An interventional study of Cognitive Behavioural Therapy with Mindfulness classes in Depressive Symptoms and Anxiety Symptoms, sponsored by University of Manitoba. Completed at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-02.
Sponsored by University of Manitoba · Not applicable, Interventional, and Treatment
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.
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:
8,240 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 52 is below the median of 84 across 6,869 interventional studies indexed under Depression.
Browse Depression studies →University of Manitoba is the lead sponsor of 554 studies on the registry; 88 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
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Exclusion Criteria:
Participants in class-based mental health intervention.
Behavioral: Cognitive Behavioural Therapy with Mindfulness classes
The standard CBTm protocol is comprised of four 90-minute classes offered virtually via videoconferencing once a week for four consecutive weeks. The classes cover topics including mindfulness, cognitive therapy principles, behaviour therapy principles, managing anger, assertiveness, problem solving, goal setting, and evidence-based self-help resources. They are lecture-based but also involve experiential elements, such as mindfulness activities and practice of cognitive therapy strategies. Participants are assigned daily homework between each class to practice the strategies taught in session.
Patient Health Questionnaire-9 (PHQ-9)
Self-report measure of severity of depressive symptoms to be completed prior to each intervention class. Each of the 9 items is scored 0-3 (0 = not at all; 3 = nearly every day), yielding a total between 0 and 27, with higher scores representing increased severity of depression symptoms.
Time frame: Change measure (baseline, week 2, week 3, and week 4)
Generalized Anxiety Disorder-7 (GAD-7)
Self-report measure of severity of generalized anxiety symptoms to be completed prior to each intervention class. Each of the 7 items is scored 0-3 (0 = not at all; 3 = nearly every day), yielding a total between 0 and 21, with higher scores representing increased severity of generalized anxiety symptoms.
Time frame: Change measure (baseline, week 2, week 3, and week 4)
Acceptability Survey
Self-report measure of the acceptability of different elements of the intervention to be completed prior to the first and fourth classes.
Time frame: Change measure (baseline and week 4)
Class Evaluation Form
Self-report measure of the acceptability of different elements of the intervention to be completed prior to the first and fourth intervention classes.
Time frame: Data collected weekly throughout the four weeks of study enrolment
Clinical Global Impression scale (CGI)
Self-report measure of improvement in symptoms to be completed prior to intervention classes 2, 3 and 4. The single item is scored 1-7 (1 = very much improved; 7 = very much worse), yielding a total between 1 and 7, with higher scores representing a worsening of symptoms.
Time frame: Change measure (baseline at week 2, week 3, and week 4)
Cognitive Behaviour Therapy Skills Questionnaire (CBTSQ)
Self-report measure of the extent of participants' learning and implementation of cognitive and behavioural coping skills to be completed prior to each intervention class. Each of the 16 items is scored 1-5 (1 = I don't do this; 5 = I always do this). The measure is comprised of two subscales, (1) Behavioural Activation (7 questions) and (2) Cognitive Restructuring (9 questions); item scores are summed to yield subscale scores, with higher scores indicating increased implementation of the respective subscale skills. The two subscales can be summed to create a total score, yielding a total between 16 and 80, with higher scores representing increased implementation of both sets of skills.
Time frame: Change measure (baseline, week 2, week 3, and week 4)
Treatment Acceptability/Adherence Scale (TAAS)
Self-report measure related to perceptions of the therapy and participants' ability to engage in the skills taught during the class to be completed prior to intervention classes 2, 3, and 4. Each of the 10 items is scored from 1-7 (1 = disagree strongly; 7 = agree strongly), yielding a total between 10 and 70, with higher scores representing positive perceptions of treatment acceptability and adherence.
Time frame: Change measure (baseline, week 2, week 3, and week 4)
Homework Record
Self-report measure of homework completion and skills practice to be completed prior to intervention classes 2, 3 and 4.
Time frame: Data collected weekly throughout the four weeks of study enrolment
Plan to share: No
Ran from Jan 2021 to primary completion in May 2021, 4 months.
Of 3,016 non-industry interventional studies with no phase under Depression, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 4 months is below that.
Counting every sponsor, half of 3,112 studies reached it within 22 months; a quarter within 10 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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