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

Evaluation of an Adaptable and Personcentered Internet-based CBT Program Aimed to Treat Stress, Anxiety and Depressive Symptoms in Patients With Cardiovascular Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Disease; Psychological Distress
• Intervention / Treatment: Behavioral: internet-based cognitive behavioral theraphy

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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter Johansson, Ph.D; Phone Number: +46-070 08 96548; Email: peter.b.johansson@liu.se

Study Locations

• Sweden
  • Linköpings Universitet
    • Norrköping, Linköpings Universitet, Sweden, 601 74
      • Recruiting
      • Peter Johansson
      • Contact: Peter Johansson, Professor; Phone Number: +46460700896548; Email: peter.b.johansson@liu.se
      • Contact: Johan Lundgren, PhD; Email: johan.lundgren@liu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Design of the CBT treatment content; Patient determined CBT content (i.e. person-centered) vs. therapist determined I-CBT content	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
Experimental: Control of support and feedback; Patient-controlled support and feedback (person-centred) vs. therapist -controlled.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: University Hospital, Linkoeping
• Investigators: Principal Investigator: Peter Johansson, Ph.D, Department of Health, Medicine and Caring Sciences, Linkoping University

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2023
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: January 22, 2021
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Psychological distress; Internet-based cognitive behavioural therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Cardiovascular Diseases
• Other Study ID Numbers: 2020-00935

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Our university works with the question of we can share IPD without violoating GPDR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No