Suicidal IdeationNCT05045677
Digital Dialectical Behavioral Therapy (d-DBT) Skills for Acute Suicidality in Psychiatric Inpatients
A study testing digital DBT skills intervention in people with Suicidal Ideation, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
Suicidality (ideation about taking one's life, suicide plans, and attempts) is a major public health concern in Ontario and worldwide. Psychiatric inpatients with suicidality represent a group that is high-risk for subsequent suicide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- digital DBT skills intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2022to 1 Nov 2022
- 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
- patients with any DSM-5 diagnosis aged 18 years and above;
- admitted to CAMH with suicidality and a baseline BSI score of > 6;
- capable and willing to give informed consent;
- anticipated length of admission is greater than 5 days;
- deemed suitable by the primary team to take part in a psychotherapeutic intervention as part of standard care
- Capacity to consent will be evaluated by the research staff performing the informed consent process. It will be assessed as the participant's ability to understand and appreciate the risks and benefits of taking part in the proposed study.
Who cannot join
- presence of psychiatric symptoms that interfere with the ability to complete the d-DBT
- Concurrent treatment with ECT or MST
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital Dialectical Behavioral Therapy (d-DBT) Skills for Treatment of Acute Suicidality in Psychiatric Inpatients: Randomized Feasibility Trial
Suicidality (ideation about taking one's life, suicide plans, and attempts) is a major public health concern in Ontario and worldwide. Psychiatric inpatients with suicidality represent a group that is high-risk for subsequent suicide. Current standard-care for suicidal psychiatric inpatients focuses on containment of risk and indirect treatment of suicidality by treating any underlying mental disorder. Though there is evidence that addressing suicidality directly is more effective than an indirect approach, there are limited evidence based treatments that target suicidality. Furthermore, there are few high-quality studies that have included inpatients. Psychotherapeutic interventions are under-utilized for inpatients and COVID-19 has further widened this gap given attempts by hospitals to reduce face-to-face contact with patients. Digital psychotherapy interventions have the ability to bridge this gap given their lower cost, ease of dissemination, acceptability by patients, and effectiveness. To our knowledge, there are no studies that have assessed the feasibility, acceptability and effectiveness of digital interventions for suicidal inpatients. Our study is a feasibility trial of a previously studied digital Dialectical Behavioural Therapy (d-DBT) skills intervention in suicidal psychiatric inpatients.
The study is a two arm randomized parallel group-controlled trial, 6-10 day, flexible timeline, randomized feasibility trial of a d-DBT skills intervention added to standard care for patients admitted to psychiatric inpatient units with suicidality. There will be 20 patients who will receive the intervention in addition to standard care and 20 patients who will receive standard care alone. There will also be a 4 week follow-up after discharge from hospital.
Participants will be admitted for psychiatric care at the Complex and Critical Care Units, Centre for Addiction and Mental Health (CAMH), Toronto.
- Conditions
- Suicidal Ideation
- Being tested
- digital DBT skills intervention, Standard Care
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital DBT skills interventionOther
The digital intervention consists of 6 modules that will be delivered over 6 to 10 days. The modules cover mindfulness skills, emotion regulation skills and distress tolerance skills.
Standard CareOther
Standard inpatient care includes a multi-disciplinary team approach including daily psychiatric review, medication management and in-person psychosocial interventions (social work, nursing).
| Study group | Role | What they receive |
|---|---|---|
| Digital DBT intervention group | Experimental | Digital intervention group plus standard care Receives: Other: digital DBT skills intervention; Other: Standard Care |
| Standard care | Active comparator | Standard care alone Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment and retention rates
Feasibility - whether the intervention is possible in the acute inpatient setting
Measured: 6-10 days
Client Satisfaction Questionnaire 8 (CSQ-8)
Acceptability - whether the intervention is appropriate for the acute inpatient setting. The CSQ-8 scores range from 8 to 32, with higher values indicating higher satisfaction with the intervention.
Measured: 6-10 days
User Experience Questionnaire (UXQ)
Usability - whether the intervention is serviceable for its intended purpose. The UXQ has 11 items exploring characteristics informing usability of mobile apps, each scored from 0-10, for a total score ranging from 10-110 (with larger scores indicating increased usability).
Measured: 6-10 days
Secondary outcomes (4)
Columbia-Suicide Severity Rating Scale (C-SSRS)
Preliminary efficacy - whether symptoms of suicidal ideation are reduced by the intervention. The sum ranges from 2 to 25, with the higher number indicating more intense ideation.
Measured: 5-10 days in addition to discharge and 4 weeks post-discharge
Clinical Global Impression (CGI)
Preliminary efficacy - whether CGI change during the clinical trial. The CGI asks the clinician to rank the current severity of illness and global improvement. Scores range form 1 to 7 with a higher score corresponding to more severe illness
Measured: 5-10 days in addition to discharge and 4 weeks post-discharge
Brief Difficulties in Emotion Regulation Scale (DERS-16)
Preliminary efficacy - whether symptoms of emotion regulation change during the trial. Total scores on the DERS-16 can range from 16 to 80, with higher scores reflecting greater levels of emotion dysregulation
Measured: 5-10 days in addition to discharge and 4 weeks post-discharge
Kessler psychological distress scale (K10)
Preliminary efficacy - whether symptoms of distress are improved by the intervention. Scores range from 10 to 50, with increasing scores indicating increasing distress and severity of symptoms.
Measured: 5-10 days in addition to discharge and 4 weeks post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Apr 2022
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Sponsor
- Investigators
- Ishrat Husain, MD (Res), Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045677
- Sponsor's protocol ID
- 047-2021
- Status last verified
- Sep 2023
- First submitted
- 9 Aug 2021
- Last updated
- 14 Sep 2023
- 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 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Dialectical Behavioral Therapy (d-DBT) Skills for Treatment of Acute Suicidality in Psychiatric Inpatients: Randomized Feasibility Trial
- ClinicalTrials.gov ID
- NCT05045677
- Acronym / sponsor ID
- 047-2021
- Conditions
- Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 16 Sep 2021 (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.
Suicidality (ideation about taking one's life, suicide plans, and attempts) is a major public health concern in Ontario and worldwide. Psychiatric inpatients with suicidality represent a group that is high-risk for subsequent suicide. Current standard-care for suicidal psychiatric inpatients focuses on containment of risk and indirect treatment of suicidality by treating any underlying mental disorder. Though there is evidence that addressing suicidality directly is more effective than an indirect approach, there are limited evidence based treatments that target suicidality. Furthermore, there are few high-quality studies that have included inpatients. Psychotherapeutic interventions are under-utilized for inpatients and COVID-19 has further widened this gap given attempts by hospitals to reduce face-to-face contact with patients. Digital psychotherapy interventions have the ability to bridge this gap given their lower cost, ease of dissemination, acceptability by patients, and effectiveness. To our knowledge, there are no studies that have assessed the feasibility, acceptability and effectiveness of digital interventions for suicidal inpatients. Our study is a feasibility trial of a previously studied digital Dialectical Behavioural Therapy (d-DBT) skills intervention in suicidal psychiatric inpatients.
The study is a two arm randomized parallel group-controlled trial, 6-10 day, flexible timeline, randomized feasibility trial of a d-DBT skills intervention added to standard care for patients admitted to psychiatric inpatient units with suicidality. There will be 20 patients who will receive the intervention in addition to standard care and 20 patients who will receive standard care alone. There will also be a 4 week follow-up after discharge from hospital.
Participants will be admitted for psychiatric care at the Complex and Critical Care Units, Centre for Addiction and Mental Health (CAMH), Toronto.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital DBT intervention group | Experimental | Other: digital DBT skills intervention, Other: Standard CareDigital intervention group plus standard care |
| Standard care | Active comparator | Other: Standard CareStandard care alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients with any DSM-5 diagnosis aged 18 years and above;
- admitted to CAMH with suicidality and a baseline BSI score of > 6;
- capable and willing to give informed consent;
- anticipated length of admission is greater than 5 days;
- deemed suitable by the primary team to take part in a psychotherapeutic intervention as part of standard care
Key exclusion criteria (2 listed)
- presence of psychiatric symptoms that interfere with the ability to complete the d-DBT
- Concurrent treatment with ECT or MST
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 |
|---|---|---|
| digital DBT skills interventionThe digital intervention consists of 6 modules that will be delivered over 6 to 10 days. The modules cover mindfulness skills, emotion regulation skills and distress tolerance skills. | Other | Digital DBT intervention group |
| Standard CareStandard inpatient care includes a multi-disciplinary team approach including daily psychiatric review, medication management and in-person psychosocial interventions (social work, nursing). | Other | Digital DBT intervention group, Standard care |
Primary outcome
Recruitment and retention rates
Time frame: 6-10 days
Feasibility - whether the intervention is possible in the acute inpatient setting
Client Satisfaction Questionnaire 8 (CSQ-8)
Time frame: 6-10 days
Acceptability - whether the intervention is appropriate for the acute inpatient setting. The CSQ-8 scores range from 8 to 32, with higher values indicating higher satisfaction with the intervention.
User Experience Questionnaire (UXQ)
Time frame: 6-10 days
Usability - whether the intervention is serviceable for its intended purpose. The UXQ has 11 items exploring characteristics informing usability of mobile apps, each scored from 0-10, for a total score ranging from 10-110 (with larger scores indicating increased usability).
4 secondary outcomes
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: 5-10 days in addition to discharge and 4 weeks post-discharge
Clinical Global Impression (CGI)
Time frame: 5-10 days in addition to discharge and 4 weeks post-discharge
Brief Difficulties in Emotion Regulation Scale (DERS-16)
Time frame: 5-10 days in addition to discharge and 4 weeks post-discharge
Kessler psychological distress scale (K10)
Time frame: 5-10 days in addition to discharge and 4 weeks post-discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- 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.
Ishrat Husain, MD (Res) principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital DBT skills intervention in people with Suicidal Ideation, run by Centre for Addiction and Mental Health 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 2 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: finished, as of the sponsor's last update on 14 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recruitment and retention rates (time frame: 6-10 days). The study lists 3 primary outcomes in all. 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 14 Sep 2023; AzTrials last refreshed its copy on 30 Oct 2026.