NCT04841603

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 12, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

April 12, 2021

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2021

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

29 days

First QC Date

March 30, 2021

Last Update Submit

July 26, 2021

Conditions

AnxietyDepressive SymptomsDistress, EmotionalAnxiety and FearAnxiety StateMental Disorders, SeverePsychiatric Hospitalization

Keywords

inpatient psychiatrypsychiatric admissionmobile appinpatient CBT

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (3)

  • Patient Health Questionnaire 9 (PHQ-9)

    1 week

  • General Anxiety Disorder 7 Scale (GAD-7)

    1 week

  • Kessler Psychological Distress Scale (K10)

    1 week

Study Arms (2)

Treatment as usual

ACTIVE COMPARATOR

Treatment as usual

Device: Treatment as Usual

Mindshift CBT

EXPERIMENTAL

Treatment as usual + Access to Mindshift CBT app

Device: Mindshift CBT

Interventions

Mindshift CBTDEVICE

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
Mindshift CBT
Treatment as UsualDEVICE

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
Treatment as usual

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Diagnosis of moderate-severe learning disability
  • Diagnosis of moderate-severe neurocognitive disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J1H4, Canada

Location

Related Publications (12)

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 21678337BACKGROUND

  • 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.

    PMID: 21382540BACKGROUND

  • 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.

    PMID: 19930367BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 32623368BACKGROUND

  • 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.

    PMID: 10259963BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • Braun V, Clarke V. Using thematic analysis in psychology. Qualitative research in psychology. 2006 Jan 1;3(2):77-101.

    BACKGROUND

  • 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.

    PMID: 36322113DERIVED

MeSH Terms

Conditions

Anxiety DisordersDepressionMental Disorders

Interventions

TherapeuticsVaginal Creams, Foams, and Jellies

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical PreparationsFeminine Hygiene ProductsEquipment and Supplies

Study Officials

  • Ishrat Husain, MBBS, MD (Res.), MRCPsych

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 12, 2021

Study Start

April 12, 2021

Primary Completion

May 11, 2021

Study Completion

May 11, 2021

Last Updated

July 27, 2021

Record last verified: 2021-07

Locations

CA(1)