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

NCT ID: NCT05045677

Last Updated: 2023-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2022-11-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Digital DBT intervention group

Digital intervention group plus standard care

Group Type: EXPERIMENTAL

digital DBT skills intervention

Intervention Type: 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.

Standard Care

Intervention Type: OTHER

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

Standard care

Standard care alone

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: OTHER

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

Interventions

digital DBT skills intervention

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

Standard Care

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role: collaborator

Centre for Addiction and Mental Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ishrat Husain, MD (Res)

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

047-2021

Identifier Type: -

Identifier Source: org_study_id