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TTM-based Intervention and MI in CHD Patients

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ClinicalTrials.gov Identifier: NCT03953924
Recruitment Status : Completed
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
SiLan Yang, Central South University

Brief Summary:

In the middle of this century, coronary heart disease (CHD) is the most common cause of death in the United States. Chinese health service survey showed that about 1000,0000 ~ 320,000 people were suffering from CHD in the mainland of China in 2008. The high mortality and morbidity of CHD will aggravate the psychological burden of patients, such as depression. Depression is the most psychological problem in CHD patients. The incidence of depression in Chinese population was in the range of 4%~6%, while it was as high as 14%~17% in patients with CHD. Depression not only affects the patients' illness, but also reducing their quality of life, the compliance of drugs and lifestyle. In addition, depression is a major risk factor for the mortality and morbidity of cardiovascular disease. Therefore, it's urgently needed to screen and treat the depression of patients with CHD.

At present, the treatment of depression in patients with CHD mainly includes antidepressant, cognitive behavioral therapy, psychological counseling, knowledge education, relaxation therapy and so on. However, the medicine would yield side - effect. Furthermore, the content of psychological interventions are not systematic and dynamic. Moreover, patients' depressive level varies in different periods, the traditional psychological intervention just focused on the ultimate psychological benefits, and cannot analyze some factors and staged results in the process of psycho-behavioral change. Thus, an dynamic and effective intervention to alleviate depression in patients with CHD is imperative.


Condition or disease Intervention/treatment Phase
Coronary Heart Disease Depression Other: Transtheoretical model-based (TTM - based) intervention and motivational interviewing (MI) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

No interventions were performed for the control patients during study. However, they received conventional care (Simple and unstructured patient education about diet, exercise and so on).

Patients in the intervention group received conventional care, TTM-based intervention and MI. The intervention was provided by nurses who were trained, including two researchers and a general nurse of cardiovascular ward. The primary researcher was leader of the study. The leader explained the purpose, significance and methods of the study.

Masking: Double (Participant, Outcomes Assessor)
Masking Description: The leader of this study entered the cardiovascular medical ward and screened potential eligible patients according to medical records in each hospital. Leaders informed the purpose, significance, methods, sessions of the study to patients. Patients were randomly divided into two groups by using a block randomization list with a block size of 4 at 1:1. A research assistant put the generated random number into opaque consecutively numbered envelopes and sealed the envelopes, and then handed it to enrolling researchers. When enrolling a new participant, the enrolling investigators opened the sealed envelope after participant's name was written on next available envelopes. A sequentially numbered and opaque, sealed envelope system was used by a non-investigator. Additionally, all data collection was conducted by another research assistant who was blind to the study design and allocation of participants.
Primary Purpose: Supportive Care
Official Title: Effects of Transtheoretical Model-based Intervention and Motivational Interviewing on the Management of Depression in Hospitalized Patients With Coronary Heart Disease : A Randomized, Controlled Trial
Actual Study Start Date : August 1, 2015
Actual Primary Completion Date : December 30, 2015
Actual Study Completion Date : December 30, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control group
No interventions were performed for the control patients during the study. While those in the control group were given conventional care ( nursing procedure, education about diet, exercise and so on)
Experimental: Intervention group
The patients in intervention group received conventional care, transtheoretical model-based (TTM-based) intervention and motivational interviewing (MI).
Other: Transtheoretical model-based (TTM - based) intervention and motivational interviewing (MI)
The MI was implemented 2 times, 20 minutes each time, the trained nurse interviewed each patient face-to-face by bedside. Based on the evaluation results and motivational interviewing, the change stages of the patients' behavior changes were identified. According to the changing stage,TTM - based intervention was given 3 times in the form of a small course, 20 minutes each time, the key point was divided into three stages.




Primary Outcome Measures :
  1. Stage of change for coronary heart disease patients with depression [ Time Frame: 2 - days (T0) before discharge. ]
    The subscale was used for measuring the stages of individual depression management behavior, it consisted of one item and five statements(precontemplation, contemplation, preparation, action, maintenance). The scale has good reliability and the retest reliability and the reliability was 0.790.

  2. Process of change for coronary heart disease patients with depression [ Time Frame: 2 - days (T0) before discharge. ]
    Process of change subscale was used to evaluated individuals' experiences or activities that can influence individuals to take effective measures to manage depression. It had 30 items. Each item was scored from 1 (never) to 5 (always). The higher the dimension score, the higher the frequency of use of the process. The Cronbach's alpha of experimental processes and behavioral processes was 0.786, 0.817.

  3. Decisional balance for coronary heart disease patients with depression [ Time Frame: 2 - days (T0) before discharge. ]
    The subscale was used to assess the importance of individuals to take effective methods to manage depression and determine the importance of taking action. It comprised 12 items and two dimensions that perceived benefits and perceived barriers. Each item was scored from 1 (not important) to 5 (extremely important). The Cronbach's alpha of perceived benefits and perceived barriers was 0.690, 0.700.

  4. Self-efficacy for coronary heart disease patients with depression: scale [ Time Frame: 2 - days (T0) before discharge. ]
    The subscale consisted of 6 items. Each item was scored from 1 (no confidence at all) to 5 (full of confidence), the scores reflect the degree of confidence in managing depression effectively. Higher scores reflect higher confidence. The Cronbach's alpha of subscale was 0.735.

  5. Hamilton Rating Scale for Depression [ Time Frame: 2 - days (T0) before discharge. ]
    The scale was compiled in 1960 by Hamilton, including 24 items. A few items (4th, 5th, 6th, 12tn, 14th, 16th, 17th, 18th, 21st items) were evaluated with 0-2 points scoring method, the rest of the items were divided into 0-4 points scoring method. Higher total scores reflect serious depression. In this study, Cronbach's alpha was 0.819.


Secondary Outcome Measures :
  1. Social Demographic Data Recording Form [ Time Frame: on admission (T). ]
    Patients' demographic information was obtained from the social demographic data recording form and medical records.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Criteria: Inclusion Criteria:

  • Be diagnosed as coronary heart disease (typical clinical angina manifestations, electrocardiogram changes, and coronary angiography) confirmed by the World Health Organization / International Cardiology in October 1997 and cardiac function is graded from I to III;
  • Must be volunteered to participate in the study;
  • Must be conscious with clear communication ability.

Exclusion Criteria:

  • Had cerebrovascular accident, malignant tumor, malignant hypertension(systolic pressure >180 and/or diastolic pressure >100 mmHg);
  • Had a psychiatric history or serious cognitive conscious obstacles;
  • Had been participated in other similar research subjects;
  • No mobile phone or home phone is available for contacts.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953924


Sponsors and Collaborators
Central South University
Investigators
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Study Chair: Jingping Zhang, PhD. Central South University

Publications of Results:
Lichtman JH, Bigger JT Jr, Blumenthal JA, Frasure-Smith N, Kaufmann PG, Lespérance F, Mark DB, Sheps DS, Taylor CB, Froelicher ES; American Heart Association Prevention Committee of the Council on Cardiovascular Nursing; American Heart Association Council on Clinical Cardiology; American Heart Association Council on Epidemiology and Prevention; American Heart Association Interdisciplinary Council on Quality of Care and Outcomes Research; American Psychiatric Association. Depression and coronary heart disease: recommendations for screening, referral, and treatment: a science advisory from the American Heart Association Prevention Committee of the Council on Cardiovascular Nursing, Council on Clinical Cardiology, Council on Epidemiology and Prevention, and Interdisciplinary Council on Quality of Care and Outcomes Research: endorsed by the American Psychiatric Association. Circulation. 2008 Oct 21;118(17):1768-75. doi: 10.1161/CIRCULATIONAHA.108.190769. Epub 2008 Sep 29.

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Responsible Party: SiLan Yang, Principal Investigator, Central South University
ClinicalTrials.gov Identifier: NCT03953924     History of Changes
Other Study ID Numbers: SYang
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The process of data collection cost a lot of human and material resources,some of the data was privacy information of participants, and so on.Considering this, it is improper to share these data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by SiLan Yang, Central South University:
transtheoretical model
motivational interviewing
depression
coronary heart disease

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Behavioral Symptoms
Mood Disorders
Mental Disorders
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases