Heart Failure, Depressive Symptoms
Conditions
Brief summary
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.
Interventions
BEHAVIORALCognitive behaviour therapy
Internet based, weekly home task and weekly feedback provided by health care professional.
BEHAVIORALDiscussion group
Internet moderated discussion group. Patients will be provided weekly question which will be used by the participant to start discuss with each others.
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
* \> 18 years * have time to participate in the study, * treatment for HF according to the European Society of Cardiology guidelines2 * stable HF (NYHA class I-III) and not being hospitalized for HF the latest month * signs of suffering of depressive symptoms (Patient Health Questionnaire-9 \>9 points
Exclusion criteria
* severe HF (NYHA IV) or another severe chronic life threatening disease. * severe depression assessed to need hospital care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms | 9 weeks | 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. |
Countries
Sweden
Participant flow
Recruitment details
Recrutiment from medical clinics
Pre-assignment details
No pre-assignment details to report
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| 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. | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 2 |
Baseline characteristics
| Characteristic | Cogntive Behaviour Therapy | Discussion Group | Total |
|---|---|---|---|
| Age, Continuous | 63.6 years STANDARD_DEVIATION 13.9 | 62.3 years STANDARD_DEVIATION 11.7 | 62.9 years STANDARD_DEVIATION 12.8 |
| Sex: Female, Male Female | 10 Participants | 14 Participants | 24 Participants |
| Sex: Female, Male Male | 15 Participants | 11 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
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.
Time frame: 9 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cogntive Behaviour Therapy | Depressive Symptoms | 8.6 units on a scale | Standard Deviation 4.6 |
| Discussion Group | Depressive Symptoms | 9.8 units on a scale | Standard Deviation 4.3 |
p-value: 0.21ANCOVA