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Clinical Trial Summary

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.

Inclusion 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.

Exclusion 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).


Clinical Trial Description

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.

Intervention 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).

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 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).

Ethical 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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02657668
Study type Interventional
Source Islamic Azad University, Najafabad Branch
Contact
Status Completed
Phase N/A
Start date September 2013
Completion date October 2014

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