Emotion Focused Therapy in Irritable Bowel Syndrome Patients

Functional Gastrointestinal Disorders Clinical Trial

Official title:

Pilot Study of Efficacy of Emotion Focused Therapy on Stress, Resiliency and Coping Strategies in Irritable Bowel Syndrome Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02657668
• Other study ID #: IslamicAUN
• Status: Completed
• Phase: N/A
• First received: January 7, 2016
• Last updated: January 13, 2016
• Start date: September 2013
• Est. completion date: October 2014

Study information

• Verified date: January 2016
• Source: Islamic Azad University, Najafabad Branch
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases
• Irritable Bowel Syndrome

Intervention

Behavioral:
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Islamic Azad University, Najafabad Branch

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Resiliency	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	pretest- post test-follow-up(in 4 month)	Yes
Primary	Stress	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)	pretest- post test-follow-up(in 4 month)	Yes
Secondary	Coping Strategies	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	pretest- post test-follow-up(in 4 month)	Yes