Coronary Heart DiseaseNCT03953924
TTM-based Intervention and MI in CHD Patients
A study testing Transtheoretical model-based (TTM - based) intervention and motivational interviewing (MI) in people with Coronary Heart Disease and Depression, run by Central South University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease, Depression
- What is being tested?
- Transtheoretical model-based (TTM - based) intervention and motivational interviewing (MI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2015to 30 Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
About this study
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
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.
Read the detailed description
The transtheoretical model (TTM) is a purposeful behavioral change model. It is a systematic study of people's behavior change based on a variety of theories. Effective outcomes with TTM also have been applied in many studies of health behavior change, especially in the field of two aspects: on the one hand, to change unhealthy behaviors such as smoking, drinking, weight control and so on. Besides, a way to involve individuals in health behavior change is motivational interviewing (MI). MI is a way that taking patients as the center approach to interpersonal communication, which helps patients discover and overcome their ambivalence, thereby triggering behavioral changes. A study showed that MI might have favorable effects on changing patients' depression and found that the effect of a single use of MI was better than that of cognitive-behavioral therapy. In summary, the TTM-based interventions and MI were used to change behavior fields. To our knowledge, few studies have been conducted to determine the effects of the TTM-based intervention and MI on depression. Therefore, this study decided to determine the effects of TTM-based intervention and MI on the management of depression in hospitalized patients with CHD.
The aim of this study was to determine the effects of TTM-based intervention and MI on patients' stages of change, processes of change, decisional balance, self-efficacy, and depression. The study's hypothesis was: (1) The patients in the intervention group would be a positive shift in stages of change, the scores of cognitive level, behavioral level, perceived benefits, self-efficacy, perceived barriers and depression after intervention compared with the control group.
The sample comprised 110 (each group: 55) patients with coronary heart disease (CHD) in the Medicine-Cardiovascular Departments of three hospitals in Changsha.
The whole trail was on the basis of the CONSORT statements and a single, blind, randomized, controlled trial. Study procedures were approved by the institutional review boards of all participating All patients were recruited by enrolling researchers for eligibility and then enrolled in the study if they were eligible and informed consent. 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 the eligible patients were recruited in the study, the enrolling researchers numbered the patients, opening the same numbers sealed envelopes. The enrolling researchers were blind about the design of this study.
The patients in the intervention group received conventional care, TTM-based intervention and MI; Interventions were provided by trained nurses. First, The leader of this research contacted the hospital, getting the consent of the relevant departments and ward heads of the hospital to screen research objects before the beginning of the study, telling patients the purpose, significance, methods of the research, times to fill out the questionnaire, and the possible risks and benefits of the study.
The MI was implemented 2 times, 20 minutes each time, the trained nurses interviewed each patient face-to-face in the unit. Data were collected at 2 time points: the patient was on admission (T, obtain the baseline information) and the patient was 2- days before discharged (T0, obtain the information after intervention), according to the assessment of their current stage of change and depression delivered by filling the Stages of Change Subscale and Hamilton Rating Scale. TTM - based intervention was given 3 times in the form of a small course, 20 minutes each time according to the changing stage.
No interventions were performed for the control group participants during the study. However, these patients received conventional care ( nursing procedure, education about diet, exercise and so on).
Data were collected by a research assistant who was blind to the study design and allocation of participants. At baseline, sociodemographic and clinical characteristics were collected from medical records and personal interviews.
- Conditions
- Coronary Heart Disease, Depression
- Being tested
- Transtheoretical model-based (TTM - based) intervention and motivational interviewing (MI)
- Keywords
- transtheoretical model, motivational interviewing, depression, coronary heart disease
- Medical subject headings
- Coronary Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Transtheoretical model-based (TTM - based) intervention and motivational interviewing (MI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 - days (T0) before discharge.
Secondary outcomes (1)
Social Demographic Data Recording Form
Patients' demographic information was obtained from the social demographic data recording form and medical records.
Measured: on admission (T).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start1 Aug 2015
- Primary completion30 Dec 2015
- Study completion30 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SiLan Yang, Central South University
- Investigators
- Jingping Zhang, PhD., Study chair, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953924
- Sponsor's protocol ID
- SYang
- Status last verified
- May 2019
- First submitted
- 11 May 2019
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Aghaei M, Samkhaniyan E, Mahdavi A, Faraji J, Roshandel Z. Effectiveness of behavioral-cognitive group therapy on depression, anxiety, and stress of patients with coronary heart disease. J Med Life. 2015;8(Spec Iss 4):252-257.
PubMed 28316740Albus C, Ladwig KH, Herrmann-Lingen C. [Psychocardiology: clinically relevant recommendations regarding selected cardiovascular diseases]. Dtsch Med Wochenschr. 2014 Mar;139(12):596-601. doi: 10.1055/s-0033-1360102. Epub 2014 Mar 11. German.
PubMed 24619718Anastopoulou K, Fradelos EC, Misouridou E, Kourakos M, Berk A, Papathanasiou IV, Kleisiaris C, Zyga S. Moderating Nutritious Habits in Psychiatric Patients Using Transtheoretical Model of Change and Counseling. Adv Exp Med Biol. 2017;988:63-71. doi: 10.1007/978-3-319-56246-9_5.
PubMed 28971389Arri SS, Ryan M, Redwood SR, Marber MS. Mental stress-induced myocardial ischaemia. Heart. 2016 Mar;102(6):472-80. doi: 10.1136/heartjnl-2014-307306. Epub 2016 Jan 4. No abstract available.
PubMed 26729692Belialov FI. [Depression, anxiety, and stress in patients with coronary heart disease]. Ter Arkh. 2017;89(8):104-109. doi: 10.17116/terarkh2017898104-109. Russian.
PubMed 28914859Blumenthal JA, Babyak MA, O'Connor C, Keteyian S, Landzberg J, Howlett J, Kraus W, Gottlieb S, Blackburn G, Swank A, Whellan DJ. Effects of exercise training on depressive symptoms in patients with chronic heart failure: the HF-ACTION randomized trial. JAMA. 2012 Aug 1;308(5):465-74. doi: 10.1001/jama.2012.8720.
PubMed 22851113Alcantara C, Muntner P, Edmondson D, Safford MM, Redmond N, Colantonio LD, Davidson KW. Perfect storm: concurrent stress and depressive symptoms increase risk of myocardial infarction or death. Circ Cardiovasc Qual Outcomes. 2015 Mar;8(2):146-54. doi: 10.1161/CIRCOUTCOMES.114.001180. Epub 2015 Mar 10.
PubMed 25759443Carney RM, Freedland KE. Depression and coronary heart disease. Nat Rev Cardiol. 2017 Mar;14(3):145-155. doi: 10.1038/nrcardio.2016.181. Epub 2016 Nov 17.
PubMed 27853162Dalen JE, Alpert JS, Goldberg RJ, Weinstein RS. The epidemic of the 20(th) century: coronary heart disease. Am J Med. 2014 Sep;127(9):807-12. doi: 10.1016/j.amjmed.2014.04.015. Epub 2014 May 5.
PubMed 24811552Skaal L, Pengpid S. The predictive validity and effects of using the transtheoretical model to increase the physical activity of healthcare workers in a public hospital in South Africa. Transl Behav Med. 2012 Dec;2(4):384-391. doi: 10.1007/s13142-012-0136-5. Epub 2012 May 31.
PubMed 23293685Evers KE, Prochaska JO, Johnson JL, Mauriello LM, Padula JA, Prochaska JM. A randomized clinical trial of a population- and transtheoretical model-based stress-management intervention. Health Psychol. 2006 Jul;25(4):521-9. doi: 10.1037/0278-6133.25.4.521.
PubMed 16846327Hammadah M, Al Mheid I, Wilmot K, Ramadan R, Shah AJ, Sun Y, Pearce B, Garcia EV, Kutner M, Bremner JD, Esteves F, Raggi P, Sheps DS, Vaccarino V, Quyyumi AA. The Mental Stress Ischemia Prognosis Study: Objectives, Study Design, and Prevalence of Inducible Ischemia. Psychosom Med. 2017 Apr;79(3):311-317. doi: 10.1097/PSY.0000000000000442.
PubMed 28002382Hoy J, Natarajan A, Petra MM. Motivational Interviewing and the Transtheoretical Model of Change: Under-Explored Resources for Suicide Intervention. Community Ment Health J. 2016 Jul;52(5):559-67. doi: 10.1007/s10597-016-9997-2. Epub 2016 Feb 17.
PubMed 26886871Johnson SS, Paiva AL, Cummins CO, Johnson JL, Dyment SJ, Wright JA, Prochaska JO, Prochaska JM, Sherman K. Transtheoretical model-based multiple behavior intervention for weight management: effectiveness on a population basis. Prev Med. 2008 Mar;46(3):238-46. doi: 10.1016/j.ypmed.2007.09.010. Epub 2007 Oct 23.
PubMed 18055007Lange-Asschenfeldt C, Lederbogen F. [Antidepressant therapy in coronary artery disease]. Nervenarzt. 2011 May;82(5):657-64; quiz 665-6. doi: 10.1007/s00115-010-3181-7. German.
PubMed 21109992
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03953924
- Acronym / sponsor ID
- SYang
- Conditions
- Coronary Heart Disease, Depression
- Keywords
- transtheoretical model, motivational interviewing, depression, coronary heart disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 30 Dec 2015 (actual)
- Study completion
- 30 Dec 2015 (actual)
- First posted
- 17 May 2019 (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.
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.
Detailed description
The transtheoretical model (TTM) is a purposeful behavioral change model. It is a systematic study of people's behavior change based on a variety of theories. Effective outcomes with TTM also have been applied in many studies of health behavior change, especially in the field of two aspects: on the one hand, to change unhealthy behaviors such as smoking, drinking, weight control and so on. Besides, a way to involve individuals in health behavior change is motivational interviewing (MI). MI is a way that taking patients as the center approach to interpersonal communication, which helps patients discover and overcome their ambivalence, thereby triggering behavioral changes. A study showed that MI might have favorable effects on changing patients' depression and found that the effect of a single use of MI was better than that of cognitive-behavioral therapy. In summary, the TTM-based interventions and MI were used to change behavior fields. To our knowledge, few studies have been conducted to determine the effects of the TTM-based intervention and MI on depression. Therefore, this study decided to determine the effects of TTM-based intervention and MI on the management of depression in hospitalized patients with CHD.
The aim of this study was to determine the effects of TTM-based intervention and MI on patients' stages of change, processes of change, decisional balance, self-efficacy, and depression. The study's hypothesis was: (1) The patients in the intervention group would be a positive shift in stages of change, the scores of cognitive level, behavioral level, perceived benefits, self-efficacy, perceived barriers and depression after intervention compared with the control group.
The sample comprised 110 (each group: 55) patients with coronary heart disease (CHD) in the Medicine-Cardiovascular Departments of three hospitals in Changsha.
The whole trail was on the basis of the CONSORT statements and a single, blind, randomized, controlled trial. Study procedures were approved by the institutional review boards of all participating All patients were recruited by enrolling researchers for eligibility and then enrolled in the study if they were eligible and informed consent. 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 the eligible patients were recruited in the study, the enrolling researchers numbered the patients, opening the same numbers sealed envelopes. The enrolling researchers were blind about the design of this study.
The patients in the intervention group received conventional care, TTM-based intervention and MI; Interventions were provided by trained nurses. First, The leader of this research contacted the hospital, getting the consent of the relevant departments and ward heads of the hospital to screen research objects before the beginning of the study, telling patients the purpose, significance, methods of the research, times to fill out the questionnaire, and the possible risks and benefits of the study.
The MI was implemented 2 times, 20 minutes each time, the trained nurses interviewed each patient face-to-face in the unit. Data were collected at 2 time points: the patient was on admission (T, obtain the baseline information) and the patient was 2- days before discharged (T0, obtain the information after intervention), according to the assessment of their current stage of change and depression delivered by filling the Stages of Change Subscale and Hamilton Rating Scale. TTM - based intervention was given 3 times in the form of a small course, 20 minutes each time according to the changing stage.
No interventions were performed for the control group participants during the study. However, these patients received conventional care ( nursing procedure, education about diet, exercise and so on).
Data were collected by a research assistant who was blind to the study design and allocation of participants. At baseline, sociodemographic and clinical characteristics were collected from medical records and personal interviews.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Transtheoretical model-based (TTM - based) intervention and motivational interviewing (MI)The patients in intervention group received conventional care, transtheoretical model-based (TTM-based) intervention and motivational interviewing (MI). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| 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. | Other | Intervention group |
Primary outcome
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.
1 secondary outcome
Social Demographic Data Recording Form
Time frame: on admission (T).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
- Results publication: PubMed 28316740Aghaei M, Samkhaniyan E, Mahdavi A, Faraji J, Roshandel Z. Effectiveness of behavioral-cognitive group therapy on depression, anxiety, and stress of patients with coronary heart disease. J Med Life. 2015;8(Spec Iss 4):252-257.
- Results publication: PubMed 24619718Albus C, Ladwig KH, Herrmann-Lingen C. [Psychocardiology: clinically relevant recommendations regarding selected cardiovascular diseases]. Dtsch Med Wochenschr. 2014 Mar;139(12):596-601. doi: 10.1055/s-0033-1360102. Epub 2014 Mar 11. German.
- Results publication: PubMed 28971389Anastopoulou K, Fradelos EC, Misouridou E, Kourakos M, Berk A, Papathanasiou IV, Kleisiaris C, Zyga S. Moderating Nutritious Habits in Psychiatric Patients Using Transtheoretical Model of Change and Counseling. Adv Exp Med Biol. 2017;988:63-71. doi: 10.1007/978-3-319-56246-9_5.
- Results publication: PubMed 26729692Arri SS, Ryan M, Redwood SR, Marber MS. Mental stress-induced myocardial ischaemia. Heart. 2016 Mar;102(6):472-80. doi: 10.1136/heartjnl-2014-307306. Epub 2016 Jan 4. No abstract available.
- Results publication: PubMed 28914859Belialov FI. [Depression, anxiety, and stress in patients with coronary heart disease]. Ter Arkh. 2017;89(8):104-109. doi: 10.17116/terarkh2017898104-109. Russian.
- Results publication: PubMed 22851113Blumenthal JA, Babyak MA, O'Connor C, Keteyian S, Landzberg J, Howlett J, Kraus W, Gottlieb S, Blackburn G, Swank A, Whellan DJ. Effects of exercise training on depressive symptoms in patients with chronic heart failure: the HF-ACTION randomized trial. JAMA. 2012 Aug 1;308(5):465-74. doi: 10.1001/jama.2012.8720.
- Results publication: PubMed 25759443Alcantara C, Muntner P, Edmondson D, Safford MM, Redmond N, Colantonio LD, Davidson KW. Perfect storm: concurrent stress and depressive symptoms increase risk of myocardial infarction or death. Circ Cardiovasc Qual Outcomes. 2015 Mar;8(2):146-54. doi: 10.1161/CIRCOUTCOMES.114.001180. Epub 2015 Mar 10.
- Results publication: PubMed 27853162Carney RM, Freedland KE. Depression and coronary heart disease. Nat Rev Cardiol. 2017 Mar;14(3):145-155. doi: 10.1038/nrcardio.2016.181. Epub 2016 Nov 17.
- Results publication: PubMed 24811552Dalen JE, Alpert JS, Goldberg RJ, Weinstein RS. The epidemic of the 20(th) century: coronary heart disease. Am J Med. 2014 Sep;127(9):807-12. doi: 10.1016/j.amjmed.2014.04.015. Epub 2014 May 5.
- Results publication: PubMed 23293685Skaal L, Pengpid S. The predictive validity and effects of using the transtheoretical model to increase the physical activity of healthcare workers in a public hospital in South Africa. Transl Behav Med. 2012 Dec;2(4):384-391. doi: 10.1007/s13142-012-0136-5. Epub 2012 May 31.
- Results publication: PubMed 16846327Evers KE, Prochaska JO, Johnson JL, Mauriello LM, Padula JA, Prochaska JM. A randomized clinical trial of a population- and transtheoretical model-based stress-management intervention. Health Psychol. 2006 Jul;25(4):521-9. doi: 10.1037/0278-6133.25.4.521.
- Results publication: PubMed 28002382Hammadah M, Al Mheid I, Wilmot K, Ramadan R, Shah AJ, Sun Y, Pearce B, Garcia EV, Kutner M, Bremner JD, Esteves F, Raggi P, Sheps DS, Vaccarino V, Quyyumi AA. The Mental Stress Ischemia Prognosis Study: Objectives, Study Design, and Prevalence of Inducible Ischemia. Psychosom Med. 2017 Apr;79(3):311-317. doi: 10.1097/PSY.0000000000000442.
- Individual participant dataSharing planned: No. 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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Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruiting
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
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.
Jingping Zhang, PhD. study chair
Central South University
Questions about this trial
What is this clinical trial studying?
A study testing Transtheoretical model-based (TTM - based) intervention and motivational interviewing (MI) in people with Coronary Heart Disease and Depression, run by Central South University.
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 0 inclusion and 4 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: finished, as of the sponsor's last update on 17 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Stage of change for coronary heart disease patients with depression (time frame: 2 - days (T0) before discharge.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03953924, which also lists 34 linked publications.
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 17 May 2019.