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J Affect Disord. Author manuscript; available in PMC 2022 February 15.
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Published in final edited form as:

J Affect Disord. 2021 February 15; 281: 673–677. doi:10.1016/j.jad.2020.11.093.

An Exploratory Brief Head-To-Head Non-Inferiority Comparison

of an Internet-Based and a Telephone-Delivered CBT
Intervention for Adults with Depression
Jennifer Nicholas, PhD1,*, Ashley A. Knapp, PhD1, Jessica L. Vergara1, Andrea K. Graham,
PhD2, Elizabeth L. Gray, MS3, Emily G. Lattie, PhD2, Mary J. Kwasny, ScD3, David C. Mohr,
PhD1
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1Centerfor Behavioral Intervention Technologies, Department of Preventive Medicine,

Northwestern University, Chicago Illinois, USA
2Centerfor Behavioral Intervention Technologies, Department of Medical Social Sciences,
Northwestern University, Chicago Illinois, USA
3Biostatistics
Collaboration Center, Preventive Medicine, Feinberg School of Medicine,
Northwestern University, Chicago Illinois, USA

Abstract
Background: Telephone-administered psychotherapy (tCBT) and internet-based treatments
(iCBT) may overcome barriers to mental health treatment. TCBT has demonstrated efficacy
similar to traditional psychotherapy, however, few studies have compared iCBT to efficacious
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interventions. This exploratory study examined the noninferiority of iCBT relative to tCBT. We
also explored pretreatment moderators of outcome and assessed treatment dropout.

Methods: As a secondary exploratory analysis of a 304-participant randomized noninferiority

trial, we compared iCBT, the first level of a stepped-care intervention, with tCBT on depression
outcome after 5 weeks of treatment (prior to stepping). Multiple linear regression models were fit
to examine moderators of 5-week depression. Differences in dropout were examined using
Kaplan-Meier survival analysis.

Results: After 5 weeks of treatment, both interventions significantly reduced depression severity.
The effect size difference between the two interventions was d=0.004 [90% CI=−0.19 to 0.19]; the
CI did not cross the non-inferiority margin. Pretreatment depression was significantly associated
with depression at week 5. The relationship between cognitive strategy usefulness and depression
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*
Address correspondence to Jennifer Nicholas, PhD, Centre for Youth Mental Health, 35 Poplar Rd, Parkville, 3052,
[email protected].
Author contributions:
DCM, EGL, and MJK conceived of the study. JLV and EGL were involved in data collection. JN, AKG, ELG, DCM and MJK
performed data analysis and interpretation. JN, AAK, JLV, and AKG drafted the manuscript. All authors read, revised, and approved
the final version of the manuscript.
Declarations of interest
None.
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 Nicholas et al. Page 2

at week 5 differed between interventions, controlling for pretreatment depression. There was no
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significant difference in dropout between interventions.

Limitations: Given the stepped-care trial design, iCBT and tCBT could not be compared at the
end of treatment or follow-up. Analyses were exploratory and should be interpreted with caution.

Conclusions: A large sample, powered for noninferiority, found iCBT no less efficacious than
tCBT at reducing depression symptoms after five weeks of treatment.

Keywords
Depression; eHealth; telehealth; iCBT; noninferiority

Introduction
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Despite the existence of effective treatments for depression, as few as 10–40% of individuals
receive timely intervention (Wang et al., 2005). Approximately 70% of individuals interested
in psychological treatment report barriers to care (e.g., high cost, low availability, stigma;
Mohr et al., 2010). Among those who do initiate treatment, only about two-thirds complete
it (Swift and Greenberg, 2012). Given the intractable problems with access to and retention
within traditional, face-to-face, psychotherapy, the last several decades have seen an increase
in remotely-delivered treatments, which can overcome many of these barriers to care. In
particular, two forms of remotely-delivered psychological treatments have been investigated,
telephone-administered cognitive-behavioral therapy (tCBT) and internet-based treatments
(iCBT).

TCBT has shown comparable efficacy to face-to-face psychotherapy and results in lower
dropout rates (Mohr et al., 2012); it is increasingly used in healthcare systems to overcome
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access barriers (Turner et al., 2018). However, because tCBT improves reach and retention,
at a similar cost and demand on clinician time to traditional CBT, it may also increase
treatment delivery costs. ICBT is also efficacious for the treatment of depression (Karyotaki
et al., 2017), resulting in clinically relevent reduction and remission of depresison symptoms
(Karyotaki et al., 2018). There are two types of iCBT. Guided iCBT interventions are
delivered with minimal therapist support, whereas self-guided iCBT interventions are
delivered with no or automated support. While meta-analyses indicate that guided iCBT has
greater efficacy and better retention than self-guided iCBT (Richards and Richardson, 2012),
with retention equivalent to traditional psychotherapy (van Ballegooijen et al., 2014), a more
recent review illuminated that the impact of human support is complex, dependent on factors
such as type and expertise of support, as well as timing and method of support given (Shim
et al., 2017). Retention is an important consideration given that low engagement and high
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dropout are often challenges of remote treatments (Carlbring et al., 2018).

Few studies have compared efficacy and retention of guided iCBT to active
psychotherapeutic interventions among individuals with clinical depression. A small trial by
Andersson and colleagues (2013) found guided iCBT to be noninferior to a face-to-face
group CBT intervention for mild to moderate depression. However, group CBT commonly
yields smaller effect sizes than individual CBT (Cuijpers et al., 2008). In another small trial,

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guided iCBT for depression was noninferior to brief individual face-to-face CBT (Wagner et
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al., 2014). Both trials had small sample sizes, which were underpowered for non-inferiority
analyses.

Given the limited evidence comparing iCBT to active therapies, larger, adequately powered
non-inferiority trials are needed. As the field increasingly looks to remote intervention to
deliver mental healthcare, it is important to understand how iCBT performs compared to
other remote treatments. This study aimed to examine the efficacy of a guided iCBT
intervention relative to remotely-delivered tCBT. Because iCBT was delivered as the first
treatment stage of a progressive stepped-care program (Mohr et al., 2019), this exploratory
analysis examines tCBT and iCBT outcome prior to stepping at 5-weeks; thus, we directly
compared these two interventions. We also sought to explore pretreatment and demographic
moderators of depression outcomes, and determine if there were any differences in treatment
dropout between the two remote interventions.
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Methods
Participants and procedure
This study was an exploratory analysis of a randomized noninferiority trial comparing a
stepped care intervention with tCBT (Mohr et al., 2019). In brief, participants were eligible
if they met criteria for current major depressive episode on the Mini-International
Neuropsychiatric Interview (MINI; Sheehan et al., 1998) and scored ≥12 on the Quick
Inventory of Depressive Symptoms (QIDS; Rush et al., 2003), were over 18 years of age, US
residents, and proficient in English. Participants were excluded if they had visual or hearing
impairments that would prevent participation, a severe psychiatric disorder, initiated or
recently modified antidepressant pharmacotherapy, were receiving psychotherapy, or severe
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suicidality, defined as participants who reported both a plan and intent when assessed using
the Columbia Suicide-Severity Rating Scale (Posner et al., 2011).

Eligible participants were randomized to receive either tCBT or a stepped care intervention
with iCBT as the first stage. This paper compares these two interventions at 5 weeks, prior
to the possibility of stepping. This study was approved by the Northwestern University
Institutional Review Board; all participants provided informed consent.

Treatments
Five PhD-level clinical psychologists (including EGL), two licensed clinical social workers,
and a masters-level therapist delivered both the tCBT therapy and iCBT coaching.
Participants had the same therapist or coach throughout treatment.
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iCBT
Participants received the web-based guided iCBT intervention, ThinkFeelDo (Schueller &
Mohr, 2015; Tomasino et al., 2017). The program teaches CBT skills in 10–15-minute
lessons four times per week via didactic material including text, visualizations and
audiovisual content, supported by interactive tools to enhance skill development.
ThinkFeelDo has a coach interface that displays participant use of and activity in the

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program; a secure messaging platform facilitates participant communication. Coaches sent

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1–2 messages per week and, during the first three weeks, had a 10–15-minute call with
participants that reduced to as-needed based on participants’ needs and preferences (e.g., to
resolve technological issues).

tCBT
Participants received a manualized tCBT program previously shown to be noninferior to
face-to-face CBT (Mohr et al., 2012). Participants spoke to their therapist weekly for 45–50
minutes and received a workbook with explanatory material and CBT worksheets.

Measures
Demographic characteristics collected included age, race, sex, and education level.
Depression severity was collected weekly using the Patient Health Questionnaire (PHQ)-9
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(Kroenke et al., 2001), with questions adjusted to indicate this timeframe. Pretreatment
anxiety severity was measured using the Generalized Anxiety Disorder (GAD)-7 (Spitzer et
al., 2006). The Coping Self-Efficacy Scale (Chesney et al., 2006) and the cognitive and
behavioral subscales of the Cognitive and Behavioral Response to Stress Scale (CB-RSS;
Miner et al., 2015) were administered pretreatment to measure self-efficacy and perceived
usefulness of coping skills respectively. Higher CB-RSS scores indicate greater perceived
usefulness of strategies for coping with depression. Treatment dropout was defined as the
last week the participant interacted with the intervention.

Data analysis
Treatment differences were explored using a noninferiority analysis. The main outcome
analyses indicated a noninferiority criterion of d=0.33 (Mohr et al., 2019), which was also
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applied here. A 1-sided test at a 5% type I error rate (equivalent to testing whether a 2-sided
90% CI for the difference does not contain the noninferiority margin, Walker & Nowacki,
2011) was used to determine whether the difference in treatment groups was less than the
noninferiority margin.

Exploratory multiple linear regression analyses examined all pretreatment variables (e.g.,
age, CB-RSS subscales) as moderators of the relationship between treatment condition and
5-week PHQ-9 symptoms. Differences in dropout between treatment groups were examined
using chi-square and Kaplan-Meier survival analysis. Statistical analyses were performed
using SPSS v25, with α=0.05.

Results
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Participants
Of the 312 randomized participants, 304 provided weekly PHQ-9 data required for the
current analysis (n=153 tCBT, n=151 iCBT). Characteristics of all randomized participants
and study flow have been published (Mohr et al., 2019). The majority of participants in this
sample were female (73.4%), identified as White (88.5%), were college educated (71.1%),
and were 37.6 years on average (SD=14.0). Mean (SD) pretreatment PHQ-9 and GAD-7

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scores were 16.5 (3.8) and 12.2 (4.5), respectively. There was no significant association
between treatment group and loss to follow-up (χ2[1, n=304] =1.92, p=.17).
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Depression outcome
Participants had significant reductions in PHQ-9 score at 5 weeks in both tCBT (Δ=−5.5
[95% CI=−6.4 to −4.6]; p<.001) and iCBT (Δ=−5.5 [95% CI=−6.3 to −4.7], p<.001). A non-
inferiority analysis showed no clinically meaningful difference between the interventions.
The effect size comparing PHQ-9 between groups at week 5 was d=0.004 [90% CI=−0.19 to
0.19].

Pretreatment PHQ-9 was associated with week 5 PHQ-9 (F[1,302] =46.05, p<.001), with an
adjusted R2 of 0.129. Individuals with greater pretreatment depression severity had higher
PHQ-9 scores at week 5, such that a one-point increase on pretreatment PHQ-9 resulted in a
0.49 increase in week 5 PHQ-9. The relationship between the usefulness of cognitive
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strategies, and PHQ-9 at week 5 differed between tCBT and iCBT (p=.023), controlling for
pretreatment PHQ-9. Per one-point change in cognitive strategy usefulness score, estimated
week 5 PHQ-9 changed by −.09 (SE=.05) in tCBT, and .07 (SE=.05) in iCBT. When
controlling for pretreatment PHQ-9, no other pretreatment demographic or clinical variables
were associated with week 5 depression severity (ps>.05).

Treatment preference and dropout

Before randomization, 36.5% of participants said they would prefer to receive tCBT, 27.3%
preferred iCBT, and 36.2% had no preference. Whether participants received their preferred
treatment was not significantly associated with depression outcome at week 5 (p=.12). A
Kaplan-Meier survival analysis with log rank test found no significant difference in rate of
dropout between treatments (p=.114; Figure 1).
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Discussion
This is the first study with a large sample of individuals with depression, sufficiently
powered for noninferiority, to examine the noninferiority of a guided iCBT intervention
compared to another active remote therapeutic intervention (tCBT). ICBT was found to be
no less effective than tCBT in reducing depression symptoms. That is, participants receiving
iCBT had similar, clinically meaningful decreases in depression symptoms at week 5 of
treatment as those receiving tCBT.

The noninferiority of iCBT compared to an active control is in keeping with meta-analytic

evidence that iCBT produces equivalent overall effects compared to traditional treatments
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over a range of mental health conditions (Andersson et al., 2014; Carlbring et al, 2018).
Further, pooled data indicate that guided iCBT produces the same effect as face-to-face
cognitive intervention for depression, social anxiety disorder, panic disorder, and insomnia
(Carlbring et al., 2018). This study adds to this evidence using the largest noninferiority
sample to date.

In support of the utility of guided iCBT, our results indicate that iCBT was as preferred and
attended by participants as tCBT, with no differences in dropout rates. Again, this is

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consistent with existing research suggesting that both guided iCBT and tCBT have similar,
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or lower, dropout rates as face-to-face CBT (Richards and Richardson, 2012; van
Ballegooijen et al., 2014; Mohr et al., 2012). Similarly, Carlbring et al’s (2018) meta-
analysis found no systematic differences in treatment dropout between iCBT and face-to-
face psychotherapy. Critically, our results directly compare the treatment dropout of two
promising types of remotely-delivered psychological interventions, and indicate that while
people may vary in their preferences, outcomes and adherence are similar between iCBT and
tCBT.

Establishing the noninferiority of iCBT compared to another remotely-delivered

intervention, with known efficacy, has potential implications for the mental healthcare
system, which is overstretched and under-resourced. Our findings support the utility of
guided iCBT as an efficacious remote treatment to increase access to mental health services
(Karyotaki et al., 2018). Given the lower clinical contact in guided iCBT compared to tCBT
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whilst supporting similar outcomes, iCBT could be implemented within a stepped-care

framework. Indeed, the primary outcome analysis of this trial (Mohr et al., 2019), in which
iCBT was the first stage of a stepped care intervention, showed that iCBT required half the
therapist time and cost compared to tCBT. However, issues of resource savings and cost-
effectiveness of implementing remote care are not clear cut (Donker et al., 2015; Paganini et
al., 2018), and remote interventions have unfortunately been under researched within
economic evaluations of stepped-care frameworks (Reeves et al., 2019).

Exploratory analyses suggested that greater pretreatment depression severity was associated
with higher week 5 depression severity. Extant research on the relationship between
pretreatment depression severity and outcome in remotely-delivered mental health is
equivocal, however we suggest our results indicate that those with more severe depression
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may require remote intervention for longer than 5 weeks. The finding that no demographic
characteristics were associated with 5-week outcome may speak to the broad utility of
remotely-delivered services for depression, as they performed similarly across a range of
users.

Limitations of the randomized trial merit mention; several of which are reported in detail in
Mohr et al (2019). In brief, participants primarily identified as Caucasian, were generally
well educated, and, due to potential selection biases resulting from research recruitment and
processes, were likely more motivated than would be observed in a real-world setting,
potentially limiting generalizability. Further, given the level of human support, results should
not be generalized to unguided iCBT (Karyotaki et al., 2017). Although fidelity to iCBT was
monitored via supervision, it was not audited quantitatively. Importantly, noninferiority trials
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cannot rule out factors such as placebo effects, natural symptom resolution, or regression to
the mean.

A few additional considerations are warranted that are unique to this exploratory analysis.
First, whilst the remote nature of tCBT likely reduced the dropout rate (Mohr et al., 2012),
eliminating potentially confounding effects of dropout on outcomes, it may also impact the
generalizability of our results to face-to-face interventions. However, results are consistent

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with, and extend, the findings of previous noninferiority trials of iCBT and face-to-face
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interventions (Andersson et al., 2013; Wagner et al., 2014).

Second, due to the secondary nature of the study, the outcome was measured at the fifth
week of treatment (prior to the pre-specified possibility of “stepping up” in the iCBT
condition); thus, these results cannot speak to the effects of guided iCBT on depression
symptoms at the end of treatment or over longer treatment or follow-up periods. As such, we
are unable to identify any bias towards efficacy that could be occurring within the short
assessment window. Therefore, given the exploratory nature of this analysis, it is critical that
future work determine the noninferiority of guided iCBT interventions compared to
evidence-based remote interventions, based on long-term depression outcomes. Longer-term
studies would also shed light on whether the significant interaction of cognitive strategy
usefulness and intervention is clinically meaningful after individuals complete the brief
intervention and practice skills in daily life.
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Third, due to the short duration, results cannot speak to whether preference for iCBT or
tCBT changed at 5 weeks as a result of participants’ experience with the interventions.
Further, participant expectations likely differ between a 5-week iCBT intervention and a 20-
week stepped care intervention which forecasts ‘stepping up’ if the initial treatment does not
successfully reduce symptoms.

Finally, moderator analyses were exploratory, and results should be interpreted with caution
until reproduced.

In a large sample, we found iCBT to be noninferior to tCBT in reducing depression

symptoms after five weeks of treatment. These findings suggest that both iCBT and tCBT
may be viable treatment options that could help address the common challenge of mental
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health service availability and reach.

Acknowledgments
Funding:

This work was supported by grants from the National Institutes of Health (R01 MH095753, T32 MH115882, K08
MH112878, and K01 DK116925).

The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the
manuscript.

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Highlights
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• ICBT was noninferior to tCBT in reducing depression after 5 weeks of

treatment

• There were no differences in dropout rates between iCBT and tCBT

• Severe baseline depression was associated with higher week 5 symptom

severity
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Figure 1.
Survival function of time to treatment dropout between iCBT and tCBT over 5 weeks.
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