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

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ClinicalTrials.gov Identifier: NCT04841603
Recruitment Status : Completed
First Posted : April 12, 2021
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
Gaurav Sharma, Centre for Addiction and Mental Health

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.

Condition or disease Intervention/treatment Phase
Anxiety Depressive Symptoms Distress, Emotional Anxiety and Fear Anxiety State Mental Disorders, Severe Psychiatric Hospitalization Device: Mindshift CBT Device: Treatment as Usual Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized control trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Brief Digital CBT for Mood and Anxiety Symptoms in Acute Psychiatric Inpatients: a Randomized Feasibility Trial
Actual Study Start Date : April 12, 2021
Actual Primary Completion Date : May 11, 2021
Actual Study Completion Date : May 11, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Treatment as usual
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 Name: 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 Name: CBT mobile app




Primary Outcome Measures :
  1. Retention rates [ Time Frame: 1 week ]
    Feasibility - whether the intervention is possible in the acute inpatient setting

  2. Recruitment rates [ Time Frame: 1 week ]
    Feasibility - whether the intervention is possible in the acute inpatient setting

  3. Client Satisfaction Questionnaire 8 (CSQ-8) [ Time Frame: 1 week ]
    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.

  4. User Experience Questionnaire (UXQ) [ Time Frame: 1 week ]
    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).

  5. Qualitative Data Analysis [ Time Frame: 1 week ]
    From focus groups, to inform feasibility, usability, and acceptability


Secondary Outcome Measures :
  1. Patient Health Questionnaire 9 (PHQ-9) [ Time Frame: 1 week ]
    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.

  2. General Anxiety Disorder 7 Scale (GAD-7) [ Time Frame: 1 week ]
    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.

  3. Kessler Psychological Distress Scale (K10) [ Time Frame: 1 week ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04841603


Locations
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Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M6J1H4
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
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Principal Investigator: Ishrat Husain, MBBS, MD (Res.), MRCPsych Centre for Addiction and Mental Health
Publications:
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.
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.
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gaurav Sharma, Resident Physician, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT04841603    
Other Study ID Numbers: 116/2020-01
First Posted: April 12, 2021    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gaurav Sharma, Centre for Addiction and Mental Health:
inpatient psychiatry
psychiatric admission
mobile app
inpatient CBT
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders
Depression
Behavioral Symptoms