CanSOLVE 2.0 Theme 3.1 Mind the Gap - Dialectical Behavioural Therapy (DBT) Skills Training Program Pilot

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Manitoba

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Dialectical Behavioural Therapy Skills Training

    Behavioral

    We 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

35 Participants
are divided into 1 treatment group
Group A: 13-Week DBT Skills Training ProgramExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
From enrollment to the end of the 13-week DBT sessions

Secondary outcomes

1

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).

Time frame
From enrollment to the end of the 13-week DBT sessions
2

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.

Time frame
From enrollment to end of the 13-week DBT sessions
3

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).

Time frame
From enrollment to the end of the 13-week DBT sessions
4

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.

Time frame
From enrollment to the end of the 13-week DBT sessions

Other outcomes

Sponsors and contacts

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University of Manitoba

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator