Mental HealthNCT07628309
CanSOLVE 2.0 Theme 3.1 Mind the Gap - Dialectical Behavioural Therapy (DBT) Skills Training Program Pilot
A study testing Dialectical Behavioural Therapy Skills Training in people with Mental Health and Mental Health Care, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health, Mental Health Care, Hemodialysis
- What is being tested?
- Dialectical Behavioural Therapy Skills Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- 5 Mar 2026to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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:
- Loss of control
- Lack of acceptance and/or adjustment to the situation
- Lack of trust and/or confidence in the healthcare system and providers
- Dialysis-related symptoms
- 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.
- Conditions
- Mental Health, Mental Health Care, Hemodialysis, DIALYSIS SYMPTOMS AND ANXIETY, Health Related Quality of Life
- Being tested
- Dialectical Behavioural Therapy Skills Training
- Keywords
- hemodialysis, mental health, dialysis anxiety, mental well-being
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical Behavioural Therapy Skills TrainingBehavioural
Also called DBT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Dialectical Behavioural Therapy Skills Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of DBT Skills Training Sessions for Hemodialysis Patients
Measured by:
- Recruitment: Number of individuals recruited/Number of eligible individuals approached ≥ 30%
- Attendance:
- Mean Proportion of total DBT sessions attended ≥ 50% ii. Proportion of participants who attend all DBT sessions and complete all weekly homework sheets
- Study withdrawal: i. Proportion of individuals who miss ≥ 4 DBT sessions in a row ii. Proportion of and reasons for study withdrawal
- Difference in recruitment and attendance rates between in-person and virtual DBT sessions
Measured: From enrollment to the end of the 13-week DBT sessions
Secondary outcomes (9)
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).
Measured: From enrollment to the end of the 13-week DBT sessions
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.
Measured: From enrollment to end of the 13-week DBT sessions
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).
Measured: From enrollment to the end of the 13-week DBT sessions
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.
Measured: From enrollment to the end of the 13-week DBT sessions
Well-being
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).
Measured: From enrollment to the end of the 13-week DBT sessions
DBT Skills Training Program Feedback
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.
Measured: From enrollment to the end of the 13-week DBT sessions
Anger/Frustration
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*
Measured: From enrollment to the end of the 12-week DBT sessions
Patient Pain
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*
Measured: From enrollment to the end of the 12-week DBT sessions
Sleep Quality
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*
Measured: From enrollment to the end of the 13-week DBT sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start5 Mar 2026
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Why it stopped: The study is currently suspended due to major protocol deviation that was submitted in May 2026, addressing recruitment of individuals that fell outside of the inclusion criteria. An amendment is currently being created to outline adjusted criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study uses a quasi-experimental pre-/post design.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Clara J Bohm, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07628309
- Sponsor's protocol ID
- CIHR 1036060
- Status last verified
- Jul 2026
- First submitted
- 29 May 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07628309
- Acronym / sponsor ID
- CIHR 1036060
- 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
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The study is currently suspended due to major protocol deviation that was submitted in May 2026, addressing recruitment of individuals that fell outside of the inclusion criteria. An amendment is currently being created to outline adjusted criteria.
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Loss of control
- Lack of acceptance and/or adjustment to the situation
- Lack of trust and/or confidence in the healthcare system and providers
- Dialysis-related symptoms
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study uses a quasi-experimental pre-/post design.
| Arm | Type | Receives |
|---|---|---|
| 13-Week DBT Skills Training Program | Experimental | Behavioral: Dialectical Behavioural Therapy Skills TrainingDBT 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialectical Behavioural Therapy Skills TrainingAlso: DBTWe 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. | Behavioural | 13-Week DBT Skills Training Program |
Primary outcome
Feasibility of DBT Skills Training Sessions for Hemodialysis Patients
Time frame: 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
9 secondary outcomes
Anxiety Symptoms
Time frame: From enrollment to the end of the 13-week DBT sessions
Resilience
Time frame: From enrollment to end of the 13-week DBT sessions
Dialysis-related Symptoms
Time frame: From enrollment to the end of the 13-week DBT sessions
Emotional Distress
Time frame: From enrollment to the end of the 13-week DBT sessions
Well-being
Time frame: From enrollment to the end of the 13-week DBT sessions
DBT Skills Training Program Feedback
Time frame: From enrollment to the end of the 13-week DBT sessions
Anger/Frustration
Time frame: From enrollment to the end of the 12-week DBT sessions
Patient Pain
Time frame: From enrollment to the end of the 12-week DBT sessions
Sleep Quality
Time frame: From enrollment to the end of the 13-week DBT sessions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clara J Bohm principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialectical Behavioural Therapy Skills Training in people with Mental Health and Mental Health Care, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of DBT Skills Training Sessions for Hemodialysis Patients (time frame: From enrollment to the end of the 13-week DBT sessions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026; AzTrials last refreshed its copy on 28 Oct 2026.