Evaluation of an online cognitive-behavioral therapy for insomnia and anxiety in older adults

Plain English summary of protocol

Background and study aims
Insomnia symptoms increase with age, affecting up to 50% of older individuals. Seniors’ vulnerability to sleep and mental health issues is further enhanced in the context of COVID-19. As sleep becomes more fragmented with age, older age may thus constitute a predisposing factor to develop sleep disturbances in the face of a precipitating factor such as the pandemic. Furthermore, social isolation in the elderly has been further exacerbated by the pandemic and constitutes a well-known risk factor for stress, insomnia, and anxiety. It is therefore critical to implement sleep and mental health interventions to address challenges faced by older adults during and after the pandemic.

Insomnia and anxiety are highly comorbid and share overlapping pathophysiological mechanisms. Untreated insomnia exacerbates psychiatric symptoms and hinders the response to standard psychiatric treatments. Cognitive-behavioral therapy for insomnia (CBTi), the first-line treatment for insomnia, involves a combination of cognitive restructuring, psychoeducation, and behavioral strategies. CBTi trials have consistently shown 70-80% response rates and better long-term efficacy than pharmacotherapy, including in older individuals. Considering the high rates of hypnotic medication use, complex polypharmacotherapy, and a marked sensitivity to adverse events in this group, CBTi is especially relevant for older adults. In addition to improving sleep, CBTi leads to sustained improvements in anxiety symptoms.

In line with the movement towards integrated mental health treatments, further therapeutic gains may be attained by combining CBTi with intervention components directly targeting psychiatric symptoms (i.e. CBTi+). Multicomponent interventions were found to be efficacious for anxiety and may result in slightly greater effects than single-disorder interventions. Multifaceted responses to complex stressors such as the current pandemic can complicate orientation towards disease-specific therapies. CBTi+ has the advantage of addressing multiple symptoms at the same time.

CBTi has been proposed as an effective approach for improving mental health at the population level. However, major barriers to accessibility result from insufficient insomnia screening in primary care settings, the lack of knowledge about CBT in the general population and healthcare providers, and the paucity of trained therapists. The need to travel for in-person visits and therapy costs further limit access in the context of social distancing and financial consequences of the outbreak. This is especially true for older individuals with COVID-19 risk factors, physical limitations, or without private health insurance.
Part of the solution may reside in the delivery of CBT+ via virtual online platforms (eCBT+) well suited for large-scale screening and intervention. A recent meta-analysis reported that online CBTi attenuates anxiety symptoms with similar effect sizes compared to its face-to-face alternative. Online platforms thus represent a cost-effective strategic alternative. This is especially relevant to the current context in which the healthcare system is overloaded, and where older individuals should limit their visits to healthcare facilities. eCBT+ may not be optimal for all cases but may be well suited as a first-line intervention that could subsequently be integrated into stepped-care models.

The aim of this pilot study is to assess the effectiveness, usability (satisfaction) as well as acceptance of an eCBT+ program to address mental health challenges in the late and post pandemic phases in older adults.

Who can participate?
Older individuals aged 65 years or older, with at least mild insomnia symptoms or at least mild symptoms of anxiety, who have reliable internet access, ability to use a smartphone, tablet, or computer.

What does the study involve?
Participants will be randomly assigned to either an immediate intervention with our eCBT+ program or a wait-list period of 2 months (followed by the eCBT+ intervention after the post-assessments). To access the eCBT+ program, participants will be invited to subscribe on the e-SPACE webpage (www.e-space.ca).

What are the possible benefits and risks of participating?
Participants may benefit from the study by experiencing fewer anxiety and insomnia symptoms and improved sleep quality as a result of the program. There is no foreseeable risk.

Where is the study run from?
Centre de Recherche de l’Institut Universitaire de Gériatrie de Montréal (CRIUGM) (Canada)

When is the study starting and how long is it expected to run for?
From March 2021 to June 2023

Who is funding the study?
Centre de Recherche de l’Institut Universitaire de Gériatrie de Montréal (CRIUGM) (Canada)

Who is the main contact?
Dr Thanh Dang-Vu, M.D., Ph.D.
TT.DangVu@concordia.ca

Contact information

Dr Thien Thanh Dang-Vu
Scientific

Centre de recherche de l'Institut universitaire de gériatrie de Montréal (CRIUGM)
4565 Chemin Queen Mary
Montreal
H2J 0B1
Canada

ORCID ID	0000-0002-7235-2721
Phone	+1 514-340-3540 Ext.3991
Email	TT.DangVu@concordia.ca

Study information

Eligibility

Locations

Countries of recruitment

• Canada

Study participating centre

Results and Publications

Study outputs

Additional files

40718_PIS_21Jun2021.pdf

Participant information sheet

Editorial Notes

16/01/2024: The intention to publish date was changed from 01/01/2024 to 01/09/2025.
14/09/2022: Total final enrolment added.
12/05/2022: The recruitment end date has been changed from 01/05/2022 to 01/09/2022.
24/01/2022: The interventions, primary/secondary outcome measures and inclusion criteria were updated.
09/12/2021: Trial’s existence confirmed by IUGM Research Ethics Committee.