BACKGROUND: The leading evidence-based treatment for anorexia nervosa (AN) in adolescents is Family-based Treatment (FBT). However, due to the intensive training requirements and lack of practitioners, it is often difficult for families to access FBT. Thus, innovations that improve access to care are needed. A pilot randomized study of a guided self-help version of Family-based Treatment (GSH-FBT) that utilized approximately 1/4 the amount of therapist time compared to FBT found that the approach was acceptable and appeared to achieve similar outcomes. The study protocol detailed in this manuscript compares the efficiency (clinician time) of GSH-FBT to Family-based Treatment via Videoconferencing (FBT-V) in a fully powered study in achieving clinical outcomes through a multi-site randomized clinical trial across the US and Ontario, Canada.
METHODS: This study will randomize the families of adolescents ages 12-18 (n = 200) who meet DSM-5 criteria for AN to receive either GSH-FBT or FBT-V. Participants will be randomized to 15 sixty-minute sessions of FBT-V or to 10 twenty-minute sessions of online GSH-FBT. Major assessments will be conducted by a masked assessor at baseline, within treatment, at the end of treatment (EOT), and 6 and 12 months after the end of treatment (EOT). The primary outcomes of this study are changes to body weight and eating disorder cognitions relative to clinician time used (relative efficiency of treatment modality).
CONCLUSIONS: The findings of this study may help increase access to care by providing a time efficient, affordable, more scalable intervention for adolescent AN compared to standard FBT.

UNASSIGNED: Chile faces a significant postpartum depression prevalence and treatment gap, necessitating accessible interventions. While cognitive-behavioral internet-based interventions have proven effective in high-income countries, this field is underdeveloped in Chile. Based on the country\'s widespread use of digital technology, a guided 8-week cognitive-behavioral web app intervention named \"Mamá, te entiendo\" was developed.
UNASSIGNED: This study aimed to assess the acceptability and feasibility of \"Mamá, te entiendo\", for reducing depressive symptomatology in postpartum women.
UNASSIGNED: Sixty-five postpartum women with minor or major depression were randomly assigned to either intervention or waitlist. Primary outcomes centered on study feasibility, intervention feasibility, and acceptability. Semi-structured interviews with a sub-sample enriched the understanding of participants\' experiences. Secondary outcomes included mental health variables assessed at baseline, post-intervention, and 1-month follow-up.
UNASSIGNED: Chilean women displayed great interest in the intervention. 44.8 % of participants completed the intervention. Participants reported high satisfaction and engagement levels, with interviewees highlighting the value of the intervention\'s content, exercises, and therapist\'s feedback. However, preliminary efficacy analysis didn\'t reveal a significant interaction between group and time for outcome measures.
UNASSIGNED: This research represents a pioneering effort in Chile to evaluate an internet-based intervention for postpartum depression symptoms. The demonstrated feasibility and acceptability highlight the potential of integrating technology-driven approaches into mental health interventions. However, the intervention did not demonstrate superiority, as both groups exhibited similar positive progress in several outcomes. Therefore, the following research phase should involve a larger and more diverse sample to assess the intervention\'s effectiveness, identify influencing factors, and determine the individuals who benefit the most.

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.

BACKGROUND: Although 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.
OBJECTIVE: This 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.
METHODS: A 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.
RESULTS: At 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.
CONCLUSIONS: The 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.

BACKGROUND: Availability of long-term psychological interventions for personality disorders is limited because of their high intensity and cost. Research in evidence-based, low-intensity interventions is needed.
OBJECTIVE: This study aimed to examine the feasibility, acceptability and potential impact of a low-intensity, digital guided self-help (GSH) intervention that is focused on emotion regulation, recovery-oriented and provides in-the-moment delivery for patients with personality disorders.
METHODS: We conducted a single-blind feasibility trial. A total of 43 patients with a personality disorder were recruited and randomly assigned to either a GSH arm (n = 22) or a treatment-as-usual arm (n = 21). The GSH intervention included a series of short videos offering psychoeducation and support, personalised feedback using text messages, and supportive telephone calls, for 4 weeks in addition to treatment as usual. Outcomes of emotional disturbance, emotion dysregulation, self-harm behaviours and decentring ability were measured at baseline, 4 weeks (end of intervention) and 8 weeks (follow-up).
RESULTS: All patients who attended the first session continued until the last session. There was an interaction effect between time and group on anxiety (P = 0.027, Δη2 = 0.10), where the GSH group showed a significant reduction in anxiety at follow-up (P = 0.003, d = 0.25). The GSH group increased in decentring ability at the end of intervention (P = 0.007, d = -0.65), and the decrease in self-harm behaviours continued until follow-up (P = 0.02, d = 0.57).
CONCLUSIONS: The results suggest that a personalised digital GSH with a focus on recovery could reduce anxiety and self-harm behaviours at short-term follow-up.

BACKGROUND: Loss of Control Eating (LOC) is the most prevalent form of eating disorder pathology in youth, but research on evidence-based treatment in this group remains scarce. We assessed for the first time the effects and acceptance of a blended treatment program for youth between 14 and 24 years with LOC (Binge-eating Adolescent Treatment, BEAT).
METHODS: Twenty-four youths (mean age 19.1 years) participated in an active treatment of nine-weeks including three face-to-face workshops and six weekly email-guided self-help sessions, followed by four email guided follow-up sessions, one, three, six and 12 months after the active treatment. All patients completed a two-weeks waiting-time period before treatment begin (within-subject waitlist control design).
RESULTS: The number of weekly LOC episodes substantially decreased during both the waiting-time (effect size d = 0.45) and the active treatment (d = 1.01) period and remained stable during the subsequent 12-months follow-up (d = 0.20). The proportion of patients with full-threshold binge-eating disorder (BED) diagnoses decreased and transformed into LOC during the study course, while the abstainer rate of LOC increased. Values for depressive symptoms (d = 1.5), eating disorder pathology (d = 1.29) and appearance-based rejection sensitivity (d = 0.68) all improved on average from pretreatment to posttreatment and remained stable or further improved during follow-up (d between 0.11 and 0.85). Body weight in contrast remained constant within the same period. Treatment satisfaction among completers was high, but so was the dropout rate of 45.8% at the end of the 12-months follow-up.
CONCLUSIONS: This first blended treatment study BEAT might be well suited to decrease core symptoms of LOC, depressive symptoms and appearance-based rejection sensitivity. More research is needed to establish readily accessible interventions targeted more profoundly at age-salient maintaining factors such as appearance-based rejection sensitivity, while at the same time keeping dropout rates at a low level.
BACKGROUND: The trial was registered at the German Clinical Trials Register (ID: DRKS00014580; registration date: 21/06/2018).

UNASSIGNED: Guided self-help has been shown to be effective for other mental conditions and, if effective for post-traumatic stress disorder, would offer a time-efficient and accessible treatment option, with the potential to reduce waiting times and costs.
UNASSIGNED: To determine if trauma-focused guided self-help is non-inferior to individual, face-to-face cognitive-behavioural therapy with a trauma focus for mild to moderate post-traumatic stress disorder to a single traumatic event.
UNASSIGNED: Multicentre pragmatic randomised controlled non-inferiority trial with economic evaluation to determine cost-effectiveness and nested process evaluation to assess fidelity and adherence, dose and factors that influence outcome (including context, acceptability, facilitators and barriers, measured qualitatively). Participants were randomised in a 1 : 1 ratio. The primary analysis was intention to treat using multilevel analysis of covariance.
UNASSIGNED: Primary and secondary mental health settings across the United Kingdom\'s National Health Service.
UNASSIGNED: One hundred and ninety-six adults with a primary diagnosis of mild to moderate post-traumatic stress disorder were randomised with 82% retention at 16 weeks and 71% at 52 weeks. Nineteen participants and ten therapists were interviewed for the process evaluation.
UNASSIGNED: Up to 12 face-to-face, manualised, individual cognitive-behavioural therapy with a trauma focus sessions, each lasting 60-90 minutes, or to guided self-help using Spring, an eight-step online guided self-help programme based on cognitive-behavioural therapy with a trauma focus, with up to five face-to-face meetings of up to 3 hours in total and four brief telephone calls or e-mail contacts between sessions.
UNASSIGNED: Primary outcome: the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, at 16 weeks post-randomisation. Secondary outcomes: included severity of post-traumatic stress disorder symptoms at 52 weeks, and functioning, symptoms of depression, symptoms of anxiety, alcohol use and perceived social support at both 16 and 52 weeks post-randomisation. Those assessing outcomes were blinded to group assignment.
UNASSIGNED: Non-inferiority was demonstrated at the primary end point of 16 weeks on the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition [mean difference 1.01 (one-sided 95% CI -∞ to 3.90, non-inferiority p = 0.012)]. Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, score improvements of over 60% in both groups were maintained at 52 weeks but the non-inferiority results were inconclusive in favour of cognitive-behavioural therapy with a trauma focus at this timepoint [mean difference 3.20 (one-sided 95% confidence interval -∞ to 6.00, non-inferiority p = 0.15)]. Guided self-help using Spring was not shown to be more cost-effective than face-to-face cognitive-behavioural therapy with a trauma focus although there was no significant difference in accruing quality-adjusted life-years, incremental quality-adjusted life-years -0.04 (95% confidence interval -0.10 to 0.01) and guided self-help using Spring was significantly cheaper to deliver [£277 (95% confidence interval £253 to £301) vs. £729 (95% CI £671 to £788)]. Guided self-help using Spring appeared to be acceptable and well tolerated by participants. No important adverse events or side effects were identified.
UNASSIGNED: The results are not generalisable to people with post-traumatic stress disorder to more than one traumatic event.
UNASSIGNED: Guided self-help using Spring for mild to moderate post-traumatic stress disorder to a single traumatic event appears to be non-inferior to individual face-to-face cognitive-behavioural therapy with a trauma focus and the results suggest it should be considered a first-line treatment for people with this condition.
UNASSIGNED: Work is now needed to determine how best to effectively disseminate and implement guided self-help using Spring at scale.
UNASSIGNED: This trial is registered as ISRCTN13697710.
UNASSIGNED: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 14/192/97) and is published in full in Health Technology Assessment; Vol. 27, No. 26. See the NIHR Funding and Awards website for further award information.
Post-traumatic stress disorder is a common, disabling condition that can occur following major traumatic events. Typical symptoms include distressing reliving, avoidance of reminders and feeling a current sense of threat. First-choice treatments for post-traumatic stress disorder are individual, face-to-face talking treatments, of 12–16 hours duration, including cognitive behavioural therapy with a trauma focus. If equally effective treatments could be developed that take less time and can be largely undertaken in a flexible manner at home, this would improve accessibility, reduce waiting times and hence the burden of disease. RAPID was a randomised controlled trial using a web-based programme called Spring. The aim was to determine if trauma-focused guided self-help provided a faster and cheaper treatment for post-traumatic stress disorder than first-choice face-to-face therapy, while being equally effective. Guided self-help using Spring is delivered through eight steps. A therapist provides a 1-hour introductory meeting followed by four further, fortnightly sessions of 30 minutes each and four brief (around 5 minutes) telephone calls or e-mail contacts between sessions. At each session, the therapist reviews progress and guides the client through the programme, offering continued support, monitoring, motivation and problem-solving. One hundred and ninety-six people with post-traumatic stress disorder to a single traumatic event took part in the study. Guided self-help using Spring was found to be equally effective to first-choice face-to-face therapy at reducing post-traumatic stress disorder symptoms at 16 weeks. Very noticeable improvements were maintained at 52 weeks post-randomisation in both groups, when most results were inconclusive but in favour of face-to-face therapy. Guided self-help using Spring was significantly cheaper to deliver and appeared to be well-tolerated. It is noteworthy that not everyone benefitted from guided self-help using Spring, highlighting the importance of considering it on a person-by-person basis, and personalising interventions. But, the RAPID trial has demonstrated that guided self-help using Spring provides a low-intensity treatment option for people with post-traumatic stress disorder that is ready to be implemented in the National Health Service.

High dropout rates and poor adherence associated with digital interventions have prompted research into modifications of these treatments to improve engagement and completion rates. This trial aimed to investigate the added benefit of clinician support when paired alongside a ten-session, online cognitive behaviour therapy (CBT) self-help intervention for bulimia nervosa (BN). As part of a three-arm, phase II randomised controlled trial, 114 participants (16 years or over) with full or subthreshold BN were randomly assigned to complete the intervention in a self-help mode (with administrative researcher contact; n = 38), with adjunct clinician support (weekly 30-minute videoconferencing sessions; n = 37), or a no-treatment waitlist control (WLC; n = 39). Baseline to post-treatment (12-weeks) decreases in objective binge episode frequency were significantly greater for clinician-supported participants as compared to WLC, but not for self-help when compared to WLC. However, due to continued improvements for self-help across follow-up (24-weeks), both arms outperformed WLC when analysed as an overall rate of change across three timepoints. Clinician-supported participants outperformed self-help in regards to laxative use and dietary restraint. Our results demonstrate that good clinical outcomes can be achieved with a relatively brief online CBT-based program even in the absence of structured clinical support, indicating a possible overreliance upon clinician support as a primary adherence-facilitating mechanism.

BACKGROUND: Huntington\'s disease (HD) is an adult-onset genetic neurodegenerative condition associated with cognitive decline, motor impairments, and emotional difficulties. Anxiety affects up to 71% of HD gene expansion carriers (i.e., those with the version of the gene that causes HD) and can negatively impact quality of life, worsen other HD symptoms, and increase suicide risk. Therefore, helping people with their anxiety should be a clinical priority. A significant evidence base now exists for low-cost talking therapies for anxiety, such as guided self-help, and with people with other neurodegenerative conditions (e.g., Parkinson\'s disease). However, this type of intervention has not been specifically assessed with HD gene expansion carriers.
METHODS: This protocol describes an exploratory randomised controlled feasibility study of a psychological intervention for anxiety for HD gene expansion carriers. The 10 session guided self-help intervention (\'GUIDE-HD\') is based on a blend of second and third wave cognitive behavioural models of anxiety (cognitive behaviour therapy [CBT] and acceptance and commitment therapy [ACT]) and is adapted to meet the specific needs of an HD population. This study will compare guided self-help with treatment as usual (TAU), with 15 HD gene expansion carriers randomly allocated to each group. Participants will be recruited across the UK. Quantitative data will be collected pre-intervention, immediately post-intervention, 3-month post-intervention and 6-month post-intervention. Qualitative data will be collected at one month post-intervention from participants, including HD carers. The data will be analysed to assess whether the current intervention and study design are feasible to progress to a larger randomised controlled trial. Feasibility has been defined in terms of recruitment rate, retention rate to both trial arms, intervention adherence, and acceptability of the intervention and measurement tools.
CONCLUSIONS: Given the lack of evidenced interventions to date to support the wellbeing of people with the expanded Huntington\'s gene, this study will assess the feasibility of progressing this particular intervention to a full trial. To try and increase the acceptability of the intervention, a number of stakeholders, including those affected by HD and in caring roles, have been fundamental to the creation of the intervention (e.g., therapy manual, planned therapy process) to date.
BACKGROUND: Trial ID: ISRCTN47330596 . Date registered: 28/09/2022. Protocol version and date: Version 2, 09/06/22. Trial sponsor organisation and contact: Leicestershire Partnership NHS Trust (Dave Clarke). Role of sponsor: Overall responsibility for the conduct and governance of the trial. Role of funder: Review of initial research proposal.

BACKGROUND: Due to several treatment barriers, many individuals with panic disorder do not receive evidence-based treatment. One promising option to narrow this treatment gap is Internet-based psychotherapy, which has been shown particularly effective in guided formats. Still, there remains room for improvement to make these digital therapies more accessible, cost-efficient, and aligned with best practices for in-person interventions (e.g., exposure). The smartphone app \"Invirto - Treatment for Anxiety\" offers digitally guided, evidence-based treatment of panic disorders including virtual reality (VR) for exposure therapy. The aim present study is to investigate the efficacy, safety, and acceptance of Invirto in comparison to a care-as-usual (CAU) control group.
METHODS: We plan to conduct a randomized controlled trial with two conditions (intervention vs. CAU), three assessment times via online surveys (t0: baseline; t1: 3 months after baseline; t2: follow-up assessment 6 months after baseline), and a total of 128 participants with a clinical diagnosis of panic disorder (symptoms must be experienced ≥ 1 year). Recruitment will take place via email, phone, and the study website. The primary outcome will be the change in anxiety symptoms as measured by Beck\'s Anxiety Inventory from t0 to t1. Secondary outcomes will be the change in anxiety symptoms (measured by the Panic and Agoraphobia Scale, PAS; Questionnaire on panic-related Anxieties, Cognitions and Avoidance, ACA), depressive symptoms (measured by the Beck-Depression-Inventory, BDI-II), treatment satisfaction (measured by the Client Satisfaction Questionnaire, CSQ-8; Treatment Adherence Perception Questionnaire, TAPQ-adapt; Positive and Negative Effects of Psychotherapy Scale, PANEPS-I), psychological flexibility (measured by the Acceptance and Action Questionnaire-II, AAQ-II), and dissociation during VR exposure (measured by an adapted version of the Peritraumatic Dissociative Experiences Questionnaire, PDEQ-adapt). Participants in the intervention group will receive access to the intervention (Invirto) right after t0, while the CAU group will receive access to Invirto after t1. We expect a larger change in both the primary and secondary outcomes from t0 to t1 in the intervention group in comparison to the CAU group.
CONCLUSIONS: This study is one of the first to evaluate an Internet-based intervention for people with panic disorder that includes self-application of VR exposure therapy. The findings are expected to extend the body of knowledge about effective Internet-based treatment options for people with panic disorder. The empirical and clinical implications and the limitations of the study are discussed.
BACKGROUND: DRKS00027585 ( www.drks.de/drks_web/ ), date of registration: 13 January 2022.