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Enhancing the quality of life of patients with inflammatory bowel disease: a multi-center study investigating cognitive behavioral therapy.

Enhancing the quality of life of patients with inflammatory bowel disease: a multi-center study investigating cognitive behavioral therapy.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON19981
Enrollment
80
Registered
2009-06-18
Start date
2009-02-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

quality of life, anxiety and depression of patients with inflammatory bowel disease and cognitive behavioral therapy. Dutch: kwaliteit van leven angst en depressie bij patienten met inflammatoire darmziekten en cognitieve gedragstherapie

Interventions

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

Sponsors

Schering_Plough
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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; 6. Sufficient command of Dutch.

Exclusion criteria

Exclusion criteria: 1. Known psychiatric disorders that may complicate treatment (e.g., psychosis); 2. Current treatment with psychotherapy.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
1. 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; 2. 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; 3. The 40-item Dysfunctional Attitude Scale (DAS) measures dysfunctional attitudes, including excessive and rigid beliefs; 4. 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; 5. 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. The scale should be a useful tool for epidemiologic studies of depression. Radloff LS (1977) The CES D Scale: a self report depression scale for research in the general population. Appl. Psychol Measure 3: 385-401. Tertiary outcome measures: 1. The SCID-I is a semi-structured i

Contacts

Public ContactF. Bennebroek Evertsz

Department of Medical psychology Academic Medical Centre Meibergdreef 9

f.bennebroek@amc.uva.nlTel: +31 20 5664661

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)