Brief Digital CBT for Mood and Anxiety Symptoms in Acute Psychiatric Inpatients
NCT ID: NCT04841603
Last Updated: 2021-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2021-04-12
2021-05-11
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment as usual
Treatment as usual
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.
Mindshift CBT
Treatment as usual + Access to Mindshift CBT app
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 neurocognitive disorder
18 Years
65 Years
ALL
No
Sponsors
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Centre for Addiction and Mental Health
OTHER
Responsible Party
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Gaurav Sharma
Resident Physician
Principal Investigators
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Ishrat Husain, MBBS, MD (Res.), MRCPsych
Role: PRINCIPAL_INVESTIGATOR
Centre for Addiction and Mental Health
Locations
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Centre for Addiction and Mental Health
Toronto, Ontario, Canada
Countries
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References
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Radcliffe J, Smith R. Acute in-patient psychiatry: how patients spend their time on acute psychiatric wards. Psychiatric Bulletin. 2007 May;31(5):167-70.
Kösters M, Burlingame GM, Nachtigall C, Strauss B. A meta-analytic review of the effectiveness of inpatient group psychotherapy. Group Dynamics: Theory, Research, and Practice. 2006 Jun;10(2):146.
Xia J, Merinder LB, Belgamwar MR. Psychoeducation for schizophrenia. Cochrane Database Syst Rev. 2011 Jun 15;2011(6):CD002831. doi: 10.1002/14651858.CD002831.pub2.
Cuijpers P, Clignet F, van Meijel B, van Straten A, Li J, Andersson G. Psychological treatment of depression in inpatients: a systematic review and meta-analysis. Clin Psychol Rev. 2011 Apr;31(3):353-60. doi: 10.1016/j.cpr.2011.01.002. Epub 2011 Jan 16.
Hopkins JE, Loeb SJ, Fick DM. Beyond satisfaction, what service users expect of inpatient mental health care: a literature review. J Psychiatr Ment Health Nurs. 2009 Dec;16(10):927-37. doi: 10.1111/j.1365-2850.2009.01501.x.
Paul AM, Fleming CJ. Anxiety management on campus: an evaluation of a mobile health intervention. J Technol Behav Sci 2018 Sep 19;4(1):58-61.
Marshall JM, Dunstan DA, Bartik W. Effectiveness of Using Mental Health Mobile Apps as Digital Antidepressants for Reducing Anxiety and Depression: Protocol for a Multiple Baseline Across-Individuals Design. JMIR Res Protoc. 2020 Jul 5;9(7):e17159. doi: 10.2196/17159.
Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.
Husain MO et al. Evaluating the feasibility and acceptability of mobile health apps that deliver psychosocial interventions: using functional criteria to capture the user's experience (under review). Digital Health 2020.
Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics: The Journal of Applied Statistics in the Pharmaceutical Industry. 2005 Oct;4(4):287-91.
Braun V, Clarke V. Using thematic analysis in psychology. Qualitative research in psychology. 2006 Jan 1;3(2):77-101.
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.
Other Identifiers
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116/2020-01
Identifier Type: -
Identifier Source: org_study_id
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