NCT02657668

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 18, 2016

Completed
Last Updated

January 18, 2016

Status Verified

January 1, 2016

Enrollment Period

4 months

First QC Date

January 7, 2016

Last Update Submit

January 13, 2016

Conditions

Keywords

Irritable Bowel SyndromeEmotion Focused TherapyStressResilienceCoping Strategies

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • Coping Strategies

    pretest- post test-follow-up(in 4 month)

Other Outcomes (1)

  • Resiliency

    pretest- post test-follow-up(in 4 month)

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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).

Interventions

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).

Also known as: EFT
Treatment Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gastrointestinal DiseasesIrritable Bowel Syndrome

Interventions

Emotion-Focused Therapy

Condition Hierarchy (Ancestors)

Digestive System DiseasesColonic Diseases, FunctionalColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant professor

Study Record Dates

First Submitted

January 7, 2016

First Posted

January 18, 2016

Study Start

September 1, 2013

Primary Completion

January 1, 2014

Study Completion

October 1, 2014

Last Updated

January 18, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will share

according to inclusion and exclusion criteria selected