About this trial
The goal of this pilot implementation study is to implement and evaluate a 13-week dialectical behavioural therapy (DBT) skills training program to address challenges to mental health and mental wellbeing in people who have recently started facility-based hemodialysis or those who may start within the next 6-12 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years old
Individuals followed in the Manitoba Kidney Health Program at Seven Oaks General Hospital or Health Sciences Centre sites with advanced chronic kidney disease not yet on facility-based hemodialysis but with plans to start within 1 month; OR
Individuals followed in the Manitoba Kidney Health Program at the SOGH or HSC sites who have initiated facility-based hemodialysis within the last 90 days
Able and willing to attend weekly DBT sessions (either virtually or in-person)
Disqualifiers
Unable to complete intervention due to planned relocation/transplant/modality change
Unable to communicate in English
Actively participating in psychiatric care with psychiatric (DSM-5) diagnosis
Requiring referral for psychiatric care as per facility-based HD care provider assessment
Trial design
Single group
Treatments tested in this trial
Dialectical Behavioural Therapy Skills Training
BehavioralWe will use a quasi-experimental pre/post study design to pilot two 13-week group DBT sessions in Manitoba that will be led by a licensed clinical psychologist who is trained and certified in delivery of DBT Skills Training. Additional staff (e.g. Licensed Kidney Health Manitoba Social Worker at Seven Oaks General Hospital and/or a clinical psychology practicum student supervised by the licensed psychologist) may also co-facilitate the group depending on timing and human resources availability. An initial DBT Skills training group will meet in person at Seven Oaks General Hospital weekly for 13 weeks (including initial orientation session). Following completion of and incorporating feedback from the first session, a second virtual 13-week DBT skills training group session will be implemented. Modules included in this training will be orientation, Mndfulness, Distress Tolerance, Emotional Regulation, Interpersonal Communication.
Treatment groups
Trial outcomes
Primary outcomes
Feasibility of DBT Skills Training Sessions for Hemodialysis Patients
Measured by: 1. Recruitment: Number of individuals recruited/Number of eligible individuals approached ≥ 30% 2. Attendance: i. Mean Proportion of total DBT sessions attended ≥ 50% ii. Proportion of participants who attend all DBT sessions and complete all weekly homework sheets c. Study withdrawal: i. Proportion of individuals who miss ≥ 4 DBT sessions in a row ii. Proportion of and reasons for study withdrawal d. Difference in recruitment and attendance rates between in-person and virtual DBT sessions
Secondary outcomes
Anxiety Symptoms
Measured by the LEVEL 2 - Anxiety - Adult (PROMIS Emotional Distress - Anxiety - Short Form). This 7-item self-reported survey asks about the current severity/presence of the individual's anxiety over the past 7 days, using a 5-point Likert scale ranging from 1 (never) to 5 (always).
Resilience
Measured using the two-item version of the Connor-Davidson Resilience Scale. This 2-item self-reported survey asks the individual to respond to the following statements: "I am able to adapt when changes occur" and "I tend to bounce back after illness, injury, or other hardships" using a 5-point Likert scale ranging from 0 (not true at all) to 4 (true nearly all of the time). Validated in multiple populations.
Dialysis-related Symptoms
Using the Edmonton Symptom Assessment System Revised (ESAS-r). This 10-item self-reported survey asks about the current severity/presence of common symptoms experienced by people receiving hemodialysis over the past 7 days, using an 11-point Likert scale ranging from 0 to 10 (i.e.; for pain: 0 = no pain at all; 10 = worst pain possible).
Emotional Distress
Using the self-reported National Comprehensive Cancer Network (NCCN) Distress Thermometer. This single-item measure asks the individual about their distress level experienced in the past 7 days, using a 10-point Likert scale ranging from 0 (no distress) to 10 (extreme distress). Additionally, there is a 39-item problem list used to identify potential sources of distress in individuals, categorized into five domains: physical, practical, social, emotional, and spiritual/religious.
Sponsors and contacts
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University of Manitoba
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator