Brief Digital CBT for Mood and Anxiety Symptoms in Acute Psychiatric Inpatients
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|ClinicalTrials.gov Identifier: NCT04841603|
Recruitment Status : Completed
First Posted : April 12, 2021
Last Update Posted : July 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Depressive Symptoms Distress, Emotional Anxiety and Fear Anxiety State Mental Disorders, Severe Psychiatric Hospitalization||Device: Mindshift CBT Device: Treatment as Usual||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized control trial|
|Masking:||None (Open Label)|
|Official Title:||Brief Digital CBT for Mood and Anxiety Symptoms in Acute Psychiatric Inpatients: a Randomized Feasibility Trial|
|Actual Study Start Date :||April 12, 2021|
|Actual Primary Completion Date :||May 11, 2021|
|Actual Study Completion Date :||May 11, 2021|
Active Comparator: Treatment as usual
Treatment as usual
Device: Treatment 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.
Other Name: Tablet
Experimental: Mindshift CBT
Treatment as usual + Access to Mindshift CBT app
Device: Mindshift CBT
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.
Other Name: CBT mobile app
- Retention rates [ Time Frame: 1 week ]Feasibility - whether the intervention is possible in the acute inpatient setting
- Recruitment 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.
- 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
- Patient Health Questionnaire 9 (PHQ-9) [ Time Frame: 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.
- General Anxiety Disorder 7 Scale (GAD-7) [ Time Frame: 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.
- Kessler Psychological Distress Scale (K10) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04841603
|Centre for Addiction and Mental Health|
|Toronto, Ontario, Canada, M6J1H4|
|Principal Investigator:||Ishrat Husain, MBBS, MD (Res.), MRCPsych||Centre for Addiction and Mental Health|