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

Primary Purpose

Coronary Artery Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
cardiac rehabilitation phase I protocols
Cardiac rehab phase I protocols + Mindfullness base therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Stenosis focused on measuring depression, cardiac rehabilitation, patient perception of illness, MBSR, IPQ, HRQOL, Mindfulness

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Punjab institute of cardiology hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cardiac rehab phase I protocols

Cardiac rehab phase I protocols + Mindfullness base therapy

Arm Description

will be treated with cardiac rehab phase I protocols

will be treated with cardiac rehab phase I protocols along with Mindfullness base therapy

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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

Full Information

First Posted
September 5, 2022
Last Updated
December 7, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05532605
Brief Title
Effects of Mindfulness Based Therapy on Illness and Depression in Cardiac Rehab Phase-i
Official Title
Effects of Mindfulness Based Therapy on Patients Perception of Illness and Depression in Cardiac Rehabilitation Phase-i
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Stenosis
Keywords
depression, cardiac rehabilitation, patient perception of illness, MBSR, IPQ, HRQOL, Mindfulness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cardiac rehab phase I protocols
Arm Type
Active Comparator
Arm Description
will be treated with cardiac rehab phase I protocols
Arm Title
Cardiac rehab phase I protocols + Mindfullness base therapy
Arm Type
Experimental
Arm Description
will be treated with cardiac rehab phase I protocols along with Mindfullness base therapy
Intervention Type
Other
Intervention Name(s)
cardiac rehabilitation phase I protocols
Intervention Description
cardiac rehab phase I protocols: ankel pumps, limbs ROMs, bed mobility. Do 5-10 minutes daily of breath awareness practice on your own.
Intervention Type
Other
Intervention Name(s)
Cardiac rehab phase I protocols + Mindfullness base therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Illness perception questionnaire
Description
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.
Time Frame
4 months
Title
PHQ9 for depression assessment
Description
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
Time Frame
4 months
Secondary Outcome Measure Information:
Title
HRQOL for quality of life
Description
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
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wajeeha Zia, PP-DPT
Phone
0323 4500788
Email
wajeeha.zia@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wajeeha Zia, PP-DPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Punjab institute of cardiology hospital
City
Lahore
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wajeeha Zia, MS
Phone
+92 323 4500788
Email
wajeeha.zia@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Sonia ilyas, MS*

12. IPD Sharing Statement

Plan to Share IPD
No
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Effects of Mindfulness Based Therapy on Illness and Depression in Cardiac Rehab Phase-i

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