The primary objective is to determine the efficacy of a disease specific cognitive behavioral therapy program in adolescents with IBD and increased symptoms of depression or anxiety on reducing symptoms of depression. Secondary objectives are to…
ID
Source
Brief title
Condition
- Other condition
- Gastrointestinal inflammatory conditions
- Mood disorders and disturbances NEC
Synonym
Health condition
angststoornissen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main outcome is reduction in symptoms of depression.
Secondary outcome
Secondary psychological outcomes are reduction in symptoms of anxiety, quality
of life, psychosocial functioning, illness perception, cognitive coping,
quality of sleep, parental anxiety and/or depression, stressful life-events,
family functioning and demographic factors. Secondary medical outcomes are
presence of clinical relapse, IBD activity scores, necessity of surgical
intervention, treatment adherence, health care utilization, disease phenotype,
treatment strategy, immune status (RNA expression profiles) and immunological
activity (blood lymfocyt profiles).
Background summary
Inflammatory bowel disease (IBD: Crohn*s disease (CD) and ulcerative colitis
(UC)) is a life-long disorder, characterized by unpredictable periods of
remission and relapse, leading to high physical morbidity and psychosocial
suffering. Despite chronic medical treatment, aimed at maintenance of
remission, 30-40% of patients experience frequent relapses resulting in
irreversible complications. Not only disease phenotypes, but also emotional
problems like depression or anxiety, stressful events, and family factors are
associated with disease activity. Youngsters with IBD are at high risk for
emotional problems, with rates of depression or anxiety disorder as high as 25%
or 40%, respectively. The association between symptoms of depression and
anxiety and intestinal inflammation seems to be bidirectional. On the one hand,
symptoms of inflammation, medical treatment and having a chronic disease can
increase the risk for emotional problems. On the other hand, emotional problems
can exacerbate intestinal inflammation, leading to frequent relapses, and
worsening of disease course. Yet, psychosocial intervention for youth with IBD
is not part of routine care. It is known that cognitive behavioral therapy
(CBT) is effective in reducing symptoms of depression and anxiety in youngsters
with IBD, the effect on disease course is not yet studied. The presented study
hypothesizes that in adolescents with IBD and increased symptoms of anxiety and
depression, the disease specific CBT program (PASCET-PI) will lead to a
reduction in symptoms of depression and anxiety, will improve quality of life
and have a positive effect on disease course.
Study objective
The primary objective is to determine the efficacy of a disease specific
cognitive behavioral therapy program in adolescents with IBD and increased
symptoms of depression or anxiety on reducing symptoms of depression.
Secondary objectives are to assess the effect of the CBT program on a) the
clinical course of disease b) reducing symptoms of anxiety, and c) improving
quality of life. We also aim to identify psychosocial and medical factors that
predict or moderate the treatment response to CBT in adolescent with IBD.
Study design
The presented study is a multicenter randomized controlled trial (RCT),
involving CBT versus care as usual (CAU). Participants will be asked to
participate in the RCT if they have increased symptoms of self-reported
depression or anxiety on the baseline screening (T1). There will be three
follow-up moments, after 3 months/after the intervention (T2) and after 6
months T3) and after 12 months (T4).
Intervention
A disease specific CBT program called PASCET-PI (Primary and Secondary Control
Enhancement Training - Physical Illness). This program focuses on reduction of
depression and anxiety specific in youngsters with IBD and consists of 13
sessions (6 outpatient visits of 1 hour, 7 telephonic (30 minutes)). The
control group (CAU), will not receive active therapy but will maintain their
regular follow up visits at the gastroenterologist every 3 months.
Study burden and risks
Participants have their regular check-up visits at their gastroenterologist,
which will be combined with the study visits. On extra baseline visit will take
place. In addition, (up to) 12 questionnaires will need to be filled in online,
which takes approximately 1.5 hour. For patients in the CBT group, 6 1-hour
sessions will be *live at the outpatient department*, and 7 sessions will be
done by telephone (30 minutes). In addition, three parent-sessions are
provided. At two points a blood sample (when patients undergo routine venous
punctures). A maximum of 10 happy patients, who show no symptoms of anxiety and
or depression, are asked to give permission to draw 2 tubes of blood at one
timepoint. Our study population consists of adolescents and young adults with
IBD, as this is a specific group with high reported symptoms of depression and
anxiety, therefore they will most likely benefit from the intervention. The
risks associated with participation can be considered negligible and the burden
minimal.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
-Patients between 10-25 years with diagnosed IBD
-Informed consent or assent by patients and (if necessary) parents
Exclusion criteria
voor screeningsfase:
• IBD patients with parental report of mental retardation
• IBD patients receiving psychopharmacological treatment (antidepressants or benzodiazepines) for anxiety of depression
• No mastery of the Dutch language
• IBD patients with diagnosed Bipolar disorder, Schizophrenia/psychotic disorder, Autism spectrum disorders, Obsessive-compulsive disorder, Posttraumatic stress disorder/Acute stress disorder, or Substance use disorder
• Physician reported substance abuse (alcohol, drugs) in the past month
• Parental report of Selective mutism
• IBD patients already participating in an (psychological of psychopharmacological) intervention study
• Current psychological treatment
• 8 sessions of protocolled cognitive behavioral therapy during the last year ;voor inclusie in RCT:
-IBD patients with scores for a major depressive disorder or an anxiety disorder
-IBD patients with a urgent need for immediate referral because of other psychological or behavioral problems than depression or anxiety
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 | NL49147.078.14 |