Determining the Effectiveness of Logotherapy on Reducing Stress, Increasing Resilience and Quality of Life in Obese People
Design
Clinical trial with control group (with 20 participants) and experimental group (with 20 participants), community-based, pragmatic, parallel groups, randomised controlled
Settings and conduct
From all patients referred to nutritionist in Razi Clinic who have a BMI above 25, 40 people will be selected by convenience sampling method and will be randomly divided into 2 groups: experimental (20 people) and control (20 people). After performing the pre-test for all participants, the group logotherapy course will be held for experimental group for 10 sessions, each session lasting 90 minutes in 5 weeks (All sessions will be conducted in person at Razi Clinic). The participants receive the training materials through presenting videos, leaflets, flashcards and introducing books, twice a week. No intervention will be performed for the control group. After the end of this course sessions, post-test will be taken from both groups
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Having a BMI higher than 25,
Not having any chronic medical condition;
Exclusion Criteria:
History of psychiatric problems,
The distortion of the questionnaire.
Intervention groups
The intervention group consisted of 20 people referred from the Razi subspecialty clinic who were randomly placed in the experimental group with the inclusion criteria. This group got trained by logotherapy topics for 10 sessions.
No intervention was performed for the control group consisted of 20 people referred from the Razi subspecialty clinic. Pre-test and post-test were given to both groups.
Main outcome variables
Stress; Resilience; Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210619051617N1
Registration date:2021-11-15, 1400/08/24
Registration timing:prospective
Last update:2021-11-15, 1400/08/24
Update count:0
Registration date
2021-11-15, 1400/08/24
Registrant information
Name
Sana Kamboozia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3342 4483
Email address
sana.kamboozia@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-18, 1400/08/27
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Logotherapy on Reducing Stress and Increasing Resilience and Quality of Life in Obese People
Public title
The Effectiveness of Logotherapy on Reducing Stress and Increasing Resilience and Quality of Life in Obese People
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a BMI higher than 25
Satisfaction of people to participate in treatment sessions
Not having any chronic medical condition based on the individual's own report
Exclusion criteria:
History of psychiatric problems
The distortion of the questionnaire
Lack of entrance criteria
Age
From 24 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The way of sampling in this research, considering the choosing of the entrance of the samples is non-random, and considering the way of placement in the intervention and control group is simple random and done through draw and individual randomization unit.
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
Ethics Committee of Islamic Azad University - Lahijan Branch
The stress score in Social Readjustment Rating Scale (SRRS)
Timepoint
Assessment will be done once at the beginning of the study and once after the intervention.
Method of measurement
Social Readjustment Rating Scale (SRRS)
2
Description
Resilience Score in the Connor-Davidson Resilience Scale (CD_RIS)
Timepoint
Assessment will be done once at the beginning of the study and once after the intervention.
Method of measurement
Connor-Davidson Resilience Scale (CD_RIS)
3
Description
WHOQOL- BREF Score
Timepoint
Assessment will be done once at the beginning of the study and once after the intervention.
Method of measurement
WHOQOL- BREF
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First, a questionnaire is given to both control group and experimental group. After separating the groups, the logotherapy training intervention was used for the experimental group. Logotherapy is a branch of the existential approach that deals with "finding the meaning and purpose of people's lives to accept their suffering.". Workshop for the experimental group consisted of 10 sessions for 5 weeks in which participants received training twice a week for 90 minutes by presenting videos, booklets, flashcards and Introducing books. The sessions are as follows: The first session includes the existential ontology and 4 concepts of death, loneliness, freedom and meaninglessness and awareness of values; The second session includes practicing identified and substituted occupations, discovering satisfying achievements, and exploring creative values; The third session includes analysis and evaluation of recent events, positive people and artistic experiences; The fourth session includes analyzing and evaluating wise quotes, taking a point of view, and doing the practice of "My obituary" in groups; The fifth session includes expanding the hierarchy of values, setting goals, changing the perspective towards goals; the sixth session includes investigating the relevance of goals to values and explaining the necessity to experience all of one's values; Seventh session includes setting new goals for the ignored values; The eighth session includes the plan to achieve short-term and long-term goals; The ninth session includes investigating the strengths and weaknesses for moving towards the goals, changing the status of the strengths and weaknesses; tenth session includes summarizing the content of all of the sessions, group discussion and motivation Then, in order to evaluate the effectiveness of the intervention, a questionnaire was given to both groups again to compare the changes obtained from training in the training group with the control group. It should be noted that no drug treatment was used in this.
Category
Behavior
2
Description
Control group: There was no intervention on the control group and this group completed the study questionnaires in only two stages.