Evaluation of a Personcentered Internet-based CBT Program for Stress, Anxiety and Depressive Symptoms in Patients With Cardiovascular Disease

University Hospital, Linkoeping

Status: Completed

Conditions: Psychological Distress; Cardiovascular Disease

Treatments: Behavioral: internet-based cognitive behavioral theraphy

Study type: Interventional

Funder types: Other

Identifiers

NCT04726722

2020-00935

Details and patient eligibility

About

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.

Full 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.

Enrollment: 215 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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215 participants in 2 patient groups

Design of the CBT treatment content

Experimental group

Description:

Patient determined CBT content (i.e. person-centered) vs. therapist determined I-CBT content

Treatment:

Behavioral: internet-based cognitive behavioral theraphy

Control of support and feedback

Experimental group

Description:

Patient-controlled support and feedback (person-centred) vs. therapist -controlled.

Treatment:

Behavioral: internet-based cognitive behavioral theraphy