The effect of nurse-led Internet-based cognitive behavioural therapy for insomnia on patients with cardiovascular disease: A randomized controlled trial with 6-month follow-up

Sandra Siebmanns, Peter Johansson, Martin Ulander, Linda Johansson, Gerhard Andersson, Anders Broström, Sandra Siebmanns, Peter Johansson, Martin Ulander, Linda Johansson, Gerhard Andersson, Anders Broström

Abstract

Aim: To test the effect of nurse-led Internet-based cognitive behavioural therapy for insomnia (I-CBTI), tailored for patients with cardiovascular disease (CVD), with a 6-month follow-up.

Design: A two-arm parallel-group randomized controlled trial (RCT) registered at clinicaltrials.gov (NTC03938805) and reported according to the CONSORT checklist.

Methods: Forty-eight patients (mean age 72 years, 65% men) diagnosed with CVD and insomnia were randomized to either 9-week nurse-led I-CBTI with support, or an Internet-based self-study programme without support (control group). Insomnia Severity Index (ISI) and Short Form Health Survey (SF-12) were used as primary and secondary outcomes.

Results: ISI showed a significant treatment effect of I-CBTI compared to the control group at 9-week follow-up. The mean ISI score in the I-CBTI group at 9 weeks post-treatment was maintained at the 6-month follow-up. Patients' adherence to I-CBTI was associated with a better effect on both the ISI and SF-12.

Trial registration: ClinicalTrials.gov NCT03938805.

Keywords: cardiovascular disease; cognitive behavioural therapy; insomnia; internet-based; nurse support.

Conflict of interest statement

The authors have no financial or personal conflicts to declare in regard to this study.

© 2021 The Authors. Nursing Open published by John Wiley & Sons Ltd.

Figures

FIGURE 1
FIGURE 1
Flow chart (CONSORT) of the inclusion process and study compliance
FIGURE 2
FIGURE 2
The number of active participants/module (%) and the total sum of completed assignments per module (%) in the I‐CBT group (N = 24). A maximum of 21 assignments were distributed in nine modules over 9 weeks
FIGURE 3
FIGURE 3
The adherent I‐CBTI group individual ISI score from baseline to post‐treatment. Adherent participants (N = 16) completed ≥ 5 modules in the program. Two participants (ISI baseline value 14 and 15) who were adherent to the intervention did not complete the post‐treatment (9 weeks) measurements
FIGURE 4
FIGURE 4
(a) The adherent I‐CBTI group (N = 16) SF‐12 physical component score (PCS) from baseline to follow‐up measurements (6 months). Four participants with baseline value 33, 36, 49 and 54, who were adherent to the intervention did not complete the follow‐up measurement. (b) The adherent I‐CBTI group (N = 16) SF‐12 mental component score (MCS) from baseline to follow‐up measurements (6 months). Four participants with baseline value 39, 42, 56 and 65, who were adherent to the intervention did not complete the follow‐up measurement. (c) The non‐adherent of the I‐CBTI group (N = 8) SF‐12 physical component score (PCS) from baseline to follow‐up measurements (6 months). Three participants with baseline value 38, 43 and 53, did not complete the follow‐up measurement. (d) The non‐adherent of the I‐CBTI group (N = 8) SF‐12 mental component score (MCS) from baseline to follow‐up measurements (6 months). Three participants with baseline value 27, 34 and 42 did not complete the follow‐up measurement

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