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Internet-guided Cognitive Behavioural Therapy to Improve Depression Patients With Cardiovascular Disease

Primary Purpose

Cardiovascular Disease, Depression

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet cognitive behavioural therapy
Moderated Discussion Forum
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 Internet Cognitive Behavioural Therapy

Eligibility Criteria

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

Inclusion Criteria:

  • treatment for CVD according to European Society of Cardiology guidelines.
  • stable CVD (NYHA class I-III) and not having been hospitalised for CVD in in the last four weeks.
  • depressive symptoms (Patient Health Questionnaire-9 17 (PHQ-9) > 5 points)

Exclusion Criteria:

  • severe CVD (NYHA IV) or another severe chronic life-threatening disease
  • severe depression assessed as requiring acute treatment
  • not being able to dedicate 3-4 hours to participate in the program

Sites / Locations

  • Linkoping University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Internet Cognitive Behavioural Therapy

Moderated discussion forum

Arm Description

Participants will perform a nine-week tailored I-CBT program developed to fit CVD patients. The program consists of psychoeducation, relaxation, problem-solving and behavioral activation.

In this arm the participants are allocated to a non mandatory discussion forum for nine weeks. Evert week will participants discuss issues regarding their CVD. Themes discussed are suggested by the study team, and a new theme is added every week. A moderator from the study group act as a supervisor and checks that issues discussed are ok. After the nine week discussion forum the participants are offered the nine week CBT program.

Outcomes

Primary Outcome Measures

Depressive Symptoms Collected With the Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a nine-item instrument for measurement of depressive symptoms during the last two weeks. Each item is answered on a four graded scale where zero represents that the item do not affect the person and numbers one to three represents that the item affects the person several days to almost every day. The answers are summed to a total sum score, range 0-27, with higher numbers representing higher level of depressive symptoms. A cut off >5 represents minor depression and a cut off >10 represents major depression

Secondary Outcome Measures

Full Information

First Posted
May 16, 2016
Last Updated
November 29, 2019
Sponsor
University Hospital, Linkoeping
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1. Study Identification

Unique Protocol Identification Number
NCT02778074
Brief Title
Internet-guided Cognitive Behavioural Therapy to Improve Depression Patients With Cardiovascular Disease
Official Title
Internet-guided Cognitive Behavioural Therapy to Improve Depression in Patients With Cardiovascular Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 6, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2019 (Actual)

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
Purpose and aims Tailored internet-based cognitive behavioural therapy (I-CBT) is a new innovative and person-centred method that is promising that may be used to decrease depression in patients with cardiovascular disease (CVD). In patients with CVD, depressive symptoms is a common co-morbidity leading to decreased wellbeing, and increased morbidity and mortality. Depressive symptoms are both underdiagnosed and undertreated in CVD patients. Earlier studies have demonstrated the efficiency of cognitive behavioural therapy (CBT) for many psychiatric conditions, but few studies have evaluated CBT in patients with CVD. The overall purpose of this study is to evaluate the effects of the tailored I-CBT program on reducing depressive symptoms and other patient reported outcomes in patients with cardiovascular disease (CVD) and to explore factors related to implementation of the I-CBT program in clinical cardiac care. The primary aim: -To evaluate the effects of the tailored I-CBT depression program on depressive symptoms. Secondary aims: To evaluate effects on quality of life´, sleep and anxiety To evaluate factors that can influence the I-CBT programs effect on depressive symptoms. To gain knowledge about the I-CBT program, as perceived by patients and health care professionals. To explore facilitators and barriers to the implementation of the I-CBT program in clinical practice from the perspectives of patients, health care professionals and policymakers.
Detailed Description
Power calculation: Effect size=0.5, alpha=0.05 (Z=1.96), Power 0.80 (Z -0.84) = 122 participants. Due to drop-outs or deaths the size of the study population for the RCT study was decided to n=140.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Depression
Keywords
Internet Cognitive Behavioural Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet Cognitive Behavioural Therapy
Arm Type
Experimental
Arm Description
Participants will perform a nine-week tailored I-CBT program developed to fit CVD patients. The program consists of psychoeducation, relaxation, problem-solving and behavioral activation.
Arm Title
Moderated discussion forum
Arm Type
Placebo Comparator
Arm Description
In this arm the participants are allocated to a non mandatory discussion forum for nine weeks. Evert week will participants discuss issues regarding their CVD. Themes discussed are suggested by the study team, and a new theme is added every week. A moderator from the study group act as a supervisor and checks that issues discussed are ok. After the nine week discussion forum the participants are offered the nine week CBT program.
Intervention Type
Behavioral
Intervention Name(s)
Internet cognitive behavioural therapy
Other Intervention Name(s)
I-CBT
Intervention Description
A nine-week tailored I-CBT program for patients with CVD. The CBT program consists of the components of psychoeducation, relaxation, problem-solving and behavioural activation.
Intervention Type
Behavioral
Intervention Name(s)
Moderated Discussion Forum
Intervention Description
Participants will be allocated to an internet moderated discussion forum during 9 weeks. Patients will discuss issues related to cardiovascular disease. A new topic will be discussed every week. After 9 weeks, those in the moderated discussion forum will be offered to perform the I-CBT program.
Primary Outcome Measure Information:
Title
Depressive Symptoms Collected With the Patient Health Questionnaire-9 (PHQ-9)
Description
The PHQ-9 is a nine-item instrument for measurement of depressive symptoms during the last two weeks. Each item is answered on a four graded scale where zero represents that the item do not affect the person and numbers one to three represents that the item affects the person several days to almost every day. The answers are summed to a total sum score, range 0-27, with higher numbers representing higher level of depressive symptoms. A cut off >5 represents minor depression and a cut off >10 represents major depression
Time Frame
Score at 9 weeks follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: treatment for CVD according to European Society of Cardiology guidelines. stable CVD (NYHA class I-III) and not having been hospitalised for CVD in in the last four weeks. depressive symptoms (Patient Health Questionnaire-9 17 (PHQ-9) > 5 points) Exclusion Criteria: severe CVD (NYHA IV) or another severe chronic life-threatening disease severe depression assessed as requiring acute treatment not being able to dedicate 3-4 hours to participate in the program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Johansson, PhD
Organizational Affiliation
Department of Social and Welfare Studies, Linköping University, Norrköping, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Linkoping University
City
Norrköping
ZIP/Postal Code
601 74
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
35657674
Citation
Johansson P, Lundgren J, Andersson G, Svensson E, Mourad G. Internet-Based Cognitive Behavioral Therapy and its Association With Self-efficacy, Depressive Symptoms, and Physical Activity: Secondary Analysis of a Randomized Controlled Trial in Patients With Cardiovascular Disease. JMIR Cardio. 2022 Jun 3;6(1):e29926. doi: 10.2196/29926.
Results Reference
derived
PubMed Identifier
35410939
Citation
Mourad G, Lundgren J, Andersson G, Husberg M, Johansson P. Cost-effectiveness of internet-delivered cognitive behavioural therapy in patients with cardiovascular disease and depressive symptoms: secondary analysis of an RCT. BMJ Open. 2022 Apr 11;12(4):e059939. doi: 10.1136/bmjopen-2021-059939.
Results Reference
derived
PubMed Identifier
35061868
Citation
Westas M, Lundgren J, Andersson G, Mourad G, Johansson P. Effects of Internet-delivered cognitive behavioural therapy adapted for patients with cardiovascular disease and depression: a long-term follow-up of a randomized controlled trial at 6 and 12 months posttreatment. Eur J Cardiovasc Nurs. 2022 Aug 29;21(6):559-567. doi: 10.1093/eurjcn/zvab131.
Results Reference
derived
PubMed Identifier
31584000
Citation
Johansson P, Westas M, Andersson G, Alehagen U, Brostrom A, Jaarsma T, Mourad G, Lundgren J. An Internet-Based Cognitive Behavioral Therapy Program Adapted to Patients With Cardiovascular Disease and Depression: Randomized Controlled Trial. JMIR Ment Health. 2019 Oct 3;6(10):e14648. doi: 10.2196/14648.
Results Reference
derived

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Internet-guided Cognitive Behavioural Therapy to Improve Depression Patients With Cardiovascular Disease

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