Clinical trial NCT04949945: Efficacy of CBT on Positive Health Outcomes of Chronic Heart Failure Patients With Depression
Official title: Efficacy of CBT on Positive Health Outcomes of Chronic Heart Failure Patients With Depression: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Heart Failure
Depression
Keywords: Chronic Heart Failure
Depression
Self Help Culturally Cognitive Behavioral Therapy
Lead sponsor: Islamia University of Bahawalpur
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion Criteria:

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

1. Diagnosed heart failure patients for 6 and more than 6 months duration,
2. EF \< 40 % on Echocardiography ,
3. class II and III of NYHA heart failure,
4. "mild" to "severe" depression based on patients health questionnaire 9
5. 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

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

Primary outcomes:
measure: change in scores of depression measured by patients' health questionnaire 9
timeFrame: change from baseline scores of depression at 2 and half months of intervention in experimental and control group.
Secondary outcomes:
measure: change in functional disability by world health organization disability assessment schedule II version.
timeFrame: Change in functional disability scores by world health organization disability assessment schedule II version will be measured from baseline to 2 and half months of intervention in control and experimental group.
measure: Change in New York Heart Association Classification of patients by a consultant cardiologist.
timeFrame: Change in class of New York Heart Association Classification of patients at 2 and half months of intervention and will be measured by a consultant cardiologist on New York Heart Association Classification in experimental and control group.
measure: Change in number of repeated hospitalization by patients' feedback.
timeFrame: Change in experimental group's number of repeated hospitalization compared to control group's repeated number of hospitalization after 2 and half months of intervention.
Other outcomes:
Locations:
city: Multan
country: Pakistan
facility: Chauhdary Pervaiz Ellahi Institute of Cardiology
state: Punjab
Study officials:
References: