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Combination of specialist treatment and psychosocial intervention in women after a cardiac event

Combination of specialist treatment and psychosocial intervention in women after a cardiac event: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN69468314
Enrollment
250
Registered
2008-12-11
Start date
1996-08-21
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting Circulatory System Chronic ischaemic heart disease

Interventions

The participants were randomly assigned (randomisation ratio 1:1) to the following two groups: Intervention group: A combination of the following two interventions: 1. Specialist treatment (cardiol

Sponsors

Public Health Committee/ EXPO-95 (Sweden)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Women aged <=75 years 2. Those who had either acute myocardial infarction, percutaneous coronary intervention or coronary artery bypass grafting

Exclusion criteria

Exclusion criteria: 1. Women >75 years of age 2. Those not communicating in the Swedish language 3. Those who participated in other research studies 4. Those who did not belong to the hospital catchment area 5. Those who had serious co-morbidity that would preclude taking part in the 1-year intervention programme, such as malignancy or psychiatric disease

Design outcomes

Primary

MeasureTime frame
Patients were followed-up for the following primary outcomes for 6.5 years on average through Swedish health care registers: 1. Mortality 2. Non-fatal myocardial infarction

Secondary

MeasureTime frame
Psychosocial functioning, assessed by the following questionnaires: 1. Beck Depression Inventory 2. Mastricht Questionnaire measuring vital exhaustion 3. Daily Stress Behaviour Questionnaire 4. Availability of Social Integration 5. Availability of Attachment All secondary outcomes were assessed at the following four timepoints: T1: At baseline (6-8 weeks after randomisation) T2: After 10 weeks i.e. after 10 intervention sessions T3: After 1 year (end of intervention) T4: At 1-2 year follow-up measurement

Countries

Sweden

Outcome results

None listed

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