Compare the effectiveness of logotherapy and mindfulness- based stress reduction therapy (MBSR) with routtine treatments on Stress, Anxiety, Depression and Quality of life in patients with coronary heart disease
The purpose of study is to compare the efficacy of group logotherapy and mindfulness therapies on stress, anxiety and depression and quality of life in cardiac patients
Design
A clinical trial with a control group, with parallel groups, triple blind and randomized with a sample size of 60 patients. Sixty cardiac patients were randomly assigned to three groups of 20 patients, 2 intervention groups and 1 control group.
Settings and conduct
This study is performed at the heart disease prevention clinic of Afshar Hospital in Yazd and in order to stay blind, the groups refer to the clinic on different days.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Cardiac patients under 75 years of age; minimum literacy; informed consent; PCI treatment; EF> 40.
non Inclusion criteria : Having heart valve disease; having arrhythmia; having chronic obstructive pulmonary disease (COPD); having diabetes complications; being on dialysis; seizure; stroke (CVA); being high risk for rehabilitation; having chronic underlying disease
Intervention groups
Intervention group one: Cardiac patients participating in mindfulness therapy group
Intervention group two: Cardiac patients participating in the meaningful group therapy.
Control group: Cardiac patients receiving routine psychological treatments at the heart rehabilitation center.
Main outcome variables
Depression; Anxiety; Stress; Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170522034081N3
Registration date:2022-07-01, 1401/04/10
Registration timing:retrospective
Last update:2022-07-01, 1401/04/10
Update count:0
Registration date
2022-07-01, 1401/04/10
Registrant information
Name
mahdieh ghanbari firoozabadi
Name of organization / entity
Yazd Cardiovascular Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Country
Iran (Islamic Republic of)
Phone
+98 35 3525 8354
Email address
m.ghanbari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effectiveness of logotherapy and mindfulness- based stress reduction therapy (MBSR) with routtine treatments on Stress, Anxiety, Depression and Quality of life in patients with coronary heart disease
Public title
the effectiveness of logotherapy and mindfulness in patients with coronary heart disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age less than 75 years
Have the least reading and writing skills
Informed consent
Type of treatment PCI
EF above 40
Exclusion criteria:
Cardiac valve disease
Cardiac arrhythmia
Chronic obstructive pulmonary disease (COPD)
Having diabetes complications
Being dialysis
convulsion
Cerebrovascular accident (CVA)
High risk In terms of cardiac rehabailitation
Having chronic underlying illnesses
Not having Heart failure disease (HF)
Not having Implantable Cardioverter Defibrillator (ICD)
Lack of pharmacotherapy and non-prescriptive therapies for psychiatric illnesses
Age
To 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization;
Individual unit;
A computer-generated random sequence number by SAS software;
Build sequences based on numbers generated by SAS software and one of the people unrelated to the Research Project
Blinding (investigator's opinion)
Triple blinded
Blinding description
Until the end of the clinical trial; participants, researchers, outcome assessor, statistical analyst, therapists and monitoring committee will not be aware of the allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Shahid Sadoughi University of Medical Sciences
Street address
Shahid Sadoughi Blvd., Bahonar Square
City
Yazd
Province
Yazd
Postal code
8917945556
Approval date
2018-03-14, 1396/12/23
Ethics committee reference number
IR.SSU.REC.1396.213
Health conditions studied
1
Description of health condition studied
Heart disease
ICD-10 code
I27
ICD-10 code description
Other pulmonary heart diseases
Primary outcomes
1
Description
Quality of life
Timepoint
Before and after intervention
Method of measurement
Sf-36 Quality of Life Questionnaire
2
Description
Stress score
Timepoint
Before and after intervention
Method of measurement
SSD Questionnaire
3
Description
Depression score
Timepoint
Before and after intervention
Method of measurement
Beck Questionnaire depression
4
Description
Anxiety score
Timepoint
Before and after intervention
Method of measurement
Beck Questionnaire anxiety
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: undergoes mindfulness-based stress reduction therapy (MBSR) treatment protocol in 8 sessions of 90 minutes.The content of the sessions is as follows:Session 1: Introducing the participants, giving explanations about anxiety and depression and its effect on heart disease, raisin eating practice, breathing-focused meditation practice, body check exercise. Session 2: Body check exercise, inviting participants to discuss experiences of mindfulness exercises, examining barriers, examining the characteristics of mindfulness such as non-judgment or abandonment, practicing sitting meditation with a focus on breathing. Session 3: Practice seeing or hearing briefly, sitting meditation on concentration and body senses, three-minute breathing space, practicing conscious body movements. Session 4: practicing sitting meditation with a focus on breathing, discussing stress and the individual's usual reactions to difficult situations and alternative attitudes and reactions, conscious walking. Session 5: practicing sitting meditation with a focus on breathing, discussing the acceptance of the reality of the present situation as you are, practicing the second series of conscious body movements. Session 6: Three-minute breathing space, discussing thoughts that are often not real. Session 7: Practicing sitting meditation and open awareness, discussing the best way to take care of yourself, reviewing pleasant versus unpleasant daily activities, and learning to plan for pleasant activities, practicing love and kindness meditation. Session 8: Body checks exercise, review of trainings, evaluation of education, providing more resources.
Category
Behavior
2
Description
Second intervention group: under the group semantic therapy protocol of James C. Cronbach (1973) in 8 sessions of 90 minutes.These goals will be pursued in all sessions:1. Helping participants to clarify values that are particularly meaningful to them. 2. Set reasonable goals. 3. Ensuring that participants' goals achieve meaningful personal values.4. Practical planning to achieve goals. 5. Identify the strengths and weaknesses of the participants that affect the achievement of their goals. 6. Consider strengths and weaknesses in planning to achieve goals that achieve participants' values.
Category
Behavior
3
Description
The control group receives the usual treatments of the Cardiac Rehabilitation Clinic, which is Cognitive-Behavioral Therapy (CBT). Cognitive-behavioral therapy will be in twelve sessions of 90 minutes. The structure of the sessions is such that in the first session, evaluation and diagnostic interview will be performed and the second to twelfth sessions will have the same structure as follows. The structure of the first session of treatment: setting the agenda and talking about its logic, examining the patient's mood, a brief overview of the patient's problems and, if necessary, their brief revision, identifying problems objectively and setting treatment goals, teaching the patient cognitive model, review patient expectations about treatment, patient education about their disorder, assigning homework, session summary, and feedback. The structure of the second session of treatment onwards includes a brief review of the previous week and the patient's mood, bridging the previous session, setting the agenda, reviewing the patient's homework, discussing the topics set in the agenda and assigning homework for next week, summarizing, and Feedback.