NCT05645666

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2022

Completed
Last Updated

December 9, 2022

Status Verified

December 1, 2022

Enrollment Period

6 months

First QC Date

December 1, 2022

Last Update Submit

December 1, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    Immediately after the intervention

  • 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

    6 months after the intervention

Study Arms (2)

Well being therapy

EXPERIMENTAL

The group of 16 which recieved well-being therapy

Behavioral: Well-being therapy

Control group

NO INTERVENTION

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

Interventions

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.

Well being therapy

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \- 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Educational Science and Psychology

Isfahan, Iran

Location

Related Publications (1)

  • Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Ziaei

    M.A student, Department of Educational Science and Psychology, Isfahan(Khorasgan) Branch, Islamic Azad University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.A Student

Study Record Dates

First Submitted

December 1, 2022

First Posted

December 9, 2022

Study Start

March 1, 2022

Primary Completion

August 30, 2022

Study Completion

October 1, 2022

Last Updated

December 9, 2022

Record last verified: 2022-12

Locations