Comparison of face-to-face versus email guided self-help for binge eating: study protocol for a randomised controlled trial.
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ABSTRACT:
SUBMITTER: Jenkins PE
PROVIDER: S-EPMC4035724 | biostudies-literature | 2014 May
REPOSITORIES: biostudies-literature
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Comparison of face-to-face versus email guided self-help for binge eating: study protocol for a randomised controlled trial.
Jenkins Paul E PE Luck Amy A Burrows Alison A Boughton Nicky N
Trials 20140522
<h4>Background</h4>Guided self-help is a recommended first-step treatment for bulimia nervosa, binge eating disorder and atypical variants of these disorders. Further research is needed to compare guided self-help that is delivered face-to-face versus via email.<h4>Methods/design</h4>This clinical trial uses a randomised, controlled design to investigate the effectiveness of providing guided self-help either face-to-face or via e-mail, also using a delayed treatment control condition. At least 1 ...[more]
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Project description:The aim of this study was to replicate and extend results of a previous blended efficacy and effectiveness trial of a low-intensity, manual-based guided self-help form of cognitive-behavioral therapy (CBT-GSH) for the treatment of binge eating disorders in a large health maintenance organization (HMO) and to compare them with usual care.To extend previous findings, the investigators modified earlier recruitment and assessment approaches and conducted a randomized clinical trial to better reflect procedures that may be reasonably carried out in real-world practices. The intervention was delivered by master's-level interventionists to 160 female members of a health maintenance organization who met diagnostic criteria for recurrent binge eating. Data collected at baseline, immediately posttreatment, and at six- and 12-month follow-ups were used in intent-to-treat analyses.At the 12-month follow-up, CBT-GSH resulted in greater remission from binge eating (35%, N=26) than usual care (14%, N=10) (number needed to treat=5). The CBT-GSH group also demonstrated greater improvements in dietary restraint (d=.71) and eating, shape, and weight concerns (d=1.10, 1.24, and .98, respectively) but not weight change.Replication of the pattern of previous findings suggests that CBT-GSH is a robust treatment for patients with recurrent binge eating. The magnitude of changes was significantly smaller than in the original study, however, suggesting that patients recruited and assessed with less intensive procedures may respond differently from their counterparts enrolled in trials requiring more comprehensive procedures.
| S-EPMC3962509 | biostudies-literature
Project description:Adoption of effective treatments for recurrent binge-eating disorders depends on the balance of costs and benefits. Using data from a recent randomized controlled trial, we conducted an incremental cost-effectiveness analysis (CEA) of a cognitive-behavioral therapy guided self-help intervention (CBT-GSH) to treat recurrent binge eating compared to treatment as usual (TAU).Participants were 123 adult members of an HMO (mean age = 37.2 years, 91.9% female, 96.7% non-Hispanic White) who met criteria for eating disorders involving binge eating as measured by the Eating Disorder Examination (C. G. Fairburn & Z. Cooper, 1993). Participants were randomized either to treatment as usual (TAU) or to TAU plus CBT-GSH. The clinical outcomes were binge-free days and quality-adjusted life years (QALYs); total societal cost was estimated using costs to patients and the health plan and related costs.Compared to those receiving TAU only, those who received TAU plus CBT-GSH experienced 25.2 more binge-free days and had lower total societal costs of $427 over 12 months following the intervention (incremental CEA ratio of -$20.23 per binge-free day or -$26,847 per QALY). Lower costs in the TAU plus CBT-GSH group were due to reduced use of TAU services in that group, resulting in lower net costs for the TAU plus CBT group despite the additional cost of CBT-GSH.Findings support CBT-GSH dissemination for recurrent binge-eating treatment.
| S-EPMC2880825 | biostudies-literature
Project description:Guided self-help treatments based on cognitive-behavior therapy (CBT-GSH) are efficacious for binge eating. With limited availability of CBT-GSH in the community, mobile technology offers a means to increase use of these interventions. The purpose of this study was to test the initial efficacy of Noom Monitor, a smartphone application designed to facilitate CBT-GSH (CBT-GSH?+?Noom), on study retention, adherence, and eating disorder symptoms compared to traditional CBT-GSH.Sixty-six men and women with DSM-5 binge-eating disorder (BED) or bulimia nervosa (BN) were randomized to receive eight sessions of CBT-GSH?+?Noom (n?=?33) or CBT-GSH (n?=?33) over 12 weeks. Primary symptom outcomes were eating disorder examination objective bulimic episodes (OBEs), subjective bulimic episodes (SBEs), and compensatory behaviors. Assessments were collected at 0, 4, 8, 12, 24, and 36 weeks. Behavioral outcomes were modeled using zero-inflated negative-binomial latent growth curve models with intent-to-treat.There was a significant effect of treatment on change in OBEs (??=?-0.84, 95% CI?=?-1.49, -0.19) favoring CBT-GSH?+?Noom. Remission rates were not statistically different between treatments for OBEs (?logit ?=?-0.73, 95% CI?=?-1.86, 3.27; CBT-GSH-Noom?=?17/27, 63.0% vs. CBT-GSH 11/27, 40.7%, NNT?=?4.5), but CBT-GSH-Noom participants reported greater meal and snack adherence and regular meal adherence mediated treatment effects on OBEs. The treatments did not differ at the 6-month follow-up.Smartphone applications for the treatment binge eating appear to have advantages for adherence, a critical component of treatment dissemination.
| S-EPMC5755703 | biostudies-literature
Project description:Despite proven efficacy of cognitive behavioral therapy (CBT) for treating eating disorders with binge eating as the core symptom, few patients receive CBT in clinical practice. Our blended efficacy-effectiveness study sought to evaluate whether a manual-based guided self-help form of CBT (CBT-GSH), delivered in 8 sessions in a health maintenance organization setting over a 12-week period by master's-level interventionists, is more effective than treatment as usual (TAU).In all, 123 individuals (mean age = 37.2; 91.9% female, 96.7% non-Hispanic White) were randomized, including 10.6% with bulimia nervosa (BN), 48% with binge eating disorder (BED), and 41.4% with recurrent binge eating in the absence of BN or BED. Baseline, posttreatment, and 6- and 12-month follow-up data were used in intent-to-treat analyses.At 12-month follow-up, CBT-GSH resulted in greater abstinence from binge eating (64.2%) than TAU (44.6%; number needed to treat = 5), as measured by the Eating Disorder Examination (EDE). Secondary outcomes reflected greater improvements in the CBT-GSH group in dietary restraint (d = 0.30); eating, shape, and weight concern (ds = 0.54, 1.01, 0.49, respectively; measured by the EDE Questionnaire); depression (d = 0.56; Beck Depression Inventory); and social adjustment (d = 0.58; Work and Social Adjustment Scale), but not weight change.CBT-GSH is a viable first-line treatment option for the majority of patients with recurrent binge eating who do not meet diagnostic criteria for BN or anorexia nervosa.
| S-EPMC2880824 | biostudies-literature
Project description:ImportanceAlthough cognitive behavioral therapy (CBT) represents the criterion standard for treatment of binge eating disorder (BED), most individuals do not have access to this specialized treatment.ObjectiveTo evaluate the efficacy of internet-based guided self-help (GSH-I) compared with traditional, individual face-to-face CBT.Design, setting, and participantsThe Internet and Binge Eating Disorder (INTERBED) study is a prospective, multicenter, randomized, noninferiority clinical trial (treatment duration, 4 months; follow-ups, 6 months and 1.5 years). A volunteer sample of 178 adult outpatients with full or subsyndromal BED were recruited from 7 university-based outpatient clinics from August 1, 2010, through December 31, 2011; final follow-up assessment was in April 2014. Data analysis was performed from November 30, 2014, to May 27, 2015.InterventionsParticipants received 20 individual face-to-face CBT sessions of 50 minutes each or sequentially completed 11 internet modules and had weekly email contacts.Main outcomes and measuresThe primary outcome was the difference in the number of days with objective binge eating episodes (OBEs) during the previous 28 days between baseline and end of treatment. Secondary outcomes included OBEs at follow-ups, eating disorder and general psychopathologic findings, body mass index, and quality of life.ResultsA total of 586 patients were screened, 178 were randomized, and 169 had at least one postbaseline assessment and constituted the modified intention-to-treat analysis group (mean [SD] age, 43.2 [12.3] years; 148 [87.6%] female); the 1.5-year follow-up was available in 116 patients. The confirmatory analysis using the per-protocol sample (n?=?153) failed to show noninferiority of GSH-I (adjusted effect, 1.47; 95% CI, -0.01 to 2.91; P?=?.05). Using the modified intention-to-treat sample, GSH-I was inferior to CBT in reducing OBE days at the end of treatment (adjusted effect, 1.63; 95% CI, 0.17-3.05; P?=?.03). Exploratory longitudinal analyses also showed the superiority of CBT over GSH-I by the 6-month (adjusted effect, 0.36; 95% CI, 0.23-0.55; P?<?.001) but not the 1.5-year follow-up (adjusted effect, 0.91; 95% CI, 0.54-1.50; P?=?.70). Reductions in eating disorder psychopathologic findings were significantly higher in the CBT group than in the GSH-I group at 6-month follow-up (adjusted effect, -0.4; 95% CI, -0.68 to -0.13; P?=?.005). No group differences were found for body mass index, general psychopathologic findings, and quality of life.Conclusions and relevanceFace-to-face CBT leads to quicker and greater reductions in the number of OBE days, abstinence rates, and eating disorder psychopathologic findings and may be a better initial treatment option than GSH-I. Internet-based guided self-help remains a viable, slower-acting, low-threshold treatment alternative compared with CBT for adults with BED.Trial registrationisrctn.org Identifier: ISRCTN40484777 and germanctr.de Identifier: DRKS00000409.
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Project description:The purpose of this investigation was to compare three types of treatment for binge eating disorder to determine the relative efficacy of self-help group treatment compared to therapist-led and therapist-assisted group cognitive-behavioral therapy.A total of 259 adults diagnosed with binge eating disorder were randomly assigned to 20 weeks of therapist-led, therapist-assisted, or self-help group treatment or a waiting list condition. Binge eating as measured by the Eating Disorder Examination was assessed at baseline, at end of treatment, and at 6 and 12 months, and outcome was assessed using logistic regression and analysis of covariance (intent-to-treat).At end of treatment, the therapist-led (51.7%) and the therapist-assisted (33.3%) conditions had higher binge eating abstinence rates than the self-help (17.9%) and waiting list (10.1%) conditions. However, no between-group differences in abstinence rates were observed at either of the follow-up assessments. The therapist-led condition also showed more reductions in binge eating at end of treatment and follow-up assessments compared to the self-help condition, and treatment or waiting period completion rates were higher in the therapist-led (88.3%) and waiting list (81.2%) conditions than in the therapist-assisted (68.3%) and self-help (59.7%) conditions.Therapist-led group cognitive-behavioral treatment for binge eating disorder led to higher binge eating abstinence rates, greater reductions in binge eating frequency, and lower attrition compared to group self-help treatment. Although these findings indicate that therapist delivery of group treatment is associated with better short-term outcome and less attrition than self-help treatment, the lack of group differences at follow-up suggests that self-help group treatment may be a viable alternative to therapist-led interventions.
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Project description:Evaluating and comparing the effectiveness of two smartphone-delivered treatments: one based on behavioural activation (BA) and other on mindfulness.Parallel randomised controlled, open, trial. Participants were allocated using an online randomisation tool, handled by an independent person who was separate from the staff conducting the study.General community, with recruitment nationally through mass media and advertisements.40 participants diagnosed with major depressive disorder received a BA treatment, and 41 participants received a mindfulness treatment. 9 participants were lost at the post-treatment.An 8-week long behaviour programme administered via a smartphone application. Mindfulness: An 8-week long mindfulness programme, administered via a smartphone application.The Beck Depression Inventory-II (BDI-II) and the nine-item Patient Health Questionnaire Depression Scale (PHQ-9).81 participants were randomised (mean age 36.0 years (SD=10.8)) and analysed. Results showed no significant interaction effects of group and time on any of the outcome measures either from pretreatment to post-treatment or from pretreatment to the 6-month follow-up. Subgroup analyses showed that the BA treatment was more effective than the mindfulness treatment among participants with higher initial severity of depression from pretreatment to the 6-month follow-up (PHQ-9: F (1, 362.1)=5.2, p<0.05). In contrast, the mindfulness treatment worked better than the BA treatment among participants with lower initial severity from pretreatment to the 6-month follow-up (PHQ-9: F (1, 69.3)=7.7, p<0.01); BDI-II: (F(1, 53.60)=6.25, p<0.05).The two interventions did not differ significantly from one another. For participants with higher severity of depression, the treatment based on BA was superior to the treatment based on mindfulness. For participants with lower initial severity, the treatment based on mindfulness worked significantly better than the treatment based on BA.Clinical Trials NCT01463020.
| S-EPMC3902198 | biostudies-literature
Project description:Introduction:This resource is a web-based and self-contained self-learning module (SLM) on binge-eating disorder (BED) that runs utilizing Articulate software. Certain skills and knowledge are required to both interview and manage patients diagnosed with the disorder. Because BED may be encountered by medical students, this module can help inform the learning process. Methods:Software was utilized to develop an SLM for third-year medical students utilizing video clips demonstrating the evolution of a clinical BED case from presentation to follow-up over 10-12 weeks. The focus is on differential diagnosis and management, with intermittent self-assessment quizzes and other evidence-based literature for further study. The module follows the case of Ms. Melanie May, who has been referred for help to lose weight. Further assessment reveals that she has BED. By having her needs therapeutically attended to, she receives help through focused cognitive behavioral therapy, the use of food log monitoring, and medications. Results:This SLM on BED has been implemented at the University of Toronto as an optional component of the psychiatry clerkship over the 2015/2016 academic year. Written and verbal feedback from faculty (n = 5) and students (n = 5) has been overwhelmingly positive. Discussion:This SLM is intended as a clinical application exercise for third-year medical students who may not encounter patients with BED or who want to increase their clinical understanding of how to help patients who present with obesity and binge-eating complaints.
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Project description:BackgroundPsychological therapies are first-line interventions for depression, but existing provision is not accessible for many adults with intellectual disabilities. We investigated the clinical and cost-effectiveness of a behavioural activation intervention (BeatIt) for people with intellectual disabilities and depression. BeatIt was compared with a guided self-help intervention (StepUp).MethodsWe did a multicentre, single-blind, randomised, controlled trial with follow-up at 4 months and 12 months after randomisation. Participants aged 18 years or older, with mild to moderate intellectual disabilities and clinically significant depression were recruited from health and social care services in the UK. The primary outcome was the Glasgow Depression Scale for people with a Learning Disability (GDS-LD) score at 12 months. Analyses were done on an intention-to-treat basis. This trial is registered with ISCRTN, number ISRCTN09753005.FindingsBetween Aug 8, 2013, and Sept 1, 2015, 161 participants were randomly assigned (84 to BeatIt; 77 to StepUp); 141 (88%) participants completed the trial. No group differences were found in the effects of BeatIt and StepUp based on GDS-LD scores at 12 months (12·03 [SD 7·99] GDS-LD points for BeatIt vs 12·43 [SD 7·64] GDS-LD points for StepUp; mean difference 0·26 GDS-LD points [95% CI -2·18 to 2·70]; p=0·833). Within-group improvements in GDS-LD scores occurred in both groups at 12 months (BeatIt, mean change -4·2 GDS-LD points [95% CI -6·0 to -2·4], p<0·0001; StepUp, mean change -4·5 GDS-LD points [-6·2 to -2·7], p<0·0001), with large effect sizes (BeatIt, 0·590 [95% CI 0·337-0·844]; StepUp, 0·627 [0·380-0·873]). BeatIt was not cost-effective when compared with StepUp, although the economic analyses indicated substantial uncertainty. Treatment costs were only approximately 3·6-6·8% of participants' total support costs. No treatment-related or trial-related adverse events were reported.InterpretationThis study is, to our knowledge, the first large randomised controlled trial assessing individual psychological interventions for people with intellectual disabilities and mental health problems. These findings show that there is no evidence that BeatIt is more effective than StepUp; both are active and potentially effective interventions.FundingNational Institute for Health Research.
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Project description:BackgroundExposure to armed conflict and forced displacement constitute significant risks for mental health. Existing evidence-based psychological interventions have limitations for scaling-up in low-resource humanitarian settings. The WHO has developed a guided self-help intervention, Self Help Plus (SH+), which is brief, implemented by non-specialists, and designed to be delivered to people with and without specific mental disorders. This paper outlines the study protocol for an evaluation of the SH+ intervention in northern Uganda, with South Sudanese refugee women.MethodsA two-arm, single-blind cluster-randomised controlled trial will be conducted in 14 villages in Rhino Camp refugee settlement, with at least 588 women experiencing psychological distress. Villages will be randomly assigned to receive either SH+ with enhanced usual care (EUC), or EUC alone. SH+ is a five-session guided self-help intervention delivered in workshops with audio-recorded materials and accompanying pictorial guide. The primary outcome is reduction in overall psychological distress over time, with 3 months post-treatment as the primary end-point. Secondary outcomes are self-defined psychosocial concerns, depression and post-traumatic stress disorder symptoms, hazardous alcohol use, feelings of anger, interethnic relations, psychological flexibility, functional impairment and subjective wellbeing. Psychological flexibility is a hypothesised mediator, and past trauma history and intervention attendance will be explored as potential moderators.DiscussionThis trial will provide important information on the effectiveness of a scalable, guided self-help intervention for improving psychological health and wellbeing among people affected by adversity.Trial registrationISRCTN50148022; registered 13/03/2017.
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