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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Anxiety, Anxiety State, Depressive Symptoms, Distress, Emotional, Anxiety and Fear, Mental Disorders, Severe, Psychiatric Hospitalization

Intervention / Treatment
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* Device: Mindshift CBT
* Device: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment as usual<br>Treatment as usual | Device: Treatment as Usual<br>* Treatment as usual. A tablet identical to the intervention group, but without the Mindshift CBT app is available for patients to use during their inpatient stay.<br>* Other names: Tablet;|
| Experimental: Mindshift CBT<br>Treatment as usual + Access to Mindshift CBT app | Device: Mindshift CBT<br>* A tablet with the Mindshift CBT app installed. Mindshift CBT is a free, evidence based app developed by Anxiety Canada, designed to help users reduce symptoms of anxiety and distress.<br>* Other names: CBT mobile app;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention rates | Feasibility - whether the intervention is possible in the acute inpatient setting | 1 week | 
| Recruitment rates | Feasibility - whether the intervention is possible in the acute inpatient setting | 1 week | 
| Client Satisfaction Questionnaire 8 (CSQ-8) | 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. | 1 week | 
| User Experience Questionnaire (UXQ) | 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). | 1 week | 
| Qualitative Data Analysis | From focus groups, to inform feasibility, usability, and acceptability | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire 9 (PHQ-9) | 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. | 1 week | 
| General Anxiety Disorder 7 Scale (GAD-7) | 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. | 1 week | 
| Kessler Psychological Distress Scale (K10) | 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. | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inpatient psychiatry, psychiatric admission, inpatient CBT, mobile app