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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
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring inpatient psychiatry, psychiatric admission, mobile app, inpatient CBT

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 30, 2021
Last Updated
July 26, 2021
Sponsor
Centre for Addiction and Mental Health
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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
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Results Reference
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Brief Digital CBT for Mood and Anxiety Symptoms in Acute Psychiatric Inpatients

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