This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Mental Health, is properly cited. The complete bibliographic information, a link to the original publication on http://mental.jmir.org/, as well as this copyright and license information must be included.
Depression is a highly prevalent mental health issue that exacts significant economic, societal, personal, and interpersonal costs. Innovative internet-delivered interventions have been designed to increase accessibility to and cost-effectiveness of treatments. These treatments have mainly targeted mild to moderate levels of depression. The increased risk associated with severe depression, particularly of suicidal ideation often results in this population being excluded from research studies. As a result, the effectiveness of internet-delivered cognitive behavioral therapy (iCBT) in more severely depressed cohorts is less researched.
The aim of this study is to examine the effect of iCBT on symptoms of severe depression, comorbid symptoms of anxiety, and levels of work and social functioning.
Retrospective consent was provided by participants with elevated scores (>28 severe depression symptoms) on the Beck Depression Inventory (BDI-II) who accessed an iCBT intervention (
A significant change was observed on all measures between pre- and postmeasurement and maintained at 3-month follow-up. Clinical improvement was observed for participants on the BDI-II from pre- to postmeasurement, and suicidal ideation also reduced from pre- to postmeasurement.
Users of
Depression is a serious public health concern and is predicted to be the leading cause of disability in the world by 2030 [
Evidence-based treatments for depression can comprise of pharmacological and psychological interventions [
A typical diagnosis of depression as per the
Innovative attempts to overcome these barriers have led to the development of internet-delivered psychological interventions, primarily based on cognitive behavioral principles for the treatment of depression and other mental health disorders [
Nevertheless, this is changing, and some studies have demonstrated the effectiveness of iCBT in reducing symptoms of severe depression [
Where some health systems have been efficient in their adoption of iCBT and other internet-delivered interventions (the improving access to psychological therapies program in the United Kingdom), the use of iCBT in natural settings is not well documented, where iCBT may be classified as an inappropriate treatment option for severe cases. For example, the NICE guidelines for depression [
iCBT can be of benefit to services as a frontline treatment for depression. As a low-intensity intervention, it consumes less clinical resource in its administration. Within a stepped care model, an individual can receive and benefit from an iCBT intervention while they wait for higher intensity treatment resources to become available. However, technology has since progressed, allowing for the delivery of treatments on more robust systems. One such intervention is SilverCloud, but the current utility of this low-intensity treatment for those with severe depression is unknown.
This study aims to explore the effect of the SilverCloud iCBT intervention on those with severe depression. It analyzes a cohort that did not meet the criteria for inclusion in a randomized controlled trial (RCT) investigating the impact of iCBT on mild to moderate depression. The authors hypothesized the following:
The intervention could impact positively on self-reported symptoms of depression, anxiety and work, and social functioning within a cohort with severe depression symptoms.
The results of this study offer a unique opportunity to assess the effects on suicidal ideation in the cohort, and the authors hypothesized that suicidal ideation would be lower post intervention.
Clinically meaningful change in depressive symptoms will be observed for the group.
Participants in this secondary analysis consisted of a subsample from a larger RCT [
Participants were assessed at baseline and posttreatment (after 8 weeks of service provision) and again at 3-month follow-up. At baseline, the BDI-II, Sociodemographic and History Questionnaire, GAD-7, and the WSAS were completed for screening purposes. After that, the BDI-II, GAD-7, and WSAS were completed at the end of treatment, week 8, and at 3-month follow-up. The 21-item BDI-II [
Participant demographics (N=67).
Characteristic | Value | |
Age (years), mean (SD); range | 36.3 (10.4); 18-58 | |
Male | 8 (12) | |
Female | 59 (88) | |
High school | 13 (19) | |
Undergraduate | 30 (45) | |
Postgraduate | 7 (10) | |
Other | 14 (21) | |
None | 3 (4) | |
Part-time/student | 14 (21) | |
Full-time | 25 (38) | |
Unemployed | 15 (22) | |
Retired | 1 (2) | |
Disabled | 2 (3) | |
Stay-at-home parent | 10 (15) |
The scale designates levels of severity: minimal (0-13), mild (14-19), moderate (20-28), and severe (29-63). The BDI-II has been found to have excellent internal consistency and test-retest reliability with a diverse range of samples [
The GAD-7 [
The Work and Social Adjustment Scale (WSAS) [
The SilverCloud
Trained volunteers from a national depression charity in Ireland provided support for the intervention. The role of the supporter in this trial was to provide motivational support and encouragement to their assigned patient. The cohort undertook several face-to-face training sessions hosted by the charity before commencing in their role, with the content of the training designed to educate on CBT, the program, the role of the supporter, and how best to respond to patients in distress. An assistant psychologist was employed by the depression charity to assist the supporters, as well as to monitor all correspondence between supporters and their patients. This individual reported directly to the Education and Online Services coordinator, who regularly consulted with the clinical director of the charity. Further risk protocols were incorporated at review points, where a client was escalated along service protocols if they shared information with their supporter that indicated a risk to themselves or others. Where patients indicated a response greater than zero on item 9 of the BDI-II, the supporter was sent an email alert, and clients were presented with “get help now” links and local crisis numbers. This protocol was standard for all patients of the charity, and not just those in the severe group. The supporter would then contact the patient at their earliest convenience, and they would discuss the options available to them.
Contents of
Module name | Brief description |
Getting started | Outlines basic premise of CBT, provides information about depression, and introduces some of the key ideas of Users are encouraged to begin to chart their current difficulties with depression |
Tune In I: getting to grips with mood | Focus is on mood monitoring and emotional literacy Users can explore different aspects of emotions, physical reactions, action and inaction, and how they are related |
Tune In II: spotting thoughts | Module focuses on noting and tracking thoughts Users can explore the connection between their cognitions and their mood, and record them graphically |
Change It I: boosting behavior | Module focuses on behavioral change as a way to improve mood Ideas about behavioral activation are included, and users can plan and record activities, and chart their relationship with their mood |
Change It II: challenge your thoughts | Module supports users to challenge distorted or overly negative thinking patterns, with thought records, as well as helpful coping thoughts |
Change It III: core beliefs | Module outlines the role that deeply held core beliefs could play in mood and depression A range of interactive activities available to identify, challenge, and balance any unhelpful core beliefs |
Bringing it all together | Module encourages bringing together all skills and ideas they have gathered so far, note their warning signs, and plan for staying well |
Original ethics approval was received for the study on November 25, 2013. Posthoc ethical approval was granted on November 16, 2015, to contact those scoring in the severe ranges of the BDI-II. The subsample was provided with information on the secondary analysis and participants were requested to provide informed consent should they wish to participate.
Baseline comparisons across the variables of age, gender, education level, and employment status were conducted, along with baseline comparisons across the measures of BDI-II, GAD-7, and WSAS between data gathered from all clients with “severe” depression (N=211) as per the BDI-II, and those who consented for their data to be used in the follow-up analysis (n=67).
Multivariate imputation by chained equations was applied to impute missing question scores using the R MICE v2.0 package [
No significant differences were observed between the BDI-II, GAD-7, and WSAS using
Participants engagement with the treatment was positive. To begin with, the participants completed a mean of 17.4 sessions (SD 17.3) over the duration of the treatment period. The mean session time per participant was 0.49 hours (SD 0.41), which amounts to a total mean exposure to the active treatment of 9.22 hours (SD 10.57). However, examining the standard deviation of this total time on the platform would suggest a large variance (ie, 10.57 hours). To illustrate this data further, quartiles have been reported in
The Little MCAR test revealed a nonsignificant result (
Linear mixed-model ANOVAs were conducted separately on the participant data (N=67) using time as the within-subjects variable for the BDI-II, GAD-7, and WSAS. For the BDI-II, a significant time effect on depression was found. The BDI-II scores significantly decreased from baseline with a mean of 35.94 (SD 6.91), to posttreatment with a mean of 23.76 (SD 9.68), to 3-month follow-up with a mean 14.52 (SD 7.45) measurement points, (
Reliable change for the imputed data of the “severely” depressed group was explored using participants that had BDI-II data at both pre- and posttime points. At posttreatment, 43/67 (64%) participants were classified as reliably improved. Of those who were classified as reliably improved, 6 of the 67 (9%) participants met the criteria for recovery. The remaining 18/67 (36%) individuals were classified as unchanged, where scores did not exceed a movement of 9 points in either direction.
Treatment response data (N=67).
Variable | Descriptive statistics | Percentiles | ||||
Mean (SD) | Median | Range (min-max) | 25th | 50th | 75th | |
Number of sessions | 17.4 (17.3) | 13 | 85 (1-86) | 5 | 13 | 25 |
Total time on platform (hours) | 9.22 (10.57) | 4.8 | 44.8 (0.0-44.8) | 1.7 | 4.8 | 12.4 |
Time per session (hours) | 0.49 (0.41) | 0.4 | 2.9 (0.0-2.9) | 0.3 | 0.4 | 0.6 |
Number of activities completed | 33.4 (41.6) | 16 | 227 (1-228) | 5 | 16 | 51 |
Activities per session | 1.79 (1.23) | 1.5 | 5.7 (0.3-6.0) | 0.9 | 1.5 | 2.1 |
Percentage of program viewed | 0.46 (0.36) | 0.4 | 1 (0.0-1.0) | 0.2 | 0.4 | 0.8 |
Descriptive statistics of the sample (n=67).
Measure | Baseline, mean (SD) | Posttreatment | 3-month follow-up | ||||
Mean (SD) | 95% CI |
Effect size |
Mean (SD) | 95% CI |
Effect size |
||
BDI-IIa | 35.9 (6.9) | 23.7 (9.7) | 21.40-26.12 | 1.14 (0.77-1.51) | 14.5 (7.4) | 12.70-6.34 | 2.29 (1.85-2.73) |
BDI-II Q9b | 0.8 (0.6) | 0.5 (0.6) | 0.39-0.66 | 0.35 (0.01-0.69) | 0.3 (0.5) | 0.17-0.43 | 0.61 (0.26-0.96) |
GAD-7c | 13.6 (4.9) | 8.0 (4.4) | 6.91-9.09 | 0.90 (0.54-1.26) | 6.00 (3.8) | 5.05-6.92 | 1.32 (0.95-1.70) |
WSASd | 20.4 (8.1) | 15.2 (7.0) | 13.49-16.93 | 0.53 (0.19-0.88) | 12.8 (5.3) | 11.49-14.09 | 0.84 (0.48-1.20) |
aBDI-II: Beck Depression Inventory-II.
bBDI-II Question 9: Beck Depression Inventory Question 9 measuring suicidality.
cGAD-7: Generalized Anxiety Disorder-7 item inventory.
dWSAS: Work and Social Adjustment Scale.
The current paper sought to investigate the impact of an internet-delivered CBT intervention for the treatment of depression,
The results demonstrate comparative effect sizes of improvement in severe depressive symptoms to those experienced in a mild to moderately depressed group, supporting the use of iCBT for severe depression [
Outcomes on secondary measures of the GAD-7 and WSAS significantly decreased from pre- to post timepoints, with significant differences and large effect sizes observed. These scores did not significantly differ at follow-up points, implying a maintenance of gains across the sample from post-treatment to 3-month follow-up, similar to what was observed by Meyer et al [
Increasingly in depression research, the need to include data points relevant to quality of life and functional impairment has been recognized [
Clinically significant change is an important concept due to its potential to provide a complete picture of the impact of interventions, which goes beyond the averages of the group and outlines change at an individual level [
Suicidal ideation was significantly reduced from pre- to postintervention. The authors acknowledge that despite mean scores being less than 1 on this item of the BDI-II (where a score of 1 on the measure indicates the presence of suicidal thoughts without intentions), the results nonetheless lend support to previous trials investigating this area [
The current study demonstrated the potential for a supported internet-delivered intervention to alleviate symptoms in individuals with severe presentations. Implementing supported iCBT interventions allows for sufficient monitoring of patients and the capability to intervene and offer further support in the case where risk escalates [
While the initial results from this study are promising, the original protocol meant that no control group was recruited and therefore caution is advised as we are unable to conclude that the treatment delivered is responsible for the observed effects. We received a response rate of 37.1% (67/211) of the sample, which can be considered a limitation and represents a potential for self-selection bias. At baseline, we found no significant differences between responders and non-responders on all clinical and socio-demographic variables apart from education. Higher levels of education were found for participants who consented for their follow-up data to be used for this secondary analysis. The authors acknowledge that this may bias the data. However, it has been highlighted that differences in education do not impact on treatment response and outcome in CBT-therapies [
Further investigations implementing RCT or feasibility designs are warranted to discern the utility of
The current study demonstrated the potential for an internet-delivered intervention to reduce symptoms of severe depression. The participants demonstrated reliable decreases in anxiety symptoms and improvements in work and social functioning. Furthermore, reliable improvement in depression symptomology was observed. Suicidal ideation was reduced as a result of engaging in the intervention, and these results suggest that internet-delivered interventions may have the potential to provide a robust method of risk assessment and monitoring. Current treatment guidelines, such as NICE [
analysis of variance
Beck Depression Inventory
cognitive behavioral therapy
The American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition)
Generalized Anxiety Disorder-7 item inventory
internet-delivered cognitive behavioral therapy
The National Institute for Health and Care Excellence
randomized controlled trial
Work and Social Adjustment Scale
The authors greatly acknowledge SilverCloud Health for funding this study. DR and LT conceptualized the original trial from which this secondary analysis was derived. DD and JB wrote the initial draft of the paper, with reviews from DR, LT, and MA contributing to the final draft. SC was the data manager and statistician. DD and SC developed and actioned the data analytic protocol.
DR, DD, JB, MA, and SC are employees of SilverCloud Health, developers of computerized psychological interventions for depression and anxiety, stress and comorbid long-term conditions. LT is a research consultant for SilverCloud Health who is based in Trinity College, Dublin.