Clinical trial NCT04726722: Evaluation of a Personcentered Internet-based CBT Program for Stress, Anxiety and Depressive Symptoms in Patients with Cardiovascular Disease
Official title: Evaluation of an Adaptable and Personcentered Internet-based CBT Program Aimed to Treat Stress, Anxiety and Depressive Symptoms in Patients with Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Disease
Psychological Distress
Keywords: Cardiovascular disease
Psychological distress
Internet-based cognitive behavioural therapy
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2 x 2
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in stress from baseline to 9 weeks on the 10 item Perceived Stress Scale
timeFrame: From baseline to 9 weeks at the end of the intervention.
measure: Change in anxiety from baseline to 9 weeks on the 7-item Generalized Anxiety Disorder Scale.
timeFrame: From baseline to 9 weeks at the end of the intervention.
measure: Change in depressive symptoms from baseline to 9 weeks on the 9 item Patient Health Questionnaire.
timeFrame: From baseline to 9 weeks at the end of the intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Norrköping
country: Sweden
facility: Peter Johansson
state: Linköpings universitet
Study officials:
affiliation: Department of Health, Medicine and Caring Sciences, Linkoping University
name: Peter Johansson, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: