Tele-Self CBTI
Trial question
What is the role of nurse-supported self-directed CBT-I in patients with insomnia disorder?
Study design
Single center
Open label
RCT
Population
Characteristics of study participants
28.0% female
72.0% male
N = 178
178 patients (50 female, 128 male).
Inclusion criteria: adult patients with insomnia disorder.
Key exclusion criteria: psychotic disorder; bipolar disorder; active substance misuse; cognitive impairment; seizure disorder; untreated/undertreated severe sleep apnea; unstable comorbid sleep disorder; excessive daytime sleepiness; shift work; severe depression or suicidality.
Interventions
N=88 self-directed CBT-I (CBT-I via 6 weekly phone calls with a nurse and related readings).
N=90 health education (6 weekly phone calls with a nurse focused on prevention and management of common health conditions).
Primary outcome
Mean reduction in Insomnia Severity Index score at 8 weeks
5.7 points
2 points
5.7 points
4.3 points
2.9 points
1.4 points
0.0 points
Self-directed
CBT-I
Health
education
Significant
increase ▲
Significantly greater reduction in mean Insomnia Severity Index score at 8 weeks (5.7 points vs. 2 points; MD 3.7, 95% CI 2.4 to 5).
Secondary outcomes
Significantly greater improvement in mean sleep diary sleep efficiency at 8 weeks (13.6 points vs. 2.6 points; MD 11, 95% CI 7.7 to 14.3).
Significantly greater reduction in mean depression at 8 weeks (2.6 points vs. 0.5 points; MD 2.1, 95% CI 0.9 to 3.3).
Significantly greater reduction in mean fatigue at 8 weeks (4.6 points vs. 1.3 points; MD 3.8, 95% CI 0.3 to 7.3).
Conclusion
In adult patients with insomnia disorder, self-directed CBT-I was superior to health education with respect to mean reduction in Insomnia Severity Index score at 8 weeks.
Reference
Christi S Ulmer, Corrine I Voils, Amy S Jeffreys et al. Nurse-Supported Self-Directed Cognitive Behavioral Therapy for Insomnia: A Randomized Clinical Trial. JAMA Intern Med. 2024 Nov 1;184(11):1356-1364.
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