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Completed

NCT Number: NCT04841603

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, M6J1H4, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindshift CBT

Device

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

Treatment as Usual

Device

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 12, 2021
Registry last updated
Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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