NCT04949945: CaCBT

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

Status unknown NA Last updated 8 September 2021

What this trial tests

NA trial testing Self Help Culturally Cognitive Behavioral Therapy in Chronic Heart Failure in 70 participants. Status unknown.

Timeline

1 February 2021

Primary endpoint
10 September 2021

29 November 2021

Quick facts

Lead sponsor	Islamia University of Bahawalpur
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	70
Start date	1 February 2021
Primary completion	10 September 2021
Estimated completion	29 November 2021
Sites	1 location across Pakistan

Drugs / interventions tested

• Self Help Culturally Cognitive Behavioral Therapy

Conditions studied

• Chronic Heart Failure — all drugs for Chronic Heart Failure →
• Depression — all drugs for Depression →

Sponsor

Islamia University of Bahawalpur

Who can join

Adults 18 to 60, any sex, with Chronic Heart Failure or Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.