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

September 5, 2021 updated by: Saima Dastgeer, Islamia University of Bahawalpur

Efficacy of CBT on Positive Health Outcomes of Chronic Heart Failure Patients With Depression: A Randomized Controlled Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Multan, Punjab, Pakistan, 60000
        • Chauhdary Pervaiz Ellahi Institute of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in scores of depression measured by patients' health questionnaire 9
Time Frame: change from baseline scores of depression at 2 and half months of intervention in experimental and control group.
change in scores of depression will be measured by Patients' Health Questionnaire 9. The PHQ-9 total score ranges from 0 to 27 (scores of 0- 4 are classified as none,5-9 mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; 20-27 as severe depression )from baseline to 2 and half months of intervention in control and experimental group.
change from baseline scores of depression at 2 and half months of intervention in experimental and control group.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in functional disability by world health organization disability assessment schedule II version.
Time Frame: 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.
change in functional disability scores in control and experimental group by world health organization disability assessment schedule II version from baseline to 2 and half months of intervention in control and experimental group. It has 12 items for each item the patient has five choices; the score, depending on the choice, ranges from 0 (none) through to 4 (extreme). Therefore, the total score ranges from 0 to 48 points, with higher scores indicating higher functional disability. The score is expressed in percentage (divided by 48 and multiplied by 100 ) .The severity of functional disability is based on the calculated percentage as follows: none (0-4%), mild (5-24%), moderate (25-49%), severe (50-95%), and complete (96-100%) .
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.
Change in New York Heart Association Classification of patients by a consultant cardiologist.
Time Frame: 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.

Change in class of patients measured by a consultant cardiologist on New York Heart Association Classification( The New York Heart Association functional class was categorized into four classification system of physical functioning which is ranged from I no symptoms that have an impact on ordinary daily activities to IV symptoms occur at rest

)in experimental and control group after 2 and half months of intervention .
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.
Change in number of repeated hospitalization by patients' feedback.
Time Frame: 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.
Change in number of repeated hospitalization of experimental group will be measured by patients' feedback comparing with control group's repeated numbers of hospitalization after 2 and half month of intervention .
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Islamia University of Bahawalpur

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Anticipated)

September 10, 2021

Study Completion (Anticipated)

November 29, 2021

Study Registration Dates

First Submitted

June 3, 2021

First Submitted That Met QC Criteria

July 1, 2021

First Posted (Actual)

July 2, 2021

Study Record Updates

Last Update Posted (Actual)

September 8, 2021

Last Update Submitted That Met QC Criteria

September 5, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IslamiaB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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