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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04841603
Enrollment
24
Registered
2021-04-12
Start date
2021-04-12
Completion date
2021-05-11
Last updated
2021-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

inpatient psychiatry, psychiatric admission, mobile app, inpatient CBT

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).

Interventions

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.

DEVICETreatment as Usual

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.

Sponsors

Centre for Addiction and Mental Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomized control trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Qualitative Data Analysis1 weekFrom focus groups, to inform feasibility, usability, and acceptability
Recruitment rates1 weekFeasibility - whether the intervention is possible in the acute inpatient setting
Client Satisfaction Questionnaire 8 (CSQ-8)1 weekAcceptability - 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.
User Experience Questionnaire (UXQ)1 weekUsability - 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).
Retention rates1 weekFeasibility - whether the intervention is possible in the acute inpatient setting

Secondary

MeasureTime frameDescription
General Anxiety Disorder 7 Scale (GAD-7)1 weekPreliminary 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.
Kessler Psychological Distress Scale (K10)1 weekPreliminary 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.
Patient Health Questionnaire 9 (PHQ-9)1 weekPreliminary 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026