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Depressive symptoms, and the associated coexistence of symptoms of anxiety and decreased quality of life (QoL), are common in patients with heart failure (HF). However, treatment strategies for depressive symptoms in patients with HF still remain to be established. Internet-based cognitive behavioral therapy (ICBT), as guided self-help CBT programs, has shown good effects in the treatment of depression. Until now, ICBT has not been evaluated in patients with HF with depressive symptoms.
The aims of this study were to (1) evaluate the effect of a 9-week guided ICBT program on depressive symptoms in patients with HF; (2) investigate the effect of the ICBT program on cardiac anxiety and QoL; and (3) assess factors associated with the change in depressive symptoms.
Fifty participants were randomized into 2 treatment arms: ICBT or a Web-based moderated discussion forum (DF). The Patient Health Questionnaire-9 was used to measure depressive symptoms, the Cardiac Anxiety Questionnaire (CAQ) was used to measure cardiac-related anxiety, and the Minnesota Living with Heart Failure questionnaire was used to measure QoL. Data were collected at baseline and at follow-up at the end of the 9-week intervention. Intention-to-treat analysis was used, and missing data were imputed by the Expectation-Maximization method. Between-group differences were determined by analysis of covariance with control for baseline score and regression to the mean.
No significant difference in depressive symptoms between the ICBT and the DF group at the follow-up was found, [F(1,47)=1.63,
Guided ICBT adapted for persons with HF and depressive symptoms was not statistically superior to participation in a Web-based DF. However, within the ICBT group, a statically significant improvement of depressive symptoms was detected.
Clinicaltrials.gov NCT01681771; https://clinicaltrials.gov/ct2/show/NCT01681771 (Archived by WebCite at http://www.webcitation.org/6ikzbcuLN)
Depressive symptoms are common in patients with heart failure (HF), affecting about 20%-40% of the HF population [
HF has an unpredictable trajectory with disturbing and limiting symptoms that frequently change, leading to a shift between good and bad days [
In CBT, patients become active participants in their treatment and perform tasks to become aware of and to modify negative thoughts and unhelpful behaviors. By developing skills to cope with these negative thoughts and behaviors, CBT also contributes to a decrease of negative emotions [
Recently our group showed that an ICBT program designed for HF patients was feasible [
An open label, randomized control design was used.
To recruit participants, an information letter was sent to all patients who had an outpatient appointment or who had been admitted to hospital with the main diagnosis of HF during 2013 and 2014 in 4 hospitals in the southeast of Sweden (
A total of 64 patients completed the Web-based screening form and 58 were found to be possible candidates for inclusion. Candidates were contacted by telephone to check any uncertainties in the screening forms and to prevent multiple registrations. A structured phone assessment using the Mini International Neuropsychiatric Interview Swedish revised version 5.0.0 [
Flow diagram of participants. DF, discussion forum; HF, heart failure; ICBT, Internet-based cognitive behavioral therapy; PHQ-9, Patient Health Questionnaire-9.
Each participant received a password and a user name. Login to the Web portal (to access the treatment program, feedback, secure email, and assessment forms) required a 2-factor authentication system (requiring both a user name and password login and a single use code sent to a preregistered mobile phone) to protect sensitive information. If technical problems occurred, both the therapist and the participants could get support from a computer technician.
The ICBT program has been described in detail elsewhere [
Overview of the guided Internet-based cognitive behavioral therapy program and the discussion forum.
Module | ICBTa (content and CBTb component) | DFc (topic/question for discussion) | Week |
1 | Introduction (values and goals) | HFd: what do you know about HF? | 1 |
2 | Living with |
The effect of HF on everyday life: do you have any tips you would like to share about handling HF? | 2 |
3 | Depression/depressive symptoms and heart failure (psychoeducation) |
Self-care: do you have any methods that make self-care easier that you can share with the others in the DF? | 3 |
4 | Behavior activation 1: to enable change | Physical activity: have you been recommended physical activity? What is good or bad about physical activity when suffering from HF? | 4 |
Health care contacts: do you prepare yourself before health care appointments? Do you have any tips you can share with the others? | 5 | ||
5 | Behavior activation 2: to implement change | Health literacy: if you do not get answers from the health care system, do you look for information in other ways? Do you have any tips on where one can find information about health and diseases such as HF and depression? | 6 |
The effect of HF and depression on significant others: do you think that your health affects your relationships with others? If so, in what ways? | 7 | ||
6 | Problem solving: a tool for dealing with problems | The effect of HF and depression on significant others: how do you handle situations where your health affects other? Do you have any good examples of how to handle this that you can share? | 8 |
7 | Consummation | Summarizing: are there questions/topics that have not been discussed that you would like to address? How did you perceive the DF? | 9 |
aICBT: Internet-based cognitive behavioral therapy.
bCBT:cognitive behavioral therapy.
cDF:discussion forum.
dHF:heart failure.
Self-assessed data were collected on the Web at baseline (before the start of the intervention) and after the end of week 9 in the intervention. The data collection system for the follow-up was accessible for the participants from the 63rd day after the start of the intervention and could be completed during a 3-week period. All data except activity in the program was self-reported. Participants who did not complete outcome measures were reminded to do so by email up to 3 times.
Depressive symptoms were measured with the self-administered PHQ-9 [
The Cardiac Anxiety Questionnaire (CAQ) [
QoL was measured with the disease-specific instrument Minnesota Living with Heart Failure questionnaire (MLHF) [
Activity in the program was calculated by the number of modules that the participants worked with (ie, the module had been assigned to the participant and the participant had done some activity related to the module, eg, handed in an assignment or posted messages regarding the module to the feedback provider; ICBT group only) as well as the number of logins to the Web portal during the 9-week period (both groups). Data concerning activity was aggregated from the Web portals log.
Analysis of participants’ characteristics was performed with descriptive statistics (mean, standard deviation, percent, and frequencies). For continuous variables, assumptions of normality were checked and primary outcome measurements were found suitable for parametric analysis. Analysis of covariance (ANCOVA) adjusting for baseline scores and regression to the mean [
A total of 18% (n=9) of the participants had missing data at the follow-up measurement. Missing values analysis was performed and data missing completely at random was assumed because there were no significant differences between background variables for participants with complete data versus incomplete data, and Little´s test for missing completely at random was not significant (χ2(111, N=50)=82.07,
The characteristics of the participants are presented in (
Participants’ characteristics.
Total (n=50) | ICBT group (n=25) | DF group (n=25) | ||||
Demographics | ||||||
Age, M (SD) | 62.9 (12.8) | 63.6 (13.9) | 62.3 (11.7) | |||
Men, n (%) | 29 (59) | 15 (60) | 14 (58) | |||
Cohabitationa, n (%) | 37 (76) | 19 (76) | 18 (75) | |||
Level of depression at screening PHQ-9, M (SD) | 11.5 (4.8) | 11.8 (4.4) | 11.2 (5.2) | |||
HFbsymptoms and treatment | ||||||
NYHAc class, n (%) | ||||||
I | 11 (22) | 8 (32) | 3 (12) | |||
II | 20 (40) | 12 (48) | 8 (32) | |||
III | 18 (36) | 5 (20) | 13 (52) | |||
IV | 1 (2) | 0 (0) | 1 (4) | |||
Dyspnead, n (%) | 48 (96) | 24 (96) | 23 (92) | |||
Fatigued, n (%) | 49 (98) | 25 (100) | 24 (96) | |||
Swollen legs or feetd, n (%) | 23 (46) | 14 (56) | 12 (48) | |||
Time with HF>6 month/<6 month, n (%) | 45/5 (88/10) | 22/3 (88/12) | 23/2 (92/8) | |||
Previously hospitalized due to HF, n (%) | 36 (72) | 17 (68) | 19 (76) | |||
Beta blocker, n (%) | 44 (88) | 22 (88) | 22 (88) | |||
ACE-Ie/ARBf, n (%) | 47 (94) | 22 (88) | 25 (100) | |||
Diuretics, n (%) | 34 (68) | 14 (56) | 20 (80)g | |||
Comorbidities, n (%) | ||||||
Ischemic heart disease | 18 (36) | 8 (32) | 10 (40) | |||
Hypertension | 26 (52) | 11 (44) | 15 (60) | |||
Arrhythmia | 26 (52) | 14 (56) | 12 (48) | |||
Diabetes | 7 (14) | 2 (8) | 5 (20) | |||
Pulmonary disease | 6 (12) | 1 (4) | 5 (20) | |||
Stroke or TIA | 11 (22) | 4 (16) | 7 (28) | |||
Kidney disease | 1 (2) | 1 (4) | 0 (0) | |||
Cancer | 5 (10) | 3 (12) | 2 (8) | |||
Other psychiatric disorderh | 2 (4) | 2 (8) | 0 (0) | |||
Pharmacological antidepressive, anxiolytic, or sleep medication | ||||||
Antidepressives | 9 (18) | 9 (12) | 6 (24) | |||
Anxiolytics | 2 (4) | 1 (4) | 1 (4) | |||
Sleep medication | 14 (28) | 4 (16) | 10 (40)g |
aCohabitation includes participants that live with someone in a long-term relationship (including married). Not living with partner includes participants who were divorced, with partner deceased or living alone.
bHF, heart failure.
cNYHA, New York Heart Association.
dSymptoms reported to affect the participant very severely to little have been collapsed and reported as presence of symptoms.
eACE-I, angiotensinogen-converting enzyme inhibitor.
fARB, angiotensin receptor blocker.
gSignificant difference between CBT and discussion groups (
hSelf-reported: anxiety disorder (n=1) and drug dependence (n=1).
In the primary ANCOVA analysis, there was no significant difference in depressive symptoms between the ICBT and the DF group at the follow-up [
Mean values for PHQ-9 at baseline and follow-up in the 2 groups (n=25 ICBT and n=25 DF). DF, discussion forum; ICBT, Internet-based cognitive behavioral therapy; PHQ-9, Patient Health Questionnaire-9.
Between group comparison (ie, ANCOVA, ICBT vs DF) showed no statistically significant difference in the CAQ total score [F(1,47)=0.51,
Between-group analysis (ie, ANCOVA, ICBT vs DF) of MLHF revealed no significant differences for the total score [
Change in cardiac anxiety—mean values for subscale of fear in the 2 groups (n=25 ICBT and n=25 DF). ANCOVA: [F(1,47)=1.57,
The median number of modules performed in the ICBT group was 4. Six (24%) of the participants in the ICBT group had worked with all 7 modules and 15 (60%) had worked with at least 4 modules (ie, 57% of the program). There was no significant relationship between the number of modules completed and the change in depressive symptoms (τb=.13,
The level of depressive symptoms at screening was not associated with the level of depressive symptoms at the follow-up. A separate analysis of participants with PHQ-9 ≥10 at screening (ICBT n=18, DF n=15) showed no significant difference between groups in the level of depressive symptoms at the follow-up [
To our knowledge, this is the first study evaluating an ICBT program aimed at decreasing depressive symptoms in patients with HF. The recruitment of participants was more difficult than expected. Based on a prevalence of depressive symptoms among HF patients at approximately 20% [
The secondary outcomes of CAQ and MLHF did not show any significant difference between the ICBT group and the DF group. However, in the ICBT group, a lower cardiac-related anxiety in the subscale of fear and an increased QoL was found in the within-group analysis. The increase in QoL of 6 points in the total MLHF score was not statistically significant; however, a change of 5 points in MLHF has been proposed as a measure of a clinically important change [
It is common for depressive symptoms in patients with HF to coexist with anxiety [
We also found that the age and sex of the participant may need to be taken into account. Higher age and male sex correlated with less change in depressive symptoms in the ICBT group. Older people to some extent seem to benefit from CBT [
The cornerstone of CBT is to encourage participants and involve them in the treatment [
The generalizability of the results is limited for several reasons. One major limitation of our study is that it is underpowered. Post hoc power calculation for this study showed a power of 16% and a need for 462 patients to be included to achieve a statistically significant result as regards depressive symptoms. A reason for the need for such a large sample could be floor effects, because patients with mild depression were also included (PHQ-9≥5). A reason for including these patients is that even mild depression has a strong negative impact on QoL in HF patients [
Guided ICBT adapted for persons with HF and depressive symptoms was not statistically superior to participation in a Web-based DF. However, within the ICBT group, a statically significant improvement of depressive symptoms was detected.
Screenshots of the treatment platform.
Video of treatment platform.
Change in cardiac anxiety—mean values for total score and subscales of avoidance and heart-focused attention in the 2 groups (n=25 ICBT and n=25 DF).
Change in Minnesota Living with Heart Failure (MLHF)—total score and factors in the 2 groups (n=25 ICBT and n=25 DF).
CONSORT-EHEALTH Checklist V1.6.
Cardiac Anxiety Questionnaire.
cognitive behavioral therapy.
discussion forum.
Expectation-Maximization.
heart failure.
Internet-based cognitive behavioral therapy.
Minnesota Living with Heart Failure questionnaire.
Patient Health Questionnaire-9.
quality of life.
The authors would like to thank the computer technicians George Vleascu and Alexander Alasjö for technical support during the intervention.
This study was funded by grants from the Swedish Heart and Lung Association (grant number E087/13 and E08/14), the Medical Research Council of Southeast Sweden (grant numbers FORSS-374721 and FORSS-470121) and the Region Östergötland (grant numbers LIO-355611, LIO-374831, LIO-443711 and LIO-470271). The funding sources had no influence on the design, procedure, analysis, or interpretation of the results in this study.
None declared.