Plain English Summary
Background and study aims
Non-cardiac chest pain is chest pain that resembles heart pain in patients who do not have heart disease. Most patients with non-cardiac chest pain experience anxiety and depressive symptoms. Commonly they receive reassurance and are referred back to primary care, leaving the psychiatric symptoms undiagnosed and untreated. A few small studies have suggested the effectiveness of 12 sessions of cognitive behavioral therapy (CBT), a talking therapy that can help you manage your problems by changing the way you think and behave. The aim of this study is to examine the effectiveness of a brief CBT treatment (six sessions) in reducing anxiety and depressive symptoms in patients with non-cardiac chest pain and panic and/or depressive disorders.
Who can participate?
Patients aged 18 or older with non-cardiac chest pain and panic disorder and/or depressive disorder.
What does the study involve?
Participants are randomly allocated to be treated with either brief cognitive behavioral therapy (CBT) or treatment as usual (TAU). CBT consists of a total of six 45-minutes individual sessions and is tailored to the individual needs of the patients. Patients allocated to TAU are reassured by the cardiologist that their complaints were not caused by heart disease. TAU is tailored to the individual needs of the patients but does not include psychotherapy, including CBT, or antidepressants. At the start of the study and after 24 weeks the patients’ anxiety and depressive symptoms are assessed using questionnaires.
What are the possible benefits and risks of participating?
Participants receive either treatment as usual (no benefit, no risk) or a psychological treatment for their diagnosed psychiatric complaints (possible benefit when effective). No side effects are expected beforehand. After the study the general practitioner receives the psychiatric diagnosis and, when needed, subjects are referred for (follow up) psychiatric treatment (possible benefit).
Where is the study run from?
VU University Medical Center, Amsterdam, the Netherlands.
When is the study starting and how long is it expected to run for?
February 2001 to March 2003.
Who is funding the study?
College voor Zorgverzekeringen/Doelmatigheidsproject00152, Amsterdam, Department of Psychiatry and EMGO Institute, VU University Medical Center, and GGZinGeest, Amsterdam, The Netherlands.
Who is the main contact?
Dr Maria van Beek
M.H.C.vanBeek@psy.umcn.nl
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Doelmatigheidsproject00152
Study information
Scientific title
A brief cognitive-behavioural intervention for treating affective disorders in patients with non-cardiac chest pain: a 24-week randomized controlled trial
Acronym
Study hypothesis
After 24 weeks a brief CBT treatment (6 sessions) is more effective in reducing anxiety and depressive symptoms in patients with non-cardiac chest pain and comorbid panic and/or depressive disorders than treatment as usual.
Ethics approval
VU University Medical Center Ethical Review Committee, 24/01/2011, ref: TJFS/bz 2000-2338a
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Non-cardiac chest pain patients with a diagnosed panic and/or depressive disorder
Intervention
Patients randomized to TAU are reassured by the cardiologist that their complaints were not caused by cardiac disease. TAU is tailored to the individual needs of the patients. However, TAU does not include psychotherapy, including CBT, or antidepressants.
CBT consists of a total of six individual sessions with a duration of 45 minutes. The CBT protocol consists of a combination of psychoeducation, cognitive restructuring and influencing behavior, according to the basic concept of CBT that physical complaints can be cognitively mediated. The treatment is matched to the subject's diagnosis, so that, if needed, more attention is given to psychoeducation on the physical symptoms of anxiety or physical symptoms associated with depressed mood.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Disease severity with the Clinical Global Inventory (CGI) by a blinded independent rater.
Secondary outcome measures
Anxiety and depressive symptoms as assessed with the State-Trait Anxiety Inventory, the Fear Questionnaire, the Hospital Anxiety and Depression Scale and the Hamilton Depression Rating Scale. Furthermore, in the completer sample, at 24 weeks the assessor-rated Clinical Global Impression-Improvement Scale (CGI-Improvement) is administered.
Overall trial start date
01/02/2001
Overall trial end date
01/04/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. All subjects aged 18 years or older who present themselves at the cardiac emergency unit of the VU University Medical Center with chest pain and are convinced they are experiencing a heart attack.
2. Full medical examination reveals no cardiopulmonary, gastrointestinal or endocrinal explanation for their complaints (and thus were diagnosed with 'non-cardiac chest pain')
3. Score 8 or higher on either or both subscales of the Hospital Anxiety and Depression Scale (HADS).
4. Meeting the DSM-IV criteria for panic disorder and/or depressive disorder
5. Providing signed informed consent after an oral and written explanation of the procedures and purpose of the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Sample size of 45 subjects per condition. Assuming a dropout rate of 30% (n=27), a total of 117 persons are to be included
Participant exclusion criteria
1. Those with insufficient knowledge of the Dutch language
2. Those who, in the month before screening, received systematic psychotherapy or used antidepressants. Benzodiazepine usage is allowed during the trial, up to a maximum of 50 mg of oxazepam or equivalent doses of other medications.
Recruitment start date
01/02/2001
Recruitment end date
01/04/2003
Locations
Countries of recruitment
Netherlands
Trial participating centre
VUmc en GGZ inGeest
Amsterdam
1081 HL
Netherlands
Sponsor information
Organisation
VU University Medical Center (Netherlands)
Sponsor details
Department of Psychiatry
EMGO Institute
A.J.Ernststraat 1187
Amsterdam
1081 HL
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
College voor Zorgverzekeringen (Netherlands)
Alternative name(s)
Health Care Insurance Board, Netherlands, CVZ
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Netherlands
Funder name
VU University Medical Center (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
GGZinGeest (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23625592
Publication citations
-
Results
van Beek MH, Oude Voshaar RC, Beek AM, van Zijderveld GA, Visser S, Speckens AE, Batelaan N, van Balkom AJ, A brief cognitive-behavioral intervention for treating depression and panic disorder in patients with noncardiac chest pain: a 24-week randomized controlled trial., Depress Anxiety, 2013, 30, 7, 670-678, doi: 10.1002/da.22106.