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

NCT07628309 | Recruiting

• 1 other identifier: CIHR 1036060
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mental Health; Mental Health Care; Hemodialysis; DIALYSIS SYMPTOMS AND ANXIETY; Health Related Quality of Life

Keywords

hemodialysis; mental health; dialysis anxiety; mental well-being

Outcome Measures

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

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

Secondary Outcomes (9)

• Anxiety Symptoms

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

• Resilience

  From enrollment to end of the 13-week DBT sessions

• Dialysis-related Symptoms

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

• Emotional Distress

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

• Well-being

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

Study Arms (1)

13-Week DBT Skills Training Program

EXPERIMENTAL

DBT Skills Training weekly sessions for 13 weeks. Groups will meet for a maximum of 2 hours per week, including snack or meal and social time, with 5-11 other participants, the DBT therapist who is leading the group (will attend virtually using MS Teams) and three in -person co-facilitators (individual who has a professional healthcare degree e.g. occupational therapist, social worker, MD, nursing). In-person sessions will be held at the Seven Oaks General Hospital campus but outside of clinical areas and away from the hemodialysis unit. Virtual sessions will be held using MS Teams. Skills Training Modules will include Orientation, Mindfulness, Emotional Regulation, Distress Tolerance and Interpersonal Communications. Group participants will have weekly homework exercise to complete and bring back to the next session.

Behavioral: Dialectical Behavioural Therapy Skills Training

Interventions

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.

Also known as: DBT

13-Week DBT Skills Training Program

Eligibility Criteria

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

You may qualify if:

• 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)
• Experiencing self-reported psychological distress related to advanced kidney disease or initiation of hemodialysis
• Deemed eligible to participate by study clinical psychologist

You may not qualify if:

• Unable to complete intervention due to planned relocation/transplant/modality change
• Unable to communicate in English
• Deemed by hemodialysis unit staff/physician/study psychologist to be unable to participate fully in study activities due to:
• Actively participating in psychiatric care with psychiatric (DSM-5) diagnosis
• Requiring referral for psychiatric care as per facility-based HD care provider assessment
• Current psychotic symptoms
• Cognitive impairment that would limit ability to participate in group or complete homework
• Safety risk to staff (e.g. physical aggression)
• Antisocial personality disorder or other issues that may limit ability to constructively participate in peer group
• Severe comorbid substance use disorder (if present will offer referral to addictions resources or Addictions Psychiatry)

Sponsors & Collaborators

• University of Manitoba: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Seven Oaks General Hospital

Winnipeg, Manitoba, R2V 3M3, Canada

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Clara J Bohm

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oksana Harasemiw

CONTACT

204-632-3834; oharasemiw@sogh.mb.ca

Clara J Bohm

CONTACT

204-632-3834; cbohm@sogh.mb.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a quasi-experimental pre-/post design.

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 5, 2026
• Study Start: March 5, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)