Enhancing the quality of life of patients with inflammatory bowel disease: a multi-center study investigating cognitive behavioral therapy.|
|- candidate number||5977|
|- NTR Number||NTR1869|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-jun-2009|
|- Secondary IDs||08/295 MEC - AMC|
|- Public Title||Enhancing the quality of life of patients with inflammatory bowel disease: a multi-center study investigating cognitive behavioral therapy.|
|- Scientific Title||Enhancing the quality of life of patients with inflammatory bowel disease: a multi-center study investigating cognitive behavioral therapy.|
|- ACRONYM||KL!C study|
|- hypothesis||Our primary hypothesis states that cognitive behavioral therapy will improve quality of life and amend illness cognitions and attitudes in IBD patients.|
Our secondary hypothesis states that improvements in quality of life are mediated by changes in illness cognitions and attitudes.
|- Healt Condition(s) or Problem(s) studied||Depression, Anxiety, Cognitive behavior therapy, Quality of life, Inflammatory bowel disease|
|- 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||1. Known psychiatric disorders that may complicate treatment (e.g., psychosis);|
2. Current treatment with psychotherapy.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2009|
|- planned closingdate||1-feb-2011|
|- Target number of participants||80|
|- 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 conducting cognitive behavioral therapy. The first session will focus on the rationale of cognitive behavioral therapy, i.e. the influence of (irrational or dysfunctional) cognitions and attitudes on (maladaptive) feelings and behaviors. Additionally, goal setting will be initiated. These therapy goals will be unique for each patient. The subsequent sessions (2-6) will be targeted at identifying and amending irrational cognitions and attitudes related to IBD. Each session will address specific illness-related cognitions. Additionally, patients will be taught how dysfunctional cognitions and attitudes affect adversely feelings and behaviors. These dysfunctional cognitions and attitudes will be challenged and replaced by functional cognitions and attitudes. After each session, patients will be given home work. For example, patients will be asked to register negative experiences, and accompanying cognitions, feelings and behaviors. Clearly, some of the negative cognitions are realistic and reflect the limitations that the disease imposes. Such thoughts will be worked through, accepted or resolved. Finally, in the last two sessions, the newly learned cognitions and attitudes will be consolidated.
|- Primary outcome||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 outcome||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 interview for the classification of psychiatric disorders following the DSM-IV-criteria. SCID-I refers to AS-I disorders (for instance anxiety and depression disorders).
Groenestijn, M.A.C. van, Akkerhuis, G.W., Kupka, R.W., Schneider, N. & Nolen, W.A. (1998), SCID-I: Gestructureerd klinisch interview voor het vaststellen van DSM-IV stoornissen, Amsterdam, Harcourt Assessment;
2. The Utrechtse Coping Lijst (UCL) (Schreurs et al.,1984; 1988) is a valid and reliable self-report measure that assesses general coping behaviour in problem situations. The subscales ‘depression reaction pattern’ (7 items) and ‘avoidance’ (8 items) will be used. A four-point response scale is employed, ranging from seldom or not to very often.
Schreurs PJG, Tellegen B, Willige van de G. Gezondheid, stress en coping: de ontwikkeling van de Utrechtse Coping Lijst. Gedrag: Tijdschr Psychol 1984; 12: 101-117.
Schreurs PJG, Willige G. Omgaan Met Problemen en Gebeurtenissen: De Utrechtse Copinglijst (UCL). Lisse: Swets & Zeitlinger, 1988.
All standard self-report questionnaires fulfill the following selection criteria. They:
1. Are relatively brief;
2. Have sufficient breadth of coverage;
3. Are widely used;
4. Yield adequate to high levels of reliability and validity.
|- Timepoints||At baseline, the questionnaires will be administered electronically via the web. The SCID will be administered by telephone by psychologists who are trained in administering the SCID. At the second and third measurement points, the questionnaires will again be administered via the web. In general if patients object to webbased completion of questionnaires, the questionnaires will be mailed and completed by paper and pencil.
Consenting patients will be asked to complete the set of questionnaires via the web. The SCID will be administered by telephone. After completion of the baseline assessment, patients will be randomly assigned to the treatment or waiting-list control condition. Treatment for those in the treatment condition will then start as soon as possible. The second assessment will take place four weeks following start of treatment and the third assessment one month following completion of treatment. Patients in the waiting list control condition will be asked to complete the questionnaires four times: in addition to the three assessments as described for the treatment condition, they will also complete the set of questionnaires after inclusion in the study, prior to randomization, i.e.3,5 months prior to the immediate pre-treatment assessment.
|- Trial web site||www.ning.com KLIC study|
|- CONTACT FOR PUBLIC QUERIES||Drs F. Bennebroek Evertsz|
|- CONTACT for SCIENTIFIC QUERIES||Prof. M.A.G. Sprangers|
|- Sponsor/Initiator ||Schering-Plough B.V.|
(Source(s) of Monetary or Material Support)
|Maag Lever Darm Stichting (MLDS)|
|- Brief summary||Rationale:|
Individuals with Inflammatory Bowel Disease (IBD; Crohn's disease and ulcerative colitis) have been found to report poorer quality of life and more psychological distress than comparison-controls from the general population. Poor quality of life in turn, may cause relapse and disease activity. Recent studies suggest that higher levels of distress in IBD patients are associated with illness-related cognitions and attitudes. One of the most promising interventions for enhancing quality of life and decreasing distress in people is cognitive behavioral therapy. Such therapy is aimed at amending unhelpful cognitions and attitudes and offers a well-developed intervention protocol that has been found to be effective in people with other chronic illnesses. In a recent exploratory, uncontrolled study cognitive behavioral therapy for IBD outpatients was found to be feasible and effective for the reduction of psychological distress. These exploratory results justify a further and more stringent investigation of this therapy’s effectiveness in IBD patients.
Objective and methods:
The primary objective is to investigate the short-term effectiveness of individual cognitive behavioral therapy in a Dutch sample of IBD patients on quality of life, cognitions and attitudes. IBD patients who have a poor level of mental quality of life will be randomly assigned to a treatment condition (n = 40) and a waiting-list control condition (n = 40). Patients will complete standardized self-report measures on quality of life, anxiety and depression complaints, illness-related cognitions and attitudes and coping prior to, mid-treatment (4 weeks following start of the treatment) and one month following treatment.
Burden, risk, and benefit:
In general there are few if any risks associated with the research in question. Since there is no indication and no evidence that the intervention might be harmful to patients, we do not anticipate premature termination of the study. One burden could be that participants will have to wait 8 extra weeks for the cognitive behavioral therapy intervention in the waiting list control condition. Secondary burden could be that participants are obliged to follow the treatment manual including 8 sessions and complementary home work assignments. The most important benefit is that the cognitive behavioral therapy intervention is expected to enhance the quality of life of the IBD patients.
If found feasible and effective, a new cognitive behavioral therapy protocol can be offered to patients with IBD and, possibly, other gastroenterological diseases. By enhancing IBD patients' quality of life, we may also improve their physical health, and ultimately lower unnecessary health care consumption.
|- Main changes (audit trail)|
|- RECORD||18-jun-2009 - 6-okt-2009|
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