Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet cognitive behavioural therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Score at 9 weeks follow-up |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter Johansson, PhD | Department of Social and Welfare Studies, Linköping University, Norrköping, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linkoping University | Norrköping | 601 74 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38093803 | Derived | 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. | |
| 37740442 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Internet Cognitive Behavioural Therapy | 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. Internet cognitive behavioural therapy: 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. |
| FG001 | Moderated Discussion Forum | 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. Moderated Discussion Forum: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Internet Cognitive Behavioural Therapy | 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. Internet cognitive behavioural therapy: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | score on a scale | Score at 9 weeks follow-up |
|
9 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Internet Cognitive Behavioural Therapy | 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. Internet cognitive behavioural therapy: 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Peter Johansson | Linkoping University | 0460700896548 | peter.b.johansson@liu.se |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 28, 2019 | Nov 29, 2019 | Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Moderated Discussion Forum | Behavioral | 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. |
|
| Westas 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. |
| 35657674 | Derived | 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. |
| 35410939 | Derived | 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. |
| 35061868 | Derived | 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. |
| 31584000 | Derived | 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. |
| BG001 | Moderated Discussion Forum | 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. Moderated Discussion Forum: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Depression by Patient Health Questonnaire-9 (range 0-27, higher numbers represents more depression | Mean | Standard Deviation | units on a scale |
|
| OG001 | Moderated Discussion Forum | 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. Moderated Discussion Forum: 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. |
|
|
|
| 0 |
| 72 |
| 0 |
| 72 |
| 0 |
| 72 |
| EG001 | Moderated Discussion Forum | 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. Moderated Discussion Forum: 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. | 0 | 72 | 0 | 72 | 0 | 72 |
Not provided
Not provided