Digital Dialectical Behavioral Therapy (d-DBT) Skills for Acute Suicidality in Psychiatric Inpatients

NCT05045677 | Completed

• 1 other identifier: 047-2021
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal Ideation

Outcome Measures

Primary Outcomes (3)

• Recruitment and retention rates

  Feasibility - whether the intervention is possible in the acute inpatient setting

  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.

  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).

  6-10 days

Secondary Outcomes (4)

• Columbia-Suicide Severity Rating Scale (C-SSRS)

  5-10 days in addition to discharge and 4 weeks post-discharge

• Clinical Global Impression (CGI)

  5-10 days in addition to discharge and 4 weeks post-discharge

• Brief Difficulties in Emotion Regulation Scale (DERS-16)

  5-10 days in addition to discharge and 4 weeks post-discharge

• Kessler psychological distress scale (K10)

  5-10 days in addition to discharge and 4 weeks post-discharge

Study Arms (2)

Digital DBT intervention group

EXPERIMENTAL

Digital intervention group plus standard care

Other: digital DBT skills intervention; Other: Standard Care

Standard care

ACTIVE COMPARATOR

Standard care alone

Other: Standard Care

Interventions

digital DBT skills intervention OTHER

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.

Digital DBT intervention group

Standard Care OTHER

Standard inpatient care includes a multi-disciplinary team approach including daily psychiatric review, medication management and in-person psychosocial interventions (social work, nursing).

Digital DBT intervention group; Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• presence of psychiatric symptoms that interfere with the ability to complete the d-DBT
• Concurrent treatment with ECT or MST

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J1h3, Canada

Location

MeSH Terms

Conditions

Suicidal Ideation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ishrat Husain, MD (Res)

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: September 16, 2021
• Study Start: April 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)