Efficacy of CBT on Positive Health Outcomes of Chronic Heart Failure

Status Active, not recruiting

Clinical Trial 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 Ch.Pervaiz Elahi Institute of Cardiology Multan.Total measured sample size is 70 calculated by using G*Power 3.1.9.4.Patients will be randomized into Interventional and Control group, with 1:1 allocation, 35 patients in each group by virtual randomization(www.randomization.com). 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 2.0 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04949945
Study type	Interventional
Source	Islamia University of Bahawalpur
Contact
Status	Active, not recruiting
Phase	N/A
Start date	February 1, 2021
Completion date	November 29, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Efficacy of CBT on Positive Health Outcomes of Chronic Heart Failure Patients With Depression — CaCBT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms