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

29 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

35

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2V 3M3
        • Reclutamento
        • Seven Oaks General Hospital
        • Contatto:
        • Investigatore principale:
          • Clara J Bohm

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.

Altri nomi:
  • DBT

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Feasibility of DBT Skills Training Sessions for Hemodialysis Patients
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Anxiety Symptoms
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Manitoba

Collaboratori

Canadian Institutes of Health Research (CIHR)

Investigatori

  • Investigatore principale: Clara J Bohm, University of Manitoba

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

5 marzo 2026

Completamento primario (Stimato)

15 luglio 2026

Completamento dello studio (Stimato)

15 luglio 2026

Date di iscrizione allo studio

Primo inviato

29 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 maggio 2026

Primo Inserito (Effettivo)

5 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CIHR 1036060

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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