | None |
| Ritterband LM, 2012 [43] | Mixed cancer patients, completed active treatment; 64.3% BC | I-IV + unknown | DSM-IV-TR + symptom criteria | Chronic | Online-CBT-I (n = 14) | Waitlist control (n = 14) | 56.7 | SR, SC, CR, SH, relapse prevention | 6–9 weeks, including 6 online cores (45–60 min each) | pre, post | ISI | SE (%), TST, SOL, WASO, TIB, awakenings | MFSI - Short Form |
| Matthews EE, 2014 [45] | BC survivors, completed BC treatment | I–III | ISI≥8 + IIS | Chronic | P-CBT-I (n=32) | Behavioral placebo treatment (n=28) | 52 | SR, SC, SH, CT | Individual, 6 weekly in-person CBTI sessions (30–60 min each) or by phone (15–20 min each). | pre, post, 3m, 6m | ISI | SE (%), SOL, WASO, TST, awakenings | PFS |
| Garland SN, 2014 [44] | Mixed cancer, 48% BC | nonmetast atic cancer | DSM-IV, ICSD-2 | >1month | CBT-I (n = 47) | MBSR (n = 64) | 58.9 | SC, SR, CT, RT | 8 weekly, 90-minute sessions, for a total of 12 contact hours, in groups of 6–10 patients | pre, post, 3m | ISI, PSQI | SOL, WASO, TST, SE (%) | None |
| Roscoe JA, 2015 [38] | Mixed cancer survivors, 68% BC | N.C. | N.C. | Chronic | CBTI + placebo (n=24) | Placebo (n=25) | 55.4 | SH, SC, SR, (CT, RT) | 7 individual sessions occurring once per week. Sessions conducted in person (30–60 min), and by phone (15–30 min). | pre, post, 3m | ISI, PSQI | SOL, WASO, TST [36] | None |
| Casault L, 2015 [47] | Mixed cancer patients, 79% BC | N.C. | ISI≥8, IIS, regular hypnotic medication usage for more than 6 months | Acute | Self-admini stered minimal CBT-I (n = 20) | No treatment control (n = 18) | 56.9 | SC, SR, CR, SH | Self-help CBT, 6 short booklets and 3 phone consultations with a psychologist, over 6 weeks | pre, post, 3m, 6m | ISI | SOL, WASO, awakenings, TST, SE (%) | MFI |
| Savard J, 2014, 2016 [46, 48] | BC patients, with radiation therapy within the past 18m | 0-III | ISI≥8 or psychotropic medication as a sleep aid≥2 nights in the past 2 wks; | Chronic | PCBT-I (n = 81) VCBT-I (n = 80) | No treatment control (n = 81) | 54.4 | SC, SR, SH | 6 weeks of CBTI P-CBT-I: weekly, 50min individual session V-CBT-I: video segment (5–20min each) + booklets each week | pre, post, 3m, 6m, 12m | ISI | SOL, WASO, EMA, TWT, TST, SE (%) | MFI |
| Irwin MR, 2017 [49] | BC survivor, completed BC treatment | N.C. | DSM-IV-TR, DSM-V, ICSD-2 | N.C | Group CBT-I (n = 45) | TCC (n = 45) | 60.0 | SC, SH, SR, RT, CT | CBT-I teaching 2 months + 1 month of skill consolidation and adherence; Groups of 7 to 10 participants in weekly 120-minute sessions. | pre, mid, post, 3m, 12m | PSQI | TST, SOL, SE (%), WASO | MFSI |
| Palesh O, 2018 [50] | Newly diagnosed BC patients, undergoing chemotherapy | I-III + unknown | ISI≥8 | N.C. | BBT-CI (n = 34) | HEAL (n = 37) | 52.5 | SH, SC, SR, Sleep scheduling, Chronorehabil itation |
Two 60min face-to-face session and four 15min phone call | pre, post, 1m | ISI | None | None |
| Zachariae R, 2018 [51] | BC survivors | 0-III | PSQI>5 + structured screening interview | Chronic | Online-CBT -I (n = 133) |
Waitlist control (n = 122) | 53.1 | SR, SC, SH, CR, relapse prevention. | 9 weeks including 6 successively delivered cores (45–60min each) | pre, post, 6wk | ISI, PSQI | SOL, awakenings, WASO, EMA, TIB, TST, SE (%), Sleep medication | FACIT- F |
| Mercier J, 2018 [52] | Mixed cancer survivors, 53.7% BC | I-III + unknown | ISI≥8 | N.C. | CBT-I (n = 21) | Home-based aerobic exercise (n=20) | 57.1 | SC, SR, CR, SE/SH | 6-weeks: 60min video (5–20min each) + 6 booklets | pre, post, 3m, 6m | ISI, PSQI | SOL, WASO, TST, SE (%) | None |
Abbreviations:
awakenings, the number of awakenings; BBT-CI, brief behavioral therapy for cancer-related insomnia; BC, breast cancer; CBT-I, Cognitive Behavioral Therapy for Insomnia; CR, cognitive restructuring; DSM, Diagnostic and Statistical Manual of Mental disorders; EMA, early morning awakening; FACIT-F, Functional Assessment of Chronic Illness Therapy for Fatigue; ISI, Insomnia Severity Index; m, month; MFI, Multidimensional Fatigue Inventory; MFSI, Multidimensional Fatigue Symptom Inventory; mid, in the middle of intervention period; N.C., not clear; PCBT-I, professionally administered CBT-I; PFS, Piper Fatigue Scale; POMS-F, Profile of Mood States - Fatigue Scale; post, post-intervention; pre, pre-intervention; PSQI, Pittsburgh Sleep Quality Index; RT, relaxation training; SC, stimulus control; SE (%), sleep efficiency, calculated as (TST/TIB)*100; SE, sleep education; SH, sleep hygiene; sleep medication, the proportion of nights on which participants took sleep medication; SOL, sleep onset latency; SR, sleep restriction; TCC, Tai Chi Chih; TIB, time in bed; TST, total sleep time; TWT, total wake time; VCBT-I, video-based CBT-I; WASO, wake after sleep onset; wk, weeks.
Studies are listed in chronological order.
Number reported in the table are for enrolled subjects in each group in each study.