Cardiovascular DiseaseNCT02778074
Internet-guided Cognitive Behavioural Therapy to Improve Depression Patients With Cardiovascular Disease
A study testing Internet cognitive behavioural therapy and Moderated Discussion Forum in people with Cardiovascular Disease and Depression, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease, Depression
- What is being tested?
- Internet cognitive behavioural therapy and Moderated Discussion Forum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteSweden
- Study dates
- 6 Feb 2017to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet-guided Cognitive Behavioural Therapy to Improve Depression in Patients With Cardiovascular Disease
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.
Read more
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.
Read the 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.
- Conditions
- Cardiovascular Disease, Depression
- Being tested
- Internet cognitive behavioural therapy, Moderated Discussion Forum
- Keywords
- Internet Cognitive Behavioural Therapy
- Medical subject headings
- Cardiovascular Diseases, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet cognitive behavioural therapyBehavioural
Also called I-CBT
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.
Moderated Discussion ForumBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Internet Cognitive Behavioural Therapy | Experimental | 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. Receives: Behavioral: Internet cognitive behavioural therapy |
| Moderated discussion forum | Placebo comparator | 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. Receives: Behavioral: Moderated Discussion Forum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Score at 9 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study start6 Feb 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Johansson, University Hospital, Linkoeping
- Investigators
- Peter Johansson, PhD, Principal investigator, Department of Social and Welfare Studies, Linköping University, Norrköping, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778074
- Sponsor's protocol ID
- 2015-02600
- Other IDs
- 2015
- Status last verified
- Nov 2019
- First submitted
- 16 May 2016
- Last updated
- 11 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mourad G, Lundgren J, Andersson G, Johansson P. Healthcare use in patients with cardiovascular disease and depressive symptoms - The impact of a nurse-led internet-delivered cognitive behavioural therapy program. A secondary analysis of a RCT. Internet Interv. 2023 Dec 5;35:100696. doi: 10.1016/j.invent.2023.100696. eCollection 2024 Mar.
PubMed 38093803Westas M, Mourad G, Andersson G, Lundgren J, Johansson P. The effects of internet-based cognitive behaviour therapy for depression in cardiovascular disease on symptoms of anxiety: a secondary analysis of a randomized trial. Eur J Cardiovasc Nurs. 2024 May 28;23(4):382-390. doi: 10.1093/eurjcn/zvad097.
PubMed 37740442Johansson 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.
PubMed 35657674Mourad 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.
PubMed 35410939Westas 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.
PubMed 35061868Johansson 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.
PubMed 31584000
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-guided Cognitive Behavioural Therapy to Improve Depression in Patients With Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT02778074
- Acronym / sponsor ID
- 2015-02600
- Conditions
- Cardiovascular Disease, Depression
- Keywords
- Internet Cognitive Behavioural Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 19 May 2016 (estimated)
- Results
- Posted 27 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet Cognitive Behavioural Therapy | Experimental | Behavioral: Internet cognitive behavioural therapyParticipants 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. |
| Moderated discussion forum | Placebo comparator | Behavioral: Moderated Discussion ForumIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet cognitive behavioural therapyAlso: I-CBTA 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. | Behavioural | Internet Cognitive Behavioural Therapy |
| Moderated Discussion ForumParticipants 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. | Behavioural | Moderated discussion forum |
Primary outcome
Depressive Symptoms Collected With the Patient Health Questionnaire-9 (PHQ-9)
Time frame: Score at 9 weeks follow-up
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38093803Mourad G, Lundgren J, Andersson G, Johansson P. Healthcare use in patients with cardiovascular disease and depressive symptoms - The impact of a nurse-led internet-delivered cognitive behavioural therapy program. A secondary analysis of a RCT. Internet Interv. 2023 Dec 5;35:100696. doi: 10.1016/j.invent.2023.100696. eCollection 2024 Mar.
- Derived from this study: PubMed 37740442Westas M, Mourad G, Andersson G, Lundgren J, Johansson P. The effects of internet-based cognitive behaviour therapy for depression in cardiovascular disease on symptoms of anxiety: a secondary analysis of a randomized trial. Eur J Cardiovasc Nurs. 2024 May 28;23(4):382-390. doi: 10.1093/eurjcn/zvad097.
- Derived from this study: PubMed 35657674Johansson 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.
- Derived from this study: PubMed 35410939Mourad 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.
- Derived from this study: PubMed 35061868Westas 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.
- Derived from this study: PubMed 31584000Johansson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Johansson, PhD principal investigator
Department of Social and Welfare Studies, Linköping University, Norrköping, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet cognitive behavioural therapy and Moderated Discussion Forum in people with Cardiovascular Disease and Depression, run by University Hospital, Linkoeping at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive Symptoms Collected With the Patient Health Questionnaire-9 (PHQ-9) (time frame: Score at 9 weeks follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02778074, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2019.