Cardiovascular Disease, Psychological Distress
Conditions
Keywords
Cardiovascular disease, Psychological distress, Internet-based cognitive behavioural therapy
Brief summary
To evaluate a nine-week adaptable and person-centred I-CBT program that can be directed towards stress, anxiety and depressive symptoms in persons with CVD.
Detailed description
All patients diagnosed as CVD (i.e. diagnosis Ischemia (ICD-code I20., I25.), Heart Failure (ICD-code I50., I42.) or Arrhythmia (ICD-code I48, I49, DF016) and who received care in the last 12 months at hospitals in the south-east of Sweden will be contacted by letter with information about the study. Participants who are interested are invited to visit our website for more information, registration and provision of informed consent. After registration, participants will respond to questions about demographics, medical history, stress, anxiety and depressive symptoms on the website. Inclusion or exclusion will be assessed by a group consisting of a psychologist, cardiology specialist nurse and a psychiatry specialist nurse. Before final inclusion and randomization eligible participants will be contacted for a telephone interview held by the study nurses. Included (n=400) participants will, on our website (www.xxxxxx), complete the baseline study questionnaires and then be randomized according to a 2 x2 factorial design.
Interventions
BEHAVIORALinternet-based cognitive behavioral theraphy
When determining the content of the I-CBT program, the participants and therapist will be allowed to choose from a library of treatment modules. Therapist controlled support and feedback are given weekly and in a structured manner. Participants will be able to contact the therapist when support and feedback is desired
Sponsors
University Hospital, Linkoeping
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
2 x 2
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age 18 years and above * treatment for cardiovascular disease (CVD) according to European Society of Cardiology guidelines * stable CVD (New York Heart Association class I-III) and not having been hospitalised for CVD in in the last four weeks. * stress (Perceived Stress Scale (PSS)-10\>13 points) and/or * anxiety (i.e. General Anxiety Disorder Scale (GAD) ≥5 points) and/or * depressive symptoms (Patient Health Questionnaire-9 28 (PHQ-9) \> 5 points)
Exclusion criteria
* severe CVD (New York Heart Association classification IV) or another severe chronic life-threatening disease * severe stress, anxiety or depression assessed as requiring acute treatment * not being able to dedicate 3-4 hours per week to participate in the program
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in stress from baseline to 9 weeks on the 10 item Perceived Stress Scale | From baseline to 9 weeks at the end of the intervention. | The 10-item Perceived Stress Scale is a valideted self-report of Stress. The instreument measures the degree to which individuals perceives their life situations as stressful. The 10 items are rated on a 5 point scale and higher scores means more stress |
| Change in anxiety from baseline to 9 weeks on the 7-item Generalized Anxiety Disorder Scale. | From baseline to 9 weeks at the end of the intervention. | General Anxiety Disorder scale is validagted self-resport that measure symptoms of general anxiety during the last two weeks. The 7-items range from 0 (not bothered at all) to 3 (nearly every day). A higher score indicate more anxiety and the cut-off 5 suggests at least mild anxiety. |
| Change in depressive symptoms from baseline to 9 weeks on the 9 item Patient Health Questionnaire. | From baseline to 9 weeks at the end of the intervention. | The 9-item Patient Health Questionnaire is a validated self-report that measure depressive symtpoms during the last two weeks. Each item is answered on a four graded scale where 0 means that the person not is affected and 3 where the person is affected several Days to almost every day. Higher numbers represents higher levels of depressive symptoms. A cut-off \>5 represents at least mild depression. |
Countries
Sweden
Outcome results
None listed