RightFit
RecruitingNot applicable

Mobile Cognitive Behavioral Therapy in Early Stroke Recovery

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 79 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 days

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be asked to use the app for 3 days per week over a 5-week period, for \~20 minutes in each use."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests Maya, a mobile app that offers cognitive behavioral therapy to help people manage thoughts, feelings, and behaviors. It is for adults who recently had a stroke and have signs of depression, anxiety, or both. Researchers will check whether people find the app useful and easy to use during early recovery, and whether it may help their symptoms.

This study aims to pilot "Maya," a mobile cognitive behavioral therapy app, for use in adults with stroke experiencing depression and/or anxiety. This study will assess the acceptability, feasibility, and preliminary efficacy of Maya within the acute rehabilitation period.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 18 to 79 years old.
  • Score 8 or higher for depression, anxiety, or both on the Hospital Anxiety and Depression Scale (HADS).
  • Had a stroke within 1 month before starting the study.
  • Can understand and agree to join the study, based on a consent test.
  • Score at least 18 on the Montreal Cognitive Assessment (MoCA), showing no more than mild trouble with memory and thinking.
  • Can use an iPhone or iPad alone or with a caregiver’s help. Use your own iPhone, or borrow an iPad from the study team.
  • Can follow all study requirements and are willing to stay for the full study.

Who can't join

  • Have language problems or trouble noticing one side of your surroundings that would prevent app use, based on routine therapy checks.
  • Are not fluent in English.
  • Have a history of a major brain or nerve disorder, or a serious mental illness such as bipolar disorder, a psychotic disorder, or an alcohol or drug use disorder.
  • Currently have thoughts of suicide that require more care.
  • Have depression or anxiety severe enough that the lead study doctor decides you need more care or an immediate mental health referral.
  • Have another health or medical reason found at the first visit that makes the study unsuitable for you.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age 18-79 * Positive screen on the Hospital Anxiety and Depression Scale (HADS), either the HADSD (depression, score \>= 8) and/or HADS-A (anxiety, score \>= 8). * Stroke that occurred within 1 month prior to study initiation. * Capacity to provide consent as determined by the UCSD Brief Assessment for Capacity to Consent (UBACC) * Montreal Cognitive Assessment (MoCA) score greater than or equal to 18, indicating no more than mild cognitive difficulties * Ability to use iPhone or iPad independently or through the assistance of a caregiver (participants will use their own iPhone if they have one, otherwise they will be loaned an iPad by the study team) * Able to adhere to all study requirements and willingness to participate in the full study duration Exclusion Criteria: * Aphasia or neglect that would interfere with use of the app, as determined through evaluation by speech-language pathology and occupational therapy conducted as part of standard clinical care * Non-fluency in English * History of a major neurologic disorder or of serious mental illness (bipolar or psychotic disorder, alcohol or substance use disorder as assessed through chart review) * Active suicidal ideation requiring a higher level of care * Severe depression and/or anxiety based on the initial evaluation and clinical judgment of the PI, which warrants a higher level of care and/or immediate referral to psychiatric services * Any other clinical or medical reason in the initial evaluation that suggests the study is not appropriate for the participant

Study sites (1)

NY