Clinical trial NCT06178328: Observations of a Brief Online Psychological Intervention Among People Seeking Online Mental Health Services
Official title: 'Things You Do': An Observational Pilot Trial of a Brief Psychological Intervention Among People Seeking Online Mental Health Services
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Depression, Anxiety
Keywords: internet-delivered cognitive behaviour therapy
brief intervention
Lead sponsor: University of Regina
Sponsor class: OTHER
First posted: 2023-12-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This observational pilot trial explores aspects of the TYD course within an online routine care setting, a first-of-its-kind in Canada. Prospective participants will self-refer after learning about the course from advertisements, information on the Online Therapy Unit website, or from healthcare providers, community organizations, or others.

Brief summary: Since 2012, the Online Therapy Unit has been offering Internet-delivered cognitive behaviour therapy (ICBT). ICBT represents a convenient method for individuals to access care for depression and anxiety. In ICBT, clients receive access to standardized lessons that provide the same information and skills as traditional face-to-face CBT. ICBT courses often span 6-12 weeks. There is now growing evidence that clients with symptoms of depression and anxiety can benefit from a single session brief intervention that offers practical strategies for improving mental health, but the investigators are uncertain about the interest in such a lesson among those seeking online mental health care. The Things You Do Course, therefore, is designed to provide clients with 5 key actions that clients can take to improve their emotional wellbeing.

In this study, the Online Therapy Unit (OTU) is examining how effective the Things You Do Course is in helping clients manage their symptoms of depression and anxiety and improve their emotional wellbeing. The OTU is also exploring the extent to which clients are satisfied with the course, and what factors contribute to improvements in symptoms, as measured by a number of questionnaires. The research will ultimately be used to improve how the OTU will deliver ICBT and to inform whether to include the single session course within existing online mental health service options.

Detailed description: A scarcity of mental health care practitioners across Canada has resulted in extensive wait times. This issue is compounded by the significant cost associated with accessing psychological services, lack of awareness about service availability, and the constraints of time that hinder using long-term (multi-session) psychological therapies. These challenges are frequently cited as barriers to the access and utilization of psychological services in Canada. Unfortunately, this situation leaves many Canadians grappling with physical and mental disabilities, economic productivity losses, and facing an elevated risk of suicide due to unmet mental health care needs. Thus, there is a need for efficient and sustainable service delivery models that enable quick access to treatment for mental health concerns.

There is substantial evidence for the use of internet-delivered cognitive behaviour therapy (ICBT) as an alternative to face-to-face cognitive behaviour therapy (CBT) for the treatment of common mental health concerns such as anxiety and depression. The duration of ICBT courses varies, but most involve several lessons spanning 6-12 weeks. Offering brief, low-intensity supports may help alleviate barriers related to treatment seekers' time constraints.In face-to-face services, there is growing evidence that clients with symptoms of depression and anxiety can benefit from a single session intervention, but there is limited research on the use of single session interventions in ICBT, particularly within Canada.

Preliminary findings from the eCentre Clinic in Australia on a single lesson intervention (i.e., the 'Things You Do' course; TYD) are promising. The TYD is a single online lesson that provides psychoeducation about factors that contribute to mental health, as well as 5 target areas that clients can focus on to improve their mental health: realistic thinking, meaningful activities, goal setting, healthy routines, and social connections. Clients who completed the TYD reported significant improvements in depression and anxiety from pre- to post-treatment, with changes maintained at 12-week follow-up.

Given these promising preliminary findings, investigators propose to implement and evaluate the acceptability and short-term effects of a single-session intervention, the 'Things You Do' (TYD), in a Canadian context. The TYD is focused on everyday behaviours and actions that most people can choose to do, that is, it comprises modifiable behaviours which most people would recognize as important for mental health. It therefore has the potential to serve as a scalable, self-guided mental health intervention.

The following research questions will be evaluated:

1. What will be the uptake of the TYD course relative to other online mental health courses in the Online Therapy Unit?
2. What are the baseline demographic and clinical (e.g., severity levels of anxiety and depression symptoms) characteristics of individuals who sign up for the TYD?
3. How acceptable is the TYD in a Canadian context, as assessed via participants' ratings and feedback on likes and dislikes about the course content and process?
4. Will participating in TYD result in a clinically significant reduction in symptoms related to anxiety and depression and improvements in other measures administered?
5. What baseline demographic and clinical characteristics are related to outcomes post-treatment?
6. What percentage of TYD participants express interest in seeking out and enrolling in other online services offered by the Online Therapy Unit and how many individuals from other online services offered by the Online Therapy Unit subsequently enroll in TYD?

The study will begin with a pilot trial to examine research question 4. The intention is to collect more information if feasible to answer the other research questions related to uptake of the course, exploration of demographic and clinical characteristics of those who take the course, acceptability of the course and feedback on the course, relationship of demographic and clinical characteristics to outcomes and subsequent use of other services after taking the TYD course.

Eligibility criteria: Inclusion Criteria:

* Canadian resident;
* Aged 18 years or older;
* Seeking services for mental health concerns

Exclusion Criteria:

* Living outside of Canada
* Unable to read and understand English

Primary outcomes:
measure: The Things You Do Questionnaire - 21 item (TYD-Q)
timeFrame: Pre-treatment, 2 weeks (mid-treatment), 4 weeks (post-treatment), and 17 weeks (follow-up)
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Pre-treatment, 2 weeks (mid-treatment), 4 weeks (post-treatment), and 17 weeks (follow-up)
measure: Generalized Anxiety Disorder 7-Item (GAD-7)
timeFrame: Pre-treatment, 2 weeks (mid-treatment), 4 weeks (post-treatment), and 17 weeks (follow-up)
Secondary outcomes:
measure: Days out of role - 1 item
timeFrame: Pre-treatment, 4 weeks (post-treatment), and 17 weeks (follow-up)
measure: Satisfaction with life scale (SWLS)
timeFrame: Pre-treatment, 4 weeks (post-treatment), and 17 weeks (follow-up)
measure: Feedback questions
timeFrame: 4 weeks (post-treatment)
Other outcomes:
Locations:
city: Regina
country: Canada
facility: Online Therapy Unit- University of Regina
state: Saskatchewan
Study officials:
affiliation: University of Regina
name: Heather Hadjistavropoulos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Khattar J, Griffith LE, Jones A, De Rubeis V, de Groh M, Jiang Y, Basta NE, Kirkland S, Wolfson C, Raina P, Anderson LN; Canadian Longitudinal Study on Aging (CLSA) Team. Symptoms of depression and anxiety, and unmet healthcare needs in adults during the COVID-19 pandemic: a cross-sectional study from the Canadian Longitudinal Study on Aging. BMC Public Health. 2022 Dec 1;22(1):2242. doi: 10.1186/s12889-022-14633-4.
citation: Statistics Canada. Health Fact Sheets: Mental Health Care Needs, 2018; Catalogue No. 82-625-X; Statistics Canada: Ottawa, ON, Canada, 2019; Available online: https://www150.statcan.gc.ca/n1/en/pub/82-625-x/2019001/article/00011-eng.pdf (accessed on 10 August 2022)