Cardiac SurgeryTRACSNCT05727865
Online Cognitive Behavioral Therapy for Rehabilitation After Cardiac Surgery
A study testing Online CBT following cardiac surgery in people with Cardiac Surgery, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of the present pilot study is to evaluate the feasibility and potential efficacy of a brief, internet-delivered CBT protocol provided early following cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Online CBT following cardiac surgery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 17 Feb 2023to 22 Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (A) Cardiac surgery (i.e., CABG, heart valve repair/replacement, aortic repair or combined CABG and valve repair/replacement) ≥ eight weeks to nine months before assessment
- (B) Age 18 years and above;
- (C) Endorses postoperative psychological distress and/or interference with daily life
- (D) On medical treatment for the cardiac condition according to clinical guidelines;
- (E) Ability to read and write in Swedish
Who cannot join
- (F) Prior cardiac surgery with ventricular assist device or heart transplant;
- (G) Hospitalized or living in a care facility;
- (H) Any medical restriction to be physical active;
- (I) Severe medical illness i.e., terminal cancer ;
- (J) Severe psychiatric disorder or risk of suicide;
- (K) Alcohol dependency;
- (L) Ongoing psychological treatment.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the present pilot study is to evaluate the feasibility and potential efficacy of a brief, internet-delivered CBT protocol provided early following cardiac surgery.
Read the detailed description
Cardiac surgery is a major surgical procedure used to treat for example coronary artery disease (CAD). The intervention increases survival rates and reduces cardiac symptom burden in cardiac patients. However, cardiac surgery is associated with elevated symptoms of psychological distress, which are related to several negative outcomes, such as poorer health-related quality of life (QoL) and response to treatment. There is a clear need to develop a brief psychological intervention that can be provided early in the clinical course after cardiac surgery to reduce psychological distress.
The purpose of this pilot study is to evaluate the feasibility and potential efficacy of a brief, exposure-based internet-delivered CBT protocol provided early after cardiac surgery. This is an uncontrolled pilot study with a pretest-posttest design. The study will include 30 participants. Assessments will be conducted pre-treatment, post-treatment, one- and six months after treatment. The one-month follow-up is the primary endpoint.
The treatment lasts for five weeks and will be provided as an early intervention following cardiac surgery ≥ eight weeks to nine months before assessment. It will include psychoeducation, behavioral activation to address post-operative fatigue and depression, interoceptive exposure to reduce fear of cardiac-related symptoms and in-vivo exposure to reduce avoided situations, and activities to enhance physical activity and wellbeing.
- Conditions
- Cardiac Surgery
- Being tested
- Online CBT following cardiac surgery
- Keywords
- Psychological distress, Cognitive behavioral therapy, Fatigue, Depression, Anxiety
- Medical subject headings
- Fatigue, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online CBT following cardiac surgeryBehavioural
It will include psychoeducation, behavioral activation to address post-operative fatigue and depression, interoceptive exposure to reduce fear of cardiac-related symptoms and in-vivo exposure to reduce avoided situations, and activities to enhance physical activity and wellbeing. Labeling (i.e., describing post-operative and/or cardiac-related symptoms, thoughts, and feelings) will be used continuously during treatment to enhance the effect of exposure and pain management
| Study group | Role | What they receive |
|---|---|---|
| Online CBT following cardiac surgery | Experimental | The treatment lasts for five weeks and will be provided as an early intervention following cardiac surgery ≥ eight weeks to nine months before assessment. The intervention is psychologist-guided (clinical psychologist and/or resident psychologist under supervision) and delivered via text-based interactive online treatment modules, where patients complete weekly homework assignments and have regular online contact with psychologists with training in CBT for cardiac disease. Receives: Behavioral: Online CBT following cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-Item Short-Form Health Survey
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life
Measured: Baseline to 2 months
Acceptability: Client satisfaction Questionnaire
Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment.
Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment.
Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment.
Measured: Baseline to 5 weeks.
Percentage of enrolled participants who complete the treatment
Feasibility of the intervention components will be assessed by >60% assessed as treatment completers. Descriptive analysis will also provide number of messages and therapist time.
Measured: Baseline to 5 weeks
Adverse events
Potential adverse reactions to the treatment. Participants will be asked to report and rate the short- and long term discomfort of the adverse event on a scale from 0 ('did not affect me at all') and 3 ('affected me very negatively').
Measured: Baseline to 5 weeks
Secondary outcomes (26)
12-Item Short-Form Health Survey
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life
Measured: Baseline to 5 weeks
12-Item Short-Form Health Survey
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life
Measured: Baseline to 7 months
Cardiac anxiety questionnaire
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Measured: Baseline to 5 weeks
Cardiac anxiety questionnaire
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Measured: Baseline to 2 months
Cardiac anxiety questionnaire
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Measured: Baseline to 7 months
Patient Health Questionnaire-9
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Measured: Baseline to 5 weeks
Patient Health Questionnaire-9
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Measured: Baseline to 2 months
Patient Health Questionnaire-9
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Measured: Baseline to 7 months
Generalized Anxiety Disorder 7-item
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Measured: Baseline to 5 weeks
Generalized Anxiety Disorder 7-item
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Measured: Baseline to 2 months
Generalized Anxiety Disorder 7-item
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Measured: Baseline to 7 months
Brief Pain Inventory Short Form
Measure of pain interference and severity, with a higher score indicating more pain.
Measured: Baseline to 5 weeks
Brief Pain Inventory Short Form
Measure of pain interference and severity, with a higher score indicating more pain.
Measured: Baseline to 2 months
Brief Pain Inventory Short Form
Measure of pain interference and severity, with a higher score indicating more pain.
Measured: Baseline to 7 months
Multidimensional fatigue inventory
Measure of fatigue, with a higher score indicating more fatigue.
Measured: Baseline to 5 weeks
Multidimensional fatigue inventory
Measure of fatigue, with a higher score indicating more fatigue.
Measured: Baseline to 2 months
Multidimensional fatigue inventory
Measure of fatigue, with a higher score indicating more fatigue.
Measured: Baseline to 7 months
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
Cardiac-related symptoms in two sub scales A) frequency: score ranging from 0-48, with higher score indicating higher frequency of symptoms, B) severity of experienced symptom: score ranging from 0- 48, with a higher score indicating more severe symptoms
Measured: Baseline to 5 weeks
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
Cardiac-related symptoms in two sub scales A) frequency: score ranging from 0-48, with higher score indicating higher frequency of symptoms, B) severity of experienced symptom: score ranging from 0- 48, with a higher score indicating more severe symptoms
Measured: Baseline to 2 months
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
Cardiac-related symptoms in two sub scales A) frequency: score ranging from 0-48, with higher score indicating higher frequency of symptoms, B) severity of experienced symptom: score ranging from 0- 48, with a higher score indicating more severe symptoms
Measured: Baseline to 7 months
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
evel of physical activity and inactivity: On the Godin leisure-time excercise: The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity. And from International Physical Activity Questionnaire we will use 1 item on inactivity
Measured: Baseline to weeks
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
evel of physical activity and inactivity: On the Godin leisure-time excercise: The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity. And from International Physical Activity Questionnaire we will use 1 item on inactivity
Measured: Baseline to 2 months
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
evel of physical activity and inactivity: On the Godin leisure-time excercise: The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity. And from International Physical Activity Questionnaire we will use 1 item on inactivity
Measured: Baseline to 7 months
University of Toronto Atrial fibrillation Severity Scale (AFSS)
3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption.
Measured: Baseline to 5 weeks
University of Toronto Atrial fibrillation Severity Scale (AFSS)
3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption.
Measured: Baseline to 2 months
University of Toronto Atrial fibrillation Severity Scale (AFSS)
3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption.
Measured: Baseline to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start17 Feb 2023
- Primary completion22 Sep 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Principal investigator, Josefin Särnholm, Karolinska Institutet
- Investigators
- Josefin Särnholm, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727865
- Sponsor's protocol ID
- TRACS-PILOT
- Acronym
- TRACS
- Status last verified
- Jun 2024
- First submitted
- 6 Feb 2023
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Cognitive Behavioral Therapy for Rehabilitation After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05727865
- Acronym / sponsor ID
- TRACS / TRACS-PILOT
- Conditions
- Cardiac Surgery
- Keywords
- Psychological distress, Cognitive behavioral therapy, Fatigue, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska University Hospital
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 14 Feb 2023 (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.
The purpose of the present pilot study is to evaluate the feasibility and potential efficacy of a brief, internet-delivered CBT protocol provided early following cardiac surgery.
Detailed description
Cardiac surgery is a major surgical procedure used to treat for example coronary artery disease (CAD). The intervention increases survival rates and reduces cardiac symptom burden in cardiac patients. However, cardiac surgery is associated with elevated symptoms of psychological distress, which are related to several negative outcomes, such as poorer health-related quality of life (QoL) and response to treatment. There is a clear need to develop a brief psychological intervention that can be provided early in the clinical course after cardiac surgery to reduce psychological distress.
The purpose of this pilot study is to evaluate the feasibility and potential efficacy of a brief, exposure-based internet-delivered CBT protocol provided early after cardiac surgery. This is an uncontrolled pilot study with a pretest-posttest design. The study will include 30 participants. Assessments will be conducted pre-treatment, post-treatment, one- and six months after treatment. The one-month follow-up is the primary endpoint.
The treatment lasts for five weeks and will be provided as an early intervention following cardiac surgery ≥ eight weeks to nine months before assessment. It will include psychoeducation, behavioral activation to address post-operative fatigue and depression, interoceptive exposure to reduce fear of cardiac-related symptoms and in-vivo exposure to reduce avoided situations, and activities to enhance physical activity and wellbeing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Online CBT following cardiac surgery | Experimental | Behavioral: Online CBT following cardiac surgeryThe treatment lasts for five weeks and will be provided as an early intervention following cardiac surgery ≥ eight weeks to nine months before assessment. The intervention is psychologist-guided (clinical psychologist and/or resident psychologist under supervision) and delivered via text-based interactive online treatment modules, where patients complete weekly homework assignments and have regular online contact with psychologists with training in CBT for cardiac disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (A) Cardiac surgery (i.e., CABG, heart valve repair/replacement, aortic repair or combined CABG and valve repair/replacement) ≥ eight weeks to nine months before assessment
- (B) Age 18 years and above;
- (C) Endorses postoperative psychological distress and/or interference with daily life
- (D) On medical treatment for the cardiac condition according to clinical guidelines;
- (E) Ability to read and write in Swedish
Key exclusion criteria (7 listed)
- (F) Prior cardiac surgery with ventricular assist device or heart transplant;
- (G) Hospitalized or living in a care facility;
- (H) Any medical restriction to be physical active;
- (I) Severe medical illness i.e., terminal cancer ;
- (J) Severe psychiatric disorder or risk of suicide;
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 |
|---|---|---|
| Online CBT following cardiac surgeryIt will include psychoeducation, behavioral activation to address post-operative fatigue and depression, interoceptive exposure to reduce fear of cardiac-related symptoms and in-vivo exposure to reduce avoided situations, and activities to enhance physical activity and wellbeing. Labeling (i.e., describing post-operative and/or cardiac-related symptoms, thoughts, and feelings) will be used continuously during treatment to enhance the effect of exposure and pain management | Behavioural | Online CBT following cardiac surgery |
Primary outcome
12-Item Short-Form Health Survey
Time frame: Baseline to 2 months
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life
Acceptability: Client satisfaction Questionnaire
Time frame: Baseline to 5 weeks.
Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment. Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment. Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment.
Percentage of enrolled participants who complete the treatment
Time frame: Baseline to 5 weeks
Feasibility of the intervention components will be assessed by >60% assessed as treatment completers. Descriptive analysis will also provide number of messages and therapist time.
Adverse events
Time frame: Baseline to 5 weeks
Potential adverse reactions to the treatment. Participants will be asked to report and rate the short- and long term discomfort of the adverse event on a scale from 0 ('did not affect me at all') and 3 ('affected me very negatively').
26 secondary outcomes
12-Item Short-Form Health Survey
Time frame: Baseline to 5 weeks
12-Item Short-Form Health Survey
Time frame: Baseline to 7 months
Cardiac anxiety questionnaire
Time frame: Baseline to 5 weeks
Cardiac anxiety questionnaire
Time frame: Baseline to 2 months
Cardiac anxiety questionnaire
Time frame: Baseline to 7 months
Patient Health Questionnaire-9
Time frame: Baseline to 5 weeks
Patient Health Questionnaire-9
Time frame: Baseline to 2 months
Patient Health Questionnaire-9
Time frame: Baseline to 7 months
Generalized Anxiety Disorder 7-item
Time frame: Baseline to 5 weeks
Generalized Anxiety Disorder 7-item
Time frame: Baseline to 2 months
Generalized Anxiety Disorder 7-item
Time frame: Baseline to 7 months
Brief Pain Inventory Short Form
Time frame: Baseline to 5 weeks
Brief Pain Inventory Short Form
Time frame: Baseline to 2 months
Brief Pain Inventory Short Form
Time frame: Baseline to 7 months
Multidimensional fatigue inventory
Time frame: Baseline to 5 weeks
Multidimensional fatigue inventory
Time frame: Baseline to 2 months
Multidimensional fatigue inventory
Time frame: Baseline to 7 months
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
Time frame: Baseline to 5 weeks
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
Time frame: Baseline to 2 months
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
Time frame: Baseline to 7 months
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
Time frame: Baseline to weeks
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
Time frame: Baseline to 2 months
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
Time frame: Baseline to 7 months
University of Toronto Atrial fibrillation Severity Scale (AFSS)
Time frame: Baseline to 5 weeks
University of Toronto Atrial fibrillation Severity Scale (AFSS)
Time frame: Baseline to 2 months
University of Toronto Atrial fibrillation Severity Scale (AFSS)
Time frame: Baseline to 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
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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.
Josefin Särnholm, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online CBT following cardiac surgery in people with Cardiac Surgery, run by Karolinska Institutet at 1 site in Sweden.
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 5 inclusion and 7 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 21 Jun 2024. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
12-Item Short-Form Health Survey (time frame: Baseline to 2 months). The study lists 4 primary outcomes in all. 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 21 Jun 2024.