Coronary Artery StenosisNCT05532605
Effects of Mindfulness Based Therapy on Illness and Depression in Cardiac Rehab Phase-i
A study testing cardiac rehabilitation phase I protocols and Cardiac rehab phase I protocols + Mindfullness base therapy in people with Coronary Artery Stenosis, run by Riphah International University at 1 site in Pakistan.
Trial summary
A randomize controlled trial will be conducted at Punjab institute of cardiology hospital Lahore, through convenience sampling technique on 48 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and Group B. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Stenosis
- What is being tested?
- cardiac rehabilitation phase I protocols and Cardiac rehab phase I protocols + Mindfullness base therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2022to 1 Jan 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Phase-I CABG
- Hypertensive patients
- DM
- Patients hemodynamically stable
Who cannot join
- Hemodynamically unstable patients
- Orthopedic conditions i.e. fracture
- Disorientated patients
- Neuromuscular disease
- pacemaker dependency
- Uncontrolled arrhythmias
- Red Flags Like: Fever, Night Sweats, Malaise
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Punjab institute of cardiology hospital
Lahore, Punjab Province
Wajeeha Zia, MS, +92 323 4500788, wajeeha.zia@riphah.edu.pk
Sonia ilyas, MS*
About this study
Official title: Effects of Mindfulness Based Therapy on Patients Perception of Illness and Depression in Cardiac Rehabilitation Phase-i
A randomize controlled trial will be conducted at Punjab institute of cardiology hospital Lahore, through convenience sampling technique on 48 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and Group B. Pretreatment values of patients' blood pressure, RR, HR, will be recorded. And patient's perception of illness through Illness Perception Questionnaire (IPQ), PHQ9 for depression assessment and HRQOL for quality of life will be assessed before and after treatment. Group A will be treated with basic Phase-I cardiac rehabilitation. And Group B will be treated with basic Phase-I cardiac rehabilitation along with Mindfulness based therapy. Treatment evaluation will be done after 8 weeks. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be use within a group or between two groups.
Read the detailed description
Cardiac rehabilitation is becoming more widely acknowledged as an important part of the overall treatment plan for individuals with cardiovascular disease. Cardiac rehabilitation programs aim to reduce the physiological and psychological impacts of heart disease.
Anxiety, depression, cardiovascular disease, and suicide are among poor health outcomes of stress, which is a global public health issue. Depression, a disorder with a significant psychological burden, has been linked to an increased risk of cardiovascular disease.
Although the exact nature of the links between depression and coronary heart disease (CHD) has yet to be determined, these links are increasingly being highlighted. The aim of the study is to find Effects of Mindfulness based therapy on patient perception of illness and depression in cardiac rehabilitation Phase-I.
A randomize controlled trial will be conducted at Punjab institute of cardiology hospital Lahore, through convenience sampling technique on 48 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and Group B. Pretreatment values of patients' blood pressure, RR, HR, will be recorded. And patient's perception of illness through Illness Perception Questionnaire (IPQ), PHQ9 for depression assessment and HRQOL for quality of life will be assessed before and after treatment. Group A will be treated with basic Phase-I cardiac rehabilitation. And Group B will be treated with basic Phase-I cardiac rehabilitation along with Mindfulness based therapy. Treatment evaluation will be done after 8 weeks. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be use within a group or between two groups.
- Conditions
- Coronary Artery Stenosis
- Being tested
- cardiac rehabilitation phase I protocols, Cardiac rehab phase I protocols + Mindfullness base therapy
- Keywords
- depression, cardiac rehabilitation, patient perception of illness, MBSR, IPQ, HRQOL, Mindfulness
- Medical subject headings
- Coronary Stenosis, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac rehabilitation phase I protocolsOther
cardiac rehab phase I protocols: ankel pumps, limbs ROMs, bed mobility. Do 5-10 minutes daily of breath awareness practice on your own.
Cardiac rehab phase I protocols + Mindfullness base therapyOther
cardiac rehab phase I protocols: ankel pumps, limbs ROMs, bed mobility. Do 5-10 minutes daily of breath awareness practice on your own. Plus Mindfullness base therapy
| Study group | Role | What they receive |
|---|---|---|
| Cardiac rehab phase I protocols | Active comparator | will be treated with cardiac rehab phase I protocols Receives: Other: cardiac rehabilitation phase I protocols |
| Cardiac rehab phase I protocols + Mindfullness base therapy | Experimental | will be treated with cardiac rehab phase I protocols along with Mindfullness base therapy Receives: Other: Cardiac rehab phase I protocols + Mindfullness base therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Illness perception questionnaire
The model proposes that situational stimuli (such as symptoms) generate both cognitive and emotional representations of the illness or health threat. These representations are processed in parallel through three stages. 0 is minimum and 10 is maximum.
Measured: 4 months
PHQ9 for depression assessment
The Patient Health Questionnaire-9 (PHQ-9) is a nine-item questionnaire used in primary care and other medical settings to assess for depression. and The conventional cut-off score for detecting suspected major depression is 10 or higher. The Brief IPQ is a frequently used questionnaire with excellent psychometric qualities
Measured: 4 months
Secondary outcomes (1)
HRQOL for quality of life
Contemporary interpretations of HRQOL are based on the World Health Organization's definition of health as a state of complete physical, mental, and social well-being and not merely the absence of disease. contemporary HRQOL instrument domains are scored with a range of 0-100, with higher values representing better outcomes.
To make useful inferences regarding absolute scores or change scores over time
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start1 Oct 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery StenosisStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wajeeha Zia, PP-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532605
- Sponsor's protocol ID
- Sonia Ilyas
- Status last verified
- Dec 2022
- First submitted
- 5 Sep 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wenger NK. Current status of cardiac rehabilitation. J Am Coll Cardiol. 2008 Apr 29;51(17):1619-31. doi: 10.1016/j.jacc.2008.01.030.
PubMed 18436113Dalal HM, Doherty P, Taylor RS. Cardiac rehabilitation. BMJ. 2015 Sep 29;351:h5000. doi: 10.1136/bmj.h5000. No abstract available.
PubMed 26419744Heran BS, Chen JM, Ebrahim S, Moxham T, Oldridge N, Rees K, Thompson DR, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD001800. doi: 10.1002/14651858.CD001800.pub2.
PubMed 21735386Goel K, Pack QR, Lahr B, Greason KL, Lopez-Jimenez F, Squires RW, Zhang Z, Thomas RJ. Cardiac rehabilitation is associated with reduced long-term mortality in patients undergoing combined heart valve and CABG surgery. Eur J Prev Cardiol. 2015 Feb;22(2):159-68. doi: 10.1177/2047487313512219. Epub 2013 Nov 21.
PubMed 24265289Romas JA, Sharma M. Practical stress management: A comprehensive workbook: Academic Press; 2017.
Milczarek M, González ER, Schneider E. OSH in figures: Stress at work-facts and figures: Office for Official Publ. of the Europ. Communities; 2009.
Sharma M, Rush SE. Mindfulness-based stress reduction as a stress management intervention for healthy individuals: a systematic review. J Evid Based Complementary Altern Med. 2014 Oct;19(4):271-86. doi: 10.1177/2156587214543143. Epub 2014 Jul 22.
PubMed 25053754Nijjar PS, Connett JE, Lindquist R, Brown R, Burt M, Pergolski A, Wolfe A, Balaji P, Chandiramani N, Yu X, Kreitzer MJ, Everson-Rose SA. Randomized Trial of Mindfulness-Based Stress Reduction in Cardiac Patients Eligible for Cardiac Rehabilitation. Sci Rep. 2019 Dec 5;9(1):18415. doi: 10.1038/s41598-019-54932-2.
PubMed 31804580Rao A, Zecchin R, Newton PJ, Phillips JL, DiGiacomo M, Denniss AR, Hickman LD. The prevalence and impact of depression and anxiety in cardiac rehabilitation: A longitudinal cohort study. Eur J Prev Cardiol. 2020 Mar;27(5):478-489. doi: 10.1177/2047487319871716. Epub 2019 Oct 9.
PubMed 31597473Chauvet-Gelinier JC, Bonin B. Stress, anxiety and depression in heart disease patients: A major challenge for cardiac rehabilitation. Ann Phys Rehabil Med. 2017 Jan;60(1):6-12. doi: 10.1016/j.rehab.2016.09.002. Epub 2016 Oct 19.
PubMed 27771272Vieira A, Melo C, Machado J, Gabriel J. Virtual reality exercise on a home-based phase III cardiac rehabilitation program, effect on executive function, quality of life and depression, anxiety and stress: a randomized controlled trial. Disabil Rehabil Assist Technol. 2018 Feb;13(2):112-123. doi: 10.1080/17483107.2017.1297858. Epub 2017 Mar 13.
PubMed 28285574Kraal JJ, Van den Akker-Van Marle ME, Abu-Hanna A, Stut W, Peek N, Kemps HM. Clinical and cost-effectiveness of home-based cardiac rehabilitation compared to conventional, centre-based cardiac rehabilitation: Results of the FIT@Home study. Eur J Prev Cardiol. 2017 Aug;24(12):1260-1273. doi: 10.1177/2047487317710803. Epub 2017 May 23.
PubMed 28534417Kachur S, Menezes AR, De Schutter A, Milani RV, Lavie CJ. Significance of Comorbid Psychological Stress and Depression on Outcomes After Cardiac Rehabilitation. Am J Med. 2016 Dec;129(12):1316-1321. doi: 10.1016/j.amjmed.2016.07.006. Epub 2016 Jul 30.
PubMed 27480388Blumenthal JA, Sherwood A, Smith PJ, Watkins L, Mabe S, Kraus WE, Ingle K, Miller P, Hinderliter A. Enhancing Cardiac Rehabilitation With Stress Management Training: A Randomized, Clinical Efficacy Trial. Circulation. 2016 Apr 5;133(14):1341-50. doi: 10.1161/CIRCULATIONAHA.115.018926. Epub 2016 Mar 21.
PubMed 27045127Shields GE, Wells A, Doherty P, Heagerty A, Buck D, Davies LM. Cost-effectiveness of cardiac rehabilitation: a systematic review. Heart. 2018 Sep;104(17):1403-1410. doi: 10.1136/heartjnl-2017-312809. Epub 2018 Apr 13.
PubMed 29654096
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mindfulness Based Therapy on Patients Perception of Illness and Depression in Cardiac Rehabilitation Phase-i
- ClinicalTrials.gov ID
- NCT05532605
- Acronym / sponsor ID
- Sonia Ilyas
- Conditions
- Coronary Artery Stenosis
- Keywords
- depression, cardiac rehabilitation, patient perception of illness, MBSR, IPQ, HRQOL, Mindfulness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 8 Sep 2022 (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.
A randomize controlled trial will be conducted at Punjab institute of cardiology hospital Lahore, through convenience sampling technique on 48 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and Group B. Pretreatment values of patients' blood pressure, RR, HR, will be recorded. And patient's perception of illness through Illness Perception Questionnaire (IPQ), PHQ9 for depression assessment and HRQOL for quality of life will be assessed before and after treatment. Group A will be treated with basic Phase-I cardiac rehabilitation. And Group B will be treated with basic Phase-I cardiac rehabilitation along with Mindfulness based therapy. Treatment evaluation will be done after 8 weeks. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be use within a group or between two groups.
Detailed description
Cardiac rehabilitation is becoming more widely acknowledged as an important part of the overall treatment plan for individuals with cardiovascular disease. Cardiac rehabilitation programs aim to reduce the physiological and psychological impacts of heart disease.
Anxiety, depression, cardiovascular disease, and suicide are among poor health outcomes of stress, which is a global public health issue. Depression, a disorder with a significant psychological burden, has been linked to an increased risk of cardiovascular disease.
Although the exact nature of the links between depression and coronary heart disease (CHD) has yet to be determined, these links are increasingly being highlighted. The aim of the study is to find Effects of Mindfulness based therapy on patient perception of illness and depression in cardiac rehabilitation Phase-I.
A randomize controlled trial will be conducted at Punjab institute of cardiology hospital Lahore, through convenience sampling technique on 48 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and Group B. Pretreatment values of patients' blood pressure, RR, HR, will be recorded. And patient's perception of illness through Illness Perception Questionnaire (IPQ), PHQ9 for depression assessment and HRQOL for quality of life will be assessed before and after treatment. Group A will be treated with basic Phase-I cardiac rehabilitation. And Group B will be treated with basic Phase-I cardiac rehabilitation along with Mindfulness based therapy. Treatment evaluation will be done after 8 weeks. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be use within a group or between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac rehab phase I protocols | Active comparator | Other: cardiac rehabilitation phase I protocolswill be treated with cardiac rehab phase I protocols |
| Cardiac rehab phase I protocols + Mindfullness base therapy | Experimental | Other: Cardiac rehab phase I protocols + Mindfullness base therapywill be treated with cardiac rehab phase I protocols along with Mindfullness base therapy |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Phase-I CABG
- Hypertensive patients
- DM
- Patients hemodynamically stable
Key exclusion criteria (7 listed)
- Hemodynamically unstable patients
- Orthopedic conditions i.e. fracture
- Disorientated patients
- Neuromuscular disease
- pacemaker dependency
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 |
|---|---|---|
| cardiac rehabilitation phase I protocolscardiac rehab phase I protocols: ankel pumps, limbs ROMs, bed mobility. Do 5-10 minutes daily of breath awareness practice on your own. | Other | Cardiac rehab phase I protocols |
| Cardiac rehab phase I protocols + Mindfullness base therapycardiac rehab phase I protocols: ankel pumps, limbs ROMs, bed mobility. Do 5-10 minutes daily of breath awareness practice on your own. Plus Mindfullness base therapy | Other | Cardiac rehab phase I protocols + Mindfullness base therapy |
Primary outcome
Illness perception questionnaire
Time frame: 4 months
The model proposes that situational stimuli (such as symptoms) generate both cognitive and emotional representations of the illness or health threat. These representations are processed in parallel through three stages. 0 is minimum and 10 is maximum.
PHQ9 for depression assessment
Time frame: 4 months
The Patient Health Questionnaire-9 (PHQ-9) is a nine-item questionnaire used in primary care and other medical settings to assess for depression. and The conventional cut-off score for detecting suspected major depression is 10 or higher. The Brief IPQ is a frequently used questionnaire with excellent psychometric qualities
1 secondary outcome
HRQOL for quality of life
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Background: PubMed 18436113Wenger NK. Current status of cardiac rehabilitation. J Am Coll Cardiol. 2008 Apr 29;51(17):1619-31. doi: 10.1016/j.jacc.2008.01.030.
- Background: PubMed 26419744Dalal HM, Doherty P, Taylor RS. Cardiac rehabilitation. BMJ. 2015 Sep 29;351:h5000. doi: 10.1136/bmj.h5000. No abstract available.
- Background: PubMed 21735386Heran BS, Chen JM, Ebrahim S, Moxham T, Oldridge N, Rees K, Thompson DR, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD001800. doi: 10.1002/14651858.CD001800.pub2.
- Background: PubMed 24265289Goel K, Pack QR, Lahr B, Greason KL, Lopez-Jimenez F, Squires RW, Zhang Z, Thomas RJ. Cardiac rehabilitation is associated with reduced long-term mortality in patients undergoing combined heart valve and CABG surgery. Eur J Prev Cardiol. 2015 Feb;22(2):159-68. doi: 10.1177/2047487313512219. Epub 2013 Nov 21.
- BackgroundRomas JA, Sharma M. Practical stress management: A comprehensive workbook: Academic Press; 2017.
- BackgroundMilczarek M, González ER, Schneider E. OSH in figures: Stress at work-facts and figures: Office for Official Publ. of the Europ. Communities; 2009.
- Background: PubMed 25053754Sharma M, Rush SE. Mindfulness-based stress reduction as a stress management intervention for healthy individuals: a systematic review. J Evid Based Complementary Altern Med. 2014 Oct;19(4):271-86. doi: 10.1177/2156587214543143. Epub 2014 Jul 22.
- Background: PubMed 31804580Nijjar PS, Connett JE, Lindquist R, Brown R, Burt M, Pergolski A, Wolfe A, Balaji P, Chandiramani N, Yu X, Kreitzer MJ, Everson-Rose SA. Randomized Trial of Mindfulness-Based Stress Reduction in Cardiac Patients Eligible for Cardiac Rehabilitation. Sci Rep. 2019 Dec 5;9(1):18415. doi: 10.1038/s41598-019-54932-2.
- Background: PubMed 31597473Rao A, Zecchin R, Newton PJ, Phillips JL, DiGiacomo M, Denniss AR, Hickman LD. The prevalence and impact of depression and anxiety in cardiac rehabilitation: A longitudinal cohort study. Eur J Prev Cardiol. 2020 Mar;27(5):478-489. doi: 10.1177/2047487319871716. Epub 2019 Oct 9.
- Background: PubMed 27771272Chauvet-Gelinier JC, Bonin B. Stress, anxiety and depression in heart disease patients: A major challenge for cardiac rehabilitation. Ann Phys Rehabil Med. 2017 Jan;60(1):6-12. doi: 10.1016/j.rehab.2016.09.002. Epub 2016 Oct 19.
- Background: PubMed 28285574Vieira A, Melo C, Machado J, Gabriel J. Virtual reality exercise on a home-based phase III cardiac rehabilitation program, effect on executive function, quality of life and depression, anxiety and stress: a randomized controlled trial. Disabil Rehabil Assist Technol. 2018 Feb;13(2):112-123. doi: 10.1080/17483107.2017.1297858. Epub 2017 Mar 13.
- Background: PubMed 28534417Kraal JJ, Van den Akker-Van Marle ME, Abu-Hanna A, Stut W, Peek N, Kemps HM. Clinical and cost-effectiveness of home-based cardiac rehabilitation compared to conventional, centre-based cardiac rehabilitation: Results of the FIT@Home study. Eur J Prev Cardiol. 2017 Aug;24(12):1260-1273. doi: 10.1177/2047487317710803. Epub 2017 May 23.
- 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.
Wajeeha Zia, PP-DPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiac rehabilitation phase I protocols and Cardiac rehab phase I protocols + Mindfullness base therapy in people with Coronary Artery Stenosis, run by Riphah International University at 1 site in Pakistan.
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 4 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: status not confirmed, as of the sponsor's last update on 9 Dec 2022. 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 Pakistan. 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 Wajeeha Zia, PP-DPT (0323 4500788, wajeeha.zia@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Illness perception questionnaire (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05532605, which also lists 22 linked publications.
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 9 Dec 2022.