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Emotion Focused Therapy in Irritable Bowel Syndrome Patients

Primary Purpose

Functional Gastrointestinal Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Emotion Focused Therapy
Sponsored by
Islamic Azad University, Najafabad Branch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Gastrointestinal Disorders focused on measuring Irritable Bowel Syndrome, Emotion Focused Therapy, Stress, Resilience, Coping Strategies

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Treatment Group

    Control Group

    Arm 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).

    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).

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    January 7, 2016
    Last Updated
    January 13, 2016
    Sponsor
    Islamic Azad University, Najafabad Branch
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02657668
    Brief Title
    Emotion Focused Therapy in Irritable Bowel Syndrome Patients
    Official Title
    Pilot Study of Efficacy of Emotion Focused Therapy on Stress, Resiliency and Coping Strategies in Irritable Bowel Syndrome Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2013 (undefined)
    Primary Completion Date
    January 2014 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Islamic Azad University, Najafabad Branch

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Functional Gastrointestinal Disorders
    Keywords
    Irritable Bowel Syndrome, Emotion Focused Therapy, Stress, Resilience, Coping Strategies

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    52 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment Group
    Arm Type
    Experimental
    Arm 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).
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm 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).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Emotion Focused Therapy
    Other Intervention Name(s)
    EFT
    Intervention 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).
    Primary Outcome Measure Information:
    Title
    Stress
    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)
    Time Frame
    pretest- post test-follow-up(in 4 month)
    Secondary Outcome Measure Information:
    Title
    Coping Strategies
    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
    Time Frame
    pretest- post test-follow-up(in 4 month)
    Other Pre-specified Outcome Measures:
    Title
    Resiliency
    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
    Time Frame
    pretest- post test-follow-up(in 4 month)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients should not have participated in other psychological interventions concurrently; Participants had not reported diagnosis of non-functional gastrointestinal illnesses. Women patients had not been in pregnancy; Participants had not met diagnosis of schizophrenia and bipolar disorders. Exclusion Criteria: Three or more absences in the group sessions Covariate variables: demographical variables (age, birth order, and education); clinical variables (global psychological status, mind-body attribution, and duration of disease).

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    according to inclusion and exclusion criteria selected

    Learn more about this trial

    Emotion Focused Therapy in Irritable Bowel Syndrome Patients

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