Clinical trial NCT05645666: The Effectiveness of Well-being Therapy on Mental Health and Self-efficacy of Patients With Ulcerative Colitis
Official title: The Effectiveness of Well-being Therapy on Mental Health and Self-efficacy of Patients With Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Lead sponsor: Islamic Azad University, Isfahan (Khorasgan) Branch
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 32
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Ulcerative colitis (UC) is a chronic and lifelong disease that causes disabilities for sufferers and causes mental health disorders in the patients. For this reason, it is important to know which psychotherapy is more effective for UC patient's problems, and since no research has been done on the effectiveness of well-being therapy on the mental health problems of these patients, this research can help psychologists and other specialists in this field to help patients with UC and other chronic disease.

The present study is conducted with the aim of determining the effectiveness of mental well-being on the mental health and quality of life of patients with ulcerative colitis. The research method was a semi-experimental type with a pre-test-post-test design with a control group. The study population included all patients with ulcerative colitis who were previously diagnosed with ulcerative colitis by a gastroenterologist and referred to one of the gastroenterology centers for treatment. The criteria for entering the patients into the study were: definitive diagnosis of ulcerative colitis according to the opinion of a gastroenterologist, consent to participate in the study, having at least a high-school education and an age range of 18 to 60 years. The patients who were excluded from the study were: patients who have acute Psychiatric or other medical disorders , patients who have participated in counseling or psychotherapy sessions in the last six months and patients who lose motivation to participate in the interview or are absent for more than two sessions. The convenience sampling method was used. The list of patients with inflammatory bowel diseases was provided to the researcher after the consent of the head of the Digestive Disease Research Institute. 300 ulcerative colitis patients of this list were contacted according to the criteria for entering the study, and they were invited to participate in the treatment sessions after a brief explanation about the objectives of the sessions, sessions duration and time. Finally, 32 patients volunteered and were randomly assigned to one of the following groups:

16 people (9 women and 7 men) were in the well-being therapy group and 16 people (8 men and 8 women) were in the control group. In the post-test phase, one person in the study group stopped working, and in the follow-up phase, which was done 6 months later , the study did face any shortages.


Eligibility criteria: Inclusion Criteria:

- definitive diagnosis of ulcerative colitis according to the opinion of a gastroenterologist, consent to participate in the study, having at least a high-school education and an age range of 16 to 60 years.

Exclusion Criteria:

patients who have acute Psychiatric or other medical disorders , patients who have participated in counseling or psychotherapy sessions in the last six months and patients who lose motivation to participate in the interview or are absent for more than two sessions

Primary outcomes:
measure: Pre-test level
timeFrame: Immediately after the intervention
measure: Follow-up level
timeFrame: 6 months after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Educational Science and Psychology
Study officials:
affiliation: M.A student, Department of Educational Science and Psychology, Isfahan(Khorasgan) Branch, Islamic Azad University
name: Ziaei
role: PRINCIPAL_INVESTIGATOR
References: