Linkoping University
Norrköping, 601 74, Sweden
NCT Number: NCT02778074
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Norrköping, 601 74, Sweden
Power calculation: Effect size=0.5, alpha=0.05 (Z=1.96), Power 0.80 (Z -0.84) = 122 participants. Due to drop-outs or deaths the size of the study population for the RCT study was decided to n=140.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A nine-week tailored I-CBT program for patients with CVD. The CBT program consists of the components of psychoeducation, relaxation, problem-solving and behavioural activation.
Other names: I-CBT
Participants will be allocated to an internet moderated discussion forum during 9 weeks. Patients will discuss issues related to cardiovascular disease. A new topic will be discussed every week. After 9 weeks, those in the moderated discussion forum will be offered to perform the I-CBT program.
Time frame: Score at 9 weeks follow-up
The PHQ-9 is a nine-item instrument for measurement of depressive symptoms during the last two weeks. Each item is answered on a four graded scale where zero represents that the item do not affect the person and numbers one to three represents that the item affects the person several days to almost every day. The answers are summed to a total sum score, range 0-27, with higher numbers representing higher level of depressive symptoms. A cut off >5 represents minor depression and a cut off >10 represents major depression
University Hospital, Linkoeping
Other
Internet-guided Cognitive Behavioural Therapy to Improve Depression in Patients With Cardiovascular Disease
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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