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

Not Applicable
Recruiting
Conditions
Coronary Artery Stenosis
Interventions
Other: cardiac rehabilitation phase I protocols
Other: Cardiac rehab phase I protocols + Mindfullness base therapy
Registration Number
NCT05532605
Lead Sponsor
Riphah International University
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.

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
48
Inclusion Criteria
  • Phase-I CABG
  • Hypertensive patients
  • DM
  • Patients hemodynamically stable
Exclusion Criteria
  • Hemodynamically unstable patients
  • Orthopedic conditions i.e. fracture
  • Disorientated patients
  • Neuromuscular disease
  • pacemaker dependency
  • Uncontrolled arrhythmias
  • Red Flags Like: Fever, Night Sweats, Malaise

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Cardiac rehab phase I protocolscardiac rehabilitation phase I protocolswill be treated with cardiac rehab phase I protocols
Cardiac rehab phase I protocols + Mindfullness base therapyCardiac rehab phase I protocols + Mindfullness base therapywill be treated with cardiac rehab phase I protocols along with Mindfullness base therapy
Primary Outcome Measures
NameTimeMethod
Illness perception questionnaire4 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 assessment4 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

Secondary Outcome Measures
NameTimeMethod
HRQOL for quality of life4 months

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

Trial Locations

Locations (1)

Punjab institute of cardiology hospital

🇵🇰

Lahore, Punjab, Pakistan

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