Condition category
Mental and Behavioural Disorders
Date applied
19/09/2012
Date assigned
10/10/2012
Last edited
29/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Anton van Balkom

ORCID ID

Contact details

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

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 measures

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

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

http://www.ggzingeest.nl/zorg/

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

federal

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23625592

Publication citations

  1. 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.

Additional files

Editorial Notes