Clinical trial NCT05045677: 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
Overall status: COMPLETED
Phase: NA
Conditions: Suicidal Ideation
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2021-09-16
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. patients with any DSM-5 diagnosis aged 18 years and above;
2. admitted to CAMH with suicidality and a baseline BSI score of \> 6;
3. capable and willing to give informed consent;
4. anticipated length of admission is greater than 5 days;
5. 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:

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

Primary outcomes:
measure: Recruitment and retention rates
timeFrame: 6-10 days
measure: Client Satisfaction Questionnaire 8 (CSQ-8)
timeFrame: 6-10 days
measure: User Experience Questionnaire (UXQ)
timeFrame: 6-10 days
Secondary outcomes:
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: 5-10 days in addition to discharge and 4 weeks post-discharge
measure: Clinical Global Impression (CGI)
timeFrame: 5-10 days in addition to discharge and 4 weeks post-discharge
measure: Brief Difficulties in Emotion Regulation Scale (DERS-16)
timeFrame: 5-10 days in addition to discharge and 4 weeks post-discharge
measure: Kessler psychological distress scale (K10)
timeFrame: 5-10 days in addition to discharge and 4 weeks post-discharge
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Ishrat Husain, MD (Res)
role: PRINCIPAL_INVESTIGATOR
References: