Preventive cognitive therapy versus treatment as usual in preventing recurrence of depression:Protocol of a multi-centered randomized controlled trial

Background Major depressive disorder (MDD) is projected to rank second on a list of 15 major diseases in terms of burden in 2030. The contribution of MDD to disability and health care costs is largely due to its highly recurrent nature. Therefore, part of the efforts to reduce the disabling effects of depression should focus on preventing recurrence, especially in patients at high risk of recurrence. The best established effective psychological intervention is cognitive therapy, with indications for prophylactic effects after remission. Methods/Design In this randomized controlled trial (cost-) effectiveness of Preventive Cognitive Therapy (PCT) after response to Acute Cognitive Therapy (A-CT) will be evaluated in comparison with Treatment As Usual (TAU). Remitted patients that responded to A-CT treatment with at least two previous depressive episodes will be recruited. Randomization will be stratified for number of previous episodes. Follow-ups are at 3, 6, 12 and 15 months. The primary outcome measure will be the time to relapse or recurrence of depression meeting DSM-IV criteria for a major depressive episode on the Structured Clinical Interview for DSM-VI Axis I Disorders (SCID-I). Costs will be measured from a societal perspective. Discussion This study is the first to examine the addition of PCT to TAU, compared to TAU alone in patients that recovered from depressive disorder with A-CT. Alongside this effect study a cost effectiveness analysis will be conducted. Furthermore, the study explores potential moderators to examine what works for whom. Trial registration Netherlands Trial Register (NTR): 2599, date of registration: 11-11-2010. Keywords Depression Relapse Recurrence Cognitive Therapy Preventio

Web-based guided self-help cognitive behavioral therapy–enhanced versus treatment as usual for binge-eating disorder: a randomized controlled trial protocol

Binge-eating disorder (BED) is a psychiatric disorder characterized by recurrent episodes of eating a large amount of food in a discrete period of time while experiencing a loss of control. Cognitive behavioral therapy-enhanced (CBT-E) is a recommended treatment for binge-eating disorder and is typically offered through 20 sessions. Although binge-eating disorder is highly responsive to CBT-E, the cost of treating these patients is high. Therefore, it is crucial to evaluate the efficacy of low-intensity and low-cost treatments for binge-eating disorder that can be offered as a first line of treatment and be widely disseminated. The proposed noninferiority randomized controlled trial aims to determine the efficacy of web-based guided self-help CBT-E compared to treatment-as-usual CBT-E. Guided self-help will be based on a self-help program to stop binge eating, will be shorter in duration and lower intensity, and will require fewer therapist hours. Patients with binge-eating disorder (N = 180) will be randomly assigned to receive guided self-help or treatment-as-usual. Assessments will take place at baseline, mid-treatment, at the end of treatment, and at 20- and 40-weeks post-treatment. Treatment efficacy will be measured by examining the reduction in binge-eating days in the previous 28 days between baseline and the end of treatment between groups, with a noninferiority margin (Δ) of 1 binge-eating day. Secondary outcomes will include full remission, body shape dissatisfaction, therapeutic alliance, clinical impairment, health-related quality of life, attrition, and an economic evaluation to assess cost-effectiveness and cost-utility. The moderators examined will be baseline scores, demographic variables, and body mass index. It is expected that guided self-help is noninferior in efficacy compared to treatment-as-usual. The proposed study will be the first to directly compare the efficacy and economically evaluate a low-intensity and low-cost binge-eating disorder treatment compared to treatment-as-usual. If guided self-help is noninferior to treatment-as-usual in efficacy, it can be widely disseminated and used as a first line of treatment for patients with binge-eating disorder. The Dutch trial register number is R21.016. The study has been approved by the Medical Research Ethics Committees United on May 25th, 2021, case number NL76368.100.21

Web-based guided self-help cognitive behavioral therapy– enhanced versus treatment as usual for binge-eating disorder:a randomized controlled trial protocol

Binge-eating disorder (BED) is a psychiatric disorder characterized by recurrent episodes of eating a large amount of food in a discrete period of time while experiencing a loss of control. Cognitive behavioral therapy-enhanced (CBT-E) is a recommended treatment for binge-eating disorder and is typically offered through 20 sessions. Although binge-eating disorder is highly responsive to CBT-E, the cost of treating these patients is high. Therefore, it is crucial to evaluate the efficacy of low-intensity and low-cost treatments for binge-eating disorder that can be offered as a first line of treatment and be widely disseminated. The proposed noninferiority randomized controlled trial aims to determine the efficacy of web-based guided self-help CBT-E compared to treatment-as-usual CBT-E. Guided self-help will be based on a self-help program to stop binge eating, will be shorter in duration and lower intensity, and will require fewer therapist hours. Patients with binge-eating disorder (N = 180) will be randomly assigned to receive guided self-help or treatment-as-usual. Assessments will take place at baseline, mid-treatment, at the end of treatment, and at 20- and 40-weeks post-treatment. Treatment efficacy will be measured by examining the reduction in binge-eating days in the previous 28 days between baseline and the end of treatment between groups, with a noninferiority margin (Δ) of 1 binge-eating day. Secondary outcomes will include full remission, body shape dissatisfaction, therapeutic alliance, clinical impairment, health-related quality of life, attrition, and an economic evaluation to assess cost-effectiveness and cost-utility. The moderators examined will be baseline scores, demographic variables, and body mass index. It is expected that guided self-help is noninferior in efficacy compared to treatment-as-usual. The proposed study will be the first to directly compare the efficacy and economically evaluate a low-intensity and low-cost binge-eating disorder treatment compared to treatment-as-usual. If guided self-help is noninferior to treatment-as-usual in efficacy, it can be widely disseminated and used as a first line of treatment for patients with binge-eating disorder. The Dutch trial register number is R21.016. The study has been approved by the Medical Research Ethics Committees United on May 25th, 2021, case number NL76368.100.21.</p

Online cognitive behavioral therapy enhanced for binge eating disorder: study protocol for a randomized controlled trial

Background: Binge eating disorder is characterized by recurrent episodes of binge eating accompanied by a sense of lack of control. Of the different treatments available, Cognitive Behavioral Therapy-Enhanced and guided self-help treatment are recommended. As online treatment offers several additional advantages, we have developed a CBT-Enhanced online guided self-help intervention. The aim of this study is to determine whether this intervention reduces eating disorder pathology and increases the amount of binge free days in adults classified with binge eating disorder or other specified feeding or eating disorder- binge eating disorder, compared to an untreated waiting list condition. The experimental condition is hypothesized to be superior to the waiting list condition. Methods: The efficacy of an online guided self-help intervention for binge eating disorder will be assessed by conducting a randomized controlled trial. The trial will target adult individuals classified with binge eating disorder or other specified feeding or eating disorder- binge eating disorder with a body mass index between 19.5 and 40, referred to an eating disorder treatment center. Dual arm allotment will be performed in a 1:1 ratio stratified for BMI above or below 30. Randomization will be blinded to the online intervention (n = 90), or to the control waiting list condition (n = 90). Assessors will be blinded and assessments will be administered at baseline, week 5, at end-of-treatment, and at 12 and 24 weeks follow-up. Primary outcome will be eating disorder pathology, operationalized as number of days on which binge eating occurred between the two conditions during the period of the intervention. Secondary outcome measures will be differences in other eating disorder pathology, clinical impairment and in quality of life, while therapeutic alliance, demographic characteristics and followed treatment module will serve as effect moderators. Several types of costs will be assessed. Discussion: This paper presents an online guided self-help Cognitive Behavioral Therapy- Enhanced study protocol for individuals classified with binge eating disorder or other specified feeding or eating disorder. Efficacy will be examined through a Randomized Controlled Trial. Trial registration: The study protocol is registered with the Netherlands Trial Registry NTR (NTR 7994) since 6 September 2019

Efficacy of Web-Based, Guided Self-help Cognitive Behavioral Therapy–Enhanced for Binge Eating Disorder:Randomized Controlled Trial (Preprint)

Background:Due to the gap between treatment supply and demand, there are long waiting-lists for patients with binge eating disorder, and an urgent need to increase their access to specialized treatment. Guided self-help CBT-E may have advantages for the patient if its efficacy can be established.Objective:The aim of this study is to examine the efficacy of guided self-help CBT-E compared to a delayed treatment control condition.Methods:A single-blind two-arm RCT evaluating guided self-help CBT-E according to an intention-to-treat analysis. A total of 180 patients were randomly assigned to the guided self-help CBT-E (N = 90) or to the delayed treatment control condition (N = 90), in which guided self-help CBT-E was provided after the initial 12 week delay. Primary outcome was reduction in binges, secondary outcome was full recovery at end-of-treatment as measured by the eating disorder examination. In addition, dropout rates were assessed in both conditions. A linear mixed model analysis was performed to compare treatment outcomes at the end-of-treatment. An additional analysis was conducted by a mixed ANOVA to measure between- and within group effects up to 24 weeks follow-up. The eating disorder examination-questionnaire and clinical impairment assessment were conducted pre- and post-treatment and during follow-up.Results:Objective binges reduced from on average 19 to 3 binges and 40% showed full recovery at end-of-treatment in the guided self-help CBT-E group, the delayed treatment control group had 16 binges at start and at end-of-treatment they had 13 binges and 6.7% showed full recovery. Between-group effect size (Cohen’s d) was 1.0 for objective binges. At follow-up, after both groups had received treatment, there was no longer a difference between groups. The guided self-help CBT-E group had 3 binges and 39% was fully recovered, the delayed treatment group had 3 binges and 29% showed full recovery. Of the total of 180 participants, 142 (78.9%) completed treatment. Treatment drop-out appeared to be associated with gender, level of education, and number of objective binges at baseline, but not with treatment condition.Conclusions:This 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 as an alternative to wait lists. The present findings underscore international guidelines recommending this form of treatment for binge eating disorder. Clinical Trial: The study protocol is registered with the Netherlands Trial Registry NTR (NTR 7994) since 6 September 2019. Study approval was given in August 2019 by the Medical Research Ethics Committees United (MEC-U) (referencenumber NL 6958.100.19) in Nieuwegein, the Netherland

Comparing the effectiveness and predictors of cognitive behavioural therapy-enhanced between patients with various eating disorder diagnoses: A naturalistic study

Cognitive behaviour therapy-enhanced (CBT-E) is an effective treatment for non-underweight patients with eating disorders. Its efficacy and effectiveness is investigated mostly among transdiagnostic samples and remains unknown for binge eating disorder. The aim of the present study was to assess several treatment outcome predictors and to compare effectiveness of CBT-E among adult out-patients with bulimia nervosa (n=370), binge eating disorder (n=113), and those with a restrictive food pattern diagnosed with other specified feeding and eating disorders (n=139). Effectiveness of CBT-E was assessed in routine clinical practice in a specialised eating disorders centre. Eating disorder pathology was measured with the EDEQ pre- and post-treatment, and at 20 weeks follow-up. Linear mixed model analyses with fixed effect were performed to compare treatment outcome among the eating disorder groups. Several predictors of treatment completion and outcome were examined with a regression analysis. No predictors for drop-out were found, except the diagnosis of bulimia nervosa. Eating disorder pathology decreased among all groups with effect sizes between 1.43 and 1.70 on the EDE-Q total score. There were no differences in remission rates between the three groups at end of treatment or at follow-up. Eating disorder severity at baseline affected treatment response. The results can be generalised to other specialised treatment centres. No subgroup of patients differentially benefited from CBT-E supporting the transdiagnostic perspective for the treatment of eating disorders. Longer-term follow-up data are necessary to measure persistence of treatment benefits. Key learning aims (1) What is the effectiveness of CBT-E among patients suffering from binge eating disorder? (2) Does any subgroup of patients suffering from an eating disorder differentially benefit from CBT-E? (3) What factors predict treatment response

Effectiveness and cost-effectiveness of cognitive behavior therapy-enhanced compared with treatment-as-usual for anorexia nervosa in an inpatient and outpatient routine setting: a consecutive cohort study

Background: For anorexia nervosa, firm evidence of the superiority of specialized psychological treatments is limited and economic evaluations of such treatments in real world settings are scarce. This consecutive cohort study examined differential (cost-)effectiveness for adult inpatients and outpatients with anorexia nervosa, after implementing cognitive behavioral therapy-enhanced (CBT-E) throughout a routine setting. Methods: Differences in remission, weight regain and direct eating disorder treatment costs were examined between one cohort (N = 75) receiving treatment-as-usual (TAU) between 2012–2014, and the other (N = 88) CBT-E between 2015–2017. The economic evaluation was performed from a health care perspective with a one-year time horizon, using EDE global score 50% probability of cost-effectiveness) assuming a WTP of €51,081 or more for each additional remission, On remission, no difference was found with 9.3% remission during TAU and 14.6% during CBT-E (p =.304). Weight regain was higher during CBT-E (EMD = 1.33 kg/m2, SE =.29, 95% CI [0.76–1.9], p <.001). Conclusions: In this mixed inpatient and outpatient cohort study, findings indicate a probability of CBT-Ebeing more effective at higher costs. These findings may contribute to the knowledge of effectiveness and cost-effectiveness of specialized psychological treatments. Plain English Summary: In this study, the effectiveness and treatment costs of a specialized psychological treatment for adult clients with anorexia nervosa were compared with a regular, non-specialist treatment. One group of inpatients and outpatients did receive non-specialist treatment, the next group of inpatients and outpatients received CBT-E, a specialized treatment, later on. CBT-E is recommended for clients with bulimia and with binge eating disorder, for clients with anorexia nervosa it is less clear which specialized psychological treatment should be recommended. Results indicate that at end-of-treatment, CBT-E was not superior on remission. When looking at weight regain, CBT-E seemed superior than the treatment offered earlier. Economic evaluation suggests that CBT-E generates better health gain, but at additional costs. This study contributes to the knowledge on the effectiveness and treatment costs of psychological treatments, as they are offered in routine practice, to adults with anorexia nervosa

The association between the number of previous episodes and modifiable vulnerability factors in remitted patients with recurrent depression.

OBJECTIVE:Remitted patients with a history of several previous major depressive episodes have a higher risk of relapse/recurrence than patients with fewer previous episodes, and the probability of another episode increases progressively with each successive episode. This study examines the association between the number of previous episodes and modifiable vulnerability factors in remitted patients with recurrent depression. METHODS:Patients with recurrent depression (DSM-IV-diagnosed) who were in remission (N = 214) were recruited between September 2011 and July 2016. The association was examined between the number of previous episodes and the following factors: i.e. interpersonal functioning, daily stress, sense of mastery, coping and dysfunctional beliefs. RESULTS:A history of more previous episodes was associated with higher levels of interpersonal problems (P < .001), daily stress (P = .04) and a lower sense of mastery (P = .05). Interpersonal problems were most strongly associated with more previous episodes in a Generalized Linear Regression model. In the domain of interpersonal problems, the subscales that showed the strongest relationship were domineering/controlling, vindictive/self-centred, socially inhibited and self-sacrificing. CONCLUSIONS:Patients with a history of more depressive episodes reported higher levels of interpersonal problems, daily stress and a lower sense of mastery. Future studies should examine these factors in a longitudinal cohort and look at whether the effect of interventions to prevent relapse can be explained by targeting these psychological factors. TRIAL REGISTRATION:Netherlands Trial Register: 2599