Chronic Heart FailureCaCBTNCT04949945
Efficacy of CBT on Positive Health Outcomes of Chronic Heart Failure Patients With Depression
A study testing Self Help Culturally Cognitive Behavioral Therapy in people with Chronic Heart Failure and Depression, run by Islamia University of Bahawalpur at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Heart Failure, Depression
- What is being tested?
- Self Help Culturally Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2021to 29 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Chauhdary Pervaiz Ellahi Institute of Cardiology
Multan, Punjab Province, 60000
About this study
Official title: 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:
Read more
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
- Being tested
- Self Help Culturally Cognitive Behavioral Therapy
- Keywords
- Chronic Heart Failure, Depression, Self Help Culturally Cognitive Behavioral Therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self Help Culturally Cognitive Behavioral TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CHF patients who will receive guided self help culturally adapted cognitive behavioral therapy | Experimental | CHF(Chronic heart failure patients)(experimental group) will receive guided self help culturally adapted cognitive behavioral therapy. Receives: Behavioral: Self Help Culturally Cognitive Behavioral Therapy |
| CHF patients will not receive guided self help culturally adapted cognitive behavioral therapy | No intervention | CHF(Chronic heart failure patients) (control group) will not receive Self Help Culturally Cognitive Behavior Therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in scores of depression measured by patients' health questionnaire 9
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.
Measured: change from baseline scores of depression at 2 and half months of intervention in experimental and control group.
Secondary outcomes (3)
change in functional disability by world health organization disability assessment schedule II version.
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%) .
Measured: 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.
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 .
Measured: 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.
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 .
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start1 Feb 2021
- Primary completion10 Sep 2021 (estimated)
- Study completion29 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Islamia University of Bahawalpur
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saima Dastgeer, Islamia University of Bahawalpur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949945
- Sponsor's protocol ID
- IslamiaB
- Acronym
- CaCBT
- Status last verified
- Sep 2021
- First submitted
- 3 Jun 2021
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of CBT on Positive Health Outcomes of Chronic Heart Failure Patients With Depression: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04949945
- Acronym / sponsor ID
- CaCBT / IslamiaB
- Conditions
- Chronic Heart Failure, Depression
- Keywords
- Chronic Heart Failure, Depression, Self Help Culturally Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Islamia University of BahawalpurUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 10 Sep 2021 (estimated)
- Study completion
- 29 Nov 2021 (estimated)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHF patients who will receive guided self help culturally adapted cognitive behavioral therapy | Experimental | Behavioral: Self Help Culturally Cognitive Behavioral TherapyCHF(Chronic heart failure patients)(experimental group) will receive guided self help culturally adapted cognitive behavioral therapy. |
| CHF patients will not receive guided self help culturally adapted cognitive behavioral therapy | No intervention | –CHF(Chronic heart failure patients) (control group) will not receive Self Help Culturally Cognitive Behavior Therapy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self Help Culturally Cognitive Behavioral TherapyExperimental 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. | Behavioural | CHF patients who will receive guided self help culturally adapted cognitive behavioral therapy |
Primary outcome
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.
3 secondary outcomes
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 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 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self Help Culturally Cognitive Behavioral Therapy in people with Chronic Heart Failure and Depression, run by Islamia University of Bahawalpur at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.