Effects of Mindfulness Based Therapy on Illness and Depression in Cardiac Rehab Phase-i

NCT05532605 | Unknown

• 1 other identifier: Sonia Ilyas
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

depression; cardiac rehabilitation; patient perception of illness; MBSR; IPQ; HRQOL; Mindfulness

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  4 months

Secondary Outcomes (1)

• HRQOL for quality of life

  4 months

Study Arms (2)

Cardiac rehab phase I protocols

ACTIVE COMPARATOR

will be treated with cardiac rehab phase I protocols

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

Other: Cardiac rehab phase I protocols + Mindfullness base therapy

Interventions

cardiac rehabilitation phase I protocols OTHER

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

Cardiac rehab phase I protocols + Mindfullness base therapy OTHER

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

Cardiac rehab phase I protocols + Mindfullness base therapy

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Phase-I CABG
• Hypertensive patients
• Patients hemodynamically stable

You may not qualify if:

• Hemodynamically unstable patients
• Orthopedic conditions i.e. fracture
• Disorientated patients
• Neuromuscular disease
• pacemaker dependency
• Uncontrolled arrhythmias
• Red Flags Like: Fever, Night Sweats, Malaise

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Punjab institute of cardiology hospital

Lahore, Punjab Province, Pakistan

RECRUITING

Related Publications (22)

• 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.

  PMID: 18436113 BACKGROUND

• Dalal HM, Doherty P, Taylor RS. Cardiac rehabilitation. BMJ. 2015 Sep 29;351:h5000. doi: 10.1136/bmj.h5000. No abstract available.

  PMID: 26419744 BACKGROUND

• Heran 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.

  PMID: 21735386 BACKGROUND

• Goel 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.

  PMID: 24265289 BACKGROUND

• Romas JA, Sharma M. Practical stress management: A comprehensive workbook: Academic Press; 2017.

  BACKGROUND

• Milczarek M, González ER, Schneider E. OSH in figures: Stress at work-facts and figures: Office for Official Publ. of the Europ. Communities; 2009.

  BACKGROUND

• 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.

  PMID: 25053754 BACKGROUND

• Nijjar 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.

  PMID: 31804580 BACKGROUND

• Rao 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.

  PMID: 31597473 BACKGROUND

• Chauvet-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.

  PMID: 27771272 BACKGROUND

• Vieira 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.

  PMID: 28285574 BACKGROUND

• Kraal 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.

  PMID: 28534417 BACKGROUND

• Kachur 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.

  PMID: 27480388 BACKGROUND

• Blumenthal 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.

  PMID: 27045127 BACKGROUND

• Shields 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.

  PMID: 29654096 BACKGROUND

• Broadbent E, Wilkes C, Koschwanez H, Weinman J, Norton S, Petrie KJ. A systematic review and meta-analysis of the Brief Illness Perception Questionnaire. Psychol Health. 2015;30(11):1361-85. doi: 10.1080/08870446.2015.1070851. Epub 2015 Aug 26.

  PMID: 26181764 BACKGROUND

• Knapen J, Vancampfort D, Morien Y, Marchal Y. Exercise therapy improves both mental and physical health in patients with major depression. Disabil Rehabil. 2015;37(16):1490-5. doi: 10.3109/09638288.2014.972579. Epub 2014 Oct 24.

  PMID: 25342564 BACKGROUND

• Jolly K, Lip GY, Sandercock J, Greenfield SM, Raftery JP, Mant J, Taylor R, Lane D, Lee KW, Stevens AJ. Home-based versus hospital-based cardiac rehabilitation after myocardial infarction or revascularisation: design and rationale of the Birmingham Rehabilitation Uptake Maximisation Study (BRUM): a randomised controlled trial [ISRCTN72884263]. BMC Cardiovasc Disord. 2003 Sep 10;3:10. doi: 10.1186/1471-2261-3-10. Epub 2003 Sep 10.

  PMID: 12964946 BACKGROUND

• Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.

  PMID: 16731240 BACKGROUND

• Martin A, Rief W, Klaiberg A, Braehler E. Validity of the Brief Patient Health Questionnaire Mood Scale (PHQ-9) in the general population. Gen Hosp Psychiatry. 2006 Jan-Feb;28(1):71-7. doi: 10.1016/j.genhosppsych.2005.07.003.

  PMID: 16377369 BACKGROUND

• Moriarty DG, Zack MM, Kobau R. The Centers for Disease Control and Prevention's Healthy Days Measures - population tracking of perceived physical and mental health over time. Health Qual Life Outcomes. 2003 Sep 2;1:37. doi: 10.1186/1477-7525-1-37.

  PMID: 14498988 BACKGROUND

• Bishop SR. What do we really know about mindfulness-based stress reduction? Psychosom Med. 2002 Jan-Feb;64(1):71-83. doi: 10.1097/00006842-200201000-00010.

  PMID: 11818588 BACKGROUND

MeSH Terms

Conditions

Coronary Stenosis; Depression

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Behavioral Symptoms; Behavior

Study Officials

• Wajeeha Zia, PP-DPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wajeeha Zia, PP-DPT

CONTACT

0323 4500788; wajeeha.zia@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 8, 2022
• Study Start: October 1, 2022
• Primary Completion: December 30, 2022
• Study Completion: January 1, 2023
• Last Updated: December 9, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)