The Acceptability and Effectiveness of Stepped Care Psychoeducation Classes in Rural Manitoba

NCT04105790 | Completed

• 1 other identifier: H2019:311
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

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.

Conditions

Depressive Symptoms; Anxiety Symptoms

Keywords

Stepped Model of Care; Class-Based Intervention

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Data collected weekly throughout the four weeks of study enrolment

Secondary Outcomes (4)

• Clinical Global Impression scale (CGI)

  Change measure (baseline at week 2, week 3, and week 4)

• Cognitive Behaviour Therapy Skills Questionnaire (CBTSQ)

  Change measure (baseline, week 2, week 3, and week 4)

• Treatment Acceptability/Adherence Scale (TAAS)

  Change measure (baseline, week 2, week 3, and week 4)

• Homework Record

  Data collected weekly throughout the four weeks of study enrolment

Study Arms (1)

Participants

EXPERIMENTAL

Participants in class-based mental health intervention.

Behavioral: Cognitive Behavioural Therapy with Mindfulness classes

Interventions

Cognitive Behavioural Therapy with Mindfulness classes BEHAVIORAL

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.

Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (2)

Prairie Mountain Health South - Adult Community Mental Health

Brandon, Manitoba, R7A 6N5, Canada

Location

Prairie Mountain Health North - Community Mental Health

Dauphin, Manitoba, R7N 1R7, Canada

Location

Related Publications (7)

• 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

  BACKGROUND

• 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.

  PMID: 31053070 BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

• 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.

  PMID: 21893554 BACKGROUND

• Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.

  PMID: 20526405 BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

• 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.

  PMID: 26091250 BACKGROUND

Related Links

• Website for Cognitive Behavioural Therapy with Mindfulness classes

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Pamela Black, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The overarching design of the proposed study is a formative program evaluation using a case series methodology.

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 26, 2019
• Study Start: January 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: June 2, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)