StrokeiSADNCT03615079
Internet-based CBT After Stroke Pilot
A study testing Cognitive behavioral therapy in people with Stroke and Depression, run by University of Pennsylvania at 1 site in United States.
Trial summary
Mood disorders occur in 25-30% of stroke patients and are associated with lower quality of life, higher mortality, increased healthcare utilization, and higher costs. Cognitive behavioral therapy (CBT) interventions have been shown to both treat and prevent post-stroke mood disorders, thus having the ability to… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Stroke, Depression
- What is being tested?
- Cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2018to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years of age
- Acute ischemic stroke within the past 3 months
- Regular access to the internet, sufficient to allow a minimum of interactions with the internet daily, either through a personal smartphone or web-based internet browser.
- Subject is willing and able to participate in internet-based cognitive behavioral therapy
- Can participate in the program in English
- Willingness and ability to sign informed consent by the patient
- Symptoms of mild to moderately depressed mood, defined as a score of 5-19 on the Patient Health Questionnaire-9 at the time of study enrollment.
Who cannot join
- Severely depressed patients, defined by a score of 20+ on the Patient Health Questionnare-9 are excluded
- Patients with an active bipolar disorder diagnosis are excluded
- Patients with personality disorder diagnoses are excluded
- Patients with active suicidality or past suicide attempts are excluded
- History of schizophrenia or schizoaffective disorder
- Active participation in face-to-face psychotherapy prior to stroke
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- Patients with a history of dementia are excluded
- Patients with aphasia, defined as a score of 1 or greater on NIH Stroke Scale Item 9 are excluded.
- Patients without regular internet access through a computer, tablet or smartphone are excluded.
- Subjects requiring long-term inpatient nursing care are excluded. For patients enrolled as inpatients, individuals being discharged to both home and acute rehab are eligible. Individuals being discharged to a skilled nursing facility or hospice are excluded.
- Expected life expectancy less than 6 months or other inability to comply with study follow-up.
- Pregnant women and prisoners are excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Internet-based Cognitive Behavioral Therapy to Reduce Depressive Symptoms After Stroke Pilot/Feasibility Study
Mood disorders occur in 25-30% of stroke patients and are associated with lower quality of life, higher mortality, increased healthcare utilization, and higher costs. Cognitive behavioral therapy (CBT) interventions have been shown to both treat and prevent post-stroke mood disorders, thus having the ability to improve quality of life and reduce costs. This study aims to test the feasibility of internet-based CBT combined with a telephone/email based coaching service after stroke.
- Conditions
- Stroke, Depression
- Being tested
- Cognitive behavioral therapy
- Medical subject headings
- Stroke, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapyBehavioural
An 8-week, internet-based cognitive behavioral therapy (CBT) program for depression
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy (CBT) program | Other | Not described Receives: Behavioral: Cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depressive Symptoms Over Time
Subject's depressive symptoms will be quantified using the Patient Health Questionnaire 9. This assessment includes 9 close-ended questions with a scoring system ranging from 0 to 27. Scores greater than 10 are considered "positive" for depressive symptoms. We will compare the average PHQ-9 score at study enrollment to the PHQ-9 at 90 days to determine the reduction in depressive symptoms over time.
Measured: Baseline and 90 days
Secondary outcomes (1)
Quality of Life Assessed by the EuroQOL-5D
EuroQOL-5D questionnaire that measures health related quality of life. The scale ranges from 1 to 100, with higher scores indicating better outcomes.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start11 Jun 2018
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Mullen, University of Pennsylvania
- Investigators
- Michael Mullen, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615079
- Sponsor's protocol ID
- 829426
- Acronym
- iSAD
- Status last verified
- Nov 2021
- First submitted
- 18 Jun 2018
- Last updated
- 11 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Cognitive Behavioral Therapy to Reduce Depressive Symptoms After Stroke Pilot/Feasibility Study
- ClinicalTrials.gov ID
- NCT03615079
- Acronym / sponsor ID
- iSAD / 829426
- Conditions
- Stroke, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Posted 10 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mood disorders occur in 25-30% of stroke patients and are associated with lower quality of life, higher mortality, increased healthcare utilization, and higher costs. Cognitive behavioral therapy (CBT) interventions have been shown to both treat and prevent post-stroke mood disorders, thus having the ability to improve quality of life and reduce costs. This study aims to test the feasibility of internet-based CBT combined with a telephone/email based coaching service after stroke.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy (CBT) program | Other | Behavioral: Cognitive behavioral therapy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years of age
- Acute ischemic stroke within the past 3 months
- Regular access to the internet, sufficient to allow a minimum of interactions with the internet daily, either through a personal smartphone or web-based internet browser.
- Subject is willing and able to participate in internet-based cognitive behavioral therapy
- Can participate in the program in English
Key exclusion criteria (12 listed)
- Severely depressed patients, defined by a score of 20+ on the Patient Health Questionnare-9 are excluded
- Patients with an active bipolar disorder diagnosis are excluded
- Patients with personality disorder diagnoses are excluded
- Patients with active suicidality or past suicide attempts are excluded
- History of schizophrenia or schizoaffective disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral therapyAn 8-week, internet-based cognitive behavioral therapy (CBT) program for depression | Behavioural | Cognitive Behavioral Therapy (CBT) program |
Primary outcome
Change in Depressive Symptoms Over Time
Time frame: Baseline and 90 days
Subject's depressive symptoms will be quantified using the Patient Health Questionnaire 9. This assessment includes 9 close-ended questions with a scoring system ranging from 0 to 27. Scores greater than 10 are considered "positive" for depressive symptoms. We will compare the average PHQ-9 score at study enrollment to the PHQ-9 at 90 days to determine the reduction in depressive symptoms over time.
1 secondary outcome
Quality of Life Assessed by the EuroQOL-5D
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Mullen, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy in people with Stroke and Depression, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depressive Symptoms Over Time (time frame: Baseline and 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2021; AzTrials last refreshed its copy on 27 Oct 2026.