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| Name | Class |
|---|---|
| Region Stockholm | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Attention control | Placebo Comparator | Weekly support from therapist without CBT-interventions |
|
| Internet CBT | Experimental | Internet-delivered cognitive behavioral therapy with therapist support |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-delivered CBT | Behavioral | Internet-delivered cognitive behavioral therapy with therapist support. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal symptoms | Gastrointestinal Symptom rating scale (GSRS) | One week before the treatment starts |
| Gastrointestinal symptoms | Gastrointestinal Symptom rating scale (GSRS) | 10 weeks after the treatment started |
| Gastrointestinal symptoms | Gastrointestinal Symptom rating scale (GSRS) | 3 months after the treatment ended |
| Gastrointestinal symptoms | Gastrointestinal Symptom rating scale (GSRS) | One year after the treatment ended |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nils Lindefors, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Internetpsykatrienheten, M46, Psykiatri sydväst | Stockholm | 141 86 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20362976 | Result | Ljotsson B, Falk L, Vesterlund AW, Hedman E, Lindfors P, Ruck C, Hursti T, Andreewitch S, Jansson L, Lindefors N, Andersson G. Internet-delivered exposure and mindfulness based therapy for irritable bowel syndrome--a randomized controlled trial. Behav Res Ther. 2010 Jun;48(6):531-9. doi: 10.1016/j.brat.2010.03.003. Epub 2010 Mar 16. |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Therapist support | Behavioral | Weekly therapist support without CBT-interventions |
|
| One week before the treatment starts |
| 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 |
| 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 |
| 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 |
| Quality of life | The Irritable Bowel Syndrome Quality of Life Instrument | One week before the treatment starts |
| Quality of life | The Irritable Bowel Syndrome Quality of Life Instrument | 10 weeks after the treatment started |
| Quality of life | The Irritable Bowel Syndrome Quality of Life Instrument | 3 months after the treatment ended |
| Quality of life | The Irritable Bowel Syndrome Quality of Life Instrument | One year after the treatment ended |
| Gastrointestinal symptom-specific anxiety | Visceral Sensitivity Index | One week before the treatment starts |
| Gastrointestinal symptom-specific anxiety | Visceral Sensitivity Index | 10 weeks after the treatment started |
| Gastrointestinal symptom-specific anxiety | Visceral Sensitivity Index | 3 months after the treatment ended |
| Gastrointestinal symptom-specific anxiety | Visceral Sensitivity Index | One year after the treatment ended |
| Depressive symptoms | The Montgomery Åsberg Depression Rating Scale | One week before the treatment starts |
| Depressive symptoms | The Montgomery Åsberg Depression Rating Scale | 10 weeks after the treatment started |
| Depressive symptoms | The Montgomery Åsberg Depression Rating Scale | 3 months after the treatment ended |
| Depressive symptoms | The Montgomery Åsberg Depression Rating Scale | One year after the treatment ended |
| Functional impairments in work, social and family life | Sheenan Disability Scale (DSD) | One week before the treatment starts |
| Functional impairments in work, social and family life | Sheenan Disability Scale (DSD) | 10 weeks after the treatment started |
| Functional impairments in work, social and family life | Sheenan Disability Scale (DSD) | 3 months after the treatment ended |
| Functional impairments in work, social and family life | Sheenan Disability Scale (DSD) | One year after the treatment ended |
| D004066 | Digestive System Diseases |