Treating affective disorders in patients with non-cardiac chest pain

ISRCTN	ISRCTN67858971
DOI	https://doi.org/10.1186/ISRCTN67858971
Secondary identifying numbers	Doelmatigheidsproject00152

Submission date: 19/09/2012
Registration date: 10/10/2012
Last edited: 29/10/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Anton van Balkom
Scientific

VUmc en GGZ inGeest
A.J.Ernststraat 1187
Amsterdam
1081 HL
Netherlands

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A brief cognitive-behavioural intervention for treating affective disorders in patients with non-cardiac chest pain: a 24-week randomized controlled trial
Study objectives	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(s)	VU University Medical Center Ethical Review Committee, 24/01/2011, ref: TJFS/bz 2000-2338a
Health condition(s) or problem(s) studied	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
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 study start date	01/02/2001
Completion date	01/04/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	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
Key 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
Key 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.
Date of first enrolment	01/02/2001
Date of final enrolment	01/04/2003

Locations

Countries of recruitment

Netherlands

Study participating centre

VUmc en GGZ inGeest

Amsterdam
1081 HL
Netherlands

Sponsor information

VU University Medical Center (Netherlands)
Hospital/treatment centre

Department of Psychiatry
EMGO Institute
A.J.Ernststraat 1187
Amsterdam
1081 HL
Netherlands

Website	http://www.ggzingeest.nl/zorg/
"ROR"	https://ror.org/00q6h8f30

Funders

Funder type

University/education

College voor Zorgverzekeringen (Netherlands)
Government organisation / National government

Alternative name(s): Health Care Insurance Board, Netherlands, CVZ
Location: Netherlands

VU University Medical Center (Netherlands)

No information available

GGZinGeest (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2013		Yes	No