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Completed

NCT Number: NCT05045677

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, M6J1h3, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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).

Primary outcomes

  1. Recruitment and retention rates

    Time frame: 6-10 days

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

  2. 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.

  3. 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).

Secondary outcomes

  1. Columbia-Suicide Severity Rating Scale (C-SSRS)

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

    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.

  2. Clinical Global Impression (CGI)

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

    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

  3. Brief Difficulties in Emotion Regulation Scale (DERS-16)

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

    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

  4. Kessler psychological distress scale (K10)

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

    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.

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • The Physicians' Services Incorporated Foundation

Registry information

Official study title

Digital Dialectical Behavioral Therapy (d-DBT) Skills for Treatment of Acute Suicidality in Psychiatric Inpatients: Randomized Feasibility Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 16, 2021
Registry last updated
Sep 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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