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Clinical Trials/NCT04841603
NCT04841603
Completed
Not Applicable

Brief Digital CBT for Mood and Anxiety Symptoms in Acute Psychiatric Inpatients: a Randomized Feasibility Trial

Centre for Addiction and Mental Health1 site in 1 country24 target enrollmentApril 12, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
Centre for Addiction and Mental Health
Enrollment
24
Locations
1
Primary Endpoint
Retention rates
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

A randomized control trial examining the feasibility, acceptability, and preliminary efficacy of providing access to the MindShift CBT mobile app via tablet for acute psychiatric inpatients.

Detailed Description

Psychiatric inpatients expect more psychosocial intervention during their inpatient stay than they receive. During the COVID-19 pandemic, existing interventions have been further reduced. Mood and anxiety symptoms are common for all inpatients across diagnostic categories. Studies have shown that cognitive behavioural therapy (CBT) can be effective for treating these symptoms among inpatients. The purpose of this study is to determine whether the Mindshift CBT app (an app based on principles of cognitive behavioural therapy) is an acceptable, feasible, and useable intervention for inpatients. The Mindshift CBT app is a tool designed and maintained by Anxiety Canada. It includes tools for daily mood check-ins, healthy thinking, calming intense emotions, and taking actions to change behaviours associated with anxiety and low mood. It also includes information about the common types of anxiety. The proposed trial includes 12 patients per arm. All participants in control and intervention groups will have access to assigned tablet devices throughout the study period, though only those in the intervention group will have the MindShift CBT app on their device. All participants will undergo assessments at baseline and at the end of the intervention period (1 week).

Registry
clinicaltrials.gov
Start Date
April 12, 2021
End Date
May 11, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gaurav Sharma

Resident Physician

Centre for Addiction and Mental Health

Eligibility Criteria

Inclusion Criteria

  • Admitted to the acute inpatient unit
  • Fluent in English
  • Dynamic Appraisal for Situational Aggression (DASA) score \<=3
  • Capable to consent to participation as assessed by the treating physician

Exclusion Criteria

  • Diagnosis of moderate-severe learning disability
  • Diagnosis of moderate-severe neurocognitive disorder

Outcomes

Primary Outcomes

Retention rates

Time Frame: 1 week

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

Client Satisfaction Questionnaire 8 (CSQ-8)

Time Frame: 1 week

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.

Recruitment rates

Time Frame: 1 week

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

User Experience Questionnaire (UXQ)

Time Frame: 1 week

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).

Qualitative Data Analysis

Time Frame: 1 week

From focus groups, to inform feasibility, usability, and acceptability

Secondary Outcomes

  • General Anxiety Disorder 7 Scale (GAD-7)(1 week)
  • Patient Health Questionnaire 9 (PHQ-9)(1 week)
  • Kessler Psychological Distress Scale (K10)(1 week)

Study Sites (1)

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