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The purpose of this study is to evaluate the short (9 weeks) and long (6 and 12 months) term effects of an 9 weeks intervention of internet-based cognitive behavioural therapy on depressive symptoms, worrying/anxiety, sleep, self-care knowledge and quality of life in patients with chronic heart failure and depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cogntive behaviour therapy | Experimental | Internet based Cognitive behaviour therapy during 9 weeks |
|
| Discussion group | Active Comparator | Internet moderated discussion group during 9 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behaviour therapy | Behavioral | Internet based, weekly home task and weekly feedback provided by health care professional. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Depressive Symptoms | Depressive Symptoms measured with Patient Health Questionnaire-9 (PHQ-9). The number of patients per study arm is planned to be n=60. According to an earlier metaanalysis, the effect size of internet CBT intervention can be expected to be at least at the level of 0.5. The score on the PHQ-9 ranges from 0-27. A score between 5-10 indicate a mild depression whereas a score >10 indicate at least moderate depression. | 9 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Johansson, Assoc. Prof | Department of Cardiology, University Hospital of Linköping and Department of Cardiovascular Medicine, Faculty of Health Sciences. University Hospital of Linköping | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deparment of Cardiology, University Hospital of Linköping | Linköping | 581 85 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27489077 | Derived | Lundgren JG, Dahlstrom O, Andersson G, Jaarsma T, Karner Kohler A, Johansson P. The Effect of Guided Web-Based Cognitive Behavioral Therapy on Patients With Depressive Symptoms and Heart Failure: A Pilot Randomized Controlled Trial. J Med Internet Res. 2016 Aug 3;18(8):e194. doi: 10.2196/jmir.5556. |
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No pre-assignment details to report
Recrutiment from medical clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Cogntive Behaviour Therapy | Internet based Cognitive behaviour therapy during 9 weeks Cognitive behaviour therapy: Internet based, weekly home task and weekly feedback provided by health care professional. |
| FG001 | Discussion Group | Internet moderated discussion group during 9 weeks Cognitive behaviour therapy: Internet based, weekly home task and weekly feedback provided by health care professional. Discussion group: Internet moderated discussion group. Patients will be provided weekly question which will be used by the participant to start discuss with each others. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cogntive Behaviour Therapy | Internet based Cognitive behaviour therapy during 9 weeks Cognitive behaviour therapy: Internet based, weekly home task and weekly feedback provided by health care professional. |
| BG001 | Discussion Group |
| 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 | Depressive Symptoms measured with Patient Health Questionnaire-9 (PHQ-9). The number of patients per study arm is planned to be n=60. According to an earlier metaanalysis, the effect size of internet CBT intervention can be expected to be at least at the level of 0.5. The score on the PHQ-9 ranges from 0-27. A score between 5-10 indicate a mild depression whereas a score >10 indicate at least moderate depression. | Posted | Mean | Standard Deviation | units on a scale | 9 weeks |
|
9 weeks
Weekly measurement of depression to asses if participants depression not deteroriated and became severe requiring contact with a health care providor
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitive Behavoural Therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. RN Peter Johansson | Linköping University, Department of social and welfare studies. Linköping University | +4613313685 | peter.b.johansson@liu.se |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D003863 | Depression |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Discussion group | Behavioral | Internet moderated discussion group. Patients will be provided weekly question which will be used by the participant to start discuss with each others. |
|
Internet moderated discussion group during 9 weeks
Cognitive behaviour therapy: Internet based, weekly home task and weekly feedback provided by health care professional.
Discussion group: Internet moderated discussion group. Patients will be provided weekly question which will be used by the participant to start discuss with each others.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Internet moderated discussion group during 9 weeks
Cognitive behaviour therapy: Internet based, weekly home task and weekly feedback provided by health care professional.
Discussion group: Internet moderated discussion group. Patients will be provided weekly question which will be used by the participant to start discuss with each others.
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Discussion Group | 0 | 25 | 0 | 25 |
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