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Completed

NCT Number: NCT04726722

Evaluation of a Personcentered Internet-based CBT Program for 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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases Psychological Distress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peter Johansson

Norrköping, Linköpings Universitet, 601 74, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Change in stress from baseline to 9 weeks on the 10 item Perceived Stress Scale

    Time frame: From baseline to 9 weeks at the end of the intervention.

    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

  2. Change in anxiety from baseline to 9 weeks on the 7-item Generalized Anxiety Disorder Scale.

    Time frame: From baseline to 9 weeks at the end of the intervention.

    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.

  3. Change in depressive symptoms from baseline to 9 weeks on the 9 item Patient Health Questionnaire.

    Time frame: From baseline to 9 weeks at the end of the intervention.

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 27, 2021
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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