Cardiovascular Disease, Depression
Conditions
Keywords
Internet Cognitive Behavioural Therapy
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.
Interventions
BEHAVIORALInternet 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.
BEHAVIORALModerated 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.
Sponsors
University Hospital, Linkoeping
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms Collected With the Patient Health Questionnaire-9 (PHQ-9) | 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 |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 72 |
| 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. | 72 |
| Total | 144 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 10 |
Baseline characteristics
| Characteristic | Internet Cognitive Behavioural Therapy | Moderated Discussion Forum | Total |
|---|---|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 13 | 64 years STANDARD_DEVIATION 12 | 63 years STANDARD_DEVIATION 12 |
| Depression by Patient Health Questonnaire-9 (range 0-27, higher numbers represents more depression | 10.71 units on a scale STANDARD_DEVIATION 4.47 | 10.22 units on a scale STANDARD_DEVIATION 5.1 | 10.47 units on a scale STANDARD_DEVIATION 4.78 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 72 Participants | 72 Participants | 144 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Sweden | 72 participants | 72 participants | 144 participants |
| Sex: Female, Male Gender Female | 25 Participants | 30 Participants | 55 Participants |
| Sex: Female, Male Gender Male | 47 Participants | 42 Participants | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 72 |
| other Total, other adverse events | 0 / 72 | 0 / 72 |
| serious Total, serious adverse events | 0 / 72 | 0 / 72 |
Outcome results
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
Time frame: Score at 9 weeks follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Internet Cognitive Behavioural Therapy | Depressive Symptoms Collected With the Patient Health Questionnaire-9 (PHQ-9) | 6.63 score on a scale | Standard Deviation 4.76 |
| Moderated Discussion Forum | Depressive Symptoms Collected With the Patient Health Questionnaire-9 (PHQ-9) | 8.68 score on a scale | Standard Deviation 4.6 |
p-value: <0.001ANCOVA