BACKGROUND: Hematopoietic cell transplantation (HCT) is a highly invasive and life-threatening treatment for hematological neoplasms and some types of cancer that can challenge the patient\'s meaning structures. Restoring meaning (i.e., building more flexible and significant explanations of the disease and treatment burden) can be aided by strengthening psychological flexibility by means of an Acceptance and Commitment Therapy (ACT) intervention. Thus, this trial aims to examine the effect of the ACT intervention on the meaning-making process and the underlying mechanisms of change in patients following HCT compared to a minimally enhanced usual care (mEUC) control group. The trial will be enhanced with a single-case experimental design (SCED), where ACT interventions will be compared between individuals with various pre-intervention intervals.
METHODS: In total, 192 patients who qualify for the first autologous or allogeneic HCT will be recruited for a two-armed parallel randomized controlled trial comparing an online self-help 14-day ACT training to education sessions (recommendations following HCT). In both conditions, participants will receive once a day a short survey and intervention proposal (about 5-10 min a day) in the outpatient period. Double-blinded assessment will be conducted at baseline, during the intervention, immediately, 1 month, and 3 months after the intervention. In addition, 6-9 participants will be invited to SCED and randomly assigned to pre-intervention measurement length (1-3 weeks) before completing ACT intervention, followed by 7-day observations at the 2nd and 3rd post-intervention measure. The primary outcome is meaning-related distress. Secondary outcomes include psychological flexibility, meaning-making coping, meanings made, and well-being as well as global and situational meaning.
CONCLUSIONS: This trial represents the first study that integrates the ACT and meaning-making frameworks to reduce meaning-related distress, stimulate the meaning-making process, and enhance the well-being of HCT recipients. Testing of an intervention to address existential concerns unique to patients undergoing HCT will be reinforced by a statistically rigorous idiographic approach to see what works for whom and when. Since access to interventions in the HCT population is limited, the web-based ACT self-help program could potentially fill this gap.
BACKGROUND: ClinicalTrials.gov ID: NCT06266182. Registered on February 20, 2024.

Meta-analysis is of increasing importance as this quantitative synthesis technique has the potential to summarize a tremendous amount of research evidence, which can help making evidence-based decisions in policy, practice, and theory. This paper examines the single-case meta-analyses within the Education and Psychology fields. The amount of methodological studies related to the meta-analysis of Single-Case Experimental Designs (SCEDs) is increasing rapidly, especially in these fields. This underscores the necessity of a succinct summary to help methodologists identify areas for further development in Education and Psychology research. It also aids applied researchers and research synthesists in discerning when to use meta-analytic techniques for SCED studies based on criteria such as bias, mean squared error, 95% confidence intervals, Type I error rates, and statistical power. Based on the summary of empirical evidence from 18 reports identified through a systematic search procedure, information related to meta-analytic techniques, data generation and analysis models, design conditions, statistical properties, conditions under which the meta-analytic technique is appropriate, and the study purpose(s) were extracted. The results indicate that three-level hierarchical linear modeling is the most empirically validated SCED meta-analytic technique, and parameter bias is the most prominent statistical property investigated. A large number of primary studies (more than 30) and at least 20 measurement occasions per participant are recommended for usage of SCED meta-analysis in Education and Psychology fields.

BACKGROUND: Health anxiety (HA) by proxy is described as parents\' obsessive worries that their child is severely ill although this is not medically confirmed. Research on HA by proxy suggests that it is highly distressing for the parent and that the child may be at risk of developing maladaptive symptom coping strategies. No targeted treatment for this group exists. We developed PROXY, an 8-week psychological internet-delivered treatment for parents with HA by proxy. The treatment components of PROXY are informed by cognitive behavioral therapy as well as acceptance and commitment therapy, and it was developed in collaboration with parents experiencing HA by proxy and clinical experts.
OBJECTIVE: This paper describes the protocol for a study investigating the potential effects of PROXY on parents\' worries about their children\'s health using a single-case experimental design (SCED).
METHODS: Five parents clinically evaluated as experiencing HA by proxy will be included. A replicated randomized SCED study will be conducted in which each participant will be randomized to receive treatment after a baseline period of between 7 and 26 days (phase A). The treatment phase duration is 8 weeks for all participants (phase B), followed by a follow-up phase lasting between 14 and 33 days (phase C), ensuring that all participants remain in the study for 96 days. Participants will report daily anxiety level by SMS text message throughout the study. They will also answer self-report questionnaires, including questions on HA by proxy and own HA, 4 times during the study. Data will be submitted to structured visual analysis to inspect anxiety level, the variability of anxiety, trends, the overlap of data points among phases, when effects occur, and the consistency of data patterns across participants. Furthermore, randomization tests will be conducted for each participant to test the null hypothesis that PROXY will have no effect on participants\' anxiety.
RESULTS: The recruitment of parents began in June 2022. As of March 2, 2023, a total of 4 parents have been included in the study. Data collection was expected to cease in April 2023.
CONCLUSIONS: To the best of our knowledge, this protocol describes the only study of treatment for HA by proxy. As the prevalence of this condition is still unknown, a SCED was chosen because this method allows the inclusion of very few participants while still providing information on effects and treatment courses. Conducting the study with a replicated randomized phase design enables methodologically sound testing despite the inclusion of very few participants. The results will inform researchers on individual treatment courses and effects, which may direct future research in terms of the possible mechanisms of change, ideas for how to refine the treatment content, and how the treatment may be offered to patients in the future.
BACKGROUND: ClinicalTrials.gov NCT04830605; https://clinicaltrials.gov/study/NCT04830605.
UNASSIGNED: DERR1-10.2196/46927.

BACKGROUND: Patients with anorexia nervosa tend to experience an inner \"eating disorder\" voice. They struggle to recognise and assert their own identity over the illness\'s identity and relate to it from a powerless and subordinate position. AVATAR therapy was developed to help patients with psychosis to gain greater power and control over distressing voices. The goal of this study was to test the feasibility, acceptability, safety and preliminary efficacy of an adaptation of AVATAR therapy for anorexia nervosa.
METHODS: Twelve adult patients with anorexia nervosa were recruited. Ten completed an assessment session and between five to seven therapy sessions. The assessment session consisted in the creation of an avatar to represent the \"eating disorder\". This was accomplished by manipulating auditory and visual characteristics through a specialist computer software. During the therapy sessions, patients interacted with the avatar to assert their own desires and will. Patients completed baseline, end of intervention and follow-up (4-week) online questionnaires. A non-concurrent multiple baselines single case experimental design (SCED) was used (A1BA2). Feasibility, acceptability, safety and preliminary efficacy of the intervention were assessed.
RESULTS: The therapy met pre-specified criteria relating to (1) Feasibility: sample recruited within three months; retention rate at the end of the treatment phase = 81.9%; therapy completion rate = 90.1%. (2) Safety: no serious adverse events associated with the intervention. (3) Acceptability: mean ratings = 7.5 (SD = 2.61) out of ten, on a 0-10 scale of acceptability (10 = complete satisfaction). With regards to efficacy, participants reported significantly lower levels of distress associated with the eating disorder voice and higher levels of self-compassion at the end of treatment. No other significant changes were observed in frequency of the eating disorder voice, voice\'s characteristics, such as omnipotence and malevolence, eating disorder symptoms and symptoms of anxiety, depression and stress. Patients\' feedback indicated that the therapy had helped with their ability to stand up to the illness, make positive changes around eating, and increase their motivation to recover and self-compassion.
CONCLUSIONS: AVATAR therapy for anorexia nervosa is feasible, acceptable and safe for patients. Larger studies are needed to test clinical efficacy.
BACKGROUND: The study was pre-registered on the clinicaltrials.gov registry (https://clinicaltrials.gov/ct2/show/NCT04778423).
People with anorexia nervosa often struggle with connecting to their identity beyond the illness. They tend to relate to the eating disorder from a powerless and submissive position. The aim of this study was to test AVATAR therapy for anorexia nervosa. The goal of the intervention was to help patients to assert themselves, their identity, will, power and desires, when confronted with the “voice” of the illness. Twelve patients with anorexia nervosa were recruited and 10 completed one assessment session and five to seven therapy sessions. During the assessment session, patients were guided by the therapist to create a representation of their illness (“the avatar”) by manipulating visual and auditory characteristics through a computer software. During treatment, they were supported by the therapist to assert themselves over the illness, responding to the abusive and critical comments of the eating disorder delivered by “the avatar”. Patients’ qualitative feedback indicated that the therapy was meaningful to them, and that it helped to recognise their own voice as distinct from the illness. The distress perceived in relation to the eating disorder voice decreased over time, and feelings of self-compassion increased at the end of therapy. Findings point towards the acceptability and usefulness of AVATAR therapy for anorexia nervosa. Larger studies are needed expand these results.

Cancer-related cognitive impairment (CRCI) affects a large proportion of cancer survivors and has significant negative effects on survivor function and quality of life (QOL). Treatments for CRCI are being developed and evaluated. Memory and attention adaptation training (MAAT) is a cognitive-behavioral therapy (CBT) demonstrated to improve CRCI symptoms and QOL in previous research. The aim of this article is to describe a single-case experimental design (SCED) approach to evaluate interventions for CRCI in clinical practice with patient-reported outcome measures (PROs). We illustrate the use of contemporary SCED methods as a means of evaluating MAAT, or any CRCI treatment, once clinically deployed. With the anticipated growth of cancer survivorship and concurrent growth in the number of survivors with CRCI, the treatment implementation and evaluation methods described here can be one way to assess and continually improve CRCI rehabilitative services.

BACKGROUND: Executive function, including prospective memory, initiating, planning, and sequencing everyday activities, is frequently affected by acquired brain injury (ABI). Executive dysfunction necessitates the use of compensatory cognitive strategies and, in more severe cases, human support over time. To compensate for the executive dysfunction experienced, growing options for electronic mainstream and assistive technologies may be used by people with ABI and their supporters.
OBJECTIVE: We outline the study protocol for a series of single-case experimental designs (SCEDs) to evaluate the effectiveness of smart home, mobile, and/or wearable technologies in reducing executive function difficulties following ABI.
METHODS: Up to 10 adults with ABI who experience executive dysfunction and have sufficient cognitive capacity to provide informed consent will be recruited across Victoria and New South Wales, Australia. Other key inclusion criteria are that they have substantial support needs for everyday living and reside in community dwellings. On the basis of the participant\'s identified goal(s) and target behavior(s), a specific electronic assistive technology will be selected for application. Both identification of the target behavior(s) and selection of the assistive technology will be determined via consultation with each participant (and their key support person, if applicable). The choice of SCED will be individualized for each participant based on the type of technology used in the intervention, the difficulty level of the behavior targeted for change, and the anticipated rate of change. For each SCED, repeated measurements of the target behavior(s) during the baseline condition will provide performance data for comparison with the performance data collected during the intervention condition (with technology introduced). Secondary outcome measures will evaluate the impact of the intervention. The protocol includes 2 customizable Microsoft Excel spreadsheets for electronic record keeping.
RESULTS: Recruitment period is June 2022 through March 2024. Trial results for the individual participants will be graphed and analyzed separately using structured visual analysis supplemented with statistical analysis. Analysis will focus on important features of the data, including both within- and between-phase comparisons for response level, trend, variability, immediacy, consistency, and overlap. An exploratory economic evaluation will determine the impact on formal and informal support usage, together with quality of life, following the implementation of the new technological intervention.
CONCLUSIONS: The study has been designed to test the cause-effect functional relationships between the intervention-in this case, electronic assistive technology-and its effect in changing the target behavior(s). The evaluation evidence gained will offer new insights into the application of various electronic assistive technologies for people who experience executive dysfunction following ABI. Furthermore, the results will help increase the capacity of key stakeholders to harness the potential of technology to build independence and reduce the cost of care for this population.
BACKGROUND: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12622000835741, https://www.anzctr.org.au/ACTRN12622000835741.aspx.
UNASSIGNED: DERR1-10.2196/48503.

UNASSIGNED: We explored the effects of a mindfulness program based on the satipatthana sutta (instead of a contemporary Western program), with participants as collaborators, using a single-case experimental design. The main question was whether such a training has positive effects and, if so, whether and how the effects vary across participants and measures.
UNASSIGNED: Participants chose the design (multiple baseline) and the measures to be repeatedly collected. Then they took part in a 6-week mindfulness training based on the satipatthana sutta; finally, they performed a preliminary data analysis of their own results. Reported are a selection of the visual analyses, intraindividual effect sizes (Tau-U), and the results of single-case meta-analyses over participants, as well as a multivariate graphical analysis of interindividual differences.
UNASSIGNED: Substantial training effects were found on average and for the majority of participants for concentration, mind wandering, decentering, positive affect, and well-being. Effects were small for negative affect, and no effects were found for emotion regulation. However, interindividual variation was high, both in respect to specific measures and concerning the overall effect of the training program. Participants\' motivation was found to be very high throughout the study.
UNASSIGNED: Our findings indicate that a traditional mindfulness program yields effects that are roughly comparable to the effects of secular mindfulness training regimens. Regarding participants as collaborators appears to have a strong motivating effect. And finally, the study demonstrates that using single-case experimental designs (instead of group designs) allows for a more fine-grained analysis of meditation effects. The high interindividual variation points to the possibility that the amount of unexplained variance in group studies is severely underestimated. Results from studies like the current one could have benefits for both theoretical advancement and custom-tailored assignment of specific forms of meditation to specific people with specific aims.
UNASSIGNED: The online version contains supplementary material available at 10.1007/s12671-023-02160-1.

Eating disorders (EDs) are serious psychiatric disorders associated with substantial morbidity and mortality that are prevalent among university students. Because many students do not receive treatment due to lack of access on university campuses, mobile-health (mHealth) adaptations of evidence-based treatments represent an opportunity to increase treatment accessibility and engagement. The purpose of this study was to test the initial efficacy of Building Healthy Eating and Self-Esteem Together for University Students (BEST-U), which is a 10-week mHealth self-guided cognitive-behavioral therapy (CBT-gsh) app that is paired with a brief 25-30-min weekly telehealth coaching, for reducing ED psychopathology in university students.
A non-concurrent multiple-baseline design (N = 8) was used to test the efficacy of BEST-U for reducing total ED psychopathology (primary outcome), ED-related behaviors and cognitions (secondary outcomes), and ED-related clinical impairment (secondary outcome). Data were examined using visual analysis and Tau-BC effect-size calculations.
BEST-U significantly reduced total ED psychopathology and binge eating, excessive exercise, and restriction (effect sizes ranged from -0.39 to -0.92). Although body dissatisfaction decreased, it was not significant. There were insufficient numbers of participants engaging in purging to evaluate purging outcomes. Clinical impairment significantly reduced from pre-to-post-treatment.
The current study provided initial evidence that BEST-U is a potentially efficacious treatment for reducing ED symptoms and ED-related clinical impairment. Although larger-scale randomized controlled trials are needed, BEST-U may represent an innovative, scalable tool that could reach greater numbers of underserved university students than traditional intervention-delivery models.
Using a single-case experimental design, we found evidence for the initial efficacy of a mobile guided-self-help cognitive-behavioral therapy program for university students with non-low weight binge-spectrum eating disorders. Participants reported significant reductions in ED symptoms and impairment after completion of the 10-week program. Guided self-help programs show promise for filling an important need for treatment among university students with an ED.

BACKGROUND: Lack of physical activity is a common issue with detrimental consequences for the health of people with severe mental illness (SMI). Existing physical activity interventions show suboptimal effects as they require substantial cognitive skills, including goal setting and writing, whereas cognitive deficits are common in this population. To bolster the effectiveness of physical activity interventions, self-control training (SCT), in which users practice the ability to override unwanted thoughts and behaviors, can be used in addition. Recent research has demonstrated the initial effectiveness of a mobile SCT app, but this has not been studied in psychiatric clinical practice.
OBJECTIVE: This study aims to evaluate to what extent adding a mobile SCT app designed for and with people with SMI to a mobile lifestyle intervention aimed at increasing physical activity increases physical activity and self-control levels.
METHODS: A mixed methods approach incorporating 2 single-case experimental designs (SCEDs) and qualitative interviews was used to evaluate and optimize SCT. Overall, 12 participants with SMI will be recruited from 2 organizations offering outpatient and inpatient care to people with SMI. Each experiment will include 6 patients. SCED I is a concurrent multiple-baseline design across participants that explores initial effectiveness and optimal intervention duration. Using accelerometry and experience sampling questionnaires, participants\' physical activity and self-control will be monitored for ≥5 days from baseline, followed by the sequential introduction of Google Fit, the physical activity intervention, for 7 days and the addition of SCIPP: Self-Control Intervention App for 28 days. SCED II is an introduction/withdrawal design in which optimized SCT will be introduced and withdrawn to validate the findings from SCED I. In both experiments, the daily average of total activity counts per hour and the state level of self-control will serve as the primary and secondary outcome measures. Data will be analyzed using visual analysis and piecewise linear regression models.
RESULTS: The study was designated as not subject to the Dutch Medical Research Involving Human Subjects Act by the Medical Research Ethical Committee Oost-Nederland and approved by the Ethics Committee/domain Humanities and Social Sciences of the Faculty of Behavioural, Management, and Social Sciences at the University of Twente. Participant recruitment started in January 2022, and we expect to publish the results in early 2023.
CONCLUSIONS: The mobile SCT app is expected to be feasible and effective. It is self-paced and scalable and can increase patient motivation, making it a suitable intervention for people with SMI. SCED is a relatively novel yet promising method for gaining insights into whether and how mobile apps work that can handle heterogeneous samples and makes it possible to involve a diverse population with SMI without having to include a large number of participants.
UNASSIGNED: PRR1-10.2196/37727.

Background: Fear of cancer recurrence (FCR) is one of the greatest problems with which cancer survivors have to deal. High levels of FCR are characterized by intrusive thoughts about cancer-related events and re-experiencing these events, avoidance of reminders of cancer, and hypervigilance, similar to post-traumatic stress disorder (PTSD). Eye movement desensitization and reprocessing (EMDR) therapy focuses on these images and memories. It is effective in reducing PTSD and may be effective in reducing high levels of FCR.Objective: The aim of the present study is to investigate the effectiveness of EMDR for severe FCR in breast and colorectal cancer survivors.Method: A multiple-baseline single-case experimental design (n = 8) was used. Daily repeated measurements for FCR were taken during the baseline phase and treatment phase, post-treatment, and at the 3 month follow-up. Participants answered the Cancer Worry Scale (CWS) and the Fear of Cancer Recurrence Inventory, Dutch version (FCRI-NL) five times, i.e. at the start and at the end of each phase (baseline, treatment, post-treatment, and follow-up). The study was prospectively registered at clinicaltrials.gov (NL8223).Results: Visual analysis and effect size calculation by Tau-U were executed for the daily questionnaire on FCR. The weighted average Tau-U score was .63 (p < .01) for baseline versus post-treatment, indicating large change, and .53 (p < .01) between baseline and follow-up, indicating moderate change. The scores on the CWS and FCRI-NL-SF decreased significantly from baseline to follow-up.Conclusion: The results seem promising for EMDR therapy as a potentially effective treatment for FCR. Further research is recommended.
Patients who experience high fear of cancer recurrence (FCR) often have intrusive memories and images about (future) cancer-related events.Eye movement desensitization and reprocessing (EMDR) therapy can focus on these intrusions.EMDR therapy is found to be a promising therapy for patients experiencing high FCR.