Brief Digital CBT for Mood and Anxiety Symptoms in Acute Psychiatric Inpatients

Not Applicable

Completed

• Conditions: Anxiety; Psychiatric Hospitalization; Distress, Emotional; Anxiety State; Anxiety and Fear; Depressive Symptoms; Mental Disorders, Severe
• Interventions: Device: Mindshift CBT; Device: Treatment as Usual

• Registration Number: NCT04841603
• Lead Sponsor: Centre for Addiction and Mental Health

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).

Study Timeline

• Study First Submitted: 2021-03-30
• Study First Submitted QC: 2021-04-09
• Study Start: 2021-04-12
• Study First Posted: 2021-04-12
• Primary Completion: 2021-05-11
• Study Completion: 2021-05-11
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindshift CBT	Mindshift CBT	Treatment as usual + Access to Mindshift CBT app
Treatment as usual	Treatment as Usual	Treatment as usual

Primary Outcome Measures

Name	Time	Method
Retention rates	1 week	Feasibility - whether the intervention is possible in the acute inpatient setting
Client Satisfaction Questionnaire 8 (CSQ-8)	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	1 week	Feasibility - whether the intervention is possible in the acute inpatient setting
User Experience Questionnaire (UXQ)	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	1 week	From focus groups, to inform feasibility, usability, and acceptability

Secondary Outcome Measures

Name	Time	Method
General Anxiety Disorder 7 Scale (GAD-7)	1 week	Preliminary efficacy - whether symptoms of anxiety are improved by the intervention. GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut points for mild, moderate, and severe anxiety.
Patient Health Questionnaire 9 (PHQ-9)	1 week	Preliminary efficacy - whether symptoms of depression are improved by the intervention. PHQ-9 is scored from 0 to 27 with higher scores indicating increasing severity of symptoms.
Kessler Psychological Distress Scale (K10)	1 week	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.

Trial Locations

Locations (1)

Centre for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada