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.The secondary objective is to investigate the extent to…
ID
Source
Brief title
Condition
- Other condition
- Gastrointestinal conditions NEC
Synonym
Health condition
geringe kwaliteit van leven, angst en depressie klachten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
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. 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
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.
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: (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.
Background summary
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.
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, illness-related
cognitions and attitudes prior to and one month following intervention or
control period.
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.
Study objective
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.
The secondary objective is to investigate the extent to which changes in
quality of life are mediated by improvements in cognitions and attitudes.
The tertiary objective is to describe the population in terms of psychiatric
diagnoses and to explore the coping styles used.
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.
Study design
Experimental design
Conditions.
The present study is designed as a multi-center randomized clinical trial. All
patients with ulcerative colitis or Crohn's disease attending the out-patient
departments of the Academic Medical Center (AMC), the University Medical Center
Nijmegen (UMC St Radboud) and the Leids University Medical Centre (LUMC), will
complete the SF 36 as part of standard care.
Those patients who score on the mental health subscale at or below the cutoff
score of 23 will be eligible for the study. The mental health subscale consists
of 5 items that require a response on a 6-point scale (range 5-30). These
patients are considered sufficiently burdened by the illness to expect a
psychological intervention to be potentially effective. The cutoff score of 23
was chosen as scores of 23 and lower were found indicative (with a high level
of sensitivity and specificity) of depression and anxiety in primary care
patients.
Within each participating center, consenting patients will be randomly assigned
to one of two conditions: cognitive behavioral therapy administered immediately
or waiting list control condition. Randomization will be stratified by age and
gender, and will be performed at the Department of Clinical Epidemiology and
Biostatistics of the AMC. Participants assigned to the waiting-list control
condition will wait eight weeks plus one month before they will be treated with
cognitive behavioral therapy. This period corresponds to the duration of the
intervention and follow-up assessment.
Assessments. Patients who consent to participate will be asked to complete the
set of questionnaires (see below) via the web, and will be administered the
SCID-I (see below) by telephone within two weeks following screening. 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.
Intervention
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, 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.
Study burden and risks
Burden.
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.
Clearly, each individual patient has the right to withdraw from the study at
any time he/she wishes.
One burden could be that participants will have to wait (8 weeks) for the
cognitive behavioral therapy intervention in the waitinglist control condition.
Secundary burden could be that participants are obliged to follow the treatment
manual including 8 sessions and complementary home work assignments.
Benefits.
The most important benefit is that the cognitive behavioral therapy
intervention will enhancing the quality of life of the IBD patients. And it may
not only benefit the psychological well-being of patients with IBD, but also
their physical health.
There is a compelling need to enhance the quality of life of patients with IBD.
Poor quality of life is not only a consequence of the disease but may in itself
be a causal factor. It may induce a higher level of symptom severity, more
reporting of unexplained physical symptoms and poorer treatment adherence.
The structured program (detailed session by session manual) will lend itself
well for quick transfer to and training of the professionals
(psychotherapists). Thus, if found effective a new cognitive behavioral therapy
protocol can be offered to patients with IBD and possibly other
gastroenterological diseases in the Netherlands.
Meibergdreef 9
1100 DD Amsterdam
NL
Meibergdreef 9
1100 DD Amsterdam
NL
Listed location countries
Age
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 are (1) known psychiatric disorders that may complicate treatment (e.g., psychosis); and (2) current treatment with psychotherapy.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL22948.018.08 |