N/A
Completed N=144
Internet-guided Cognitive Behavioural Therapy to Improve Depression Patients With Cardiovascular Disease
Source: ClinicalTrials.gov NCT02778074 ↗Enrolled (actual)
144
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Depressive Symptoms Collected With the Patient Health Questionnaire-9 (PHQ-9) — 6.63; 8.68 score on a scale — p=<0.001
Summary
Purpose and aims Tailored internet-based cognitive behavioural therapy (I-CBT) is a new innovative and person-centred method that is promising that may be used to decrease depression in patients with cardiovascular disease (CVD). In patients with CVD, depressive symptoms is a common co-morbidity leading to decreased wellbeing, and increased morbidity and mortality. Depressive symptoms are both underdiagnosed and undertreated in CVD patients. Earlier studies have demonstrated the efficiency of cognitive behavioural therapy (CBT) for many psychiatric conditions, but few studies have evaluated CBT in patients with CVD.
The overall purpose of this study is to evaluate the effects of the tailored I-CBT program on reducing depressive symptoms and other patient reported outcomes in patients with cardiovascular disease (CVD) and to explore factors related to implementation of the I-CBT program in clinical cardiac care.
The primary aim:
-To evaluate the effects of the tailored I-CBT depression program on depressive symptoms.
Secondary aims:
* To evaluate effects on quality of life´, sleep and anxiety
* To evaluate factors that can influence the I-CBT programs effect on depressive symptoms.
* To gain knowledge about the I-CBT program, as perceived by patients and health care professionals.
* To explore facilitators and barriers to the implementation of the I-CBT program in clinical practice from the perspectives of patients, health care professionals and policymakers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depressive Symptoms Collected With the Patient Health Questionnaire-9 (PHQ-9) |
6.63; 8.68 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- treatment for CVD according to European Society of Cardiology guidelines.
- stable CVD (NYHA class I-III) and not having been hospitalised for CVD in in the last four weeks.
- depressive symptoms (Patient Health Questionnaire-9 17 (PHQ-9) > 5 points)
Exclusion Criteria
- severe CVD (NYHA IV) or another severe chronic life-threatening disease
- severe depression assessed as requiring acute treatment
- not being able to dedicate 3-4 hours to participate in the program
Data sourced from ClinicalTrials.gov (NCT02778074). 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. Informational only — not medical advice.