An interventional study of Mindshift CBT and Treatment as Usual in Anxiety, Depressive Symptoms and Distress, Emotional, sponsored by Centre for Addiction and Mental Health. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-07-27.
Sponsored by Centre for Addiction and Mental Health · Not applicable, Interventional, and Treatment
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.
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).
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 24 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Centre for Addiction and Mental Health is the lead sponsor of 327 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment as usual
Device: Treatment as Usual
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.
Also known as: CBT mobile app
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.
Also known as: Tablet
Retention rates
Feasibility - whether the intervention is possible in the acute inpatient setting
Time frame: 1 week
Recruitment rates
Feasibility - whether the intervention is possible in the acute inpatient setting
Time frame: 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.
Time frame: 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).
Time frame: 1 week
Qualitative Data Analysis
From focus groups, to inform feasibility, usability, and acceptability
Time frame: 1 week
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.
Time frame: 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.
Time frame: 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.
Time frame: 1 week
Plan to share: Undecided
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Centre for Addiction and Mental Health