TTM-based Intervention and MI in CHD Patients

NCT03953924 | Completed

• 1 other identifier: SYang
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Heart Disease; Depression

Keywords

transtheoretical model; motivational interviewing; depression; coronary heart disease

Outcome Measures

Primary Outcomes (5)

• Stage of change for coronary heart disease patients with depression

  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 - days (T0) before discharge.

• Process of change for coronary heart disease patients with depression

  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.

  2 - days (T0) before discharge.

• Decisional balance for coronary heart disease patients with depression

  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.

  2 - days (T0) before discharge.

• Self-efficacy for coronary heart disease patients with depression: scale

  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.

  2 - days (T0) before discharge.

• Hamilton Rating Scale for Depression

  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.

  2 - days (T0) before discharge.

Secondary Outcomes (1)

• Social Demographic Data Recording Form

  on admission (T).

Study Arms (2)

Control group

NO INTERVENTION

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)

Intervention group

EXPERIMENTAL

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)

Interventions

Transtheoretical model-based (TTM - based) intervention and motivational interviewing (MI) OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central South University: lead

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MeSH Terms

Conditions

Coronary Disease; Depression

Interventions

Methods; Motivational Interviewing

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques; Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jingping Zhang, PhD.

  Central South University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 11, 2019
• First Posted: May 17, 2019
• Study Start: August 1, 2015
• Primary Completion: December 30, 2015
• Study Completion: December 30, 2015
• Last Updated: May 17, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share