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Clinical Trials/NCT05645666
NCT05645666CompletedNot Applicable

The Effectiveness of Well-being Therapy on Mental Health and Self-efficacy of Patients With Ulcerative Colitis

Islamic Azad University, Isfahan (Khorasgan) Branch1 site in 1 country32 target enrollmentStarted: March 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
32
Locations
1
Primary Endpoint
Pre-test level

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
15 Years to 60 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Well being therapy

Experimental

The group of 16 which recieved well-being therapy

Intervention: Well-being therapy (Behavioral)

Control group

No Intervention

The group of 16 which did not recieve well-being therapy

Outcomes

Primary Outcomes

Pre-test level

Time Frame: Immediately after the intervention

The results demonstrated that the effectiveness of this treatment on the level of self-efficacy and mental health was significant in the pretest phase.

Follow-up level

Time Frame: 6 months after the intervention

The results demonstrated that the effectiveness of this treatment on the level of self-efficacy and mental health was significant in the follow-up phase

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Islamic Azad University, Isfahan (Khorasgan) Branch
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Arezoo Ziaei

M.A Student

Islamic Azad University, Isfahan (Khorasgan) Branch

Study Sites (1)

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