Clinical trial NCT02657668: 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
Overall status: COMPLETED
Phase: NA
Conditions: Functional Gastrointestinal Disorders
Keywords: Irritable Bowel Syndrome
Emotion Focused Therapy
Stress
Resilience
Coping Strategies
Lead sponsor: Islamic Azad University, Najafabad Branch
Sponsor class: OTHER
First posted: 2016-01-18
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: Stress
timeFrame: pretest- post test-follow-up(in 4 month)
Secondary outcomes:
measure: Coping Strategies
timeFrame: pretest- post test-follow-up(in 4 month)
Other outcomes:
measure: Resiliency
timeFrame: pretest- post test-follow-up(in 4 month)
Locations:
Study officials:
References: