Clinical trial NCT04105790: The Acceptability and Effectiveness of Stepped Care Psychoeducation Classes in Rural Manitoba
Official title: The Acceptability and Effectiveness of Stepped Care Psychoeducation Classes in Rural Manitoba
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Anxiety Symptoms
Keywords: Stepped Model of Care
Class-Based Intervention
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The overarching design of the proposed study is a formative program evaluation using a case series methodology.
Primary purpose: TREATMENT

Brief summary: This study will examine the acceptability and effectiveness of using a stepped care treatment model, and specifically, the CBTm classes, in a rural population. The introduction of CBTm classes, developed in Winnipeg and used in outpatient mental health clinics there, is new to Adult Community Mental Health in the Prairie Mountain Health region. This research is being done to explore whether this is a treatment model that is effective at reducing symptoms of anxiety and depression and also whether it affects the workload for Community Mental Health Workers in a more rural area. Further, this research is being done to explore whether clients perceive this form of services to be useful and acceptable.

Detailed description: This study will evaluate the acceptability and effectiveness of class-based psychoeducation as the first step of a stepped care model in a community mental health program. In April of 2019, the Prairie Mountain Health (PMH) Adult Community Mental Health programs (both Northern and Southern regions) instituted a change to their existing service model. Previously, all individuals who sought access to public mental health services underwent an intake interview and were subsequently assigned a community mental health worker (CMHW) with whom they met for individual counselling. Due to the ever-increasing demand for services, CMHWs were required to manage large caseloads which resulted in extended periods between counselling appointments and strain on care providers. In an effort to introduce a stepped-care framework to mitigate workload, the Adult Community Mental Health programs in PMH North and South began to offer psychology-led psychoeducation classes as a step below individual counselling. Specifically, the Cognitive Behavioural Therapy with Mindfulness (CBTm) classes, developed at the University of Manitoba by Sareen, Sala, Wong, Whitney, and Kinley (2016), were delivered. This program is comprised of four 90-minute sessions that deliver information about basic cognitive and behavioural therapy principles and effective self-help resources. It was developed to offer services to clients on the waitlist for outpatient mental health services in Winnipeg and preliminary research on this program has demonstrated that it is an acceptable form of treatment and effectively reduces symptoms of anxiety and depression (with a small to medium effect).

As the change in the service delivery model and the introduction of large psychoeducation classes in PMH's Adult Community Mental Health programs is novel, evaluation of this change is warranted. This study will examine foundational program variables including retention, acceptability, and effectiveness (see Thakur, Bolton, \& Sareen, 2018). Assessing these factors will provide critical information about the potential for further development of a stepped care model, including the CBTm program, in this rural health region and afford the opportunity to compare outcome measures in a rural setting to those from an urban centre (data published by Thakur et al., 2018). In order to further increase access to services, the program was also intended to be delivered to remote rural sites via telehealth; exploration of the acceptability and efficacy of telehealth use in service delivery also merits assessment. However, at the start of the COVID-19 pandemic, in-person and MBTelehealth CBTm classes were suspended to abide by provincial physical distancing guidelines. Moving forward, the CBTm classes will be offered via MS Teams, a virtual videoconferencing platform for all attendees, allowing individuals to participate via videoconference or telephone from their preferred location within Manitoba.

The research questions and hypotheses are as follows:

1. Is the implementation of CBTm as the first step in a stepped model acceptable to rural clients? The investigators hypothesize that class-based clinical service will be acceptable to rural clients as it will increase their access to valuable mental health services in their region; this will be demonstrated in a high rate of retention and positive feedback from participants.
2. How are issues unique to rural settings, such as concerns about confidentiality and virtual delivery of programming, in a class-based setting viewed by rural clients? The investigators anticipate initial concerns about confidentiality and virtual service delivery related to the nature of the rural setting.
3. Are class-based clinical services (i.e., CBTm) effective for reducing symptoms of depression and anxiety for participants living in rural areas? Consistent with previous research, the investigators anticipate a small to medium effect size in the decrease of symptoms of depression and anxiety and increased incorporation of cognitive behavioural strategies into daily life.

Eligibility criteria: Inclusion Criteria:

* Adult clients (18+ years) accessing community mental health services for symptoms of depression and anxiety, and
* Interest in attending Cognitive Behaviour Therapy with Mindfulness classes.

Exclusion Criteria:

* Active psychosis or mania,
* Acutely elevated suicide risk,
* Severe cognitive impairment, and/or
* Non-English speaking.

Primary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Change measure (baseline, week 2, week 3, and week 4)
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Change measure (baseline, week 2, week 3, and week 4)
measure: Acceptability Survey
timeFrame: Change measure (baseline and week 4)
measure: Class Evaluation Form
timeFrame: Data collected weekly throughout the four weeks of study enrolment
Secondary outcomes:
measure: Clinical Global Impression scale (CGI)
timeFrame: Change measure (baseline at week 2, week 3, and week 4)
measure: Cognitive Behaviour Therapy Skills Questionnaire (CBTSQ)
timeFrame: Change measure (baseline, week 2, week 3, and week 4)
measure: Treatment Acceptability/Adherence Scale (TAAS)
timeFrame: Change measure (baseline, week 2, week 3, and week 4)
measure: Homework Record
timeFrame: Data collected weekly throughout the four weeks of study enrolment
Other outcomes:
Locations:
city: Brandon
country: Canada
facility: Prairie Mountain Health South - Adult Community Mental Health
state: Manitoba
city: Dauphin
country: Canada
facility: Prairie Mountain Health North - Community Mental Health
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Pamela Black, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sareen, J., Sala, T., Wong, J., Whitney, D., & Kinley, J. (2016). CBTm facilitator training manual. Retrieved from http://cbtm.ca/wp-content/uploads/2017/08/Facilitators_binder.pdf
citation: Thakur VK, Wong JY, Randall JR, Bolton JM, Parikh SV, Mota N, Whitney D, Palay J, Kinley J, Diocee S, Sala T, Sareen J. An evaluation of large group cognitive behaviour therapy with mindfulness (CBTm) classes. BMC Psychiatry. 2019 May 3;19(1):132. doi: 10.1186/s12888-019-2124-5.
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
citation: Jacob KL, Christopher MS, Neuhaus EC. Development and validation of the cognitive-behavioral therapy skills questionnaire. Behav Modif. 2011 Nov;35(6):595-618. doi: 10.1177/0145445511419254. Epub 2011 Sep 5.
citation: Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
citation: Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
citation: Milosevic I, Levy HC, Alcolado GM, Radomsky AS. The Treatment Acceptability/Adherence Scale: Moving Beyond the Assessment of Treatment Effectiveness. Cogn Behav Ther. 2015;44(6):456-69. doi: 10.1080/16506073.2015.1053407. Epub 2015 Jun 19.