Ignite Creation Date:
2024-05-06 @ 4:19 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04949945
Status:
UNKNOWN
Last Update Posted:
2021-09-08
First Post:
2021-06-03
Brief Title:
Efficacy of CBT on Positive Health Outcomes of Chronic Heart Failure Patients With Depression
Sponsor:
Islamia University of Bahawalpur
Organization:
Islamia University of Bahawalpur
Study Overview
Official Title:
Efficacy of CBT on Positive Health Outcomes of Chronic Heart Failure Patients With Depression A Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CaCBT
Brief Summary:
The purpose of the study is to know the efficacy of Cognitive Behaviour Therapy on Positive Health Outcomes of Chronic Heart Failure Patients with Depression It is a Randomized Control Trial RCT in which patients will be selected through purposive sampling techniques Ages of patients will be 18-60 years Data will be collected at outpatient department OPD of ChPervaiz Elahi Institute of Cardiology MultanTotal measured sample size is 70 calculated by using GPower 3194Patients will be randomized into Interventional and Control group with 11 allocation 35 patients in each group by virtual randomizationwwwrandomizationcom Diagnosed patients of heart failure for 6 or more than 6 months duration EF 40 on Trans Thoracic Echocardiography patients with NYHA Heart Failure class II and III patients with mild to severe level of depression based on PHQ-9 Patients with other Psychiatric Disorders except depression any substance dependence mentally retarded having personality disorders already have received any psychotherapy or any psychiatric medication will be excluded Patients will be assessed for functional disability by WHODAS 20 and severity of Heart Failure will be assessed by a Cardiologist using NYHA Heart Failure classification Patients in experimental group will receive treatment as usual TAU and culturally adapted Cognitive Behavior Therapy Patients in control group will receive treatment as usual TAU by a Cardiologist
The aim of this experimental study is to study the efficacy of culturally adapted Cognitive Behavioral Therapy in patients with chronic heart failure with depression To study the above-mentioned phenomenon following hypotheses are formulated
Hypothesis 1
Patients receiving culturally adapted Cognitive-Behavioral Therapy will show reduction in their level of depression than patients not receiving intervention
Hypothesis 2
Patients will improve in NHYA heart failure class by receiving CaCBT in experimental group as compared to control group
Hypothesis 3
Patients who will receive CaCBT will show less repeated Hospitalization in experimental group as compared to control group
Hypothesis 4
Patients in the intervention group will show betterment in the functional disability from pretest to post-test as compared to non- interventional group
The aim of this experimental study is to study the efficacy of culturally adapted Cognitive Behavioral Therapy in patients with chronic heart failure with depression To study the above-mentioned phenomenon following hypotheses are formulated
Hypothesis 1
Patients receiving culturally adapted Cognitive-Behavioral Therapy will show reduction in their level of depression than patients not receiving intervention
Hypothesis 2
Patients will improve in NHYA heart failure class by receiving CaCBT in experimental group as compared to control group
Hypothesis 3
Patients who will receive CaCBT will show less repeated Hospitalization in experimental group as compared to control group
Hypothesis 4
Patients in the intervention group will show betterment in the functional disability from pretest to post-test as compared to non- interventional group
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None