Internet-delivered CBT for Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:

Internet-delivered Exposure and Mindfulness Based Therapy for Irritable Bowel Syndrome - A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01171053
• Other study ID #: IBS-S
• Status: Completed
• Phase: N/A
• First received: July 26, 2010
• Last updated: July 27, 2010
• Start date: June 2008
• Est. completion date: June 2010

Study information

• Verified date: July 2010
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the efficacy of a 10 week Internet-delivered CBT treatment for patients diagnosed with IBS. The patients' work with the treatment and is supported through online contact with a therapist.

Approximately 86 patients will be included in the study and randomized to either condition.

All included patients are assessed one week before the treatment starts. After 10 weeks (post treatment). Follow-up assessments are conducted at 3 and 12 months follow-up after treatment.

Patients in treatment condition are hypothesized to experience significant reduction IBS symptoms, societal costs and quality of life compared to patients on waiting list.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of IBS given by physician

• At screening fulfilling Rome III-criteria for IBS

Exclusion Criteria:

• Severe depression

• Suicidal ideation

• Presence of unexplained IBS alarm symptoms

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Behavioral:
• Internet-delivered CBT
Internet-delivered cognitive behavioral therapy with therapist support.
• Therapist support
Weekly therapist support without CBT-interventions

Locations

Country	Name	City	State
Sweden	Internetpsykatrienheten, M46, Psykiatri sydväst	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Ljótsson B, Falk L, Vesterlund AW, Hedman E, Lindfors P, Rück C, Hursti T, Andréewitch S, Jansson L, Lindefors N, Andersson G. Internet-delivered exposure and mindfulness based therapy for irritable bowel syndrome--a randomized controlled trial. Behav Res — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal symptoms	Gastrointestinal Symptom rating scale (GSRS)	One week before the treatment starts	No
Primary	Gastrointestinal symptoms	Gastrointestinal Symptom rating scale (GSRS)	10 weeks after the treatment started	No
Primary	Gastrointestinal symptoms	Gastrointestinal Symptom rating scale (GSRS)	3 months after the treatment ended	No
Primary	Gastrointestinal symptoms	Gastrointestinal Symptom rating scale (GSRS)	One year after the treatment ended	No
Secondary	Health economic data	"Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry". In this questionnaire, patients register their monthly health care consumption (e.g. GP visits) as well as time spent in informal health enhancing activities (e.g. self-help groups and informal care from friends). In addition, work loss and work cutback both at work and in the domestic realm is measured.	One week before the treatment starts	No
Secondary	Health economic data	"Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry". In this questionnaire, patients register their monthly health care consumption (e.g. GP visits) as well as time spent in informal health enhancing activities (e.g. self-help groups and informal care from friends). In addition, work loss and work cutback both at work and in the domestic realm is measured.	10 weeks after the treatment started	No
Secondary	Health economic data	"Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry". In this questionnaire, patients register their monthly health care consumption (e.g. GP visits) as well as time spent in informal health enhancing activities (e.g. self-help groups and informal care from friends). In addition, work loss and work cutback both at work and in the domestic realm is measured.	3 months after the treatment ended	No
Secondary	Health economic data	"Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry". In this questionnaire, patients register their monthly health care consumption (e.g. GP visits) as well as time spent in informal health enhancing activities (e.g. self-help groups and informal care from friends). In addition, work loss and work cutback both at work and in the domestic realm is measured.	One year after the treatment ended	No
Secondary	Quality of life	The Irritable Bowel Syndrome Quality of Life Instrument	One week before the treatment starts	No
Secondary	Quality of life	The Irritable Bowel Syndrome Quality of Life Instrument	10 weeks after the treatment started	No
Secondary	Quality of life	The Irritable Bowel Syndrome Quality of Life Instrument	3 months after the treatment ended	No
Secondary	Quality of life	The Irritable Bowel Syndrome Quality of Life Instrument	One year after the treatment ended	No
Secondary	Gastrointestinal symptom-specific anxiety	Visceral Sensitivity Index	One week before the treatment starts	No
Secondary	Gastrointestinal symptom-specific anxiety	Visceral Sensitivity Index	10 weeks after the treatment started	No
Secondary	Gastrointestinal symptom-specific anxiety	Visceral Sensitivity Index	3 months after the treatment ended	No
Secondary	Gastrointestinal symptom-specific anxiety	Visceral Sensitivity Index	One year after the treatment ended	No
Secondary	Depressive symptoms	The Montgomery Åsberg Depression Rating Scale	One week before the treatment starts	No
Secondary	Depressive symptoms	The Montgomery Åsberg Depression Rating Scale	10 weeks after the treatment started	No
Secondary	Depressive symptoms	The Montgomery Åsberg Depression Rating Scale	3 months after the treatment ended	No
Secondary	Depressive symptoms	The Montgomery Åsberg Depression Rating Scale	One year after the treatment ended	No
Secondary	Functional impairments in work, social and family life	Sheenan Disability Scale (DSD)	One week before the treatment starts	No
Secondary	Functional impairments in work, social and family life	Sheenan Disability Scale (DSD)	10 weeks after the treatment started	No
Secondary	Functional impairments in work, social and family life	Sheenan Disability Scale (DSD)	3 months after the treatment ended	No
Secondary	Functional impairments in work, social and family life	Sheenan Disability Scale (DSD)	One year after the treatment ended	No