Brief Digital CBT for Mood and Anxiety Symptoms in Acute Psychiatric Inpatients
Primary Purpose
Anxiety, Depressive Symptoms, Distress, Emotional
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mindshift CBT
Treatment as Usual
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring inpatient psychiatry, psychiatric admission, mobile app, inpatient CBT
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
Sites / Locations
- Centre for Addiction and Mental Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Treatment as usual
Mindshift CBT
Arm Description
Treatment as usual
Treatment as usual + Access to Mindshift CBT app
Outcomes
Primary Outcome Measures
Retention rates
Feasibility - whether the intervention is possible in the acute inpatient setting
Recruitment rates
Feasibility - whether the intervention is possible in the acute inpatient setting
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.
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).
Qualitative Data Analysis
From focus groups, to inform feasibility, usability, and acceptability
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04841603
First Posted
March 30, 2021
Last Updated
July 26, 2021
Sponsor
Centre for Addiction and Mental Health
1. Study Identification
Unique Protocol Identification Number
NCT04841603
Brief Title
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
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
May 11, 2021 (Actual)
Study Completion Date
May 11, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depressive Symptoms, Distress, Emotional, Anxiety and Fear, Anxiety State, Mental Disorders, Severe, Psychiatric Hospitalization
Keywords
inpatient psychiatry, psychiatric admission, mobile app, inpatient CBT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
Treatment as usual
Arm Title
Mindshift CBT
Arm Type
Experimental
Arm Description
Treatment as usual + Access to Mindshift CBT app
Intervention Type
Device
Intervention Name(s)
Mindshift CBT
Other Intervention Name(s)
CBT mobile app
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Treatment as Usual
Other Intervention Name(s)
Tablet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Retention rates
Description
Feasibility - whether the intervention is possible in the acute inpatient setting
Time Frame
1 week
Title
Recruitment rates
Description
Feasibility - whether the intervention is possible in the acute inpatient setting
Time Frame
1 week
Title
Client Satisfaction Questionnaire 8 (CSQ-8)
Description
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
Title
User Experience Questionnaire (UXQ)
Description
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
Title
Qualitative Data Analysis
Description
From focus groups, to inform feasibility, usability, and acceptability
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire 9 (PHQ-9)
Description
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
Title
General Anxiety Disorder 7 Scale (GAD-7)
Description
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
Title
Kessler Psychological Distress Scale (K10)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ishrat Husain, MBBS, MD (Res.), MRCPsych
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J1H4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
21678337
Citation
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.
Results Reference
background
PubMed Identifier
21382540
Citation
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.
Results Reference
background
PubMed Identifier
19930367
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
32623368
Citation
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.
Results Reference
background
PubMed Identifier
10259963
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
Braun V, Clarke V. Using thematic analysis in psychology. Qualitative research in psychology. 2006 Jan 1;3(2):77-101.
Results Reference
background
PubMed Identifier
36322113
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.
Results Reference
derived
Learn more about this trial
Brief Digital CBT for Mood and Anxiety Symptoms in Acute Psychiatric Inpatients
We'll reach out to this number within 24 hrs