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

Cardiovascular Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04726722
• Other study ID #: 2020-00935
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2023
• Est. completion date: June 2027

Study information

• Verified date: May 2024
• Source: University Hospital, Linkoeping
• Contact: Peter Johansson, Ph.D
• Phone: +46-070 08 96548
• Email: peter.b.johansson[@]liu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 2027
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Depression
• Psychological Distress

Intervention

Behavioral:
• internet-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

Locations

Country	Name	City	State
Sweden	Peter Johansson	Norrköping	Linköpings Universitet

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in stress from baseline to 9 weeks on the 10 item Perceived Stress Scale	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	From baseline to 9 weeks at the end of the intervention.
Primary	Change in anxiety from baseline to 9 weeks on the 7-item Generalized Anxiety Disorder Scale.	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.	From baseline to 9 weeks at the end of the intervention.
Primary	Change in depressive symptoms from baseline to 9 weeks on the 9 item Patient Health Questionnaire.	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.	From baseline to 9 weeks at the end of the intervention.