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

29 maja 2026 zaktualizowane przez: University of Manitoba

CanSOLVE 2.0 Theme 3.1 Mind the Gap: Addressing Mental Health Care Gaps for Canadians Receiving Facility-Based Hemodialysis - Dialectical Behavioural Therapy (DBT) Skills Training Program Pilot Intervention

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

BACKGROUND:

Mental health "Mental health" refers to the state of one's psychological and emotional well-being. It's about one's feelings and thoughts, whether they are experiencing positive emotions, such as happiness and contentment, or facing challenges like stress, sadness, or anxiety. This is not the same as mental illness, but poor mental health can lead to physical and mental illness.

People with chronic kidney disease face a significant burden on their mental health and although recognized as a serious issue, an approach to addressing mental health care for people with kidney disease and kidney failure is lacking. New models are needed to meet the mental health needs of people with kidney disease in Canada.

In earlier stages of the Mind the Gap project, we identified that the top 5 challenges to mental health in people receiving hemodialysis were:

  1. Loss of control
  2. Lack of acceptance and/or adjustment to the situation
  3. Lack of trust and/or confidence in the healthcare system and providers
  4. Dialysis-related symptoms
  5. Feeling overwhelmed

Possible solutions identified to the above mental health challenges included counselling/therapy and peer support. Dialectical Behavioural Therapy (DBT) is a form of counselling that focuses on learning ways to change unhelpful thoughts and behaviours and teaches skills for interpersonal relationships. Group DBT could help address most of the priority challenges to mental health listed above and provides an opportunity for peer support.

DIALECTICAL BEHAVIOURAL THERAPY (DBT) Skills Training:

Based on data gathered through the Mind the Gap surveys and the Priority Setting Workshop, we have identified the top 5 challenges to mental well-being in facility-based hemodialysis as: loss of control, lack of acceptance and/or adjustment to the situation, lack of trust and confidence in the healthcare system and providers, dialysis-related symptoms, and feeling overwhelmed. After discussions with various stakeholders, we reached consensus that implementation of a Dialectical Behavioural Therapy (DBT) skills training program, which targets 4 key concepts: mindfulness, distress tolerance, emotional regulation, and interpersonal effectiveness, has potential to address most of these five challenges. DBT skills training has been used in many different settings (treatment of borderline personality disorder, substance abuse, improving self-esteem in adolescents, improving corporate culture) and populations, but to our knowledge has not been studied in the hemodialysis population.

We will pilot two 13-week group DBT skills training program sessions in Manitoba that will be led by a licensed clinical psychologist who is trained and certified in delivery of DBT. Additional staff (e.g. Licensed Kidney Health Manitoba Social Workers and Occupational Therapists) will co-facilitate the group. An initial DBT skills training group will meet in person at SOGH weekly for 13 weeks. Following completion of and incorporating feedback from the first session, we will consider implementing a second virtual 13-week DBT group session.

STUDY PROCEDURES:

Both in-person and virtual DBT group participants will complete 8 short questionnaires regarding their mental health before the program starts at 6 weeks into the program, and after the DBT program ends (12 weeks). These questionnaires ask questions about your wellbeing, distress tolerance, anxiety, ability to cope, resilience, sleep, pain, anger and will take approximately 20-30 minutes to complete at each study assessment time point. Participants will also complete an end of study questionnaire (10-15 minutes to complete) to gather their perspectives on their experience in the DBT program. Both in-person and virtual DBT group participants will be provided with weekly session reminders and the relevant program materials by the research coordinator. This will include electronic or hardcopies of worksheets and handouts accompanying each week's content and videos that will be delivered by mail/email/drop off in HD unit as per your preference. The group leader or co-leader may also check in with all participants throughout the 13-week program periodically in an individual meeting.

The total time commitment (in sessions and home assignments) for this DBT program study will be approximately 36-39 hours:

Questionnaires will take approximately 1.5-2 hours in total over the 3 study assessment time points (pre-, 6-week, 12-week, post-intervention).

The DBT program content will be 25 hours of commitment (around 2 hours/week + orientation).

Home assignments and program material will take the additional 9-12 hours over the 12-week program.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

35

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Kanada
    • Manitoba
      • Winnipeg, Manitoba, Kanada, R2V 3M3
        • Rekrutacyjny
        • Seven Oaks General Hospital
        • Kontakt:
        • Główny śledczy:
          • Clara J Bohm

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 13-Week DBT Skills Training Program

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.
Behawioralne: Dialectical Behavioural Therapy Skills Training

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.

Inne nazwy:
  • DBT

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Feasibility of DBT Skills Training Sessions for Hemodialysis Patients
Ramy czasowe: From enrollment to the end of the 13-week DBT sessions

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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Anxiety Symptoms
Ramy czasowe: From enrollment to the end of the 13-week DBT sessions
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).
From enrollment to the end of the 13-week DBT sessions
Resilience
Ramy czasowe: From enrollment to end of the 13-week DBT sessions
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.
From enrollment to end of the 13-week DBT sessions
Dialysis-related Symptoms
Ramy czasowe: From enrollment to the end of the 13-week DBT sessions
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).
From enrollment to the end of the 13-week DBT sessions
Emotional Distress
Ramy czasowe: From enrollment to the end of the 13-week DBT sessions
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.
From enrollment to the end of the 13-week DBT sessions
Well-being
Ramy czasowe: From enrollment to the end of the 13-week DBT sessions
Using the PROMIS Neuro-QOL V1.0 Positive Affect and Well-Being Short Form. This 9-item self-reported survey measures positive aspects of mental health and well-being in the past week, using a 5-point Likert scale ranging from 1 (never) to 5 (always).
From enrollment to the end of the 13-week DBT sessions
DBT Skills Training Program Feedback
Ramy czasowe: From enrollment to the end of the 13-week DBT sessions
The initial version of this 10-item self-reported questionnaire investigating perspectives on participant experiences in the DBT groups will be piloted by study patient partners to ensure readability and face validity and modified accordingly. The survey includes questions that require yes/no and open text answers to provide participants with ample opportunity to provide and explain feedback regarding the DBT program. We will use perspectives shared through this questionnaire to modify the plans for the virtual DBT session and future in-person DBT groups.
From enrollment to the end of the 13-week DBT sessions
Anger/Frustration
Ramy czasowe: From enrollment to the end of the 12-week DBT sessions

Measured using the LEVEL 2 - Anger - Adult (PROMIS Emotional Distress - Anger - Short Form). This 5-item self-reported survey measures the pure domain of anger over the past 7 days, using a 5-point Likert scale ranging from 1 (never) to 5 (always).

*only individuals who endorse difficulty with the described item will be asked to complete the questionnaire*
From enrollment to the end of the 12-week DBT sessions
Patient Pain
Ramy czasowe: From enrollment to the end of the 12-week DBT sessions

Using the PROMIS V1.1 - Pain Interference 6a Short Form. This 6-item self-reported survey measures the severity of pain and its impact on a person's ability to function over the past 7 days, using a 5-point Likert scale ranging from 5 (never) to 1 (always).

*only individuals who endorse difficulty with the described item will be asked to complete the questionnaire*
From enrollment to the end of the 12-week DBT sessions
Sleep Quality
Ramy czasowe: From enrollment to the end of the 13-week DBT sessions

Using the LEVEL 2 - Sleep Disturbance - Adult (PROMIS Sleep Disturbance - Short Form). This 7-item self-reported survey measures sleep quality, sleep depth, and restoration, including difficulties with falling asleep or staying asleep and satisfaction with sleep over the past 7 days, using a 5-point Likert scale ranging from 1 (not at all) to 5 (very much).

*only individuals who endorse difficulty with the described item will be asked to complete the questionnaire*
From enrollment to the end of the 13-week DBT sessions

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Manitoba

Współpracownicy

Canadian Institutes of Health Research (CIHR)

Śledczy

  • Główny śledczy: Clara J Bohm, University of Manitoba

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

5 marca 2026

Zakończenie podstawowe (Szacowany)

15 lipca 2026

Ukończenie studiów (Szacowany)

15 lipca 2026

Daty rejestracji na studia

Pierwszy przesłany

29 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 maja 2026

Pierwszy wysłany (Rzeczywisty)

5 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

5 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CIHR 1036060

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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