DepressionNCT04053244
Internet-based Cognitive Behavioural Therapy for Cardiac Patients
A study testing internet-based cognitive behavioural therapy in people with Depression and Cardiovascular Diseases, run by University of British Columbia at 1 site in Canada.
Trial summary
Our overall objective is to evaluate the efficacy of therapist-assisted, internet-based cognitive-behavioural therapy (iCBT) for depressed cardiac patients with respect to clinical outcomes, and the feasibility of the program. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Depression, Cardiovascular Diseases
- What is being tested?
- internet-based cognitive behavioural therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 26 Aug 2019to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- admitted to one of study units with any cardiac diagnosis OR cardiac procedure on this admission
- able to speak and read English
- able to provide informed consent and participate in therapy
- access to and ability to use a computer with internet access.
- Between 4 and 12 weeks after discharge, consenting participants will be required to meet a further inclusion criterion of:
- current depressive symptoms of at least mild severity on 2 successive assessments, 4 weeks apart or a single assessment of mild symptoms at 12 weeks post-discharge.
Who cannot join
- Applied at screening (and criteria 1 and 2 reapplied before enrolment):
- active suicidal ideation (since this requires immediate referral for intense psychiatric care)
- previous suicide attempt
- currently undergoing psychotherapy for depression
- receiving antidepressant medication that has been initiated or adjusted within previous 3 months
- concurrent psychiatric disorder, other than anxiety;
Show all 9Show fewer
- self-reported substance misuse within past 6 months
- concurrent terminal illness
- clinical status interfering with ability to independently engage in iCBT.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Paul's Hospital, Providence Health Care
Vancouver, British Columbia, V6Z1Y6
Martha Mackay, PhD, 6046822344 ext. 63127, mmackay@providencehealth.bc.ca
About this study
Official title: A Single-Centre, Open-Label Trial of Therapist-Assisted Internet-Based Cognitive Behaviour Therapy for Cardiac Patients With Depression
Our overall objective is to evaluate the efficacy of therapist-assisted, internet-based cognitive-behavioural therapy (iCBT) for depressed cardiac patients with respect to clinical outcomes, and the feasibility of the program. Our primary outcome will be depression severity; secondary outcomes will be hospitalization for a cardiac cause, recurrent myocardial infarction or revascularization. The study will inform a proposal to incorporate iCBT into the resources routinely available to cardiac patients following hospitalization for a cardiac event.
Read the detailed description
We are planning we are planning a single-arm, open label trial to evaluate the feasibility, acceptability and efficacy of iCBT among persistently depressed cardiac patients. Cardiac patients will be recruited from inpatient units in a university-affiliated hospital and screened for depression at 4 and possibly 8 or 12 weeks following discharge. Eligible patients will be enrolled in the iCBT program.Data regarding the primary outcome, improvement in depression severity, will be collected at completion of the intervention and at 8 weeks after completion. In addition to depression severity data, we will also obtain other data related to clinical feasibility, such as treatment adherence and the acceptability of the intervention to patients. Self-reported rates of hospital readmission or emergency visits for a cardiac cause will also be tracked.
- Conditions
- Depression, Cardiovascular Diseases
- Being tested
- internet-based cognitive behavioural therapy
- Keywords
- iCBT, cardiac event, cognitive behavioural therapy, depression
- Medical subject headings
- Depression, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internet-based cognitive behavioural therapyBehavioural
Designed for general clinical use (but not specifically cardiac patients), it consists of 5 online modules outlining cognitive-behavioural skills for depression, completed over 7-8 weeks. The participants will be guided step-wise through the modules by the therapist. Participants can work more or less at their own pace, but are expected to proceed to the next module within 1-2 weeks. Because the content is identical for each participant, fidelity to the web-based component of the intervention is ensured.
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | all participants will be assigned to the treatment, consisting of therapist-assisted iCBT. Receives: Behavioral: internet-based cognitive behavioural therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Severity
change in severity of depression as measured by Patient Health Questionnaire-9
Measured: baseline, completion of treatment (average of 12 weeks), study completion (treatment completion + 8 weeks)
Secondary outcomes (3)
major adverse cardiac events
death, myocardial infarction, revascularization, hospitalization for a cardiac cause
Measured: completion of treatment, average of 8 weeks
Treatment Satisfaction Questionnaire
participants' satisfaction with treatment
Measured: completion of treatment, average of 8 weeks
Web-Based Program Usability Questionnaire
participants' experience with using the web-based program
Measured: completion of treatment, average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start26 Aug 2019
- Primary completion1 Jun 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A Single-Centre, Open-Label Trial of Therapist-Assisted Internet-Based Cognitive Behaviour Therapy
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martha Mackay, University of British Columbia
- Investigators
- Martha H Mackay, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053244
- Sponsor's protocol ID
- H19-01695
- Status last verified
- Oct 2019
- First submitted
- 7 Aug 2019
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We would share all of our de-identified, individual-level data with any credentialed researcher.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Centre, Open-Label Trial of Therapist-Assisted Internet-Based Cognitive Behaviour Therapy for Cardiac Patients With Depression
- ClinicalTrials.gov ID
- NCT04053244
- Acronym / sponsor ID
- H19-01695
- Conditions
- Depression, Cardiovascular Diseases
- Keywords
- iCBT, cardiac event, cognitive behavioural therapy, depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 12 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our overall objective is to evaluate the efficacy of therapist-assisted, internet-based cognitive-behavioural therapy (iCBT) for depressed cardiac patients with respect to clinical outcomes, and the feasibility of the program. Our primary outcome will be depression severity; secondary outcomes will be hospitalization for a cardiac cause, recurrent myocardial infarction or revascularization. The study will inform a proposal to incorporate iCBT into the resources routinely available to cardiac patients following hospitalization for a cardiac event.
Detailed description
We are planning we are planning a single-arm, open label trial to evaluate the feasibility, acceptability and efficacy of iCBT among persistently depressed cardiac patients. Cardiac patients will be recruited from inpatient units in a university-affiliated hospital and screened for depression at 4 and possibly 8 or 12 weeks following discharge. Eligible patients will be enrolled in the iCBT program.Data regarding the primary outcome, improvement in depression severity, will be collected at completion of the intervention and at 8 weeks after completion. In addition to depression severity data, we will also obtain other data related to clinical feasibility, such as treatment adherence and the acceptability of the intervention to patients. Self-reported rates of hospital readmission or emergency visits for a cardiac cause will also be tracked.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A Single-Centre, Open-Label Trial of Therapist-Assisted Internet-Based Cognitive Behaviour Therapy
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Behavioral: internet-based cognitive behavioural therapyall participants will be assigned to the treatment, consisting of therapist-assisted iCBT. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- admitted to one of study units with any cardiac diagnosis OR cardiac procedure on this admission
- able to speak and read English
- able to provide informed consent and participate in therapy
- access to and ability to use a computer with internet access.
- Between 4 and 12 weeks after discharge, consenting participants will be required to meet a further inclusion criterion of:
Key exclusion criteria (9 listed)
- active suicidal ideation (since this requires immediate referral for intense psychiatric care)
- previous suicide attempt
- currently undergoing psychotherapy for depression
- receiving antidepressant medication that has been initiated or adjusted within previous 3 months
- concurrent psychiatric disorder, other than anxiety;
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 |
|---|---|---|
| internet-based cognitive behavioural therapyDesigned for general clinical use (but not specifically cardiac patients), it consists of 5 online modules outlining cognitive-behavioural skills for depression, completed over 7-8 weeks. The participants will be guided step-wise through the modules by the therapist. Participants can work more or less at their own pace, but are expected to proceed to the next module within 1-2 weeks. Because the content is identical for each participant, fidelity to the web-based component of the intervention is ensured. | Behavioural | treatment |
Primary outcome
Depression Severity
Time frame: baseline, completion of treatment (average of 12 weeks), study completion (treatment completion + 8 weeks)
change in severity of depression as measured by Patient Health Questionnaire-9
3 secondary outcomes
major adverse cardiac events
Time frame: completion of treatment, average of 8 weeks
Treatment Satisfaction Questionnaire
Time frame: completion of treatment, average of 8 weeks
Web-Based Program Usability Questionnaire
Time frame: completion of treatment, average of 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Individual participant dataSharing planned: Yes. We would share all of our de-identified, individual-level data with any credentialed researcher.
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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.
Martha H Mackay, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing internet-based cognitive behavioural therapy in people with Depression and Cardiovascular Diseases, run by University of British Columbia at 1 site in Canada.
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 3 Oct 2019. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martha H Mackay, PhD (6046822344 ext. 63127, mmackay@providencehealth.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Severity (time frame: baseline, completion of treatment (average of 12 weeks), study completion (treatment completion + 8 weeks)). 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 3 Oct 2019.