TTM-based Intervention and MI in CHD Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03953924|
Recruitment Status : Completed
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Study Chair:||Jingping Zhang, PhD.||Central South University|