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

Islamia University of Bahawalpur

Status

Unknown

Conditions

Chronic Heart Failure

Depression

Treatments

Behavioral: Self Help Culturally Cognitive Behavioral Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04949945

IslamiaB

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Chronic heart failure patient will be assessed by the following inclusion criteria; patients with

Diagnosed heart failure patients for 6 and more than 6 months duration,
EF < 40 % on Echocardiography ,
class II and III of NYHA heart failure,
"mild" to "severe" depression based on patients health questionnaire 9
who can understand, read, and write in Urdu will be included in study.

Exclusion criteria

Chronic heart failure patient will be assessed by the following exclusion criteria; patient with

any psychiatric disorders except depression,
substance dependence, mental retardation, personality disorders,
who have had received any psychotherapy or any psychiatric medication,
who are not willing to continue the sessions anymore, and the absence in more than two sessions will be excluded.