This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and license information must be included.
There are few published controlled trials examining the efficacy of Internet-based treatment for postnatal depression (PND) and none that assess diagnostic status (clinical remission) as the primary outcome. This is despite the need to improve treatment uptake and accessibility because fewer than 50% of postnatally depressed women seek help, even when identified as depressed.
In a randomized controlled trial (RCT), we aimed to test the efficacy of a 6-session Internet intervention (the MumMoodBooster program, previously evaluated in a feasibility trial) in a sample of postnatal women with a clinical diagnosis of depression. The MumMoodBooster program is a cognitive behavioral therapy (CBT) intervention, is highly interactive, includes a partner website, and was supported by low-intensity telephone coaching.
This was a parallel 2-group RCT (N=43) comparing the Internet CBT treatment (n=21) to treatment as usual (n=22). At baseline and at 12 weeks after enrollment, women’s diagnostic status was assessed by telephone with the Standardized Clinical Interview for DSM-IV (SCID-IV) and symptom severity with the Beck Depression Inventory (BDI-II). Depression symptoms were measured repeatedly throughout the study period with the Patient Health Questionnaire (PHQ-9).
At the end of the study, 79% (15/19) of women who received the Internet CBT treatment no longer met diagnostic criteria for depression on the SCID-IV (these outcome data were missing for 2 intervention participants). This contrasted with only 18% (4/22) remission in the treatment as usual condition. Depression scores on the BDI-II showed a large effect favoring the intervention group (
Our results suggest that our Internet CBT program, MumMoodBooster, is an effective treatment option for women clinically diagnosed with PND. This is one of only two controlled evaluations of specialized online psychological treatment among women clinically diagnosed with PND. MumMoodBooster appears to be a feasible, effective treatment option, which is potentially accessible to large numbers of women in metropolitan, rural, and remote areas. Future work might be focused profitably on establishing comparability with face-to-face treatments and purely self-guided delivery. We have commenced a larger RCT comparing MumMoodBooster with face-to-face CBT.
Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613000113752; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363561 (Archived by WebCite® at http://www.webcitation.org/6f64kuyLf).
Approximately 13% of women suffer postnatal depression (PND) by the time their baby is 3 months old [
Encouraging results of online intervention for problems including panic disorder, anxiety, posttraumatic stress [
We developed a PND intervention (MumMoodBooster) with low-intensity guided support based on cognitive behavioral therapy (CBT), which is an established treatment of choice for depressive disorders with its efficacy supported by much research [
MumMoodBooster is now one of two evaluated Internet interventions for PND. O’Mahen and colleagues have also developed and tested Netmums, a guided online behavioral activation (BA) treatment [
Here we report on the efficacy of the MumMoodBooster intervention delivered with low-intensity guided telephone support in a randomized controlled trial (RCT) compared to a treatment as usual (TAU) condition. We included a sample of women diagnosed with a depressive disorder and reassessed diagnostic status 12 weeks after enrollment. We hypothesized that MumMoodBooster would lead to a reduction in depressive symptomatology and an increased rate of remission from the diagnosed depressive episode compared to TAU. Current evidence points to similar potential for efficacy between online and face-to-face CBT for depression in general. Our study sought first to establish whether a PND-specific online CBT program is clinically effective compared to TAU care practices.
This was a parallel 2-group RCT comparing MumMoodBooster to TAU. The main outcomes were remission from the depressive episode and severity of symptoms of depression at 12 weeks postenrollment. See
The study was approved by the Austin Health Human Research Ethics Committee (approval number H2012/04682) and informed consent was obtained from all participants.
Recruitment occurred between March 2013 and July 2014. Participants were women resident in Australia aged 18 years and older with a child aged less than 1 year. A stepped process was used to recruit eligible participants: initial screening, clinical assessment, baseline data acquisition, and randomization. The research project was available to women across Australia, in both rural and metropolitan areas. Marketing focused on Internet campaigns using Google AdWords, Facebook, and Twitter. The project was also advertised to Maternal and Child Health Centres in Melbourne who were encouraged to direct clients to the project. Messages prompted interested individuals to obtain more information and to begin a screening process by visiting the secure project recruitment website or to call project staff directly.
Screening criteria were determined online as follows: Australian residency, 18 years of age or older, English speaking, less than 1 year postpartum, Internet access with regular email use, an Edinburgh Postnatal Depression Scale (EPDS) [
Individuals who satisfied screening criteria were emailed a participant information and consent form to complete and return by email. Consenting women were subsequently telephoned by a psychologist/psychology trainee to explain the study and to schedule a clinical assessment. At this stage, women who scored 1 to 2 on item #10 of the EPDS were asked a series of questions following the risk assessment protocol of Simon and colleagues [
Following initial telephone contact, eligible consenting women were assessed by telephone by a clinical psychologist/psychology trainee using the Structured Clinical Interview for
Women satisfying all eligibility criteria were told verbally about the unique log-in they could use to complete the baseline (prerandomization) questionnaires.
Women who completed the baseline assessment questionnaires were randomized immediately online to either MumMoodBooster or to TAU. The randomization procedure used a 1:1 allocation ratio and a pregenerated permuted blocks allocation schedule with the sequence concealed from the researchers consistent with CONSORT standards [
The structure and content of the MumMoodBooster intervention and its associated websites (partner’s website, coach’s website, administrative website) have been described in detail elsewhere [
Treatment consisted of six interactive sessions that were sequentially accessed and designed to encourage optimal engagement and behavior change. For illustration,
Initial steps of the program provided explicit direction, whereas later steps encouraged participants to assume greater responsibility for managing their own plan for change. Later sessions commenced by reviewing previous material before presenting new content and concepts. The program’s charting function was used to help participants see the functional relation of mood and activity levels. Information from past sessions was used to reinforce gains made, to tailor subsequent program content, and to provide ipsative feedback. Although participants were allowed to set their own pace, of particular importance because women with PND are often overwhelmed by the demands of infant care, the program encouraged the completion of all six sessions at a rate of one session per week. A printable summary was used to describe key content covered in each session and provided a tailored list of recommended home practice activities. Participants were also granted unrestricted access to browse additional “library” articles on relevant topics ranging from relaxation, to problem solving, to parenting support resources. Participants also had unrestricted access to a monitored peer-based Web forum on which they could post, read, and comment on messages from other program participants. Additionally, in recognition of the role of women’s partners [
Participants in MumMoodBooster received guided support from a telephone coach to assist and encourage them in their use and practice of particular strategies (coaches were instructed to spend a maximum of 30 minutes per week per participant). There were 7 coaches (3 graduate psychology trainees, 3 clinical psychologists, and 1 health psychologist) who were supported and supervised by 2 senior psychologists. Training for the coaching role involved working through the program (as if they were a participant), reading the coach manual, observing other coaches’ complete calls, and a verbal explanation from a senior psychologist about the role and the tasks involved. Content of coaching calls adhered to a manualized script with the defined and limited aims of reinforcing progress; encouraging engagement, practice of strategies, and completion of tasks; and introducing the themes of upcoming sessions. The role of the coaches was only to support mothers in using the program and they were instructed to refrain from giving clinical guidance, but rather to point participants to relevant program content that may address their questions (similar to the “technician” role described by Titov and colleagues [
Diagrammatic structure of the MumMoodBooster postnatal depression program.
The charting function on a user’s “My Status” page displaying a breakdown of pleasant activities since starting the program.
Participants in the TAU condition received the same clinical assessment as those in the MumMoodBooster condition. In this condition (as for those in the MumMoodBooster condition), women’s nominated health professional received a written notification of the depressive diagnosis that encouraged them to consult with their patient regarding mental health care needs and to form a collaborative care plan with the patient’s other relevant health care practitioners. In most cases, women nominated their Maternal and Child Health Nurse (MCHN) or general practitioner (GP) who were then free to treat or to refer to other services/agencies as they judged appropriate, as would normally happen where specialized programs are not available. Therefore, in practice, TAU varied at the discretion of each participant’s nominated health professional and was expected to include a heterogeneous mix of interventions/supports. TAU participants were also provided with links to general Internet resources on mental health. They also received the email prompts to complete online assessments.
Safety monitoring was used to provide crisis intervention and referrals to mental health specialty care if needed and a reminder of the emergency contacts provided at baseline assessment. For women in the MumMoodBooster condition, these were carried out by the allocated telephone coach. For women in TAU, a separate safety monitor was allocated (from the same pool of staff as the telephone coaches). All study participants were monitored via safety calls on five occasions: at baseline and at weeks 3, 5, and 9 (immediately posttreatment) and at 12 weeks postenrollment. We used the protocol of Simon et al [
Measures were administered via online questionnaire or by telephone. Demographic data (eg, age, parity, education, income) were gathered both during telephone assessment and in the online battery of baseline questionnaires. The key depression measures (described subsequently) are well validated and their psychometric properties are well described in general populations. The performance and psychometric properties of both generic and perinatal-specific depression measures used in the context of perinatal populations have been recently reviewed and were the subject of a full health technology report in 2009 [
Before completion of baseline questionnaires and at 12 weeks postenrollment, trained diagnostic interviewers conducted the SCID-IV [
At baseline and at 12 weeks postenrollment, severity of depressive symptoms was measured online using the revised Beck Depression Inventory (BDI-II) [
Participants completed the 9-item PHQ-9 [
Participants’ anxiety and stress symptom severity were measured at baseline and at weeks 9 and 12 using the anxiety and stress scales of the Depression, Anxiety and Stress Scales—Short Form (DASS-21) [
At baseline and at 12 weeks postenrollment, participants were asked to indicate how frequently over the previous week they had negative thoughts using the 30-item Automatic Thoughts Questionnaire (ATQ) [
To measure changes in behavior patterns, at baseline and at 12 weeks postenrollment, women completed the 25-item Behavioral Activation for Depression Scale (BADS) [
Women’s relationships with their partners were assessed using the abbreviated 7-item version of the Dyadic Adjustment Scale (DAS-7) [
At baseline and at 12 weeks postenrollment, we used the Parenting Sense of Competence Scale (PSOC) [
Website analytic tools and database flags allowed us to measure MumMoodBooster program usage in an unobtrusive manner, generating records of number and duration of visits to the website and number of program sessions attended.
Satisfaction with the MumMoodBooster program was assessed using a 4-point Likert scale (1=not at all satisfied; 4=very satisfied). Helpfulness of phone coach calls was similarly assessed using a 4-point Likert scale (1=not at all helpful; 4=very helpful).
Participants were also asked to provide details of access to other support services and treatments during the study interval.
The primary outcomes were changes in depressive diagnostic status (assessed by the SCID-IV) and depression symptom severity (BDI-II). The categorical outcome (ie, diagnostic status) was analyzed using a contingency table and chi-square test. The continuous outcome (ie, BDI-II) was analyzed in general linear models, which accounted for baseline values as a covariate. Continuous repeated measures data (PHQ-9) were analyzed in mixed-effects growth models using restricted maximum likelihood. Log-likelihood ratio and Akaike information criterion were used to assess model fit.
Consistent with CONSORT standards [
There was some missing data (<5%) on the primary outcomes. Little’s missing completely at random (MCAR) test [
For the outcome measure of depressive symptom severity (BDI-II), data from a previous trial of CBT [
A total of 178 women began the study registration process (see
Women in the two conditions appeared comparable in terms of baseline characteristics (
Baseline characteristics of participants (N=43).
Characteristic | MumMoodBooster |
TAU |
|
Mother’s age (years), mean (SD) | 31.7 (4.6) | 31.5 (4.3) | |
Baby’s age (months), mean (SD) | 6.52 (2.8) | 6.15 (3.1) | |
EPDS at screening, mean (SD) | 16.6 (3.1) | 15.8 (2.8) | |
Born in Australia, n (%) | 18 (86) | 21 (96) | |
Current major depression, n (%) | 20 (95) | 20 (91) | |
Current minor depression, n (%) | 1 (5) | 2 (9) | |
Past major depression, n (%) | 14 (67) | 15 (68) | |
|
|
|
|
|
Married/Living with partner | 18 (86) | 20 (91) |
|
Single | 3 (14) | 2 (9) |
|
|
|
|
|
Did not finish school | 0 (0.0) | 1 (5) |
|
High school only | 2 (9) | 3 (14) |
|
Certificate level | 4 (19) | 3 (14) |
|
Diploma level | 5 (24) | 4 (18) |
|
Undergraduate degree | 6 (29) | 7 (32) |
|
Postgraduate degree | 4 (19) | 4 (18) |
|
|
|
|
|
1 | 7 (33) | 7 (32) |
|
2 | 7 (33) | 11 (50) |
|
≥3 | 7 (33) | 4 (18) |
|
|
|
|
|
≤$20,000 | 0 (0) | 1 (5) |
|
$20,001-$40,000 | 0 (0) | 1 (5) |
|
$40,001-$60,000 | 2 (10) | 1 (5) |
|
$60,001-$80,000 | 3 (14) | 6 (27) |
|
>$80,000 | 13 (62) | 13 (59) |
|
Not divulged | 3 (14) | 0 (0) |
In the MumMoodBooster condition, 20 of 21 women (95%) were diagnosed with current major depression and 1 of 21 women (5%) with minor depression. In the TAU condition, 20 of 22 women (91%) met diagnostic criteria for current major depression and 2 of 22 women (9%) for minor depression (
The mean age of mothers was close to the most recently available Australian national average (30 years [
CONSORT diagram of participant flow through the study.
In the MumMoodBooster condition, 79% (15/19) of women no longer met
Similarly, women in the MumMoodBooster condition also showed reduced severity of depression symptoms, whereas those in the TAU condition displayed little improvement (see
Severity of depression, anxiety, and stress symptoms over time.a
Outcome measureb | MumMoodBooster, |
TAU, |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Baseline | 25.3 (6.4) | 26.3 (8.6) |
|
|
|
|
|
12 weeks | 14.5 (12.2) | 23.0 (7.5) | 7.4 |
|
.01 | 0.83 (0.20, 1.45) |
|
|
|
|
|
|
|
|
|
Baseline | 9.0 (7.0) | 6.7 (5.3) |
|
|
|
|
|
9 weeks | 5.0 (6.2) | 5.9 (4.3) |
|
176.0 | .17 | 0.18 (–0.42, 0.78) |
|
12 weeks | 4.2 (5.5) | 5.4 (3.0) |
|
153.0 | .05 | 0.27 (–0.33, 0.87) |
|
|
|
|
|
|
|
|
|
Baseline | 22.1 (8.0) | 20.7 (7.2) |
|
|
|
|
|
9 weeks | 14.2 (9.0) | 18.5 (7.1) |
|
142.5 | .03 | 0.54 (–0.07, 1.15) |
|
12 weeks | 13.1 (8.7) | 18.1 (10.2) |
|
153.5 | .06 | 0.53 (–0.08, 1.14) |
a Tabled values are from intention-to-treat analyses after imputation of missing values.
b BDI-II: Beck Depression Inventory II; DASS: Depression, Anxiety and Stress Scales.
DSM-IV diagnoses at baseline and 12 weeks postenrollment.
Longitudinal trajectories of Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 12 weeks.
At baseline, mean anxiety scores were within the normal-to-mild range of severity (0-9). Mean baseline stress scores fell in the moderate range of severity (19-25). At 9 weeks (immediately posttreatment) and at 12 weeks postenrollment, average symptom severity on the Anxiety scale of the DASS-21 was not significantly lower in the MumMoodBooster condition compared to the TAU condition (
Mean scores for measures of both negative thinking (ATQ) and behavioral activation (BADS) showed some improvement in both the MumMoodBooster and TAU conditions (see
Secondary outcomes at baseline and 12 weeks.a
Outcome measureb | MumMoodBooster, mean (SD) |
TAU, mean (SD) |
|
|
|
|
|
|
|
|
|
|
|
|
Baseline | 70.19 (16.49) | 80.55 (22.89) |
|
|
|
|
12 weeks | 56.33 (26.73) | 72.05 (20.78) | 3.71 | .06 | 0.61 (–0.01, 1.22) |
|
|
|
|
|
|
|
|
Baseline | 79.86 (15.76) | 78.27 (15.08) |
|
|
|
|
12 weeks | 103.24 (24.49) | 84.77 (17.07) | 7.96 | .01 | 0.86 (0.23, 1.48) |
|
|
|
|
|
|
|
|
Baseline | 21.10 (6.95) | 19.41 (7.92) |
|
|
|
|
12 weeks | 22.67 (6.43) | 21.23 (6.36) | 0.10 | .75 | 0.10 (–0.50, 0.70) |
|
|
|
|
|
|
|
|
Baseline | 27.52 (7.50) | 21.23 (7.37) |
|
|
|
|
12 weeks | 30.19 (7.53) | 23.36 (7.85) | 2.54 | .12 | 0.53 (–0.08, 1.13) |
a Tabled values are from intention-to-treat analyses after imputation of missing values.
b ATQ: Automatic Thoughts Questionnaire; BADS: Behavioral Activation for Depression Scale; DAS-7: Dyadic Adjustment Scale: PSOC: Parenting Sense of Competence.
c Lower score is superior.
d Higher score is superior.
The intervention had no statistically significant effect on partner relationships (DAS-7 scores), although its impact on the parenting self-efficacy measure (PSOC) constituted a medium effect size (
All women offered the MumMoodBooster intervention (21/21) completed four or more sessions and 86% (18/21) completed all six sessions. Women visited the program on a mean of 20.5 occasions (SD 10.6) and the mean number of sessions attended was 5.7 (SD 0.7). The total time spent using the online program averaged 370 minutes (range 120-1076). Content on the Web forum was viewed, to varying degrees, by all participants and 57% (12/21) posted their own comments to the forum. The mean number of library articles accessed was 4 out of a possible 8. Of the six scheduled coach calls, participants completed a mean 4.3 calls (SD 2.2, range 0-6). A total of 76% (16/21) of participant partners accessed the partner support website.
Of the 21 women in the MumMoodBooster condition, 90% (19/21) provided ratings of the program’s satisfaction and the helpfulness of coaching calls. Mean satisfaction ratings were in the moderately satisfied range (mean 3.1, SD 0.60, range 2-4) on a 4-point scale. Similarly, mean ratings of the helpfulness of telephone coach calls were in the moderately helpful range (mean 3.2, SD 0.89, range 1-4) on a 4-point scale.
At the 12-week assessment, all study participants were asked: “Since you enrolled in the study, which of the following products or programs have you used to manage your mood? (choose all that apply).” A checklist was presented and participants checked the items relevant to their usage. The possible items were (1) I participated in a group treatment program, (2) I participated in an individual treatment program, (3) I participated in another Internet-based treatment program, (4) I saw my doctor who gave me advice, (5) I saw my Maternal & Child Health Nurse/Pediatrician who gave me advice, (6) I took medication for depression, (7) I used hypnosis or acupuncture, (8) I read self-help books, and (9) other (please specify). Of the respondents in the MumMoodBooster condition, 32% (6/19) reported that they had accessed one or more sources of support, whereas 81% (17/21) of those in TAU reported using one or more supports while enrolled in the trial; this was a statistically significant difference (continuity corrected χ2
1
Of note, individual psychological treatment was reported only by TAU participants, whereas one respondent (5%) in the MumMoodBooster condition reported commencing the use of antidepressant medication compared to 4 (19%) in TAU. More respondents in the TAU group reported having accessed their GP, child health nurse, or pediatrician. Various supports reported by participants, categorized collectively as “other,” included Internet research, meditation, telephone helplines, and talking to friends/other mothers. More respondents in the TAU group (10/21, 48%) accessed these “other” supports compared to the MumMoodBooster condition (3/19, 16%).
Other supports and treatments accessed during the trial (n=6 women in the MumMoodBooster condition and n=17 in the TAU condition reported accessing other supports).
Postnatal depression is prevalent, with enormous negative effects on maternal and infant well-being, yet postnatally depressed women receive adequate treatment in less than 10% of cases [
This RCT demonstrates that the MumMoodBooster intervention results in very good participant engagement with the program, increased rates of remission from diagnosed depression, as well as a significantly more rapid reduction in severity of depressive symptoms. This improvement was evidenced in a sample with baseline depression severity in the moderately severe range and with the vast majority of participants diagnosed with major depression. The intervention produced a 4-fold improvement in the rate of depression remission compared to the TAU condition—even when worst-case results were imputed for the few missing data values.
These results are an encouraging replication of the findings of our previous uncontrolled feasibility study of MumMoodBooster with postnatally depressed women in both Australia and the United States [
This RCT also evaluated changes in symptoms of anxiety and stress, commonly comorbid with depression, and found medium effects favoring the intervention in terms of stress but not anxiety. In interpreting this result, it is worth noting that, at baseline, the mean DASS-21 Anxiety score for participants already fell inside the normal range for anxious symptoms. Although comorbid anxiety symptoms are commonly reported among women with PND, in this sample there may have been little potential gain to make in terms of reducing anxiety scores.
The study has some limitations. First, the RCT was based on a relatively small sample size meaning that some caution is required in trying to generalize our results to the wider perinatal population. Second, women allocated to TAU reported high levels of alternative help seeking and this may have made the detection of true treatment effects relative to TAU more difficult. Conceivably, the comprehensive psychological assessment process for trial inclusion (which is not a consistent feature of TAU in real-world practice) may itself have affected rates of alternative help seeking. It was not unexpected to see the considerable variation in treatments and supports accessed in TAU, as has been discussed in a recent review of what constitutes TAU in the context of RCTs of psychological interventions [
Despite these limitations, the robustness of the intention-to-treat analysis tends to uphold the reliability of the results for the primary outcomes. Finally, a major strength of the study is that the efficacy of the MumMoodBooster intervention in treating PND was evaluated against
In summary, this RCT confirms and adds to existing evidence for the efficacy of online treatment for PND [
CONSORT-EHEALTH checklist V1.6.2 [
Selected Screenshots.
Automatic Thoughts Questionnaire
behavioral activation
Behavioral Activation for Depression Scale
Beck Depression Inventory
cognitive behavioral therapy
Dyadic Adjustment Scale
Depression, Anxiety and Stress Scales—Short Form
Edinburgh Postnatal Depression Scale
general practitioner
Maternal and Child Health Nurse
Patient Health Questionnaire
postnatal depression
Parenting Sense of Competence
randomized controlled trial
treatment as usual
We thank
None declared