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

Primary Purpose

Cardiovascular Disease, Psychological Distress

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
internet-based cognitive behavioral theraphy
Sponsored by
University Hospital, Linkoeping
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Disease focused on measuring Cardiovascular disease, Psychological distress, Internet-based cognitive behavioural therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peter JohanssonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Design of the CBT treatment content

Control of support and feedback

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 22, 2021
Last Updated
March 13, 2023
Sponsor
University Hospital, Linkoeping
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1. Study Identification

Unique Protocol Identification Number
NCT04726722
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Linkoeping

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Psychological Distress
Keywords
Cardiovascular disease, Psychological distress, Internet-based cognitive behavioural therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
2 x 2
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Design of the CBT treatment content
Arm Type
Experimental
Arm Description
Patient determined CBT content (i.e. person-centered) vs. therapist determined I-CBT content
Arm Title
Control of support and feedback
Arm Type
Experimental
Arm Description
Patient-controlled support and feedback (person-centred) vs. therapist -controlled.
Intervention Type
Behavioral
Intervention Name(s)
internet-based cognitive behavioral theraphy
Intervention Description
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 Outcome Measure Information:
Title
Change in stress from baseline to 9 weeks on the 10 item Perceived Stress Scale
Description
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
Time Frame
From baseline to 9 weeks at the end of the intervention.
Title
Change in anxiety from baseline to 9 weeks on the 7-item Generalized Anxiety Disorder Scale.
Description
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.
Time Frame
From baseline to 9 weeks at the end of the intervention.
Title
Change in depressive symptoms from baseline to 9 weeks on the 9 item Patient Health Questionnaire.
Description
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.
Time Frame
From baseline to 9 weeks at the end of the intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Johansson, Ph.D
Phone
+46-070 08 96548
Email
peter.b.johansson@liu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Johansson, Ph.D
Organizational Affiliation
Department of Health, Medicine and Caring Sciences, Linkoping University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peter Johansson
City
Norrköping
State/Province
Linköpings Universitet
ZIP/Postal Code
601 74
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Johansson, Professor
Phone
+46460700896548
Email
peter.b.johansson@liu.se
First Name & Middle Initial & Last Name & Degree
Johan Lundgren, PhD
Email
johan.lundgren@liu.se

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Our university works with the question of we can share IPD without violoating GPDR

Learn more about this trial

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

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