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Defining treatment response in trichotillomania: a signal detection analysis.

ABSTRACT: The Massachusetts General Hospital Hairpulling Scale (MGH-HPS) and the NIMH Trichotillomania Severity Scale (NIMH-TSS) are two widely used measures of trichotillomania severity. Despite their popular use, currently no empirically-supported guidelines exist to determine the degrees of change on these scales that best indicate treatment response. Determination of such criteria could aid in clinical decision-making by defining clinically significant treatment response/recovery and producing accurate power analyses for use in clinical trials research. Adults with trichotillomania (N=69) participated in a randomized controlled trial of psychotherapy and were assessed before and after treatment. Response status was measured via the Clinical Global Impressions-Improvement Scale, and remission status was measured via the Clinical Global Impressions-Severity Scale. For treatment response, a 45% reduction or 7-point raw score change on the MGH-HPS was the best indicator of clinically significant treatment response, and on the NIMH-TSS, a 30-40% reduction or 6-point raw score difference was most effective cutoff. For disorder remission, a 55-60% reduction or 7-point raw score change on the MGH-HPS was the best predictor, and on the NIMH-TSS, a 65% reduction or 6-point raw score change was the best indicator of disorder remission. Implications of these findings are discussed.

SUBMITTER: Houghton DC

PROVIDER: S-EPMC4658278 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature

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Defining treatment response in trichotillomania: a signal detection analysis.

Houghton David C DC Capriotti Matthew R MR De Nadai Alessandro S AS Compton Scott N SN Twohig Michael P MP Neal-Barnett Angela M AM Saunders Stephen M SM Franklin Martin E ME Woods Douglas W DW

Journal of anxiety disorders 20150924

The Massachusetts General Hospital Hairpulling Scale (MGH-HPS) and the NIMH Trichotillomania Severity Scale (NIMH-TSS) are two widely used measures of trichotillomania severity. Despite their popular use, currently no empirically-supported guidelines exist to determine the degrees of change on these scales that best indicate treatment response. Determination of such criteria could aid in clinical decision-making by defining clinically significant treatment response/recovery and producing accurat ...[more]

PMID: 26422605

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Project description:Objectives: In clinical trials of pediatric trichotillomania (TTM), three instruments are typically employed to rate TTM severity: (1) the Massachusetts General Hospital Hair Pulling Scale (MGH-HPS), (2) the National Institute of Mental Health Trichotillomania Severity Scale (NIMH-TSS), and (3) the Trichotillomania Scale for Children (TSC). These instruments lack standardized definitions of treatment response, which lead researchers to determine their own definitions of response post hoc and potentially inflate results. We performed a meta-analysis to provide empirically determined accuracy measures for percentage reduction cut points in these three instruments. Methods: MEDLINE was searched for TTM clinical trials. A total of 67 studies were initially identified, but only 5 were clinical trials focused on TTM in pediatric populations and therefore were included in this meta-analysis (n = 180). A Clinical Global Impressions Improvement score ≤2 was used to define clinical response. Receiver operating characteristic principles were employed to determine accuracy measures for percentage reduction cut points on each one of the instruments. Meta-DiSc software was employed to provide pooled accuracy measures for each cut point for each instrument. The Youden Index and the distance to corner methods were used to determine the optimal cut point. Results: The optimal cut points to determine treatment response were a 45% reduction on the MGH-HPS (Youden Index 0.40, distance to corner 0.20), a 35% reduction on the NIMH-TSS (Youden Index 0.42, distance to corner 0.17), a 25% reduction on the TSC child version (TSC-C; Youden Index 0.40, distance to corner 0.18), and a 45% (distance to corner 0.30) or 50% reduction (Youden Index 0.33) on the TSC parent version (TSC-P). The TSC-C had less discriminative ability at determining response in younger children in comparison to older children; no age-related differences were observed on the TSC-P. Conclusions: This study provides empirically determined cut points of treatment response on three instruments that rate TTM severity. These data-driven cut points will benefit future research on pediatric TTM.

Project description:BACKGROUND:Most clinical trials comparing treatments evaluate the separate effects on each of several efficacy and toxicity outcomes. However, population-averaged summary measures of treatment differences may not accurately reflect individual responses to treatment, and drawing conclusions about which treatment is "best" is straightforward if one treatment is superior across all outcomes, but challenging when this is not the case. METHODS:We created a study outcome based on expert opinion, which captures the risk/benefit profile of response to a treatment. Treatments were compared using this ordered outcome with standard statistical techniques. To illustrate the approach, we used as an example a study designed to evaluate initial antiretroviral therapy (ART) in human immunodeficiency virus-1-infected infants, in which results were contradictory across the study's primary and secondary efficacy and toxicity outcomes. The proposed risk/benefit outcome was evaluated retrospectively in each participant. RESULTS:In the International Maternal Pediatric Adolescent AIDS Clinical Trials P1060 study, one treatment regimen (lopinavir/ritonavir-based ART) was superior to the other (nevirapine-based ART) in reducing viral load (primary outcome) but inferior for immunologic and growth outcomes (important secondary outcomes in resource-limited settings). Treatment comparisons using the risk/benefit outcome indicated that the lopinavir/ritonavir-based ART regimen had a higher proportion of participants with the best overall response to treatment. Comparisons focusing on individual-level responses for the secondary outcomes also favored lopinavir/ritonavir-based ART, results that differed from the original population-averaged analyses ones. CONCLUSIONS:Designing studies prospectively using risk/benefit outcomes focusing on an individual's responses to treatment more closely matches the needs of clinicians making decisions about how best to treat patients in clinical settings.

Project description:BackgroundA randomized controlled trial examining the efficacy of behavior therapy for pediatric trichotillomania was recently completed with 24 participants ranging in age from 7 - 17. The broad age range raised a question about whether young children, older children, and adolescents would respond similarly to intervention. In particular, it is unclear whether the younger children have the cognitive capacity to understand concepts like "urges" and whether they are able to introspect enough to be able to benefit from awareness training, which is a key aspect of behavior therapy for trichotillomania.MethodsParticipants were randomly assigned to receive either behavior therapy (N = 12) or minimal attention control (N = 12), which was included to control for repeated assessments and the passage of time. Primary outcome measures were the independent evaluator-rated NIMH-Trichotillomania Severity Scale, a semi-structured interview often used in trichotillomania treatment trials, and a post-treatment clinical global impression improvement rating (CGI-I).ResultsThe correlation between age and change in symptom severity for all patients treated in the trial was small and not statistically significant. A 2 (group: behavioral therapy, minimal attention control) x 2 (time: week 0, 8) x 2 (children < 9 yrs., children > 10) ANOVA with independent evaluator-rated symptom severity scores as the continuous dependent variable also detected no main effects for age or for any interactions involving age. In light of the small sample size, the mean symptom severity scores at weeks 0 and 8 for younger and older patients randomized to behavioral therapy were also plotted. Visual inspection of these data indicated that although the groups appeared to have started at similar levels of severity for children </= 9 vs. children >/= 10; the week 8 data show that the three younger children did at least as well as if not slightly better than the nine older children and adolescents.ConclusionsBehavior therapy for pediatric trichotillomania appears to be efficacious even in young children. The developmental and clinical implications of these findings will be discussed.Trial registrationClinicaltrials.gov NCT00043563.

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Defining treatment response in trichotillomania: a signal detection analysis.

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Defining treatment response in trichotillomania: a signal detection analysis.

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