Phone and Web Program for Depression, Anxiety and Stress
Details of enrolment into the trial, organised according to the CONSORT guidelines, are shown in Figure 1. Of the 3561 people who expressed an interest in the study, 720 were randomised. Among those who returned completed screening information, reasons for ineligibility included: symptoms too severe (975, 73.1%); no internet-enabled mobile phone (167, 12.3%); symptoms in the normal range (150, 11%); no access to the internet or mobile phone (49, 3.6%) and not an Australian resident (17, 0.01%). Fifteen people subsequently withdrew from the study and, in the absence of consent to use their data, we excluded them from the analyses.
(Enlarge Image)
Figure 1.
Participant flow diagram.
The recruitment process yielded a sample of N = 720 participants. The sample was predominantly female (491, 69.6%), university educated (387, 53.7%), employed (591, 83.8%), married (288, 41%), and with a mean age of 38.9 years. The three groups did not differ on the demographic and clinical history variables assessed at baseline, with two exceptions: WL participants (66%) were more likely than myCompass (58%) and AC (52%) participants to report a stressful episode in the month preceding the study (X = 8.08, P < 0.02), and had a significantly lower score at baseline on the DASS Anxiety subscale than myCompass participants (F2, 702 = 4.44, P = 0.01; Table 1).
The rate of attrition for the total sample was 27.9% at post-intervention and 51.4% at the 3-month follow-up assessment (see Figure 1). At post-intervention, attrition was higher among employed (27.9%) than unemployed participants (18.4%; X1 = 4.04, P = 0.04), slightly higher in males (31.6%) than females (24.4%; X1 = 3.77, P = 0 .05) and higher in the myCompass group (45.5%) than the AC (20.7%) and WL groups (13.2%; X2 = 67.84, P < 0.001). Those who did not complete the post-intervention assessment also reported significantly lower DASS Anxiety scores at baseline (t703 = -1.96, P = 0.05). Attrition rates at 3-month follow-up were 56.7% and 32.1%, for the myCompass and AC groups respectively, and differed significantly (X1 = 29.25, P < 0.001). Demographic variables did not differ between dropouts and non-dropouts at follow-up, however, dropouts reported significantly less functional impairment at baseline on the WSAS (t703 = -2.01, P = 0.04).
For the myCompass group, there were no significant baseline differences between non-dropouts and dropouts at post-intervention and follow-up on any of the demographic and clinical history variables.
Table 2 reports observed and estimated marginal mean (EMM) scores on the study outcomes at baseline, post-intervention and follow-up for the three groups.
The MMRM analyses of pre-post intervention data yielded significant 3 (groups) by 2 (times) interactions across the DASS subscales and total scores and the WSAS (Table 3). Bonferroni adjusted contrasts comparing change from baseline for each group showed a consistent pattern of significantly greater improvement at post-intervention for the myCompass group compared to the AC and WL groups on the Depression, Anxiety, DASS Total and WSAS scales. Compared to the WL group, myCompass participants also showed significant gains on the Stress scale.
Figures 2 and 3 depict the estimated marginal means for the myCompass and AC conditions on the primary and secondary outcome measures at baseline, post-intervention and follow-up.
(Enlarge Image)
Figure 2.
Estimated marginal DASS means for the intervention and attention control groups.
(Enlarge Image)
Figure 3.
Estimated marginal WSAS means for the intervention and attention control groups.
When data for the myCompass and AC groups at the three time points were subjected to MMRM analysis, significant overall group by time interactions were observed across all of the primary and secondary measures, except for the DASS Stress subscale (F2, 800 = 5.33, P = 0.12). In these analyses, the interaction contrasts computed for the intervention phase examined the same group differences as the contrast comparing the myCompass and AC group reported in Table 3. Interaction contrasts comparing groups during the follow-up phase showed significantly greater change for the AC group than the myCompass group on the WSAS, DASS Depression and DASS Total scales. Within-group comparisons of means in the myCompass group showed that treatment gains were maintained from post-test through the follow-up phase, with scores remaining low and stable, the only exception being a small increase in DASS Depression scores (mean difference = 1.52, P = 0.05) Table 4.
Between- and within-group effect sizes on the primary and secondary outcomes calculated using observed and adjusted means are presented in Table 5. At post-intervention, between-group effect sizes calculated using observed means ranged from small-to-moderate (myCompass vs. AC; d range = .22 - .41: myCompass vs. WL; d range = .29 to .55), with effect sizes based on adjusted means tending to be only marginally lower. Within-group effects for the myCompass group were mostly moderate based on observed means (d range = .24 to .49), and slightly larger based on adjusted means. For the AC and WL groups, within-group effects were generally small (d range = .01 to .27).
WL participants were given access to myCompass at the end of the waiting period, and 52% (103) returned a questionnaire after using the myCompass intervention for seven weeks. Paired samples t-tests showed significant immediate improvement for participants on the three DASS subscales and the total DASS (t101 range = 1.97–3.10; P range 0.001 to 0.05) and on the WSAS (t95 = 2.94; P = .004). Follow-up data were provided by 66% (68) of this group and showed that these improvements were maintained at follow-up (t67 range = -1.22–1.30; NS). Within-group effect sizes calculated immediately after the intervention and using observed means were small (d range = .17 for DASS Anxiety to .31 for DASS Depression).
Participants in the intervention group logged in to use the myCompass program an average of 14.7 times (s.d.=16.7; range 0 to 105) and self-monitored an average of 49 times (s.d.=54.1; range 0 to 262) during the 7-week intervention period. The mean number of modules completed was 1.6 (s.d.=1.7; range 0 to 9). There was no difference at baseline between people who did and did not log in to use myCompass during the intervention period. None of the adherence indices correlated with demographic, clinical history and primary and secondary outcome data obtained at baseline.
Scores on the program satisfaction measure ranged from 1 (dissatisfied) to 5 (extremely satisfied). On average, ratings of program satisfaction were above the mid-points of the scale and did not differ for participants in the myCompass (mean rating = 3.86, s.d.=0.82) and AC (mean rating = 3.66, s.d.=0.85) conditions (t299 = 1.92; NS). Eighty-three per cent of myCompass participants reported that they would recommend the program to others, and 87.4% indicated that they would happily use the program again.
Results
Randomisation and Study Attrition
Details of enrolment into the trial, organised according to the CONSORT guidelines, are shown in Figure 1. Of the 3561 people who expressed an interest in the study, 720 were randomised. Among those who returned completed screening information, reasons for ineligibility included: symptoms too severe (975, 73.1%); no internet-enabled mobile phone (167, 12.3%); symptoms in the normal range (150, 11%); no access to the internet or mobile phone (49, 3.6%) and not an Australian resident (17, 0.01%). Fifteen people subsequently withdrew from the study and, in the absence of consent to use their data, we excluded them from the analyses.
(Enlarge Image)
Figure 1.
Participant flow diagram.
The recruitment process yielded a sample of N = 720 participants. The sample was predominantly female (491, 69.6%), university educated (387, 53.7%), employed (591, 83.8%), married (288, 41%), and with a mean age of 38.9 years. The three groups did not differ on the demographic and clinical history variables assessed at baseline, with two exceptions: WL participants (66%) were more likely than myCompass (58%) and AC (52%) participants to report a stressful episode in the month preceding the study (X = 8.08, P < 0.02), and had a significantly lower score at baseline on the DASS Anxiety subscale than myCompass participants (F2, 702 = 4.44, P = 0.01; Table 1).
The rate of attrition for the total sample was 27.9% at post-intervention and 51.4% at the 3-month follow-up assessment (see Figure 1). At post-intervention, attrition was higher among employed (27.9%) than unemployed participants (18.4%; X1 = 4.04, P = 0.04), slightly higher in males (31.6%) than females (24.4%; X1 = 3.77, P = 0 .05) and higher in the myCompass group (45.5%) than the AC (20.7%) and WL groups (13.2%; X2 = 67.84, P < 0.001). Those who did not complete the post-intervention assessment also reported significantly lower DASS Anxiety scores at baseline (t703 = -1.96, P = 0.05). Attrition rates at 3-month follow-up were 56.7% and 32.1%, for the myCompass and AC groups respectively, and differed significantly (X1 = 29.25, P < 0.001). Demographic variables did not differ between dropouts and non-dropouts at follow-up, however, dropouts reported significantly less functional impairment at baseline on the WSAS (t703 = -2.01, P = 0.04).
For the myCompass group, there were no significant baseline differences between non-dropouts and dropouts at post-intervention and follow-up on any of the demographic and clinical history variables.
Outcomes at Post-intervention
Table 2 reports observed and estimated marginal mean (EMM) scores on the study outcomes at baseline, post-intervention and follow-up for the three groups.
The MMRM analyses of pre-post intervention data yielded significant 3 (groups) by 2 (times) interactions across the DASS subscales and total scores and the WSAS (Table 3). Bonferroni adjusted contrasts comparing change from baseline for each group showed a consistent pattern of significantly greater improvement at post-intervention for the myCompass group compared to the AC and WL groups on the Depression, Anxiety, DASS Total and WSAS scales. Compared to the WL group, myCompass participants also showed significant gains on the Stress scale.
Outcomes at Follow-up
Figures 2 and 3 depict the estimated marginal means for the myCompass and AC conditions on the primary and secondary outcome measures at baseline, post-intervention and follow-up.
(Enlarge Image)
Figure 2.
Estimated marginal DASS means for the intervention and attention control groups.
(Enlarge Image)
Figure 3.
Estimated marginal WSAS means for the intervention and attention control groups.
When data for the myCompass and AC groups at the three time points were subjected to MMRM analysis, significant overall group by time interactions were observed across all of the primary and secondary measures, except for the DASS Stress subscale (F2, 800 = 5.33, P = 0.12). In these analyses, the interaction contrasts computed for the intervention phase examined the same group differences as the contrast comparing the myCompass and AC group reported in Table 3. Interaction contrasts comparing groups during the follow-up phase showed significantly greater change for the AC group than the myCompass group on the WSAS, DASS Depression and DASS Total scales. Within-group comparisons of means in the myCompass group showed that treatment gains were maintained from post-test through the follow-up phase, with scores remaining low and stable, the only exception being a small increase in DASS Depression scores (mean difference = 1.52, P = 0.05) Table 4.
Effect Size
Between- and within-group effect sizes on the primary and secondary outcomes calculated using observed and adjusted means are presented in Table 5. At post-intervention, between-group effect sizes calculated using observed means ranged from small-to-moderate (myCompass vs. AC; d range = .22 - .41: myCompass vs. WL; d range = .29 to .55), with effect sizes based on adjusted means tending to be only marginally lower. Within-group effects for the myCompass group were mostly moderate based on observed means (d range = .24 to .49), and slightly larger based on adjusted means. For the AC and WL groups, within-group effects were generally small (d range = .01 to .27).
Waitlist Group Results
WL participants were given access to myCompass at the end of the waiting period, and 52% (103) returned a questionnaire after using the myCompass intervention for seven weeks. Paired samples t-tests showed significant immediate improvement for participants on the three DASS subscales and the total DASS (t101 range = 1.97–3.10; P range 0.001 to 0.05) and on the WSAS (t95 = 2.94; P = .004). Follow-up data were provided by 66% (68) of this group and showed that these improvements were maintained at follow-up (t67 range = -1.22–1.30; NS). Within-group effect sizes calculated immediately after the intervention and using observed means were small (d range = .17 for DASS Anxiety to .31 for DASS Depression).
Program Adherence and Satisfaction
Participants in the intervention group logged in to use the myCompass program an average of 14.7 times (s.d.=16.7; range 0 to 105) and self-monitored an average of 49 times (s.d.=54.1; range 0 to 262) during the 7-week intervention period. The mean number of modules completed was 1.6 (s.d.=1.7; range 0 to 9). There was no difference at baseline between people who did and did not log in to use myCompass during the intervention period. None of the adherence indices correlated with demographic, clinical history and primary and secondary outcome data obtained at baseline.
Scores on the program satisfaction measure ranged from 1 (dissatisfied) to 5 (extremely satisfied). On average, ratings of program satisfaction were above the mid-points of the scale and did not differ for participants in the myCompass (mean rating = 3.86, s.d.=0.82) and AC (mean rating = 3.66, s.d.=0.85) conditions (t299 = 1.92; NS). Eighty-three per cent of myCompass participants reported that they would recommend the program to others, and 87.4% indicated that they would happily use the program again.