Treatment Fidelity in a Randomized Controlled Trial of Cognitive Behavioral Therapy for Insomnia in Heart Failure.
Meghan O'Connell, Joanne DeSanto Iennaco, Sarah Linsky and 4 others
PMID 35997691WHAT IT FOUND
High fidelity was achieved in nurse-delivered CBT-I for heart failure insomnia: sessions covered 93%-95% of protocol content, and 82 participants used the sleep tracker.
This describes delivery, not proof of sleep improvement.
Key findings
01The CBT-I sessions covered 93%-95% of the protocol content, and two coders agreed very closely.
02In the CBT-I group, 82 participants used the sleep tracker, 49 used sleep schedule strategies, and 35 of 47 who awakened for more than 15-30 minutes got out of bed.
03Because treatment use was high and varied little, the study could not examine whether specific CBT-I strategies were associated with post-intervention sleep.
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What it does not show
This is a treatment fidelity report, not the trial's clinical outcome report, so it cannot establish that CBT-I improved sleep outcomes. Fidelity and enactment were analysed in the CBT-I group only, with 91 participants completing the intervention and follow-up assessments. High treatment use and low variability prevented the researchers from examining whether specific CBT-I strategies were associated with sleep outcomes. One dedicated provider with 48 hr of CBT-I training and research-team time delivered the intervention, so results may not transfer to usual care settings with multiple providers or less training. Many enactment measures relied on self-report and phone calls, although actigraphy and diaries were also used. Most participants were White (76%) and had New York Heart Association class I-II heart failure (76%), limiting generalizability to more diverse or more severely affected patients.
The easy way to misread this
Do not conclude from this paper that CBT-I improved sleep in heart failure or that any component caused benefit. It reports high fidelity and participant use, but it could not link enactment to sleep outcomes.