Digital Dialectical Behavioral Therapy (d-DBT) Skills for Acute Suicidality in Psychiatric Inpatients
Primary Purpose
Suicidal Ideation
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
digital DBT skills intervention
Standard Care
Sponsored by
About this trial
This is an interventional treatment trial for Suicidal Ideation
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- presence of psychiatric symptoms that interfere with the ability to complete the d-DBT
- Concurrent treatment with ECT or MST
Sites / Locations
- Centre for Addiction and Mental Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Digital DBT intervention group
Standard care
Arm Description
Digital intervention group plus standard care
Standard care alone
Outcomes
Primary Outcome Measures
Recruitment and retention rates
Feasibility - whether the intervention is possible in the acute inpatient setting
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.
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).
Secondary Outcome Measures
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.
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
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
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.
Full Information
NCT ID
NCT05045677
First Posted
August 9, 2021
Last Updated
September 13, 2023
Sponsor
Centre for Addiction and Mental Health
Collaborators
The Physicians' Services Incorporated Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05045677
Brief Title
Digital Dialectical Behavioral Therapy (d-DBT) Skills for Acute Suicidality in Psychiatric Inpatients
Official Title
Digital Dialectical Behavioral Therapy (d-DBT) Skills for Treatment of Acute Suicidality in Psychiatric Inpatients: Randomized Feasibility Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
The Physicians' Services Incorporated Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Digital DBT intervention group
Arm Type
Experimental
Arm Description
Digital intervention group plus standard care
Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
Standard care alone
Intervention Type
Other
Intervention Name(s)
digital DBT skills intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
Standard inpatient care includes a multi-disciplinary team approach including daily psychiatric review, medication management and in-person psychosocial interventions (social work, nursing).
Primary Outcome Measure Information:
Title
Recruitment and retention rates
Description
Feasibility - whether the intervention is possible in the acute inpatient setting
Time Frame
6-10 days
Title
Client Satisfaction Questionnaire 8 (CSQ-8)
Description
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.
Time Frame
6-10 days
Title
User Experience Questionnaire (UXQ)
Description
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).
Time Frame
6-10 days
Secondary Outcome Measure Information:
Title
Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
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.
Time Frame
5-10 days in addition to discharge and 4 weeks post-discharge
Title
Clinical Global Impression (CGI)
Description
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
Time Frame
5-10 days in addition to discharge and 4 weeks post-discharge
Title
Brief Difficulties in Emotion Regulation Scale (DERS-16)
Description
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
Time Frame
5-10 days in addition to discharge and 4 weeks post-discharge
Title
Kessler psychological distress scale (K10)
Description
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.
Time Frame
5-10 days in addition to discharge and 4 weeks post-discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
presence of psychiatric symptoms that interfere with the ability to complete the d-DBT
Concurrent treatment with ECT or MST
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ishrat Husain, MD (Res)
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J1h3
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Digital Dialectical Behavioral Therapy (d-DBT) Skills for Acute Suicidality in Psychiatric Inpatients
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