The effectiveness of group training of hope therapy approach on quality of life and meaning of life of patients with MS and their family caregivers in Rafideh Rehabilitation Hospital
Overall Objective: To determine the effectiveness of hope therapy group training on increasing the quality of life and meaning of life of patients with MS referred to Rafideh Hospital in Tehran and their family caregivers
Design
Study design: included MS patients. The sample size was about 60 people.
15 patients and 15 caregivers were in two groups
Settings and conduct
Type of study: This research will be done by quasi-experimental method (quasi-experimental) and pre-test and post-test with control group.
Participants/Inclusion and exclusion criteria
1- Patients with inflammation between the ages of 20 to 70 years
2- Conscious consent to participate in research
3- At least six months have passed since their diagnosis
Intervention groups
Intervention group 1: Patients with MS: Hope therapy training protocol for MS patients
Intervention group 2: Caregivers of patients with MS: Protocol of hope therapy training for caregivers of MS patients
Main outcome variables
Quality of life and meaning of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201119049440N1
Registration date:2020-12-04, 1399/09/14
Registration timing:retrospective
Last update:2020-12-04, 1399/09/14
Update count:0
Registration date
2020-12-04, 1399/09/14
Registrant information
Name
moslem arian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5612 2224
Email address
mo.arian@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
2019-07-23, 1398/05/01
Actual recruitment end date
2019-09-22, 1398/06/31
Trial completion date
2019-09-22, 1398/06/31
Scientific title
The effectiveness of group training of hope therapy approach on quality of life and meaning of life of patients with MS and their family caregivers in Rafideh Rehabilitation Hospital
Public title
The effectiveness of group training in hope therapy approach on quality of life and meaning of life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Criteria for admission of the patient: with MS
Informed consent
Get a low or average score in the meaning of life and quality of life questionnaire
Criteria for patient exit: dissatisfaction and withdrawal
Achieve high scores in the questionnaires of meaning of life and quality of life
Criteria for caregiver entry: Family member of a patient with MS and being the primary caregiver
Informed consent
Get a medium or low score in the Meaning and Quality of Life Questionnaire
Criteria for leaving the caregiver: dissatisfaction or withdrawal from continuing the research
Get a high score in the Meaning and Quality of Life Questionnaire
Exclusion criteria:
Get a high score on the Quality of Life Questionnaire
Get a high score on the meaning of life questionnaire
Receive parallel psychological treatment or interventions
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
First, inclusion and exclusion criteria in patients with MS and their caregivers were evaluated. Then, meaning of life and quality of life questionnaires were distributed. Then 30 patients and 30 caregivers
Average or low scores were obtained in these two questionnaires. The names of these 30 patients were written on paper. The name paper was separated and placed in a basket. Then we took a piece of paper each time and put it in the test basket or control basket. This process continued for 30 patients until 15 patients were included in the experimental basket and 15 patients in the control group. The researcher used the lottery method when selecting the names, and therefore there was no bias or intentionality in assigning individuals to the two groups. Exactly the same procedure was performed for 30 patient caregivers. In fact, the randomization was simple and by lottery. Due to the low number of samples, this was done manually.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Social Welfare and Rehabilitation Sciences
Street address
Tehran, Evin, Daneshjoo Blvd., Koodkiar dead end
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2019-06-28, 1398/04/07
Ethics committee reference number
IR.USWR.REC.1398.047
Health conditions studied
1
Description of health condition studied
Meaning of life and quality of life
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Meaning of life: This variable, which is designed by the meaning of life questionnaire of Steger et al., Has two subscales: meaning presence and meaning search. This variable was evaluated before and after the implementation of the protocol to measure the changes resulting from the implementation of the protocol in the two intervention groups.
Timepoint
A pre-test is taken before the protocol is implemented and after the protocol is implemented (which takes one month). So the test is taken. That is, this variable is measured twice.
Method of measurement
questionnaire
2
Description
Quality of life: This variable has been evaluated with the MSIS-29 Quality of Life Questionnaire, which includes two subscales of physical and mental quality of life. This variable was evaluated before and after the implementation of the protocol to measure the changes resulting from the implementation of the protocol in the two intervention groups.
Timepoint
A pre-test is taken before the protocol is implemented and after the protocol is implemented (which takes one month). So the test is taken. That is, this variable is measured twice.
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
experimental group 1: or group of patients with MS: For this group, a group training protocol of hope therapy was provided. This treatment protocol is designed for eight two-hour sessions that are performed for the group of MS patients and their family members with the necessary adjustments and adaptations. For example, patient assignments and family member assignments are different. Also, each session consists of 4 sections. In the first section, which lasts approximately 83 minutes, group members discuss the topics of the per session, review the assignment of the previous session, and encourage members to help each other solve homework problems. In the second section, which lasts approximately 83 minutes, group members are taught a new hope-related skill that includes three dimensions: goals, directions, and agent thinking. Apply these skills in their lives, discuss and encourage them to articulate their problems and help each other learn how to use these skills to solve their problems. During this part of group therapy, the therapist leads the group to discuss the skill as the main topic of the group. Finally, in the final ten minutes of the group, members are given a homework assignment for the next session, with the goal of having the members of the group apply hope-related skills in their daily lives. At the beginning of the group, as a general task, members are asked to choose a specific goal to work in group meetings to apply the skills learned on that specific goal in each session Control group 1: A group of MS patients remained in a non-intervention state and after the intervention and post-test and to observe ethics. They received several training sessions.
Category
Behavior
2
Description
Intervention group 2: or experimental group 2 (group of caregivers of patient with MS): For this group, a group training protocol of hope therapy was provided. This treatment protocol is designed for eight two-hour sessions that are performed for the group of MS patients and their family members with the necessary adjustments and adaptations. For example, patient assignments and family member assignments are different. Also, each session consists of 4 sections. In the first section, which lasts approximately 83 minutes, group members discuss the topics of the per-session, review the assignment of the previous session, and encourage members to help each other solve homework problems. In the second section, which lasts approximately 83 minutes, group members are taught a new hope-related skill that includes three dimensions: goals, directions, and agent thinking. Apply these skills in their lives, discuss and encourage them to articulate their problems and help each other learn how to use these skills to solve their problems. During this part of group therapy, the therapist leads the group to discuss the skill as the main topic of the group. Finally, in the final ten minutes of the group, members are given a homework assignment for the next session, with the goal of having the members of the group apply hope-related skills in their daily lives. At the beginning of the group, as a general task, members are asked to choose a specific goal to work in group meetings to apply the skills learned on that specific goal in each session. Control group 2: The caregiver of patients with MS remained in a non-intervention state and after the intervention and post-test and to observe ethics. They received several training sessions.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Rafideh Hospital
Full name of responsible person
Research Committee of University of Social Welfare and Rehabilitation Sciences