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.

Treatment of patients with anorexia nervosa and comorbid post-traumatic stress disorder; where do we stand? A systematic scoping review.

Objective: Comorbid post-traumatic stress disorder in patients with anorexia nervosa may negatively affect the course of anorexia nervosa treatment, which is already challenging. There are currently no guidelines or recommendations on concurrent treatment approaches for both anorexia nervosa and post-traumatic stress disorder. This systematic scoping review aims to explore the feasibility, acceptability and effectiveness of psychological trauma-focused treatment concurrently offered to underweight patients receiving anorexia nervosa treatment. Method: A multi-step literature search, according to an a priori protocol was performed. Databases PubMed, Embase, APA PsycINFO, Web of Science, Scopus and Cochrane Central were searched up to September 19th 2022, and the search was rerun June 19th 2023. For quality assessment, Risk of Bias in Non-randomised Studies-of Interventions tool was used. Results: The extensive search yielded 1769 reports, out of which only three observational pilot studies, both English and German, published between 2004 and 2022, could be included. The included studies reported on a total of 13 female participants between 16 and 58 years old, with anorexia nervosa or otherwise specified feeding or eating disorder, baseline BMI ranging between 14.6 and 16.5, who received concurrent anorexia and post-traumatic stress disorder treatment. In all participants, the emotional and cognitive functioning was sufficient to process the offered trauma-focused interventions, despite their significantly low body weight. Discussion: The findings of this review identify a dearth of treatment research on knowledge of concurrent trauma-focused treatments for patients with anorexia nervosa. Refraining patients with anorexia nervosa from trauma-focused treatment may not be warranted.

Economic evaluation of web-based guided self-help cognitive behavioral therapy-enhanced for binge-eating disorder compared to a waiting list: A randomized controlled trial.

INTRODUCTION: The aim is to perform an economic evaluation alongside a randomized controlled trial comparing guided self-help cognitive behavioral therapy-enhanced (CBT-E) for binge-eating disorder (BED) to a waiting list control condition. METHODS: BED patients (N = 212) were randomly assigned to guided self-help CBT-E or the 3-month waiting list. Measurements took place at baseline and the end-of-treatment. The cost-effectiveness analysis was performed using the number of binge-eating episodes during the last 28 days as an outcome indicator according to the eating disorder examination. A cost-utility analysis was performed using the EuroQol-5D. RESULTS: The difference in societal costs over the 3 months of the intervention between both conditions was €679 (confidence interval [CI] 50-1330). The incremental costs associated with one incremental binge eating episode prevented in the guided self-help condition was approximately €18 (CI 1-41). From a societal perspective there was a 96% likelihood that guided self-help CBT-E led to a greater number of binge-eating episodes prevented, but at higher costs. Each additional quality-adjusted life year (QALY) gained was associated with incremental costs of €34,000 (CI 2494-154,530). With a 95% likelihood guided self-help CBT-E led to greater QALY gain at higher costs compared to waiting for treatment. Based on the National Institute for Health and Clinical Excellence willingness-to-pay threshold of €35,000 per QALY, guided self-help CBT-E can be considered cost-effective with a likelihood of 95% from a societal perspective. DISCUSSION: Guided self-help CBT-E is likely a cost-effective treatment for BED in the short-term (3-month course of treatment). Comparison to treatment-as-usual is recommended for future research, as it enables an economic evaluation with a longer time horizon. PUBLIC SIGNIFICANCE: Offering treatment remotely has several benefits for patients suffering from binge-eating disorders. Guided self-help CBT-E is an efficacious and likely cost-effective treatment, reducing binge eating and improving quality-of-life, albeit at higher societal costs.

Economic evaluation of preventive cognitive therapy versus care as usual in cognitive behavioral therapy responders.

Background: The highly recurrent nature of Major Depressive Disorder is a major contributor to disability and health care costs. Several studies indicate that recurrence may be prevented with Preventive Cognitive Therapy (PCT). This study is the first to perform an economic evaluation of PCT in comparison with care as usual for recurrently depressed patients who experienced two or more depressive episodes and remitted after receiving Cognitive Behavioural Therapy. Methods: An economic evaluation from the societal perspective was performed alongside a randomized trial (N = 214). Health-related quality of life (QALYs), depression-free days, health care utilization, and productivity losses were measured between randomization and 15 months follow-up. The costs were indexed to the reference year 2014. Results: QALY gains did not differ significantly between the groups (p = 0.69). Depression-free days were higher after PCT (p = 0.02). Societal costs of PCT were 10,417 euro and for care as usual 9,545 euro per person. We found a 47% likelihood that PCT led to additional QALYs at higher costs, and there was a 26% likelihood that PCT led to fewer QALYs at higher costs. When depression-free days was used as an outcome, we found PCT had a 72% likelihood of leading to more depression-free days at higher costs than care as usual and a 27% likelihood of leading to more depression-free days at lower societal costs. Limitations: The 15-month follow-up might be too short to draw long-term conclusions about the cost-effectiveness of the PCT. The data collected for this study is part of an RCT to examine the effectiveness of adding PCT to care as usual. Therefore, the study was powered primarily to detect an effect in time to relapse/recurrences. Conclusion: The economic evaluation is slightly in favour of the PCT condition when depression-free days is used as an outcome. PCT is not cost-effective given the high costs per additional QALYs from the societal perspective when QALYs are the effect measure. Clinical trial registration: https://www.onderzoekmetmensen.nl/en, identifier NL2482.

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 < 2.77, the absence of eating disorder behaviors combined with a BMI ≥ 18.5, as effect measure. Incremental cost-effectiveness ratios were calculated and cost-effectiveness planes and cost-effectiveness acceptability curves were displayed to assess the probability that CBT-E is cost effective compared to TAU. RESULTS: Using direct eating disorder treatment costs in the cost-effectiveness analysis, the cost-effectiveness plane of the base case scenario for all patients indicated a 84% likelihood of CBT-E generating better health gain at additional costs. The median ICER is €51,081, indicating a probable preference for CBT-E (> 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. 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.

Reasons for Participation and Nonparticipation in Psychological Relapse Prevention for Anxiety and Depression: A Qualitative Study.

BACKGROUND: Anxiety and depressive disorders frequently recur, but participation in effective psychological interventions to prevent relapse is limited. The reasons for nonparticipation are largely unknown, hampering successful implementation. The aims of this study were: (1) to investigate reasons why patients with remitted anxiety or depressive disorders refuse cognitive-behavioral therapy relapse prevention interventions (RPIs), (2) to compare these reasons with reasons to participate, and (3) to gain insight into patients' preferences regarding relapse prevention. METHODS: A qualitative study was conducted in which data were gathered from 52 semistructured interviews with patients who either refused or agreed to participate in psychological relapse prevention. The constant comparative method was used. RESULTS: The data showed that those who refused to participate (1) did have knowledge about relapse risks in general, (2) but did not relate this risk to themselves, and therefore, did not feel the need for relapse prevention, or (3) declined to participate for logistical reasons or reasons related to the content of the intervention. Preferences concerning the form and content of RPIs were very diverse. CONCLUSIONS: Psychoeducation on relapse should be provided to patients to help them relate recurrence risks to themselves. RPIs should also be individually tailored.

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.

Preventive cognitive therapy versus care as usual in cognitive behavioral therapy responders: A randomized controlled trial.

OBJECTIVE: The optimization of long-term outcomes is an important goal in the treatment of major depressive disorder. Offering subsequent preventive cognitive therapy (PCT) to patients who responded to acute cognitive behavioral therapy (CBT) may reduce the risk of relapse/recurrence. METHOD: Therefore, a multicenter randomized controlled trial was conducted comparing the addition of eight weekly sessions of PCT to care as usual (CAU) versus CAU alone in patients with a history of depression in remission following treatment with CBT. A total of 214 recurrently depressed patients who remitted following treatment with CBT were randomized to PCT (n = 107) or CAU (n = 107). Primary outcome was time to relapse/recurrence over 15 months and was assessed by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I). Secondary outcomes were depressive symptoms measured by the Inventory of Depressive Symptomatology-Self Report and number and severity of relapses/recurrences measured by the SCID-I. RESULTS: Over the 15-month follow-up, the addition of PCT significantly delayed time to relapse/recurrence relative to CAU alone, hazard ratio = 1.807 (number needed to treat = 8.1), p = .02, 95% CI [1.029, 3.174]. No significant differences were found between the conditions on number or severity of relapses/recurrences and residual symptoms. CONCLUSION: Adding PCT was significantly more effective than CAU alone in delaying time to relapse/recurrence of depression over a period of 15 months among CBT responders. After response on CBT, therapists should consider providing PCT to recurrently depressed patients. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

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.

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.