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Treating affective disorders in patients with non-cardiac chest pain

A brief cognitive-behavioural intervention for treating affective disorders in patients with non-cardiac chest pain: a 24-week randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN67858971
Enrollment
117
Registered
2012-10-10
Start date
2001-02-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-cardiac chest pain patients with a diagnosed panic and/or depressive disorder Mental and Behavioural Disorders Depressive episode, unspecified

Interventions

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 in

Sponsors

VU University Medical Center (Netherlands)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Disease severity with the Clinical Global Inventory (CGI) by a blinded independent rater.

Secondary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026