N/A
N=100
Treatment of Depression in Acute Coronary Syndrome (ACS) Patients
Depression
Bottom Line
View on ClinicalTrials.gov: NCT00998400 ↗Enrolled (actual)
100
Serious AEs
15.0%
Results posted
Feb 2020
Primary outcome: Primary: Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Clinical Interview for Depression, Compared to Clinical Management — 38.18; 36.20; 29.39; 32.30 score on a scale — p=0.030
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CBT in combination with WBT and life style modification (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University of Bologna
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Clinical Interview for Depression, Compared to Clinical Management |
38.18; 36.20; 29.39; 32.30; 30.48; 31.89 | 0.030 sig |
| PRIMARY Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Symptom Questionnaire ("Anxiety" Subscale), Compared to Clinical Management |
8.60; 7.24; 7.04; 6.39; 6.60; 6.13 | >0.05 |
| PRIMARY Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales ("Autonomy" Dimension), Compared to Clinical Management |
62.20; 61.80; 64.58; 62.82; 64.54; 63.20 | >0.05 |
| PRIMARY Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Symptom Questionnaire ("Depression" Subscale), Compared to Clinical Management |
7.92; 6.90; 7.21; 5.94; 6.38; 5.83 | >0.05 |
| PRIMARY Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Symptom Questionnaire ("Somatization" Subscale), Compared to Clinical Management |
9.82; 7.82; 8.80; 8.24; 8.67; 7.87 | >0.05 |
| PRIMARY Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Symptom Questionnaire ("Hostility" Subscale), Compared to Clinical Management |
4.70; 5.34; 5.19; 4.12; 5.18; 4.71 | 0.013 sig |
| PRIMARY Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales ("Environmental Mastery" Dimension), Compared to Clinical Management |
55.28; 55.32; 57.33; 56.69; 59.48; 57.81 | >0.05 |
| PRIMARY Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales ("Personal Growth" Dimension), Compared to Clinical Management |
60.48; 56.18; 61.46; 56.54; 61.95; 56.67 | >0.05 |
| PRIMARY Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales ("Positive Relations" Dimension), Compared to Clinical Management |
61.26; 60.20; 61.82; 59.90; 61.88; 59.93 | >0.05 |
| PRIMARY Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales ("Purpose in Life" Dimension), Compared to Clinical Management |
56.80; 56.22; 57.31; 54.97; 58.35; 55.47 | >0.05 |
| PRIMARY Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales ("Self-acceptance" Dimension), Compared to Clinical Management |
54.58; 55.80; 55.70; 56.03; 57.59; 57.86 | >0.05 |
| SECONDARY Number of Participants With Hospitalizations for Cardiac Problems, Revascularization, Recurrent Nonfatal Myocardial Infarction or Cardiac Mortality at 30-month Follow-up. |
8; 5; 1; 1; 41; 44 | >0.05 |
Summary
Emotional states of depression in association with ischemic heart diseases, such as myocardial infarction or unstable angina, are risk factors for subsequent cardiac events and mortality. However, the only psychological intervention trial attempting to reduce cardiac risk in depressed ACS patients showed that changes in depression did not translate into improved survival. Such intervention did not address issues such as lifestyle modification and improvement in psychological well-being, which were found to affect individual vulnerability to medical disease. Our research group has developed a well-being enhancing psychotherapeutic strategy, well-being therapy (WBT), which has been validated in a number of clinical trials. The aim of this project is to evaluate the efficacy of cognitive behavioral treatment (CBT) together with lifestyle modification and WBT in reducing cardiac risk in depressed and/or demoralized ACS patients compared to a standard clinical procedure of patients' management, the clinical management (CM). The same protocol will be carried out in two centres (Bologna and Torino). 100 patients after a first episode of myocardial infarction or unstable angina, meeting DSM-IV criteria for depressive disorders and DCPR criteria for demoralization will be randomized to one of two treatment groups: 1) CBT supplemented by lifestyle modification and WBT; 2) CM. In both groups, treatment will consist of twelve, 45-minute sessions once a week. A two-year follow-up will be performed. It is expected that psychological treatment may significantly decrease cardiac morbidity and mortality at follow-up compared to clinical management. The findings may entail considerable preventive implications and possible large reductions in health costs.
Eligibility Criteria
Inclusion Criteria
- a current diagnosis of at least one of the following: major or minor depression, dysthymia according to DSM-IV criteria, and demoralization according to DCPR criteria
- Mini-Mental State Examination score higher than 24
- written informed consent provided by the patient to participate
Exclusion Criteria
- history of bipolar disorder (DSM-IV criteria)
- major depression with psychotic features
- history of substance abuse or dependency during the previous 12 months
- serious suicide risk
- current use of antidepressants
- current treatment with any form of psychotherapy
Data sourced from ClinicalTrials.gov (NCT00998400). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.