THE DEPRESSION INVENTORY DEVELOPMENT SCALE: Assessment of Psychometric Properties Using Classical and Modern Measurement Theory in a CAN-BIND Trial.

Objective: The goal of the Depression Inventory Development (DID) project is to develop a comprehensive and psychometrically sound rating scale for major depressive disorder (MDD) that reflects current diagnostic criteria and conceptualizations of depression. We report here the evaluation of the current DID item bank using Classical Test Theory (CTT), Item Response Theory (IRT) and Rasch Measurement Theory (RMT). Methods: The present study was part of a larger multisite, open-label study conducted by the Canadian Biomarker Integration Network in Depression (ClinicalTrials.gov: NCT01655706). Trained raters administered the 32 DID items at each of two visits (MDD: baseline, n=211 and Week 8, n=177; healthy participants: baseline, n=112 and Week 8, n=104). The DID's "grid" structure operationalizes intensity and frequency of each item, with clear symptom definitions and a structured interview guide, with the current iteration assessing symptoms related to anhedonia, cognition, fatigue, general malaise, motivation, anxiety, negative thinking, pain, and appetite. Participants were also administered the Montgomery- Åsberg Depression Rating Scale (MADRS) and Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) that allowed DID items to be evaluated against existing "benchmark" items. CTT was used to assess data quality/reliability (i.e., missing data, skewness, scoring frequency, internal consistency), IRT to assess individual item performance by modelling an item's ability to discriminate levels of depressive severity (as assessed by the MADRS), and RMT to assess how the items perform together as a scale to capture a range of depressive severity (item targeting). These analyses together provided empirical evidence to base decisions on which DID items to remove, modify, or advance. Results: Of the 32 DID items evaluated, eight items were identified by CTT as problematic, displaying low variability in the range of responses, floor effects, and/or skewness; and four items were identified by IRT to show poor discriminative properties that would limit their clinical utility. Five additional items were deemed to be redundant. The remaining 15 DID items all fit the Rasch model, with person and item difficulty estimates indicating satisfactory item targeting, with lower precision in participants with mild levels of depression. These 15 DID items also showed good internal consistency (alpha=0.95 and inter-item correlations ranging from r=0.49 to r=0.84) and all items were sensitive to change following antidepressant treatment (baseline vs. Week 8). RMT revealed problematic item targeting for the MADRS and QIDSSR, including an absence of MADRS items targeting participants with mild/moderate depression and an absence of QIDS-SR items targeting participants with mild or severe depression. Conclusion: The present study applied CTT, IRT, and RMT to assess the measurement properties of the DID items and identify those that should be advanced, modified, or removed. Of the 32 items evaluated, 15 items showed good measurement properties. These items (along with previously evaluated items) will provide the basis for validation of a penultimate DID scale assessing anhedonia, cognitive slowing, concentration, executive function, recent memory, drive, emotional fatigue, guilt, self-esteem, hopelessness, tension, rumination, irritability, reduced appetite, insomnia, sadness, worry, suicidality, and depressed mood. The strategies adopted by the DID process provide a framework for rating scale development and validation.

Web-Based Therapist Training in Interpersonal Psychotherapy for Depression: Pilot Study.

BACKGROUND: Training mental health professionals to deliver evidence-based therapy (EBT) is now required by most academic accreditation bodies, and evaluating the effectiveness of such training is imperative. However, shortages of time, money, and trained EBT clinician teachers make these challenges daunting. New technologies may help. The authors have developed the first empirically evaluated comprehensive Internet therapist training program for interpersonal psychotherapy (IPT). OBJECTIVE: The aim of this study was to examine whether (1) the training protocol would increase clinicians' knowledge of IPT concepts and skills and (2) clinicians would deem the training feasible as measured by satisfaction and utility ratings. METHODS: A total of 26 clinicians enrolled in the training, consisting of (1) a Web-based tutorial on IPT concepts and techniques; (2) live remote training via videoconference, with trainees practicing IPT techniques in a role-play using a case vignette; and (3) a Web-based portal for therapists posttraining use to help facilitate implementation of IPT and maintain adherence over time. RESULTS: Trainees' knowledge of IPT concepts and skills improved significantly (P<.001). The standardized effect size for the change was large: d=2.53, 95% CI 2.23-2.92. Users found the technical features easy to use, the content useful for helping them treat depressed clients, and felt the applied training component enhanced their professional expertise. Mean rating of applied learning was 3.9 (scale range from 1=very little to 5=a great deal). Overall satisfaction rating was 3.5 (range from 1=very dissatisfied to 4=very satisfied). CONCLUSIONS: Results support the efficacy and feasibility of this technology in training clinicians in EBTs and warrant further empirical evaluation.

Therapist Training on Cognitive Behavior Therapy for Anxiety Disorders Using Internet-Based Technologies.

This study investigated a technology-enhanced training protocol to facilitate dissemination of therapist training on cognitive behavior therapy (CBT) for anxiety disorders. Seventy community clinicians received an online tutorial followed by live remote observation of clinical skills via videoconference. Impact of training on patient outcomes was also assessed. Training resulted in a significant increase in both trainee knowledge of CBT concepts and techniques and therapist competence in applying these skills. Patients treated by trainees following training had significant reductions in anxiety and depression. Ratings of user satisfaction were high. Results provide support for the use of these technologies for therapist training in CBT.

The Depression Inventory Development Workgroup: A Collaborative, Empirically Driven Initiative to Develop a New Assessment Tool for Major Depressive Disorder.

The Depression Inventory Development project is an initiative of the International Society for CNS Drug Development whose goal is to develop a comprehensive and psychometrically sound measurement tool to be utilized as a primary endpoint in clinical trials for major depressive disorder. Using an iterative process between field testing and psychometric analysis and drawing upon expertise of international researchers in depression, the Depression Inventory Development team has established an empirically driven and collaborative protocol for the creation of items to assess symptoms in major depressive disorder. Depression-relevant symptom clusters were identified based on expert clinical and patient input. In addition, as an aid for symptom identification and item construction, the psychometric properties of existing clinical scales (assessing depression and related indications) were evaluated using blinded datasets from pharmaceutical antidepressant drug trials. A series of field tests in patients with major depressive disorder provided the team with data to inform the iterative process of scale development. We report here an overview of the Depression Inventory Development initiative, including results of the third iteration of items assessing symptoms related to anhedonia, cognition, fatigue, general malaise, motivation, anxiety, negative thinking, pain and appetite. The strategies adopted from the Depression Inventory Development program, as an empirically driven and collaborative process for scale development, have provided the foundation to develop and validate measurement tools in other therapeutic areas as well.

Erratum to: Integrating technology into cognitive behavior therapy for adolescent depression: a pilot study.

[This corrects the article DOI: 10.1186/s12991-015-0077-8.].

Integrating technology into cognitive behavior therapy for adolescent depression: a pilot study.

BACKGROUND: Rapid advances in information technology and telecommunications have resulted in a dramatic increase in the use of mobile devices and the internet to enhance and facilitate access to treatment. Cognitive behavior therapy (CBT) is an empirically based treatment that is well suited for enhancement by new technologies, particularly with youth. To facilitate the dissemination of this evidence-based treatment, we developed a technology-enhanced CBT intervention for the treatment of adolescent depression consisting of (1) online therapist training (2) in-session use of tablets for teaching clients CBT concepts and skills, and (3) text messaging for between session homework reminders and self-monitoring. METHODS: Eighteen licensed clinicians (social workers n = 7, psychologists n = 9) were randomized to have their patients receive either the intervention (CBT) or treatment as usual (TAU). Each clinician treated four adolescents for 12 weeks. Clinicians in the CBT arm completed an online tutorial on CBT treatment of adolescent depression, then received an iPad with access to patient education materials for teaching CBT concepts to patients during sessions. Individualized text messages were integrated into treatment for homework reminders, support, and outcomes measurement. Outcome measures included a 49-item multiple choice test for tutorial effectiveness; the system usability scale (SUS) for user satisfaction; quick inventory of depressive symptomatology-adolescent version (QIDS-A-Pat); and clinician and patient ratings on the therapeutic alliance scale for adolescents (TASA). RESULTS: A significant increase in knowledge of CBT concepts was found after completing the tutorial, t(8) = 7.02, p < 0.001. Clinician and patient ratings of user satisfaction were high for both the iPad teaching tools, and the text messaging. Ninety-five percent of teens said reviewing their text messages with their therapist was helpful, and all said they would use text messaging in treatment again. Ratings of the therapeutic alliance were higher in the CBT arm t(131) = 4.03, p = 0.001. A significant reduction in depression was found in both groups [t(34) = 8.453, p < 0.001 and t(29) = 6.67, p < 0.001 for CBT and TAU, respectively). Clinical ratings of improvement were greater on all outcome measures for the CBT arm; however, none reached statistical significance. Effect sizes (Cohen's d) ranged from small (QIDS-A) to large (TASA). CONCLUSIONS: Results support the feasibility of this technology-enhanced CBT intervention as a means of improving CBT treatment of adolescent depression and may help address the critical shortage of therapists trained on empirically based treatments.

Comparison of Site-Based Versus Central Ratings in a Study of Generalized Anxiety Disorder.

Lack of standardization across sites and raters, poor interrater reliability, and possible scoring bias affecting the primary outcome measure contribute to a high failure rate in anxiety trials. Remote centralized raters who are blinded to protocol inclusion and exclusion criteria as well as visit number may standardize assessments across raters and eliminate scoring bias, decreasing placebo response and thereby increasing signal detection. The purpose of the primary study was to test the safety and efficacy of an anxiolytic in a double-blind, placebo-controlled (no active comparator), multicenter trial. However, there was an additional prospective objective to explore site ratings compared with remote centralized ratings in the cohort of subjects on placebo. Site raters assessed subjects 6 times over an 8-week period. The primary outcome measure was the week 8 site-rated Hamilton Anxiety Scale (HAM-A). Remote centralized raters by telephone independently rated these subjects on the HAM-A at baseline and week 6. Of the 122 subjects selected by site raters and therefore randomized, remote centralized raters would have admitted 59 (48%) and excluded 63 (52%), based on their HAM-A ratings. The mean change from baseline in HAM-A total score in the placebo group admitted to the study by site raters was 9.3, significantly higher than the 5.9 point mean change on placebo as measured by the remote centralized raters.The data are consistent with the potential for qualification bias at baseline when rated by sites. The results make a strong case for using strategies to ensure that baseline scoring is truly independent of the pressure to enroll.

Computer-assisted cognitive behavior therapy for obsessive-compulsive disorder: a randomized trial on the impact of lay vs. professional coaching.

BACKGROUND: The purpose of the study was to examine the impact of computerized cognitive behavior therapy (CBT) self-help treatment for obsessive-compulsive disorder (OCD) (BT Steps) both alone and when supported by coaching from either a lay non-therapist coach or an experienced CBT therapist. METHODS: Eighty-seven subjects with clinically significant OCD were recruited through newspaper ads and randomly assigned to receive 12 weeks of treatment with either BT Steps alone (n = 28), BT Steps with non-therapist coaching (n = 28), or BT Steps with CBT therapist coaching (n = 31). Subjects worked on BT Steps at their own pace. Subjects receiving BT Steps alone received a welcome call from the project manager. Subjects randomized to either of the coaching arms received regularly scheduled weekly phone calls for coaching, encouragement, and support. No formal therapy was provided by the coaches; thus, both lay and CBT coaches completed the same tasks. RESULTS: All three treatment arms showed a significant reduction in Yale-Brown Obsessive Compulsive Scale (YBOCS) scores, with mean (SD) changes of 6.5 (5.7), 7.1 (6.1), and 6.5 (6.1) for the no coaching, lay coaching, and therapist coaching arms, respectively (all p's < .001). These represent effect sizes of 1.16, 1.41, and 1.12, respectively. No significant differences were found between treatment arms on YBOCS change scores, F(2) = 0.10, p = .904, or number of exposures sessions done (F(2) = 0.033, p = .967). When asked which method of therapy (computer vs. clinician) they preferred, 48% said computer, 33% said face-to-face therapy, and 19% had no preference. CONCLUSIONS: Results support the use of online self-help for the treatment of moderate OCD. The addition of coaching by either a lay coach or a CBT therapist coach did not significantly improve outcomes.

Web-based therapist training on cognitive behavior therapy for anxiety disorders: a pilot study.

The need for clinicians to use evidence-based practices (such as cognitive behavior therapy [CBT]) is now well recognized. However, a gap exists between the need for empirically based treatments and their availability. This is due, in part, to a shortage of clinicians formally trained on CBT. To address this problem, we developed a Web-based therapist CBT training program, to increase accessibility to this training. The program uses a two-step approach: an interactive multimedia online tutorial for didactic training on CBT concepts, followed by live remote observation through a videoconference of trainees conducting CBT, with immediate feedback in real time during critical moments to enhance learning through iterative guidance and practice. Thirty-nine clinicians from around the county completed the online didactic training and 22 completed the live remote training. Results found a significant increase in knowledge of CBT concepts and a significant increase in clinical skills, as judged by a blind rater. User satisfaction was high for both the online tutorial and the videoconference training. Utilization of CBT by trainees increased after training. Results support the acceptability and effectiveness of this Web-based approach to training.

A web-based tutorial for parents of young children with autism: results from a pilot study.

OBJECTIVE: Early intervention can significantly improve long-term outcomes for children with autism. Unfortunately, many children do not receive early intervention services due to a critical shortage of trained professionals in this area. To bridge this gap, we evaluated a Web-based parent training tutorial (Enhancing Interactions), based on evidence-based practices and utilizing the Web-based platform to maximize learning. METHODS: Twenty-three parents with a child between 18 months and 6 years with an autism spectrum disorder participated. Pre- and posttest scores of parents' knowledge were used to evaluate tutorial effectiveness. The system usability scale (SUS) evaluated technical user-friendliness and the user satisfaction questionnaire (USQ), gauged satisfaction with content. RESULTS: The mean number of correct items on the posttest significantly increased, from 12.6 to 20.4, p<0.001. The mean SUS score was 85 (standard deviation=17), corresponding to a score of "excellent." All participants found the tutorial user friendly, well integrated, and 96% (all but one participant) thought it was easy to use, felt confident using the technical features, and would use a tutorial like this again. On the USQ, all participants found that the tutorial was well organized, clearly presented, and easy to understand; that it increased their knowledge about communicating with their child; and that they felt capable of applying these techniques with their child. CONCLUSIONS: The tutorial appears effective in increasing parents' knowledge with high user satisfaction.

Web-based training in early autism screening: results from a pilot study.

BACKGROUND: Lack of familiarity with early signs of autism by community service providers has resulted in significant delays in children receiving early intervention services necessary to improve long-term outcomes. The Screening Tool for Autism in Toddlers and Young Children (STAT) was specifically developed to identify early behavioral features of autism. Although STAT training has been available for years, access is limited because of few STAT trainers and geographic concerns. This study evaluated the efficacy and acceptability of Web-based training of the STAT as a means of increasing accessibility to this training. MATERIALS AND METHODS: Thirty professionals from three geographic areas participated. Roughly 1 of 3 had little or no training on autism assessment. The tutorial contains a general overview, administration and scoring conventions, and item-specific content and concepts. Participants completed a pretest and then completed the STAT tutorial at their own pace, followed by a post-test and a user satisfaction questionnaire. RESULTS: Mean scores on STAT concepts significantly improved after taking the tutorial (p<0.001). At pretest, only 1 person (3%) obtained correct scores on at least 80% of the items (a priori cutoff for a "pass"), compared with 22 (73%) at post-test (p<0.001). The majority of trainees enjoyed taking the tutorial, thought it was well organized, relevant, interesting, and useful, and felt it was easy to understand and operate. DISCUSSION: Results support Web-based training as a promising method for promoting early identification of autism and may help overcome problems associated with the critical shortage of autism-screening professionals.

The use of videoconferencing with patients with psychosis: a review of the literature.

Videoconferencing has become an increasingly viable tool in psychiatry, with a growing body of literature on its use with a range of patient populations. A number of factors make it particularly well suited for patients with psychosis. For example, patients living in remote or underserved areas can be seen by a specialist without need for travel. However, the hallmark symptoms of psychotic disorders might lead one to question the feasibility of videoconferencing with these patients. For example, does videoconferencing exacerbate delusions, such as paranoia or delusions of reference? Are acutely psychotic patients willing to be interviewed remotely by videoconferencing? To address these and other issues, we conducted an extensive review of Medline, PsychINFO, and the Telemedicine Information Exchange databases for literature on videoconferencing and psychosis. Findings generally indicated that assessment and treatment via videoconferencing is equivalent to in person and is tolerated and well accepted. There is little evidence that patients with psychosis have difficulty with videoconferencing or experience any exacerbation of symptoms; in fact, there is some evidence to suggest that the distance afforded can be a positive factor. The results of two large clinical trials support the reliability and effectiveness of centralized remote assessment of patients with schizophrenia.

Site versus centralized raters in a clinical depression trial: impact on patient selection and placebo response.

The use of centralized raters who are remotely linked to sites and interview patients via videoconferencing or teleconferencing has been suggested as a way to improve interrater reliability and interview quality. This study compared the effect of site-based and centralized ratings on patient selection and placebo response in subjects with major depressive disorder. Subjects in a 2-center placebo and active comparator controlled depression trial were interviewed twice at each of 3 time points: baseline, 1-week postbaseline, and end point--once by the site rater and once remotely via videoconference by a centralized rater. Raters were blind to each others' scores. A site-based score of greater than 17 on the 17-item Hamilton Depression Rating Scale (HDRS-17) was required for study entry. When examining all subjects entering the study, site-based raters' HDRS-17 scores were significantly higher than centralized raters' at baseline and postbaseline but not at end point. At baseline, 35% of subjects given an HDRS-17 total score of greater than 17 by a site rater were given an HDRS total score of lower than 17 by a centralized rater and would have been ineligible to enter the study if the centralized rater's score was used to determine study entry. The mean placebo change for site raters (7.52) was significantly greater than the mean placebo change for centralized raters (3.18, P < 0.001). Twenty-eight percent were placebo responders (>50% reduction in HDRS) based on site ratings versus 14% for central ratings (P < 0.001). When examining data only from those subjects whom site and centralized raters agreed were eligible for the study, there was no significant difference in the HDRS-17 scores. Findings suggest that the use of centralized raters could significantly change the study sample in a major depressive disorder trial and lead to significantly less change in mood ratings among those randomized to placebo.

Sources of unreliability in depression ratings.

BACKGROUND: Good interrater reliability is essential to minimize error variance and improve study power. Reasons why raters differ in scoring the same patient include information variance (different information obtained because of asking different questions), observation variance (the same information is obtained, but raters differ in what they notice and remember), interpretation variance (differences in the significance attached to what is observed), criterion variance (different criteria used to score items), and subject variance (true differences in the subject). We videotaped and transcribed 30 pairs of interviews to examine the most common sources of rater unreliability. METHOD: Thirty patients who experienced depression were independently interviewed by 2 different raters on the same day. Raters provided rationales for their scoring, and independent assessors reviewed the rationales, the interview transcripts, and the videotapes to code the main reason for each discrepancy. One third of the interviews were conducted by raters who had not administered the Hamilton Depression Rating Scale before; one third, by raters who were experienced but not calibrated; and one third, by experienced and calibrated raters. RESULTS: Experienced and calibrated raters had the highest interrater reliability (intraclass correlation [ICC]; r = 0.93) followed by inexperienced raters (r = 0.77) and experienced but uncalibrated raters (r = 0.55). The most common reason for disagreement was interpretation variance (39%), followed by information variance (30%), criterion variance (27%), and observation variance (4%). Experienced and calibrated raters had significantly less criterion variance than the other cohorts (P = 0.001). CONCLUSIONS: Reasons for disagreement varied by level of experience and calibration. Experienced and uncalibrated raters should focus on establishing common conventions, whereas experienced and calibrated raters should focus on fine tuning judgment calls on different thresholds of symptoms. Calibration training seems to improve reliability over experience alone. Experienced raters without cohort calibration had lower reliability than inexperienced raters.

Use of remote centralized raters via live 2-way video in a multicenter clinical trial for schizophrenia.

Factors associated with clinician assessment may play a role in the increasing rate of failed trials. The use of centralized raters, a small group of highly skilled, tightly calibrated, and continuously monitored raters linked to the study sites through videoconferencing can address these issues by reducing the sheer number of raters involved, using rigorous calibration procedures not logistically feasible with a larger dispersed group of raters, and by blinding raters to visit and protocol. This phase 2 study was the first randomized controlled trial to use centralized raters in a study of treatments for schizophrenia. Subjects (N = 313) from 32 sites were randomly assigned to 6 weeks of treatment with 1 of 2 doses of an investigational antipsychotic, olanzapine 15 mg, or placebo. Subjects were evaluated weekly using the Positive and Negative Syndrome Scale. Data from the olanzapine (n = 68) and placebo (n = 68) arms were provided by the sponsor. The mean Positive and Negative Syndrome Scale change was significantly greater with olanzapine (-15.2) than placebo (-4.43), P = 0.002. The significant difference was apparent at week 1. The effect size was 0.48. Internal consistency was high throughout the study. Scores at screening were normally distributed and not skewed toward the cutoff score. Results found that hospitalized patients with schizophrenia were willing and able to participate in clinical trials using remote interviews conducted via videoconference. This methodology shows enormous promise for use in clinical trials, even with acutely psychotic patients.

The GRID-HAMD: standardization of the Hamilton Depression Rating Scale.

This report describes the GRID-Hamilton Depression Rating Scale (GRID-HAMD), an improved version of the Hamilton Depression Rating Scale that was developed through a broad-based international consensus process. The GRID-HAMD separates the frequency of the symptom from its intensity for most items, refines several problematic anchors, and integrates both a structured interview guide and consensus-derived conventions for all items. Usability was established in a small three-site sample of convenience, evaluating 29 outpatients, with most evaluators finding the scale easy to use. Test-retest (4-week) and interrater reliability were established in 34 adult outpatients with major depressive disorder, as part of an ongoing clinical trial. In a separate study, interrater reliability was found to be superior to the Guy version of the HAMD, and as good as the Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D), across 30 interview pairs. Finally, using the SIGH-D as the criterion standard, the GRID-HAMD demonstrated high concurrent validity. Overall, these data suggest that the GRID-HAMD is an improvement over the original Guy version as well as the SIGH-D in its incorporation of innovative features and preservation of high reliability and validity.

Development and reliability of a structured interview guide for the Montgomery Asberg Depression Rating Scale (SIGMA).

BACKGROUND: The Montgomery-Asberg Depression Rating Scale (MADRS) is often used in clinical trials to select patients and to assess treatment efficacy. The scale was originally published without suggested questions for clinicians to use in gathering the information necessary to rate the items. Structured and semi-structured interview guides have been found to improve reliability with other scales. AIMS: To describe the development and test-retest reliability of a structured interview guide for the MADRS (SIGMA). METHOD: A total of 162 test-retest interviews were conducted by 81 rater pairs. Each patient was interviewed twice, once by each rater conducting an independent interview. RESULTS: The intraclass correlation for total score between raters using the SIGMA was r=0.93, P<0.0001. All ten items had good to excellent interrater reliability. CONCLUSIONS: Use of the SIGMA can result in high reliability of MADRS scores in evaluating patients with depression.

A comparison of face-to-face and remote assessment of inter-rater reliability on the Hamilton Depression Rating Scale via videoconferencing.

Poor inter-rater reliability (IRR) is an important methodological factor that may contribute to failed trials. The sheer number of raters at diverse sites in multicenter trials presents a formidable challenge in calibration. Videoconferencing allows for the evaluation of IRR of raters at diverse sites by enabling raters at different sites to each independently interview a common patient. This is a more rigorous test of IRR than passive rating of videotapes. To evaluate the potential impact of videoconferencing on IRR, we compared IRR obtained via videoconference to IRR obtained using face-to-face interviews. Four raters at three different locations were paired using all pair-wise combinations of raters. Using videoconferencing, each paired rater independently conducted an interview with the same patient, who was at a third, central location. Raters were blind to each others' scores. ICC from this cohort (n=22) was not significantly different from the ICC obtained by a cohort using two face-to-face interviews (n=21) (0.90 vs. 0.93, respectively) nor from a cohort using one face-to-face interview and one remote interview (n=21) (0.88). The mean Hamilton Depression Rating Scale (HAMD) scores obtained were not significantly different. There appears to be no loss of signal using remote methods of calibration compared with traditional face-to-face methods.

Face-to-face versus remote administration of the Montgomery-Asberg Depression Rating Scale using videoconference and telephone.

Although the use of telemedicine in psychiatry has a long history in providing clinical care to patients, its use in clinical trials research has not yet been commonly employed. Telemedicine allows for the remote assessment of study patients, which could be done by a centralized, highly calibrated, and impartial cohort of raters independent of the study site. This study examined the comparability of remote administration of the Montgomery-Asberg Depression Rating Scale (MADRS) by videoconference and by telephone to traditional face-to-face administration. Two parallel studies were conducted: one compared face-to-face with videoconference administration (N=35), and the other compared face-to-face with telephone administration (N=35). In each study, depressed patients were interviewed independently twice: once in the traditional face-to-face manner, and the second time by either videoconference or teleconference. A counterbalanced order was used. The mean MADRS score for interviews conducted remotely by videoconference was not significantly different from the mean MADRS scores conducted by face-to-face administration (mean difference=0.51 points), P=.388, intraclass correlation (ICC)=.94, P<0001. Similarly, the mean MADRS score for interviews conducted by telephone was not significantly different from the mean MADRS score conducted by face-to-face administration (mean difference=0.74 points), P=.270, ICC=.93, P<0001. Results of the study support the comparability of remote administration of the MADRS, by both telephone and videoconference, to face-to-face administration. Comparability of the administration mode allows for remote assessment of patients in both research and clinical applications.

Primary care patients in psychiatric clinical trials: a pilot study using videoconferencing.

BACKGROUND: While primary care physicians play a pivotal role in the treatment of depression, collaboration between primary care and psychiatry in clinical research has been limited. Primary care settings provide unique opportunities to improve the methodology of psychiatric clinical trials, by providing more generalizable and less treatment-resistant patients. We examined the feasibility of identifying, recruiting, screening and assessing primary care patients for psychiatric clinical trials using high-quality videoconferencing in a mock clinical trial. METHODS: 1329 patients at two primary care clinics completed a self-report questionnaire. Those screening positive for major depression, panic, or generalized anxiety were given a diagnostic interview via videoconference. Those eligible were provided treatment as usual by their primary care physician, and had 6 weekly assessments by the off-site clinician via videoconferencing. RESULTS: 45 patients were enrolled over 22 weeks, with 36 (80%) completing the six-week study with no more than two missed appointments. All diagnostic groups improved significantly; 94% reported they would participate again, 87% would recommend participation to others, 96% felt comfortable communicating via videoconference, and 94% were able to satisfactorily communicate their feelings via video. CONCLUSION: Results showed that primary care patients will enroll, participate in and complete psychiatric research protocols using remote interviews conducted via videoconference.