Emotion Focused Therapy in Irritable Bowel Syndrome Patients

Not Applicable

Completed

• Conditions: Functional Gastrointestinal Disorders
• Interventions: Behavioral: Emotion Focused Therapy

• Registration Number: NCT02657668
• Lead Sponsor: Islamic Azad University, Najafabad Branch

Brief 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).

Detailed 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 Timeline

• Study Start: 2013-09
• Primary Completion: 2014-01
• Study Completion: 2014-10
• Status Verified: 2016-01
• Study First Submitted: 2016-01-07
• Study First Submitted QC: 2016-01-13
• Last Update Submitted: 2016-01-13
• Study First Posted: 2016-01-18
• Last Update Posted: 2016-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Covariate variables:

1. demographical variables (age, birth order, and education);
2. clinical variables (global psychological status, mind-body attribution, and duration of disease).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Emotion Focused Therapy	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).

Primary Outcome Measures

Name	Time	Method
Stress	pretest- post test-follow-up(in 4 month)	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)

Secondary Outcome Measures

Name	Time	Method
Coping Strategies	pretest- post test-follow-up(in 4 month)	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