Clinical trial NCT04841603: Brief Digital CBT for Mood and Anxiety Symptoms in Acute Psychiatric Inpatients
Official title: Brief Digital CBT for Mood and Anxiety Symptoms in Acute Psychiatric Inpatients: a Randomized Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depressive Symptoms
Distress, Emotional
Anxiety and Fear
Anxiety State
Mental Disorders, Severe
Psychiatric Hospitalization
Keywords: inpatient psychiatry
psychiatric admission
mobile app
inpatient CBT
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Retention rates
timeFrame: 1 week
measure: Recruitment rates
timeFrame: 1 week
measure: Client Satisfaction Questionnaire 8 (CSQ-8)
timeFrame: 1 week
measure: User Experience Questionnaire (UXQ)
timeFrame: 1 week
measure: Qualitative Data Analysis
timeFrame: 1 week
Secondary outcomes:
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: 1 week
measure: General Anxiety Disorder 7 Scale (GAD-7)
timeFrame: 1 week
measure: Kessler Psychological Distress Scale (K10)
timeFrame: 1 week
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Ishrat Husain, MBBS, MD (Res.), MRCPsych
role: PRINCIPAL_INVESTIGATOR
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citation: Sharma G, Schlosser L, Jones BDM, Blumberger DM, Gratzer D, Husain MO, Mulsant BH, Rappaport L, Stergiopoulos V, Husain MI. Brief App-Based Cognitive Behavioral Therapy for Anxiety Symptoms in Psychiatric Inpatients: Feasibility Randomized Controlled Trial. JMIR Form Res. 2022 Nov 2;6(11):e38460. doi: 10.2196/38460.