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: Background
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.Methods/design
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 17 individuals are required per group, giving a minimum N of 51.Discussion
Symptom outcomes will be assessed and estimates of cost-effectiveness made. Results are proposed to be disseminated locally and internationally (through submission to conferences and peer-reviewed journals), and will hopefully inform local service provision. The trial has been approved by an ethics review board and was registered with ClinicalTrials.gov NCT01832792 on 9 April 2013.
SUBMITTER: Jenkins PE
PROVIDER: S-EPMC4035724 | biostudies-literature | 2014 May
REPOSITORIES: biostudies-literature
Publications
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:ObjectiveGuided 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.MethodSixty-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.ResultsThere was a significant effect of treatment on change in OBEs (β = -0.84, 95% CI = -1.49, -0.19) favoring CBT-GSH + Noom. Remission rates were not statistically different between treatments for OBEs (βlogit = -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.DiscussionSmartphone applications for the treatment binge eating appear to have advantages for adherence, a critical component of treatment dissemination.
| S-EPMC5755703 | biostudies-literature
Project description:ObjectiveAdoption 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).MethodParticipants 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.ResultsCompared 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.ConclusionsFindings support CBT-GSH dissemination for recurrent binge-eating treatment.
| S-EPMC2880825 | biostudies-literature
Project description:ObjectiveThe 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.MethodsTo 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.ResultsAt 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.ConclusionsReplication 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:ObjectiveDespite 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).MethodIn 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.ResultsAt 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.ConclusionsCBT-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.
| S-EPMC5710472 | biostudies-literature
Project description:BackgroundOwing to the gap between treatment supply and demand, there are long waiting periods for patients with binge eating disorder, and there is an urgent need to increase their access to specialized treatment. Guided self-help cognitive behavioral therapy-enhanced (CBT-E) may have great advantages for patients if its efficacy can be established.ObjectiveThe aim of this study was to examine the efficacy of guided self-help CBT-E compared with that of a delayed-treatment control condition.MethodsA single-blind 2-arm randomized controlled trial was designed to evaluate guided self-help CBT-E according to an intention-to-treat analysis. A total of 180 patients were randomly assigned to guided self-help CBT-E (n=90, 50%) or the delayed-treatment control condition (n=90, 50%) for which guided self-help CBT-E was provided after the initial 12-week delay. The primary outcome was reduction in binges. The secondary outcome was full recovery at the end of treatment, as measured using the Eating Disorder Examination during the last 4 weeks of treatment. A linear mixed model analysis was performed to compare treatment outcomes at the end of treatment. A second linear mixed model analysis was performed to measure between- and within-group effects for up to 24 weeks of follow-up. The Eating Disorder Examination-Questionnaire and clinical impairment assessment were conducted before and after treatment and during follow-up. In addition, dropout rates were assessed in both conditions.ResultsDuring the last 4 weeks of treatment, objective binges reduced from an average of 19 (SD 16) to 3 (SD 5) binges, and 40% (36/90) showed full recovery in the guided self-help CBT-E group. Between-group effect size (Cohen d) was 1.0 for objective binges. At follow-up, after both groups received treatment, there was no longer a difference between the groups. Of the 180 participants, 142 (78.9%) completed treatment. The overall treatment dropout appeared to be associated with gender, level of education, and number of objective binges at baseline but not with treatment condition.ConclusionsThis is the first study to investigate the efficacy of guided self-help CBT-E. Guided self-help CBT-E appeared to be an efficacious treatment. This study's findings underscore the international guidelines recommending this type of treatment for binge eating disorder.Trial registrationNetherlands Trial Registry (NTR) NL7994; https://trialsearch.who.int/Trial2.aspx?TrialID=NL7994.International registered report identifier (irrid)RR2-10.1186/s12888-020-02604-1.
| S-EPMC10186189 | biostudies-literature
Project description:BackgroundAlthough effective treatments for bulimic-spectrum eating disorders exist, access is often delayed because of limited therapist availability and lengthy waiting lists. Web-based self-help interventions have the potential to bridge waiting times for face-to-face treatment and overcome existing treatment gaps.AimsThis study aims to assess the effectiveness of a web-based guided self-help intervention (everyBody Plus) for patients with bulimia nervosa, binge eating disorder and other specified feeding and eating disorders who are waiting for out-patient treatment.MethodA randomised controlled trial was conducted in Germany and the UK. A total of 343 patients were randomly assigned to the intervention 'everyBody Plus' or a waitlist control condition. The primary outcome was the number of weeks after randomisation until a patient achieved a clinically relevant improvement in core symptoms for the first time. Secondary outcomes included eating disorder attitudes and behaviours, and general psychopathology.ResultsAt 6- and 12-month follow-up, the probability of being abstinent from core symptoms was significantly larger for the intervention group compared with the control group (hazard ratio: 1.997, 95% CI 1.09-3.65; P = 0.0249). The intervention group also showed larger improvements in eating disorder attitudes and behaviours, general psychopathology, anxiety, depression and quality of life, compared with the control group at most assessment points. Working alliance ratings with the online therapist were high.ConclusionsThe self-help intervention everyBody Plus, delivered with relatively standardised online guidance, can help bridge treatment gaps for patients with bulimic-spectrum eating disorders, and achieve faster and greater reductions in core symptoms.
| S-EPMC10897701 | biostudies-literature
Project description:ObjectiveThe 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.MethodA 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).ResultsAt 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.ConclusionsTherapist-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.
| S-EPMC3041988 | biostudies-literature
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:BackgroundGuided self-help (GSH) for anxiety is widely implemented in primary care services because of service efficiency gains, but there is also evidence of poor acceptability, low effectiveness and relapse.AimsThe aim was to compare preferences for, acceptability and efficacy of cognitive-behavioural guided self-help (CBT-GSH) versus cognitive-analytic guided self-help (CAT-GSH).MethodThis was a pragmatic, randomised, patient preference trial (Clinical trials identifier: NCT03730532). The Beck Anxiety Inventory (BAI) was the primary outcome at 8- and 24-week follow-up. Interventions were delivered competently on the telephone via structured workbooks over 6-8 (30-35 min) sessions by trained practitioners.ResultsA total of 271 eligible participants were included, of whom 19 (7%) accepted being randomised and 252 (93%) chose their treatment. In the preference cohort, 181 (72%) chose CAT-GSH and 71 (28%) preferred CBT-GSH. BAI outcomes in the preference and randomised cohorts did not differ at 8 weeks (-0.80, 95% confidence interval (CI) -4.52 to 2.92) or 24 weeks (0.85, 95% CI -2.87 to 4.57). After controlling for allocation method and baseline covariates, there were no differences between CAT-GSH and CBT-GSH at 8 weeks (F(1, 263) = 0.22, P = 0.639) or at 24 weeks (F(1, 263) = 0.22, P = 0.639). Mean BAI change from baseline was a reduction of 9.28 for CAT-GSH and 9.78 for CBT-GSH at 8 weeks and 12.90 for CAT-GSH and 12.43 for CBT-GSH at 24 weeks.ConclusionsPatients accessing routine primary care talking treatments prefer to choose the intervention they receive. CAT-GSH expands the treatment offer in primary care for patients with anxiety seeking a brief but analytically informed GSH solution.
| S-EPMC10895510 | biostudies-literature