Colleen Stiles-Shields

Trials of Intervention Principles: Evaluation Methods for Evolving Behavioral Intervention Technologies

In recent years, there has been increasing discussion of the limitations of traditional randomized controlled trial (RCT) methodologies for the evaluation of eHealth and mHealth interventions, and in particular, the requirement that these interventions be locked down during evaluation. Locking down these interventions locks in defects and eliminates the opportunities for quality improvement and adaptation to the changing technological environment, often leading to validation of tools that are outdated by the time that trial results are published. Furthermore, because behavioral intervention technologies change frequently during real-world deployment, even if a tested intervention were deployed in the real world, its shelf life would be limited. We argue that RCTs will have greater scientific and public health value if they focus on the evaluation of intervention principles (rather than a specific locked-down version of the intervention), allowing for ongoing quality improvement modifications to the behavioral intervention technology based on the core intervention principles, while continuously improving the functionality and maintaining technological currency. This paper is an initial proposal of a framework and methodology for the conduct of trials of intervention principles (TIPs) aimed at minimizing the risks of in-trial changes to intervention technologies and maximizing the potential for knowledge acquisition. The focus on evaluation of intervention principles using clinical and usage outcomes has the potential to provide more generalizable and durable information than trials focused on a single intervention technology.

IntelliCare: An Eclectic, Skills-Based App Suite for the Treatment of Depression and Anxiety

Background Digital mental health tools have tended to use psychoeducational strategies based on treatment orientations developed and validated outside of digital health. These features do not map well to the brief but frequent ways that people use mobile phones and mobile phone apps today. To address these challenges, we developed a suite of apps for depression and anxiety called IntelliCare, each developed with a focused goal and interactional style. IntelliCare apps prioritize interactive skills training over education and are designed for frequent but short interactions. Objective The overall objective of this study was to pilot a coach-assisted version of IntelliCare and evaluate its use and efficacy at reducing symptoms of depression and anxiety. Methods Participants, recruited through a health care system, Web-based and community advertising, and clinical research registries, were included in this single-arm trial if they had elevated symptoms of depression or anxiety. Participants had access to the 14 IntelliCare apps from Google Play and received 8 weeks of coaching on the use of IntelliCare. Coaching included an initial phone call plus 2 or more texts per week over the 8 weeks, with some participants receiving an additional brief phone call. Primary outcomes included the Patient Health Questionnaire-9 (PHQ-9) for depression and the Generalized Anxiety Disorder-7 (GAD-7) for anxiety. Participants were compensated up to US

A Review of Family-Based Treatment for Adolescents with Eating Disorders

90 for completing all assessments; compensation was not for app use or treatment engagement. Results Of the 99 participants who initiated treatment, 90.1% (90/99) completed 8 weeks. Participants showed substantial reductions in the PHQ-9 and GAD-7 (P<.001). Participants used the apps an average of 195.4 (SD 141) times over the 8 weeks. The average length of use was 1.1 (SD 2.1) minutes, and 95% of participants downloaded 5 or more of the IntelliCare apps. Conclusions This study supports the IntelliCare framework of providing a suite of skills-focused apps that can be used frequently and briefly to reduce symptoms of depression and anxiety. The IntelliCare system is elemental, allowing individual apps to be used or not used based on their effectiveness and utility, and it is eclectic, viewing treatment strategies as elements that can be applied as needed rather than adhering to a singular, overarching, theoretical model. Trial Registration Clinicaltrials.gov NCT02176226; http://clinicaltrials.gov/ct2/show/NCT02176226 (Archived by WebCite at http://www.webcitation/6mQZuBGk1)

Therapeutic alliance in face-to-face and telephone-administered cognitive behavioral therapy

This review focuses on the use of family-based treatment (FBT) for adolescents with eating disorders, including anorexia nervosa (AN) and bulimia nervosa (BN). AN and BN are serious disorders with significant psychiatric and medical morbidity. Data support the use of family treatments for adolescents with eating disorders. Developed at the Maudsley Hospital, FBT is a theoretically agnostic approach that externalizes the illness from the patient and empowers families to actively work to bring about recovery in their relative with an eating disorder. FBT appears to be an effective treatment for adolescents with AN and support is developing for the treatment of adolescents with BN. Manual development is currently underway for the implementation of FBT for young adults with eating disorders, overweight adolescents, and those with subsyndromal AN. Further research is needed to determine the effectiveness of FBT with other populations. In this review, we will provide a critical overview of the literature by focusing upon empirical findings regarding FBT, with particular emphasis on studies conducted with adolescents.

Therapeutic alliance in two treatments for adults with severe and enduring anorexia nervosa.

OBJECTIVE Telephone-administered therapies have emerged as an alternative method of delivery for the treatment of depression, yet concerns persist that the use of the telephone may have a deleterious effect on therapeutic alliance. The purpose of this study was to compare therapeutic alliance in clients receiving cognitive behavioral therapy (CBT) for depression by telephone (T-CBT) or face-to-face (FtF-CBT). METHOD We randomized 325 participants to receive 18 sessions of T-CBT or FtF-CBT. The Working Alliance Inventory (WAI) was administered at Weeks 4 and 14. Depression was measured during treatment and over 1 year posttreatment follow-up using the Hamilton Rating Scale for Depression and Patient Health Questionnaire-9. RESULTS There were no significant differences in client or therapist WAI between T-CBT or FtF-CBT (Cohens f² ranged from 0 to .013, all ps > .05). All WAI scores predicted depression end of treatment outcomes (Cohens f² ranged from .009 to .06, all ps < .02). The relationship between the WAI and depression outcomes did not vary by treatment group (Cohens f² ranged from 0 to .004, ps > .07). The WAI did not significantly predict depression during posttreatment follow-up (all ps > .12). CONCLUSIONS Results from this analysis do not support the hypothesis that the use of the telephone to provide CBT reduces therapeutic alliance relative to FtF-CBT.

Uptake and Usage of IntelliCare: A Publicly Available Suite of Mental Health and Well-Being Apps.

OBJECTIVE The aim of this study was to investigate the strength and role of therapeutic alliance in a trial comparing Cognitive Behavioral Therapy for anorexia nervosa (CBT-AN) and Specialist Supportive Clinical Management for the treatment of severe and enduring AN (SE-AN). METHOD Participants were 63 adult females with SE-AN presenting to an outpatient, multisite randomized controlled trial conducted at two clinical sites. Participants completed measures assessing their perception of the quality of the therapeutic relationship, eating disorder (ED) symptomatology, and depressive symptomatology. RESULTS Beyond the effect of early treatment change and treatment assignment, early therapeutic alliance was a significant predictor of Restraint and Shape Concern at follow-up (ps < .02). Late therapeutic alliance was a significant predictor of weight change, depressive symptomatology, and ED symptomatology at end of treatment and follow-up (ps < .008), with the exception of Shape Concern at follow-up (p = .07). DISCUSSION The results suggest that therapeutic alliance can be effectively established in the treatment of SE-AN and may be relevant for treatment response, particularly in late treatment, on some aspects of ED and depressive symptomatology.

A meta‐analysis of the relation between therapeutic alliance and treatment outcome in eating disorders

Background Treatments for depression and anxiety have several behavioral and psychological targets and rely on varied strategies. Digital mental health treatments often employ feature-rich approaches addressing several targets and strategies. These treatments, often optimized for desktop computer use, are at odds with the ways people use smartphone applications. Smartphone use tends to focus on singular functions with easy navigation to desired tools. The IntelliCare suite of apps was developed to address the discrepancy between need for diverse behavioral strategies and constraints imposed by typical app use. Each app focuses on one strategy for a limited subset of clinical aims all pertinent to depression and anxiety. This study presents the uptake and usage of apps from the IntelliCare suite following an open deployment on a large app marketplace. Methods Thirteen lightweight apps, including 12 interactive apps and one Hub app that coordinates use across those interactive apps, were developed and made free to download on the Google Play store. De-identified app usage data from the first year of IntelliCare suite deployment were analyzed for this study. Results In the first year of public availability, 5210 individuals downloaded one or more of the IntelliCare apps, for a total of 10,131 downloads. Nearly a third of these individuals (31.8%) downloaded more than one of these apps. The modal number of launches for each of the apps was 1, however the mean number of app launches per app ranged from 3.10 to 16.98, reflecting considerable variability in the use of each app. Conclusions The use rate of the IntelliCare suite of apps is higher than public deployments of other comparable digital resources. Our findings suggest that people will use multiple apps and provides support for the concept of app suites as a useful strategy for providing diverse behavioral strategies.

Same-Sex Domestic Violence: Prevalence, Unique Aspects, and Clinical Implications.

The therapeutic alliance has demonstrated an association with favorable psychotherapeutic outcomes in the treatment of eating disorders (EDs). However, questions remain about the inter-relationships between early alliance, early symptom improvement, and treatment outcome. We conducted a meta-analysis on the relations among these constructs, and possible moderators of these relations, in psychosocial treatments for EDs. Twenty studies met inclusion criteria and supplied sufficient supplementary data. Results revealed small-to-moderate effect sizes, βs = 0.13 to 0.22 (p < .05), indicating that early symptom improvement was related to subsequent alliance quality and that alliance ratings also were related to subsequent symptom reduction. The relationship between early alliance and treatment outcome was partially accounted for by early symptom improvement. With regard to moderators, early alliance showed weaker associations with outcome in therapies with a strong behavioral component relative to nonbehavioral therapies. However, alliance showed stronger relations to outcome for younger (vs. older) patients, over and above the variance shared with early symptom improvement. In sum, early symptom reduction enhances therapeutic alliance and treatment outcome in EDs, but early alliance may require specific attention for younger patients and for those receiving nonbehaviorally oriented treatments.

Median arcuate ligament syndrome in the pediatric population

Domestic violence is a significant public health issue. Prevalence rates for same-sex domestic violence vary because of methodological issues related to recruitment and definitions of sexual orientation. However, such prevalence rates are currently considered to be similar to slightly greater than other-sex prevalence rates. Research has identified differences between same-sex domestic violence and other-sex domestic violence, including internalized and externalized stressors associated with being a sexual minority that interact with domestic violence to create or exacerbate vulnerabilities, higher risk for complex trauma experiences, and difficulties accessing services. This review provides a critical review of the literature, focusing upon empirical findings regarding same-sex domestic violence.

The effect of driven exercise on treatment outcomes for adolescents with anorexia and bulimia nervosa.

OBJECTIVES Median arcuate ligament syndrome (MALS) is a vascular compression syndrome with symptoms that overlap chronic functional abdominal pain (CFAP). We report our experience treating MALS in a pediatric cohort previously diagnosed with CFAP. PATIENTS AND METHODS We prospectively evaluated 46 pediatric (<21years of age) patients diagnosed with MALS at a tertiary care referral center from 2008 to 2012. All patients had previously been diagnosed with CFAP. Patients were evaluated for celiac artery compression by duplex ultrasound and diagnosis was confirmed by computed tomography. Quality of life (QOL) was determined by pre- and postsurgical administration of PedsQL™ questionnaire. The patients underwent laparoscopic release of the median arcuate ligament overlying the celiac artery which included surgical neurolysis. We examined the hemodynamic changes in parameters of the celiac artery and perioperative QOL outcomes to determine correlation. RESULTS All patients had studies suggestive of MALS on duplex and computed tomography; 91% (n=42) positive for MALS were females. All patients underwent a technically satisfactory laparoscopic surgical release resulting in a significant improvement in blood flow through the celiac artery. There were no deaths and a total of 9 complications, 8 requiring a secondary procedure; 33 patients were administered QOL surveys. 18 patients completed the survey with 15 (83%) patients reporting overall improvement in the QOL. Overall, 31/46 patients (67%) reported improvement of symptoms since the time of surgery. CONCLUSIONS MALS was found to be more common in pediatric females than males. Laparoscopic release of the celiac artery can be performed safely in the pediatric population. Surgical release of the artery and resultant neurolysis resulted in significant improvement in the blood flow, symptoms, and overall QOL in this cohort. The overall improvement in QOL outcome measures after surgery leads us to conclude that MALS might be earlier diagnosed and possibly treated in patients with CFAP. We recommend a multidisciplinary team approach to care for these complex patients.