Clinical trial NCT05532605: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Stenosis
Keywords: depression
cardiac rehabilitation
patient perception of illness
MBSR
IPQ
HRQOL
Mindfulness
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Illness perception questionnaire
timeFrame: 4 months
measure: PHQ9 for depression assessment
timeFrame: 4 months
Secondary outcomes:
measure: HRQOL for quality of life
timeFrame: 4 months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Punjab institute of cardiology hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Wajeeha Zia, PP-DPT
role: PRINCIPAL_INVESTIGATOR
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