Ulcerative ColitisNCT05645666
The Effectiveness of Well-being Therapy on Mental Health and Self-efficacy of Patients With Ulcerative Colitis
A study testing Well-being therapy in people with Ulcerative Colitis, run by Islamic Azad University, Isfahan (Khorasgan) Branch at 1 site in Iran.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Well-being therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIran
- Study dates
- 1 Mar 2022to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Ulcerative Colitis
- Being tested
- Well-being therapy
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Well-being therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Well being therapy | Experimental | The group of 16 which recieved well-being therapy Receives: Behavioral: Well-being therapy |
| Control group | No intervention | The group of 16 which did not recieve well-being therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 6 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Mar 2022
- Primary completion30 Aug 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Islamic Azad University, Isfahan (Khorasgan) Branch
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arezoo Ziaei, Islamic Azad University, Isfahan (Khorasgan) Branch
- Investigators
- Ziaei, Principal investigator, M.A student, Department of Educational Science and Psychology, Isfahan(Khorasgan) Branch, Islamic Azad University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645666
- Sponsor's protocol ID
- 13115
- Status last verified
- Dec 2022
- First submitted
- 1 Dec 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40243391
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Well-being Therapy on Mental Health and Self-efficacy of Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT05645666
- Acronym / sponsor ID
- 13115
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Islamic Azad University, Isfahan (Khorasgan) BranchUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Well being therapy | Experimental | Behavioral: Well-being therapyThe group of 16 which recieved well-being therapy |
| Control group | No intervention | –The group of 16 which did not recieve well-being therapy |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Well-being therapyWell-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. | Behavioural | Well being therapy |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Derived from this study: PubMed 40243391Tiles-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ziaei principal investigator
M.A student, Department of Educational Science and Psychology, Isfahan(Khorasgan) Branch, Islamic Azad University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Well-being therapy in people with Ulcerative Colitis, run by Islamic Azad University, Isfahan (Khorasgan) Branch at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-test level (time frame: Immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05645666, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022.