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

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Well-being therapy
Sponsored by
Islamic Azad University, Isfahan (Khorasgan) Branch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ulcerative Colitis

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Educational Science and Psychology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Well being therapy

Control group

Arm Description

The group of 16 which recieved well-being therapy

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

Outcomes

Primary Outcome Measures

Pre-test level
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
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 Outcome Measures

Full Information

First Posted
December 1, 2022
Last Updated
December 1, 2022
Sponsor
Islamic Azad University, Isfahan (Khorasgan) Branch
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1. Study Identification

Unique Protocol Identification Number
NCT05645666
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Islamic Azad University, Isfahan (Khorasgan) Branch

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Well being therapy
Arm Type
Experimental
Arm Description
The group of 16 which recieved well-being therapy
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The group of 16 which did not recieve well-being therapy
Intervention Type
Behavioral
Intervention Name(s)
Well-being therapy
Intervention Description
Well-being therapy is a short-term, organized and problem-oriented treatment program that is based on Riff's psychological well-being model. Its purpose is to help patient in order to improve His/her functions in six dimensions; personal growth, environmental mastery, purposefulness of life, and autonomy, self-acceptance and positive relationships with others Therapists help patients find well-being experiences in their present and past lives and pay attention to these experiences, no matter how small or short they are.
Primary Outcome Measure Information:
Title
Pre-test level
Description
The results demonstrated that the effectiveness of this treatment on the level of self-efficacy and mental health was significant in the pretest phase.
Time Frame
Immediately after the intervention
Title
Follow-up level
Description
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
Time Frame
6 months after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziaei
Organizational Affiliation
M.A student, Department of Educational Science and Psychology, Isfahan(Khorasgan) Branch, Islamic Azad University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Educational Science and Psychology
City
Isfahan
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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