ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12609000913279

Ethics application status

Approved

Date submitted

7/10/2009

Date registered

21/10/2009

Date last updated

14/04/2016

Type of registration

Retrospectively registered

Titles & IDs

Public title

Does cognitive-behavioural therapy (CBT) improve outcomes in inflammatory bowel disease (IBD)? A pilot randomised controlled trial

Scientific title

Does cognitive-behavioural therapy (CBT) improve outcomes in inflammatory bowel disease (IBD)? A pilot randomised controlled trial

Secondary ID [1]

CBT and IBD

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Inflammatory bowel disease (IBD)

Condition category

Condition code

Oral and Gastrointestinal

Inflammatory bowel disease

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Preliminary screening of interested subjects will ensure that patients who have an existing psychotic disorder or are currently receiving any form of psychotherapy, or are alcohol or substance dependant as assessed by their treating clinician or the investigators are excluded from both groups (by notes review, discussion with treating doctor, and by checklist of questions to subjects). Subjects will then be randomised to either the CBT or standard care group. Patients in the CBT group will be offered a choice between a face-to-face therapy and online therapy. All participants randomised to the CBT group will then have a screening interview with a Clinical Psychologist to assess suitability for CBT before the beginning of the trial. Moreover, patients will need to be available to attend the 2-hour 10 week group program (1 x 2 hour session per week) at the RAH or complete online exercises under the guidance of Senior Clinical Psychologist in a similar format to face-to-face sessions and agree to complete questionnaires at baseline, (10 weeks), 6, 12 and 24 months. Patients will be required to provide written informed consent before the beginning of the trial. CBT and standard care groups will have separate patient information sheets. The CBT will be a group program designed specifically for this patient population. It will be delivered in two modes, face-to-face and online providing a patient with a choice, with both following exactly the same program. Online CBT will have a weekly chat option and option to exchange emails with a Senior Clinical Psychologist built-in, in order to provide the opportunity to interact with the therapist mirroring face-to-face group’s mode. CBT is a form of psychotherapy that aims to identify and modify unhelpful negative thinking styles and the maladaptive behaviors associated with those thinking styles. The CBT intervention will also comprise elements of education about IBD and psychoeducation in addition to relaxation. The 10 week program will consist of:

Session 1: Education about CBT, IBD (gastroenterologists from the clinic will be facilitating the part on IBD). Psycho-education about stress responses and stress management techniques. Breathing control excercises.
Session 2: Stress and Awareness. Introduction to relaxation techniques.
Session 3: Automatic thoughts and cognitive distortions. Becoming aware of negative thinking patterns, learning to recognize anxiety-producing appraisals.
Session 4: Cognitve restructuring: Replacing distorted thinking with more rational and balanced thoughts.
Session 5. Exposure and overcoming avoidance. Planning and increasing activities.
Session 6. Introducation to coping strategies. Mindfulness exercise. Goal setting.
Session 7. Assertivness training. Developing awareness of unpleasant feelings (i.e. anger) and changing maladaptive patterns.
Session 8. Social support. Relationships and Communciation. Increasing communication around sensitve topics (i.e. sexuality).
Session 9. Attention and Distraction techniques.
Session 10. Relapse prevention. Predict problems for the future. Reinforce plan to use coping skills and reassess physical illness narrative using new skills learned.

The program can be accessed via: http://www.tameyourgut.com/

Attendance at each weekly session will be noted and patients that did not attend at least 5 sessions will be excluded from the main analysis.

At baseline and at the end of the final group session (10 weeks) questionnaires will be handed in to participants. Follow-up questionnaires (6, 12 and 24 months) as well as all the assessments in the control group will be conducted while participants visit the clinic for a blood test. Patients will be reminded about their scheduled blood tests and will be sent a referral.

Intervention code [1]

Other interventions

Comparator / control treatment

Gastroenterology IBD patients

The control group will receive standard medical care, and also be asked to have all study bloods, disease activity indices, psychological assessments and QoL measures performed at baseline, 6 and 12 months.

Control group

Active

Outcomes

Primary outcome [1]

Disease-specific activity indices will be measured with Crohns Disease Activity Index (CDAI) or the Simple Clinical Colitis Activity Index (SCCAI).

Timepoint [1]