The Generalizability of Randomized Controlled Trials of Self-Guided Internet-Based Cognitive Behavioral Therapy for Depressive Symptoms: Systematic Review and Meta-Regression Analysis

Abstract

BackgroundSelf-guided internet-based cognitive behavioral therapies (iCBTs) for depressive symptoms may substantially increase accessibility to mental health treatment. Despite this, questions remain as to the generalizability of the research on self-guided iCBT.ObjectiveWe sought to describe the clinical entry criteria used in studies of self-guided iCBT, explore the criteria’s effects on study outcomes, and compare the frequency of use of these criteria with their use in studies of face-to-face psychotherapy and antidepressant medications. We hypothesized that self-guided iCBT studies would use more stringent criteria that would bias the sample toward those with a less complex clinical profile, thus inflating treatment outcomes.MethodsWe updated a recently published meta-analysis by conducting a systematic literature search in PubMed, MEDLINE, PsycINFO, and EMBASE. We conducted a meta-regression analysis to test the effect of the different commonly used psychiatric entry criteria on the treatment-control differences. We also compared the frequency with which exclusion criteria were used in the self-guided iCBT studies versus studies of face-to-face psychotherapy and antidepressants from a recently published review.ResultsOur search yielded 5 additional studies, which we added to the 16 studies identified by Karyotaki and colleagues in 2017. Few self-guided iCBT studies excluded patients with severe depressive symptoms (6/21, 29%), but self-guided iCBT studies were more likely than antidepressant (14/170, 8.2%) studies to use this criterion. However, self-guided iCBT studies did not use this criterion more frequently than face-to-face psychotherapy studies (6/16, 38%). Beyond this, we found no evidence that self-guided iCBTs used more stringent entry criteria. Strong evidence suggested that they were actually less likely to use most entry criteria, especially exclusions on the basis of substance use or personality pathology. None of the entry criteria used had an effect on outcomes.ConclusionsA conservative interpretation of our findings is that the patient population sampled in the literature on self-guided iCBT is relatively comparable with that of studies of antidepressants or face-to-face psychotherapy. Alternatively, studies of unguided cognitive behavioral therapy may sample from a more heterogeneous and representative patient population. Until evidence emerges to suggest otherwise, the patient population sampled in self-guided iCBT studies cannot be considered as less complex than the patient population from face-to-face psychotherapy or antidepressant studies.

Recruiting to a Randomized Controlled Trial of a Web-Based Program for People With Type 2 Diabetes and Depression: Lessons Learned at the Intersection of e-Mental Health and Primary Care

“…The individuals who enrolled in SpringboarD and are reported here represent less than 1% of people who were potentially exposed to one or more invitations or advertisements. Our findings support those of previous authors, who reported similar biases in both online and offline recruitment methods [36], and similar characteristics of participants who enroll in trials of eMH and traditional psychological and pharmacological treatments [45]. In other words, people who take part in mental health research differ from people who do not, regardless of the recruitment approach or intervention being tested.…”

Twelve-Month Follow-Up to a Fully Automated Internet-Based Cognitive Behavior Therapy Intervention for Rural Adults With Depression Symptoms: Single-Arm Longitudinal Study

“…A growing number of studies report evidence of equivalent effectiveness of iCBT compared with clinician-delivered CBT [ 7 ]. Lorenzo-Luaces and colleagues’ [ 34 ] meta-analysis concluded comparable effectiveness of self-guided iCBT with that of antidepressants and in-person psychotherapy. In our trial, Thrive’s 8-week RCT between group (intervention vs control) effect size of 0.63 compared well with “mostly 8-week clinical trials of antidepressants for adults with unipolar major depression” between group (antidepressant vs placebo) effect sizes of 0.27 (Hamilton Depression Rating Scale) and 0.30 (Montgomery-Asberg Depression Rating Scale) in 109 antidepressant medication RCTs [ 35 ].…”

Use of a Fully Automated Internet-Based Cognitive Behavior Therapy Intervention in a Community Population of Adults With Depression Symptoms: Randomized Controlled Trial

“…Additionally, a recent meta-analysis showed comparable effectiveness of iCBT interventions for reducing depression and anxiety symptoms among urban and rural populations outside the United States [19]. These results, combined with increasing broadband access in US rural communities [20], suggest that effective iCBT interventions have the potential for widespread public health impact by expanding the availability of low-cost, effective depression treatments [21,22] and providing an attractive alternative or complementary delivery strategy for populations that face the aforementioned barriers. However, no randomized controlled trials (RCTs) of iCBT interventions for depression have been conducted among US adult rural residents [21,22].…”

“…Although, in theory, the use of iCBT interventions to treat depression symptoms in US regions lacking sufficient mental health care services is an attractive treatment strategy, determining which iCBT intervention might be most effective is complicated by the considerable differences that exist in iCBT program design (eg, static text and pictures vs video-centric formats), support (fully automated to extensive human supports), adherence, and demonstrated effectiveness for treating depression symptoms in adults with a range of symptom severities (mild to severe) and diagnoses (none, major depressive disorder, unipolar affective disorder, or dysthymia) [10,21,22]. Additionally, participant engagement has been a significant challenge for some depression iCBT interventions.…”