A tailored Internet-delivered modular intervention based on cognitive behavioral therapy for depressed older adults: a study protocol for a randomized controlled trial

BACKGROUND: Depression is most common among the elderly and is associated with major impairment. With limited accessible treatments available, remotely provided interventions are needed. Internet-based interventions have been proven effective for a number of mental and somatic health problems. However, the elderly population has received relatively limited attention in previous studies. This study aims to address this gap by investigating the effectiveness of a tailored Internet-delivered modular intervention based on cognitive behavioral therapy (CBT). METHODS: A minimum of 60 participants will be recruited and randomly assigned to groups in a two-armed parallel controlled trial with a waiting list. The intervention group will have access to an 8-week therapist-supported modular intervention. The waiting list group will be instructed to wait for 8 weeks and then granted access to the intervention for 8 weeks. Pre, post, and 3-, 12-, and 24-month follow-up assessments are planned for measuring changes in depression symptoms, anxiety symptoms, and psychological well-being using PHQ-9, GDS, GAD-7, and WHO-5. Primary outcomes of all the participants will be analyzed using the intention-to-treat principle, and within- and between-group effect sizes will be calculated. DISCUSSION: Internet-based interventions could help address the existing treatment gap for depressed older adults. However, to date, the effectiveness of Internet-based CBT (ICBT) for depressed older adults has only been tested in a few studies. This trial will demonstrate if Internet-based CBT is effective for this population when compared to a waiting list control. Further analysis of secondary outcomes and participant behavior in the intervention will potentially reveal effectiveness moderating factors. TRIAL REGISTRATION: ClinicalTrials.gov NCT04728204. Registered on 15 January 2021. https://www.clinicaltrials.gov/ct2/show/NCT04728204?term=NCT04728204&draw=2&rank=1