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

NCT ID: NCT04949945

Last Updated: 2021-09-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2021-11-29

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.

Conditions

Chronic Heart Failure; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CHF patients who will receive guided self help culturally adapted cognitive behavioral therapy

CHF(Chronic heart failure patients)(experimental group) will receive guided self help culturally adapted cognitive behavioral therapy.

Group Type: EXPERIMENTAL

Self Help Culturally Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

Experimental group (CHF patients)will be screened on PHQ9 questionnaire for depression after receiving guided self help culturally adapted cognitive therapy they will be reassessed for their depression,improvement in functional disability ,improvement in classification of NYHA,reduction in hospital admission as compare to control group.

CHF patients will not receive guided self help culturally adapted cognitive behavioral therapy

CHF(Chronic heart failure patients) (control group) will not receive Self Help Culturally Cognitive Behavior Therapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Self Help Culturally Cognitive Behavioral Therapy

Experimental group (CHF patients)will be screened on PHQ9 questionnaire for depression after receiving guided self help culturally adapted cognitive therapy they will be reassessed for their depression,improvement in functional disability ,improvement in classification of NYHA,reduction in hospital admission as compare to control group.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Islamia University of Bahawalpur

OTHER

Sponsor Role: lead

Responsible Party

Saima Dastgeer

Student of PhD of Applied psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chauhdary Pervaiz Ellahi Institute of Cardiology

Multan, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

IslamiaB

Identifier Type: -

Identifier Source: org_study_id