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

NCT04726722 | Completed

• 1 other identifier: 2020-00935
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease; Psychological Distress

Keywords

Cardiovascular disease; Psychological distress; Internet-based cognitive behavioural therapy

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

Design of the CBT treatment content

EXPERIMENTAL

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

Behavioral: internet-based cognitive behavioral theraphy

Control of support and feedback

EXPERIMENTAL

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

Behavioral: internet-based cognitive behavioral theraphy

Interventions

internet-based cognitive behavioral theraphy BEHAVIORAL

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

Control of support and feedback; Design of the CBT treatment content

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Linkoeping: lead

Study Sites (1)

Peter Johansson

Norrköping, Linköpings Universitet, 601 74, Sweden

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Peter Johansson, Ph.D

  Department of Health, Medicine and Caring Sciences, Linkoping University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 2 x 2

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: January 27, 2021
• Study Start: March 13, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

SE (1)