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Clinical Trial
. 2023 Mar;12(5):6225-6243.
doi: 10.1002/cam4.5377. Epub 2022 Nov 20.

Internet-administered, low-intensity cognitive behavioral therapy for parents of children treated for cancer: A feasibility trial (ENGAGE)

Affiliations
Clinical Trial

Internet-administered, low-intensity cognitive behavioral therapy for parents of children treated for cancer: A feasibility trial (ENGAGE)

Ella Thiblin et al. Cancer Med. 2023 Mar.

Abstract

Background: Parents of children treated for cancer may experience mental health difficulties, such as depression and anxiety. There is a lack of evidence-based psychological interventions for parents, with psychological support needs unmet. An internet-administered, guided, low-intensity cognitive behavioral therapy-based (LICBT) self-help intervention may provide a solution.

Methods: The feasibility and acceptability of such an intervention was examined using a single-arm feasibility trial (ENGAGE). Primary objectives examined: (1) estimates of recruitment and retention rates; (2) feasibility and acceptability of data collection instruments and procedures; and (3) intervention feasibility and acceptability. Clinical outcomes were collected at baseline, post-treatment (12 weeks), and follow-up (6 months).

Results: The following progression criteria were met: sample size was exceeded within 5 months, with 11.0% enrolled of total population invited, study dropout rate was 24.0%, intervention dropout was 23.6%, missing data remained at ≤10% per measure, and no substantial negative consequences related to participation were reported. Intervention adherence was slightly lower than progression criteria (47.9%).

Conclusion: Findings suggest an internet-administered, guided, LICBT self-help intervention may represent a feasible and acceptable solution for parents of children treated for cancer. With minor study protocol and intervention modifications, progression to a pilot randomized controlled trial (RCT) and subsequent superiority RCT is warranted.

Keywords: anxiety; cancer; cognitive behavioral therapy; depression; internet-based intervention; parents.

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Conflict of interest statement

Declaration of interest: none.

Figures

FIGURE 1
FIGURE 1
Study flow of participants in the ENGAGE feasibility trial. Solid black lines denote participant flow through the study, including study drop outs i.e., those who discontinued the study. Dashed gray lines represent participants that were lost to follow‐up during assessments at post‐treatment (12 weeks) and follow‐up (6 months) respectively, but had not dropped out of the study.

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