Trial Outcomes & Findings for Internet-guided Cognitive Behavioural Therapy to Improve Depression Patients With Cardiovascular Disease (NCT NCT02778074)
NCT ID: NCT02778074
Last Updated: 2019-12-11
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
144 participants
Primary outcome timeframe
Score at 9 weeks follow-up
Results posted on
2019-12-11
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
72
|
|
Overall Study
COMPLETED
|
65
|
62
|
|
Overall Study
NOT COMPLETED
|
7
|
10
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
10
|
Baseline Characteristics
Internet-guided Cognitive Behavioural Therapy to Improve Depression Patients With Cardiovascular Disease
Baseline characteristics by cohort
| Measure |
Internet Cognitive Behavioural Therapy
n=72 Participants
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.
|
Moderated Discussion Forum
n=72 Participants
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.
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 13 • n=5 Participants
|
64 years
STANDARD_DEVIATION 12 • n=7 Participants
|
63 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Gender · Female
|
25 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Gender · Male
|
47 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
72 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
72 participants
n=5 Participants
|
72 participants
n=7 Participants
|
144 participants
n=5 Participants
|
|
Depression by Patient Health Questonnaire-9 (range 0-27, higher numbers represents more depression
|
10.71 units on a scale
STANDARD_DEVIATION 4.47 • n=5 Participants
|
10.22 units on a scale
STANDARD_DEVIATION 5.10 • n=7 Participants
|
10.47 units on a scale
STANDARD_DEVIATION 4.78 • n=5 Participants
|
PRIMARY outcome
Timeframe: Score at 9 weeks follow-upThe 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
Outcome measures
| Measure |
Internet Cognitive Behavioural Therapy
n=72 Participants
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.
|
Moderated Discussion Forum
n=72 Participants
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.
|
|---|---|---|
|
Depressive Symptoms Collected With the Patient Health Questionnaire-9 (PHQ-9)
|
6.63 score on a scale
Standard Deviation 4.76
|
8.68 score on a scale
Standard Deviation 4.60
|
Adverse Events
Internet Cognitive Behavioural Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Moderated Discussion Forum
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place