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. Author manuscript; available in PMC: 2024 May 1.
Published in final edited form as: J Consult Clin Psychol. 2023 Jan 12;91(5):280–284. doi: 10.1037/ccp0000786

Moderators and mediators of a digital cognitive behavior therapy-guided self-help intervention for eating disorders: Informing future design efforts

Andrea K Graham 1,*, Ellen E Fitzsimmons-Craft 2, Shiri Sadeh-Sharvit 3, Katherine N Balantekin 4, Dawn M Eichen 5, Marie-Laure Firebaugh 2, Neha J Goel 6, Grace E Monterubio 2, Anna M Karam 2, Rachael E Flatt 7, Booil Jo 8, Corinna Jacobi 9, Denise E Wilfley 2, C Barr Taylor 3,9, Mickey Trockel 8
PMCID: PMC10198808  NIHMSID: NIHMS1864934  PMID: 36634022

Abstract

Objective:

The Student Bodies–Eating Disorders intervention (SB-ED), a digital cognitive behavior therapy-guided self-help intervention for college women with an eating disorder, is effective for reducing eating disorder psychopathology. The purpose of this study was to evaluate moderators and mediators of the SB-ED intervention. To our knowledge, this is the first evaluation of clinical mediators of a digital intervention for women with eating disorders.

Method:

This is an exploratory secondary analysis of a cluster randomized trial comparing the SB-ED intervention to referral to usual care among 690 women at 27 U.S. colleges. Moderators included body mass index (BMI), race, ethnicity, weight/shape concerns, eating disorder impairment, thin ideal internalization, depression, anxiety, and motivation for treatment, assessed at baseline. Thin ideal internalization and depressive symptoms were tested as predictors at post-intervention and mediators at 2-year follow-up. Outcome was change in global eating disorder psychopathology.

Results:

BMI moderated the effect of the intervention at follow-up (but not post-treatment), with individuals with a lower BMI experiencing more continued improvements in eating disorder psychopathology following the intervention than individuals with a higher BMI. Thin ideal internalization mediated the effect of the intervention at follow-up, and depression partially mediated the effect of the intervention at follow-up.

Conclusions:

Results of the mediator analyses suggest that helping college women reduce inflated internalization of the thin ideal and improve depressive symptoms leads to improvements in eating disorder psychopathology. Results also suggest opportunities to optimize the intervention so individuals across the BMI spectrum experience ongoing improvements over time.

Keywords: eating disorders, moderators, mediators, guided self-help, digital mental health intervention

Introduction

Eating disorders (EDs) are serious and impairing mental health problems (American Psychiatric Association, 2013; Association, 2006). College students are at elevated risk for EDs and face a treatment gap between those who need and who receive care (Eisenberg et al., 2011; Kazdin et al., 2017). To address this gap, scalable interventions are needed. Student Bodies–Eating Disorders (SB-ED) is a digital cognitive behavior therapy-guided self-help intervention for college women with an ED (Fitzsimmons-Craft et al., 2020). In a cluster randomized clinical trial, SB-ED yielded greater reductions in ED psychopathology at post-treatment and over two-year follow-up compared to referral to usual care among women at 27 U.S. universities who screened positive for an ED (excluding anorexia nervosa) (Fitzsimmons-Craft et al., 2020).

The impetus for developing SB-ED was to ensure all college students in need of mental health services for EDs can receive accessible, affordable, evidence-based care (Wilfley et al., 2013). To best achieve this goal, it is necessary to identify possible subpopulations of users for whom SB-ED had a differential effect in improving outcomes. We evaluated moderators of SB-ED comprised of individual characteristics and baseline psychopathology variables that might theoretically affect outcomes, in line with past research (e.g., Taylor et al., 2016). An analysis of intervention moderators is important for informing where to direct future design efforts to ensure SB-ED meets the unique needs of and can be individually tailored for subpopulations of users.

Additionally, testing mediators of the intervention helps us understand mechanisms of change (Domhardt et al., 2020). SB-ED, based on cognitive behavior therapy for EDs (Fairburn, 2008), includes intervention targets to reduce users’ thin ideal internalization and improve depressive symptoms, given that we and others have shown these constructs are associated with ED psychopathology among young women (e.g., Flatt et al., 2021; Jacobi et al., 2011; Stice et al., 2017; Stice et al., 2011). We thus assessed these constructs over the intervention period so we could test our hypothesis that changes in these constructs would mediate the effect of the intervention on changes in overall ED psychopathology.

Thus, this paper explores moderators and mediators of the SB-ED intervention on the primary outcome of change in ED psychopathology. To our knowledge, no published studies have evaluated clinical mediators of a digital intervention for women with EDs.

Methods

This is an exploratory, secondary analysis of a cluster randomized clinical trial (see Fitzsimmons-Craft et al., 2020; ClinicalTrials.gov Identifier: NCT02076464).

Participants & Procedure

In brief, 27 U.S. colleges were enrolled in this study and randomized to one of two experimental conditions. Across all universities, students were first invited to complete an online screen (Fitzsimmons-Craft et al., 2019; Graham et al., 2019). Individuals who screened positive for a subclinical/clinical ED (excluding anorexia nervosa, for whom more intensive intervention was indicated) were invited to enroll in the trial. In total, 690 college women with EDs enrolled and were randomized at the university level. At universities in the intervention condition, participants were invited to complete SB-ED. At universities in the control condition, participants received a referral to usual care. Participants completed assessments at baseline, post-intervention (i.e., 8 months after baseline), and 1- and 2-year follow-up. All participants provided online informed consent. The study was approved by the Institutional Review Board (IRB) at individual participating universities or deferred to the IRB of record at Washington University in St. Louis. A Data Safety Monitoring Board provided study oversight.

Measures

We examined nine baseline measures as potential treatment effect moderators. Body mass index (BMI, kg/m2) was assessed based on participants’ self-reported height and weight. Race and ethnicity (i.e., identifying as Hispanic/Latina) were collected via self-report. Weight and shape concerns were measured using the 5-item Weight Concerns Scale (Killen et al., 1994). ED impairment was measured using the 16-item Clinical Impairment Assessment (Bohn & Fairburn, 2008). Thin ideal internalization was measured using the Perceived Benefits of Thinness Scale (PBTS; Flatt et al., 2021). Depression was assessed using the Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001). Anxiety was assessed using the Patient-Reported Outcomes Measurement Information System anxiety short-form version 1.0 questionnaire (Pilkonis et al., 2011). Motivation for treatment was assessed using a single item (“How motivated are you to work on any issues you might have related to eating, weight, or body shape?”) with 5-point scale response options ranging from “not at all” to “very much”, with higher scores indicating greater motivation. For mediators, we examined the changes in thin ideal internalization (PBTS) and depressive symptoms (PHQ-9) from baseline to post-treatment as potential treatment effect mediators on the change in the outcome from baseline to follow-up. We also assessed the changes in these measures from baseline to post-treatment as potential predictors of change in the outcome from baseline to post-treatment. Consistent with the primary outcome analysis on which the trial was adequately powered, the outcome measure in this study was ED psychopathology measured by the Eating Disorder Examination Questionnaire (EDE-Q) global score (Fairburn & Beglin, 2008) at post-treatment and follow-up.

Analyses

Analyses were conducted using HLM7 software version 2013 (Scientific Software International, Inc). How the sample size was determined, as well as how to access data and study materials, is detailed in Fitzsimmons-Craft et al. (2020). The trial was powered to detect an effect in the primary outcome. Consistent with the primary outcome analysis in the parent trial, the year 1 and year 2 follow-up assessments were combined and labeled as “follow-up” (Fitzsimmons-Craft et al., 2020). Moderator and mediator analyses followed recommendations of Kraemer and colleagues (2002). Moderators were specified a priori, and we evaluated the interaction between the moderator and intervention condition at post-intervention and follow-up, with EDE-Q global score as the dependent variable. Mediators were specified a priori and included variables measured in both conditions (Kraemer et al., 2002). Effect of intervention on both hypothesized mediators by post-intervention was demonstrated previously (Fitzsimmons-Craft et al., 2020). Changes in mediators were evaluated at post-intervention for their impact on EDE-Q global scores at follow-up (Kraemer et al., 2002), and as predictors at post-intervention. Significance thresholds were based on statistical (p < 0.05) and substantive (effect size, > 0.2 standard deviation difference in the outcome variable) significance. Data were analyzed with mixed effects models in line with the intention to treat principle, including everyone in the analyses as long as they completed at least one assessment (78% intervention condition, 89% control condition; Fitzsimmons-Craft et al., 2020). In moderator analyses involving categorical baseline variables, dummy variable coding was used to model “missing” or “other” categories.

Results

The 690 participants had a mean (SD) BMI of 25.69 (6.02) kg/m2. Participants identified as White (60.0%), Asian or South Asian (17.1%), Black or African American (5.4%), Native Hawaiian or Pacific Islander (0.1%), American Indian or Alaskan Native (0.4%), multiracial (7.7%), and other races (6.7%); 120 (17.4%) identified as Hispanic.

Moderator Analyses

Results of the moderator analyses are in Table 1. There was no effect of baseline BMI at post-treatment (β = 0.09, SE = 0.09, p = 0.33), but BMI significantly moderated the effect of the intervention at follow-up (β = 0.24, SE = 0.06, p < 0.001). Individuals with a lower BMI had more continued improvements in global ED psychopathology following the intervention than individuals with a higher BMI. Race also emerged as a moderator at follow-up, but not post-treatment, based on effect size but not statistical significance. Individuals who identified as Black experienced less improvement in ED psychopathology at follow-up compared to individuals who identified as White (β = 0.72, SE = 0.38, p = 0.06). By contrast, individuals who identified as Asian experienced slightly greater improvement in ED psychopathology at follow- up compared to individuals who identified as White (β = −0.42, SE = 0.24, p = 0.07). Because the moderating effect of race may be better explained by individuals’ BMI (as BMI has been shown to differ by racial group, Flegal et al., 2016), we conducted a subsequent analysis evaluating race as a moderator controlling for BMI. Results of this analysis showed that the moderating effects of race were explained by BMI. Specifically, the moderating effects of identifying as Black or as Asian compared to White were no longer significant, whereas the moderating effect of BMI remained significant at follow-up (β = 0.19, SE = 0.09, p = 0.03). Baseline weight and shape concerns, ethnicity, perceived benefits of thinness, clinical impairment, depression, anxiety, and motivation for treatment were not found to be significant moderators of the intervention effects.

Table 1.

Results of moderator analyses evaluating the interaction between the moderator and intervention condition at post-intervention and follow-up.

Moderator Time Point Coefficient (SE) p-value
Body Mass Index (standardized) Post 0.090 (0.091) 0.325
Follow-up 0.237 (0.064) <0.001*
Race‡
 Black Post −0.371 (0.452) 0.412
Follow-up 0.717 (0.384) 0.062
 Asian Post −0.164 (0.277) 0.555
Follow-up −0.425 (0.236) 0.072
 Other Post 0.341 (0.468) 0.467
Follow-up −0.105 (0.373) 0.779
 Prefer not to answer Post 0.105 (0.629) 0.867
Follow-up −0.007 (0.524) 0.989
Ethnicity Post 0.102 (0.267) 0.703
Follow-up 0.068 (0.282) 0.811
Weight/Shape Concerns (WCS) Post −0.044 (0.093) 0.637
Follow-up −0.024 (0.102) 0.816
Thin Ideal Internalization (PBTS) Post −0.090 (0.134) 0.501
Follow-up 0.053 (0.124) 0.672
Clinical Impairment (CIA) Post −0.008 (0.009) 0.401
Follow-up −0.001 (0.009) 0.944
Depression (PHQ-9) Post −0.005 (0.018) 0.788
Follow-up 0.004 (0.017) 0.806
Anxiety (PROMIS) Post −0.038 (0.026) 0.152
Follow-up −0.005 (0.027) 0.842
Motivation Post −0.076 (0.101) 0.457
Follow-up 0.051 (0.122) 0.675
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Notes:

*

p < 0.05.

‡

White individuals were the referent groups.

Abbreviations: WCS = Weight Concerns Scale; PTBS = Perceptions of the Benefits of Thinness Scale; CIA = Clinical Impairment Assessment; PHQ-9 = Patient Health Quesionnaire-9; PROMIS = Patient-Reported Outcomes Measurement Information System anxiety short-form version 1.0 questionnaire.

Mediator Analyses

Change in thin ideal internalization at post-treatment partially predicted the effect of the intervention at post-treatment (β = 0.64, SE = 0.05, p < 0.001), as the direct effect of the intervention on outcomes remained significant (β = −0.24, SE = 0.09, p = 0.01). At follow-up, change in thin ideal internalization at post-treatment fully mediated the effect of the intervention (β = 0.45, SE = 0.05, p < 0.001), as consistent with Baron and Kenny, the direct effect of the intervention on outcomes was small and no longer significant with the mediator added (β = −0.17, SE = 0.12, p = 0.18). This suggests thin ideal internalization was a full mediator, and reducing this construct is a mechanism of change. Change in depression at post-treatment was a partial predictor of the effect of the intervention at post-treatment (β = 0.08, SE = 0.007, p < 0.001) and partial mediator at follow-up (β = 0.07, SE = 0.009, p < 0.001), as the direct effect of the intervention on outcomes remained significant (post-treatment: β = −0.33, SE = 0.08, p < 0.001; follow-up: β = −0.27, SE = 0.10, p = 0.007).

Discussion

In this study, BMI was a moderator of the evidence-based SB-ED intervention at follow-up, including accounting for the potential moderating impact of race. Further, in this first study of clinical mediators of a digital ED intervention, thin ideal internationalization fully mediated, and depressive symptoms partially mediated, the intervention effect at follow-up. This suggests the SB-ED ingredients are well chosen and targeted, supporting our theory of mechanism.

The finding that BMI moderated the effect of the intervention at follow-up suggests an opportunity to improve the digital SB-ED intervention for individuals with higher BMIs to help them experience continued improvements over time. In our study, all individuals on average had reductions in ED psychopathology over the intervention, but those with lower BMIs experienced more continued improvement following the intervention than those with higher BMIs. While face-to-face CBT for EDs has demonstrated efficacy for improving ED psychopathology among individuals with higher BMIs (e.g., Wilfley et al., 2002) and our SB preventive intervention prevented ED onset in college women with higher BMIs (Taylor et al., 2006), more work is needed to ensure SB-ED elicits ongoing improvements in ED psychopathology over time among individuals across the BMI spectrum. For example, because individuals with higher BMIs may experience real and perceived pressures to lose weight and achieve thinness (Hart et al., 2021), it may be more challenging for this subpopulation to experience continued improvements, such as in thin ideal internalization, after the intervention. A longer intervention dose may be beneficial. Yet because our analyses do not address why this finding emerged, design work to understand the long-term needs and goals of individuals with higher BMIs who engage in a digital ED intervention may inform areas for SB-ED optimization for this subgroup.

Our findings on intervention mediators supported our hypothesis that targeting perceived benefits of thinness, a construct of the well-established ED risk factor thin ideal internalization (Stice et al., 2017), and depressive symptoms in treatment is important for improving clinical outcomes in this population. For example, depression can lead to and maintain EDs, such that addressing depressive symptoms can be a pathway for reducing ED psychopathology; further, some strategies for addressing depressive symptoms (e.g., engaging in positive activities) can be useful strategies in themselves for addressing ED behaviors and cognitions. Therefore, these findings suggest that focusing on these two transdiagnostic constructs as target mechanisms in ED interventions may be useful, in addition to focusing on established mediators of CBT for EDs like dietary restraint (Wilson et al., 2002) and early symptom change (Linardon et al., 2017).

Study limitations should be noted. This was an exploratory secondary analysis; the trial was not formally powered to detect mediation effects. We also may have been underpowered to detect moderation effects by race, as only 5% of students identified as Black/African American. Mediation analyses were based on two theorized constructs that are targets of SB-ED; additional mediators may be important to target and evaluate. Finally, we intentionally randomized at the university level; moderation/mediation results could differ for individual-level randomization.

In conclusion, this study informs our understanding of who might benefit most from a guided digital cognitive behavior therapy intervention for EDs. Results indicate a design opportunity to make the intervention more potent for women across the weight spectrum to having ongoing changes in ED psychopathology. Mediation results also indicate that reducing women’s thin ideal internalization and decreasing depressive symptoms are intervention mechanisms that lead to improvements in ED psychopathology.

Public Health Significance.

The digital guided self-help Student Bodies-Eating Disorders intervention reduces women’s thin ideal internalization and depressive symptoms, which in turn leads to improvements in eating disorder psychopathology. Women with higher BMIs experienced less continued improvement following the intervention, indicating future directions for intervention optimization.

Funding/Support:

This work was supported by grants from the National Institutes of Health (R01 MH100455, K01 DK116925, T32 HL007456, T32 HL130357, K08 MH120341, K23 DK114480, K01 DK120778, F31 MD015679). Additionally, REF is supported by the National Science Foundation Graduate Research Fellowship Program under Grant No. (DGE-1650116). Any opinions, findings, and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the National Science Foundation.

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