Brief Digital CBT for Mood and Anxiety Symptoms in Acute Psychiatric Inpatients

Brief Digital CBT for Mood and Anxiety Symptoms in Acute Psychiatric Inpatients: a Randomized Feasibility Trial

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Depressive Symptoms; Anxiety State; Mental Disorders, Severe; Distress, Emotional; Anxiety and Fear; Psychiatric Hospitalization
• Intervention / Treatment: Device: Treatment as Usual; Device: Mindshift CBT

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).

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M6J1H4
      • Centre for Addiction and Mental Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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 Names: 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 Names: CBT mobile app

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention rates	Feasibility - whether the intervention is possible in the acute inpatient setting	1 week
Recruitment rates	Feasibility - whether the intervention is possible in the acute inpatient setting	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.	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).	1 week
Qualitative Data Analysis	From focus groups, to inform feasibility, usability, and acceptability	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	1 week

Collaborators and Investigators

• Sponsor: Centre for Addiction and Mental Health
• Investigators: Principal Investigator: Ishrat Husain, MBBS, MD (Res.), MRCPsych, Centre for Addiction and Mental Health

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 12, 2021
• Primary Completion (ACTUAL): May 11, 2021
• Study Completion (ACTUAL): May 11, 2021

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: April 9, 2021
• First Posted (ACTUAL): April 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: mobile app; inpatient psychiatry; psychiatric admission; inpatient CBT
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Anxiety Disorders; Mental Disorders
• Other Study ID Numbers: 116/2020-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No