OBJECTIVE: Group activities are commonly offered to residents of nursing homes, and increasingly with a person-centred care approach. The aim of this study is to compare the impacts of a Montessori-based reading activity with a more traditional reading activity.
METHODS: A multiple baseline design was used, with 3 groups of 5 older adults with moderate to severe dementia. All sessions were videorecorded and analysed by independent judges, blinded to our hypotheses and conditions. Impacts of the type of activity (storytelling or Montessori-based reading) on verbal interactions, engagement level, affect and behavioural aspects were estimated with both visual analyses and statistical analyses using the between-case standardised mean differences method.
RESULTS: Significant differences were found in favour of the Montessori-based activities with regard to the number of verbal interactions, constructive and passive engagement and positive affect expressed, with moderate to large effect size (from 0.46 to 1.66).
CONCLUSIONS: The Montessori-based reading group activity really seems to be preferable to a more traditional storytelling activity, with multiple benefits for residents. Depending on the preserved abilities and interests of the participants, it can also be aimed at people with severe dementia.

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.

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.

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: Chronic musculoskeletal (MSK) pain is a prominent health concern, resulting in pain-related disability, loss of functioning, and high health care costs. Physiotherapy rehabilitation is a gold-standard treatment for improving functioning in youth with chronic MSK pain. However, increasing physical activity can feel unattainable for many adolescents because of pain-related fear and movement avoidance. Virtual reality (VR) offers an immersive experience that can interrupt the fear-avoidance cycle and improve engagement in physiotherapy. Despite promising initial findings, data are limited and often lack the rigor required to establish VR as an evidence-based treatment for MSK pain.
OBJECTIVE: This trial evaluates physiorehabilitation with VR in adolescents with MSK pain. This protocol outlines the rationale, design, and implementation of a randomized controlled trial enhanced with a single-case experimental design.
METHODS: This study is a 2-group randomized controlled trial assessing the use of physiorehabilitation with VR in adolescents with MSK pain. The authors will collaborate with physical therapists to integrate VR into their standard clinical care. For participants enrolled in standard physiotherapy, there will be no VR integrated into their physical therapy program. Primary outcomes include physical function and engagement in VR. Secondary outcomes include pain-related fear and treatment adherence. Moreover, we will obtain clinician perspectives regarding the feasibility of integrating the intervention into the flow of clinical practice.
RESULTS: The pilot study implementing physiorehabilitation with VR demonstrated that high engagement and use of physiorehabilitation with VR were associated with improvements in pain, fear, avoidance, and function. Coupled with qualitative feedback from patients, families, and clinicians, the pilot study results provide support for this trial to evaluate physiorehabilitation with VR for youth with chronic MSK pain. Analysis of results from the main clinical trial will begin as recruitment progresses, and results are expected in early 2024.
CONCLUSIONS: Significant breakthroughs for treating MSK pain require mechanistically informed innovative approaches. Physiorehabilitation with VR provides exposure to progressive challenges, real-time feedback, and reinforcement for movement and can include activities that are difficult to achieve in the real world. It has the added benefit of sustaining patient motivation and adherence while enabling clinicians to use objective benchmarks to influence progression. These findings will inform the decision of whether to proceed with a hybrid effectiveness-dissemination trial of physiorehabilitation with VR, serving as the basis for potential large-scale implementation of physiorehabilitation with VR.
BACKGROUND: ClinicalTrials.gov NCT04636177; https://clinicaltrials.gov/ct2/show/NCT04636177.
UNASSIGNED: DERR1-10.2196/40705.

BACKGROUND: Regular physical activity (PA) is recommended to optimize weight and health outcomes in patients who have undergone metabolic and bariatric surgery (MBS). However, >70% of patients have low PA levels before MBS that persist after MBS. Although behavioral interventions delivered face-to-face have shown promise for increasing PA among patients who have undergone MBS, many may experience barriers, preventing enrollment into and adherence to such interventions. Delivering PA behavior change interventions via telehealth to patients who have undergone MBS may be an effective strategy to increase accessibility and reach, as well as adherence.
OBJECTIVE: This paper reports the protocol for a study that aims to assess the feasibility and acceptability of the protocol or methods and the Telehealth Bariatric Behavioral Intervention (TELE-BariACTIV). The intervention is designed to increase moderate-to-vigorous intensity PA (MVPA) in patients awaiting bariatric surgery and is guided by a multitheory approach and a patient perspective. Another objective is to estimate the effect of the TELE-BariACTIV intervention on presurgical MVPA to determine the appropriate sample size for a multicenter trial.
METHODS: This study is a multicenter trial using a repeated (ABAB\'A) single-case experimental design. The A phases are observational phases without intervention (A1=pre-MBS phase; A2=length personalized according to the MBS date; A3=7 months post-MBS phase). The B phases are interventional phases with PA counseling (B1=6 weekly pre-MBS sessions; B2=3 monthly sessions starting 3 months after MBS). The target sample size is set to 12. Participants are inactive adults awaiting sleeve gastrectomy who have access to a computer with internet and an interface with a camera. The participants are randomly allocated to a 1- or 2-week baseline period (A1). Protocol and intervention feasibility and acceptability (primary outcomes) will be assessed by recording missing data, refusal, recruitment, retention, attendance, and attrition rates, as well as via web-based acceptability questionnaires and semistructured interviews. Data collected via accelerometry (7-14 days) on 8 occasions and via questionnaires on 10 occasions will be analyzed to estimate the effect of the intervention on MVPA. Generalization measures assessing the quality of life, anxiety and depressive symptoms, and theory-based constructs (ie, motivational regulations for PA, self-efficacy to overcome barriers to PA, basic psychological needs satisfaction and frustration, PA enjoyment, and social support for PA; secondary outcomes for a future large-scale trial) will be completed via web-based questionnaires on 6-10 occasions. The institutional review board provided ethics approval for the study in June 2021.
RESULTS: Recruitment began in September 2021, and all the participants were enrolled (n=12). Data collection is expected to end in fall 2023, depending on the MBS date of the recruited participants.
CONCLUSIONS: The TELE-BariACTIV intervention has the potential for implementation across multiple settings owing to its collaborative construction that can be offered remotely.
UNASSIGNED: DERR1-10.2196/39633.

Vulvodynia is common and has an immense impact on affected women and their partners. Psychological factors have been found to contribute to pain maintenance and exacerbation, and treatments addressing psychological factors have yielded positive results. This study employed a replicated single-case experimental design to examine a cognitive behavioral therapy (CBT) group treatment with partner involvement in vulvodynia. Repeated measures of pain intensity related to pain-inflicting behaviors were collected weekly throughout baseline and treatment phases. Associated outcomes were measured pre-, post- and at two follow-up assessments. Participants were 18-45-year-old women, in a stable sexual relationship with a man, experiencing vulvodynia. Five women completed the treatment consisting of 10 group sessions and 3 couple sessions. Data were analyzed through visual inspection and supplementary nonparametric calculations. The study showed promising results of the CBT treatment in alleviating pain intensity in connection to specific pain-inflicting behavior since three out of five participants showed improvements. For the participants who improved, sexual function, pain catastrophizing, avoidance, and endurance behavior changed during treatment and were maintained at follow-ups. These results warrant further study of the CBT treatment, in larger, and controlled formats.

BACKGROUND: Disruptive behavior is a common reason for young children to be referred to mental health care services worldwide. Research indicates that treatments for child disruptive behavior where parents are the primary agents of change are most impactful. Parent-Child Interaction Therapy (PCIT) is an effective parent management training program currently implemented in therapeutic settings within the Netherlands. Ongoing research into improving the effectiveness of PCIT is being done within these settings. To further promote the key elements of PCIT, this study focuses on creating the opportunity for parents to practice positive parenting skills more outside of the clinical setting by adding virtual reality (VR) as an additional homework element. PCIT has shown to make impactful long-term improvements in parental warmth, responsiveness, and the parent-child relationship. Through VR, parents practice the taught parenting skills out loud in the comfort of their own homes in VR scenarios. We expect that VR addition will innovatively increase the effectiveness of PCIT.
OBJECTIVE: This study aimed to evaluate the added value of VR to PCIT by using a multiple baseline single-case experimental design (SCED). We expect to find that PCIT-VR will ameliorate positive parenting skills. By implementing the VR element, we secondarily expected that meeting the skill criteria will be achieved sooner, treatment completion rates will increase, and the parent-child relationship will be better, whereas parental stress and child disruptive behavior will decrease.
METHODS: A total of 15 children (aged 2-7 years) with disruptive behavior and their parents will be followed throughout the PCIT-VR treatment. Using a multiple baseline SCED with 3 phases, 15 families will fill out questionnaires weekly, in addition to having pre- and posttreatment and follow-up measurements to monitor their positive parenting skills, child disruptive behavior, parenting stress, and VR progress. Moreover, quantitative information and qualitative interviews will be analyzed visually and statistically and summarized to provide a complete picture of experiences.
RESULTS: As of February 2021, 6 families have been enrolled in the study at the moment of submission. Data collection is projected to be completed in 2023. Quantitative and qualitative results are planned to be published in peer-reviewed journals, as well as being presented at national and international conferences.
CONCLUSIONS: The SCED-with its phased design, randomization, and the opportunity to replicate and assess both individual and group treatment effects-and adaptability of the VR technology are the strengths of the study. The risks of increased type I errors, maturation effects, or technological failure will be mitigated with the right statistical support. This study aims to magnify the scope of the treatment through additional skill training, ultimately in support of routinely implementing VR within PCIT.
UNASSIGNED: DERR1-10.2196/34120.

Background: Loneliness in later life is often addressed with befriending interventions, yet evidence for their effectiveness is limited. Meanwhile it is known that loneliness has a deleterious impact on health. The aim of the study is to evaluate whether a befriending service for older adults mitigates the impact of loneliness on health outcomes, and to identify mechanisms through which befriending interventions might impact upon health. Methods: A mixed methods design is used. The quantitative component utilises an AB single-case experimental design, to gather intensive longitudinal data. These data will be analysed using a generalised additive modelling approach. The qualitative component of the study uses semi-structured dyadic interviews, structured and analysed according to the principles of constructivist grounded theory. Findings will then be triangulated according to an existing mixed methods integration protocol. Discussion: This mixed methods design has the potential to inform national and international policy in relation to befriending interventions for older adults. In addition, there is the potential for study results to inform our theoretical understanding of the nature of the relationship between loneliness and health. Trial registration: ClinicalTrials.gov identifier NCT04301167 (10 th March 2020). Protocol version 1.1, 26 th June 2020.