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Emotion Focused Therapy in Irritable Bowel Syndrome Patients

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ClinicalTrials.gov Identifier: NCT02657668
Recruitment Status : Completed
First Posted : January 18, 2016
Last Update Posted : January 18, 2016
Sponsor:
Information provided by (Responsible Party):
Sayed Abbas Haghayegh, 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).


Condition or disease Intervention/treatment Phase
Functional Gastrointestinal Disorders Behavioral: Emotion Focused Therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Efficacy of Emotion Focused Therapy on Stress, Resiliency and Coping Strategies in Irritable Bowel Syndrome Patients
Study Start Date : September 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
Experimental: Treatment Group
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).
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).
Other Name: EFT

No Intervention: Control Group
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).



Primary Outcome Measures :
  1. Stress [ Time Frame: 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 :
  1. Coping Strategies [ Time Frame: 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


Other Outcome Measures:
  1. Resiliency [ Time Frame: pretest- post test-follow-up(in 4 month) ]
    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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

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Responsible Party: Sayed Abbas Haghayegh, Assisstant professor, Islamic Azad University, Najafabad Branch
ClinicalTrials.gov Identifier: NCT02657668     History of Changes
Other Study ID Numbers: IslamicAUN
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: January 18, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: according to inclusion and exclusion criteria selected

Keywords provided by Sayed Abbas Haghayegh, Islamic Azad University, Najafabad Branch:
Irritable Bowel Syndrome
Emotion Focused Therapy
Stress
Resilience
Coping Strategies

Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases