Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-03-06 @ 9:16 PM
Study NCT ID:
NCT02657668
Status:
COMPLETED
Last Update Posted:
2016-01-18
First Post:
2016-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Emotion Focused Therapy in Irritable Bowel Syndrome Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000071441', 'term': 'Emotion-Focused Therapy'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-13', 'studyFirstSubmitDate': '2016-01-07', 'studyFirstSubmitQcDate': '2016-01-13', 'lastUpdatePostDateStruct': {'date': '2016-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Resiliency', 'timeFrame': 'pretest- post test-follow-up(in 4 month)', 'description': 'Resiliency Questionnaire: This questionnaire was published by Connor\\& Davidson in 2003.This instrument consists 25 questions that are completed in a likert range(0-4).In Iranian form, Internal reliability has been reported 0/89 and construct of this questionnaire has been confirmed in factor analysis'}], 'primaryOutcomes': [{'measure': 'Stress', 'timeFrame': 'pretest- post test-follow-up(in 4 month)', 'description': 'Depression-Anxiety-Stress scale(DASS):DASS was published by Lovibond \\& Lovibond in 1995.Short form of DASS conclude 21 sentences that each 7 sentences in related to one subscale. In this research, has been used of subscale of stress. Iranian form of this subscale has been significant relation(concurrent validity) with Holms-Rahe stress questionnaire(r:0/49)'}], 'secondaryOutcomes': [{'measure': 'Coping Strategies', 'timeFrame': 'pretest- post test-follow-up(in 4 month)', 'description': 'Coping Strategies Questionnaire: This questionnaire was published by Andler and Parker in 1990.This instrument conclude 3 subscales: problem-oriented ,Emotion-oriented strategies and Aversion-oriented strategies. This questionnaire consist 48 questions that are completed in a likert range(1-5).Retest reliability of these subscales has been 0/6,0/61 and 0/64.Internal reliability has been reported higher than 0/7'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Irritable Bowel Syndrome', 'Emotion Focused Therapy', 'Stress', 'Resilience', 'Coping Strategies'], 'conditions': ['Functional Gastrointestinal Disorders']}, 'descriptionModule': {'briefSummary': 'The study was quasi-experimental including patients in two intervention and control groups. Three measurements were done: pretest, post-test, and a two-months follow-up. The study population included patients with irritable bowel syndrome(diagnosed by specialists and based on the criteria of Rome III), who referred to a general Hospital. Fifty two irritable bowel syndrome patients were selected and assigned to two experiment (26 cases) and control (26 cases) groups. The criteria below were considered in selection of patients.\n\nInclusion criteria: 1) Patients should not have participated in other psychological interventions concurrently; 2) Participants had not reported diagnosis of non-functional gastrointestinal illnesses. 3) Women patients had not been in pregnancy; 4) Participants had not met diagnosis of schizophrenia and bipolar disorders.\n\nExclusion criteria: Three or more absences in the group sessions Co-variate variables: 1) demo-graphical variables (age, birth order, and education); 2) clinical variables (global psychological status, mind-body attribution, and duration of disease).', 'detailedDescription': "The study was quasi-experimental including patients in two intervention and control groups. Three measurements were done: pretest, post-test, and a two-months follow-up. The study population included patients with irritable bowel syndrome(diagnosed by specialists and based on the criteria of Rome III), who referred to general Hospital . Fifty two irritable bowel syndrome patients were selected and assigned to two experiment (26 cases) and control (26 cases) groups. The criteria below were considered in selection of patients.\n\nIntervention design Experimental group: Emotion focused therapy was conducted in eight sessions (without pretest and post-test sessions) according to Greenberg's manual (22) in a clinic of gastrointestinal patients. According to Greenberg manual, emotion focused therapy consists of three steps:1) emotional awareness 2) accessing healthy emotions 3) skills of emotional intelligence.There were five individuals in the post-test (because of being absent more than three sessions or not participating in the post-test).\n\nControl group: For control group interactions to be effective in therapeutic outcomes, the psycho-educational group was assigned as control group. The Psycho-educational group was conducted in four sessions (without pretest and post-test sessions). They became familiar with etiology and role of psychological factors in irritable bowel syndrome, without any psychotherapy. Eight members were removed (because of being absent more than three sessions).\n\nEthical permission This study was approved by the research committee of University of Isfahan. To appreciate participants, after group therapy, the results of therapy were reported to the participants."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients should not have participated in other psychological interventions concurrently;\n2. Participants had not reported diagnosis of non-functional gastrointestinal illnesses.\n3. Women patients had not been in pregnancy;\n4. Participants had not met diagnosis of schizophrenia and bipolar disorders.\n\nExclusion Criteria:\n\nThree or more absences in the group sessions\n\nCovariate variables:\n\n1. demographical variables (age, birth order, and education);\n2. clinical variables (global psychological status, mind-body attribution, and duration of disease).'}, 'identificationModule': {'nctId': 'NCT02657668', 'briefTitle': 'Emotion Focused Therapy in Irritable Bowel Syndrome Patients', 'organization': {'class': 'OTHER', 'fullName': 'Islamic Azad University, Najafabad Branch'}, 'officialTitle': 'Pilot Study of Efficacy of Emotion Focused Therapy on Stress, Resiliency and Coping Strategies in Irritable Bowel Syndrome Patients', 'orgStudyIdInfo': {'id': 'IslamicAUN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': "Emotion focused therapy: EFT was conducted in eight sessions (without pretest and posttest sessions) according to Greenberg's manual (22) in a clinic of gastrointestinal patients. According to Greenberg manual, EFT consists of three steps: 1) emotional awareness 2) accessing healthy emotions 3) skills of emotional intelligence. There were five individuals in the posttest (because of being absent more than three sessions or not participating in the posttest).", 'interventionNames': ['Behavioral: Emotion Focused Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Control group: For control group interactions to be effective in therapeutic outcomes, the psycho-educational group was assigned as control group. The Psycho-educational group was conducted in four sessions (without pretest and posttest sessions). They became familiar with etiology and role of psychological factors in IBS, without any psychotherapy. Eight members were removed (because of being absent more than three sessions).'}], 'interventions': [{'name': 'Emotion Focused Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['EFT'], 'description': "EFT was conducted in eight sessions (without pretest and posttest sessions) according to Greenberg's manual (22) in a clinic of gastrointestinal patients. According to Greenberg manual, EFT consists of three steps: 1) emotional awareness 2) accessing healthy emotions 3) skills of emotional intelligence. There were five individuals in the posttest (because of being absent more than three sessions or not participating in the posttest).", 'armGroupLabels': ['Treatment Group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'according to inclusion and exclusion criteria selected'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Islamic Azad University, Najafabad Branch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assisstant professor', 'investigatorFullName': 'Sayed Abbas Haghayegh', 'investigatorAffiliation': 'Islamic Azad University, Najafabad Branch'}}}}