Enhancing the quality of life of patients with inflammatory bowel disease; a multicentre study investigating cognitive behavioral therapy

Enhancing the quality of life of patients with inflammatory bowel disease; a multicentre study investigating cognitive behavioral therapy - CBT and IBD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON32226

Enrollment

Registered

2008-12-11

Start date

2009-09-26

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

geringe kwaliteit van leven, angst en depressie klachten Inflammatory bowel disease

Interventions

Intervention The intervention spans an 8-week period, consisting of eight weekly sessions, each lasting one hour. The cognitive behavioral therapy will be conducted by registered psychotherapists,

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria are: (1) a diagnosis of Crohn*s disease or ulcerative colitis; (2) age above 18; (3) a score on the mental health scale of the SF-36 of 23 or lower; (4) physically and mentally able to attend eight weekly sessions; (5) willing to give written informed consent; and (6) sufficient command of Dutch.

Exclusion criteria

Exclusion criteria: Exclusion criteria are (1) known psychiatric disorders that may complicate treatment (e.g., psychosis); and (2) current treatment with psychotherapy.

Design outcomes

Primary

Measure	Time frame
Measures Sociodemographic and clinical data Sociodemographic data will include age, gender, educational level, employment status, marital status, ethnicity, and treatment center. Clinical data will be completed by the treating gastroenterologist, and will include type of disease (Crohn's disease and ulcerative colitis), date of onset of disease, having a colostomy, and comorbidity. Finally, disease activity of each patient attending the outpatient department will be registered in an electronic database, using the following illness specific questionnaires: the Harvey Bardshaw index (HBI) for patients with Crohn*s disease and the Modified Truelove and Witts Severity Index (MTWSI) for patients with ulcerative colitis. Outcome measures Primary outcome measure. The Inflammatory Bowel Disease Questionnaire (IBD-Q) will be used to assess primary outcome of the intervention. The IBD-Q measures health-related quality of life and consists of 32 items assessing four dimensions; bowel symptoms, systemic symptoms, emotional functioning, and social functioning. In addition to these four subscale scores, a total score can be calculated.	—

Measure

Time frame

Measures Sociodemographic and clinical data Sociodemographic data will include age, gender, educational level, employment status, marital status, ethnicity, and treatment center. Clinical data will be completed by the treating gastroenterologist, and will include type of disease (Crohn's disease and ulcerative colitis), date of onset of disease, having a colostomy, and comorbidity. Finally, disease activity of each patient attending the outpatient department will be registered in an electronic database, using the following illness specific questionnaires: the Harvey Bardshaw index (HBI) for patients with Crohn*s disease and the Modified Truelove and Witts Severity Index (MTWSI) for patients with ulcerative colitis. Outcome measures Primary outcome measure. The Inflammatory Bowel Disease Questionnaire (IBD-Q) will be used to assess primary outcome of the intervention. The IBD-Q measures health-related quality of life and consists of 32 items assessing four dimensions; bowel symptoms, systemic symptoms, emotional functioning, and social functioning. In addition to these four subscale scores, a total score can be calculated.

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Secondary

Measure	Time frame
Secondary outcome measures. The MOS SF-36 is a 36-item questionnaire assessing generic health-related quality of life or health status. The items can be aggregated into a Physical Component Summary score and a Mental Component Summary score, which will be used as outcome variables. The Illness Perception Questionnaire-Revised (IPQ-R) assesses illness-related cognitions. The 48 items measure seven dimensions: timeline acute/chronic, timeline cyclical, consequences, personal control, treatment control, emotional representations, and illness coherence. The 40-item Dysfunctional Attitude Scale (DAS) measures dysfunctional attitudes, including excessive and rigid beliefs. All standard self-report questionnaires fulfill the following selection criteria. They: (a) are relatively brief, (b) have sufficient breadth of coverage, (c) are widely used, and (d) yield adequate to high levels of reliability and validity. The Hospital Anxiety and Depression Scale (HADS; Zigmund et al., 1983; Spinhoven et al., 1997) assesses the possible presence of anxiety and depressive states. The HADS is considered to be unbiased by the presence of somatic illness and is found to be reliable and valid. It consists of two sub-scales, anxiety and depression, both containing seven items. Each item is rated on a 4-point scale from 0 to 3. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr.Scand. 1983;67:361-70. Spinhoven P, Ormel J, Sloekers PP, Kempen GI, Speckens AE, Van Hemert AM. A validation study of the Hospital Anxiety and Depression Scale (HADS) in different groups of Dutch subjects. Psychol.Med. 1997;27:363-70. The CES-D scale (The Centre for Epidemiologic Studies Depression Scale) is a short self-report scale designed to measure depressive symptomatology in the general population. Reliability, validity, and factor structure were similar across a wide variety of demographic characteristics in the general population samples tested. T	—

Measure

Time frame

Secondary outcome measures. The MOS SF-36 is a 36-item questionnaire assessing generic health-related quality of life or health status. The items can be aggregated into a Physical Component Summary score and a Mental Component Summary score, which will be used as outcome variables. The Illness Perception Questionnaire-Revised (IPQ-R) assesses illness-related cognitions. The 48 items measure seven dimensions: timeline acute/chronic, timeline cyclical, consequences, personal control, treatment control, emotional representations, and illness coherence. The 40-item Dysfunctional Attitude Scale (DAS) measures dysfunctional attitudes, including excessive and rigid beliefs. All standard self-report questionnaires fulfill the following selection criteria. They: (a) are relatively brief, (b) have sufficient breadth of coverage, (c) are widely used, and (d) yield adequate to high levels of reliability and validity. The Hospital Anxiety and Depression Scale (HADS; Zigmund et al., 1983; Spinhoven et al., 1997) assesses the possible presence of anxiety and depressive states. The HADS is considered to be unbiased by the presence of somatic illness and is found to be reliable and valid. It consists of two sub-scales, anxiety and depression, both containing seven items. Each item is rated on a 4-point scale from 0 to 3. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr.Scand. 1983;67:361-70. Spinhoven P, Ormel J, Sloekers PP, Kempen GI, Speckens AE, Van Hemert AM. A validation study of the Hospital Anxiety and Depression Scale (HADS) in different groups of Dutch subjects. Psychol.Med. 1997;27:363-70. The CES-D scale (The Centre for Epidemiologic Studies Depression Scale) is a short self-report scale designed to measure depressive symptomatology in the general population. Reliability, validity, and factor structure were similar across a wide variety of demographic characteristics in the general population samples tested. T

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)