Wait-list Control Group Research Articles

Spiritual Connectivity Intervention for Individuals with Depressive Symptoms: A Randomized Control Trial.

Depression is one of the most prevalent mental disorders worldwide. This study examined the effect of a spiritual connectivity intervention on individuals with depression in a randomized waitlist-controlled trial. Fifty-seven participants with mild or moderate depressive symptoms were randomly assigned to either the intervention group (n = 28) or the waitlist control group (n = 29). The intervention comprised eight weekly sessions focusing on divine connection, forgiveness and freedom, suffering and transcendence, hope, gratitude, and relapse prevention. The outcome measures included depressive symptoms, anxiety, hope, meaning in life, self-esteem, and social support. Participants completed self-administered questionnaires at baseline (week 0), post-intervention (week 8), and 3-month follow-up (week 20). Repeated-measures ANOVA and one-way ANCOVA were used to compare the within-group and between-group differences in the changes in outcome variables. Participants in the intervention group showed significant improvements in depression, anxiety, spiritual experience, hope, self-esteem, and perceived social support after the intervention. Effect size statistics showed small to large differences (Cohen's d, 0.308 to -1.452). Moreover, 85.71% of participants in the intervention group also experienced clinically significant reductions in PHQ-9 scores from baseline to immediate post-intervention. This study highlights the effectiveness of a low-cost, accessible intervention suitable for community implementation by clergy and faith-based organizations.

Digital Cognitive-Behavioral Therapy for Insomnia in Cancer Survivors: Protocol for a Pragmatic Clinical Trial.

Insomnia is one of the most prevalent, persistent, and distressing conditions associated with cancer, affecting almost half of all cancer survivors. Although cognitive-behavioral therapy for insomnia is well established as the gold-standard treatment for insomnia, its accessibility is very limited in routine care. We aim to examine the real-world effectiveness and acceptability of a digital cognitive-behavioral therapy for insomnia for cancer survivors with insomnia symptoms through a randomized controlled trial in Portugal. Our cancer trial will test the effects and acceptability of an accessible internet-delivered self-administered cognitive-behavioral therapy for insomnia digital intervention with clinician support, OncoSleep. This online program includes six interactive, personalized weekly sessions featuring evidence-based techniques targeting psychophysiological hyperarousal and maladaptive conditioning, tailored for cancer survivors. Research study procedures include screening for eligibility in the general population and randomization into one of two arms: the digital CBT-I program or a waitlist control group. Insomnia severity (primary outcome), fatigue, sleep diary outcomes, psychological distress, and quality of life (secondary outcomes) will be assessed at baseline and post-intervention.

Effects of virtual reality-based cognitive training for adolescents with depressive episodes: A pilot randomized controlled study

Cognitive impairment is a common symptom in depression, yet few intervention strategies target adolescents. This study investigated the effects of an attention and working memory cognitive training system based on virtual reality (VRCT) in adolescents with mild to moderate depressive episodes. Adolescents with depression were randomized into a VR training group (VRG, n = 47) or a waitlist control group (WT, n = 46). The VR training consisted of three 10-min tasks per session, conducted three sessions per week for 20 sessions over 7 weeks. Forty-four healthy adolescents participated as a comparison group for baseline cognitive assessment. Cognitive functions and depressive symptoms were assessed using the Das-Naglieri cognitive assessment system, driven by the Planning, Attention, Simultaneous, and Successive (PASS) processing theory, and the Hamilton Depression Rating Scale-24 at pre- and post-intervention. Baseline results indicated significantly lower cognitive scores in patients compared to healthy adolescents. Post-intervention, the VRG demonstrated significant improvements in all four cognitive scales (effect sizes 0.56 to 0.76) and a significant reduction in depressive symptoms compared to the WT. These findings suggest that VRCT holds potential for improving cognitive impairments and alleviating depressive symptoms in adolescents with depression. Further large-scale and follow-up studies are necessary to confirm long-term benefits.

Effects of a waiting list control design on alcohol consumption among online help-seekers: A randomised controlled trial

BackgroundIndirect evidence suggests that using waiting list control designs in behavioural research may have unintended consequences. The aim of this study was to estimate the effects of a waiting list design on alcohol consumption among individuals who had looked online for help. MethodsA two-arm randomised controlled trial was employed. The intervention group was informed that they belonged to the intervention group and would receive immediate access to a digital alcohol intervention. The waiting list control group was informed that they belonged to the group that had to wait four weeks to be given access to the intervention and in the meantime, they would be given a summary of their drinking. However, both groups received immediate access to the same digital alcohol intervention; the experimental contrast was thus between being told to wait or not. ResultsWe randomised 3388 participants (intervention: 1692, waiting list: 1696). Data were available for 954 participants at 1-month follow-up. We found no strong evidence that alcohol consumption differed between groups, but the evidence pointed towards the intervention group reporting lowering weekly alcohol consumption compared to the waiting list control group (IRR = 0.95, 95 % CI = 0.83; 1.08, probability of effect = 78.8 %). ConclusionWe found no strong evidence that being informed that access to an intervention would be delayed produced differential self-reported alcohol consumption compared to being informed that access would be immediate. We did find a difference in engagement with the intervention materials, indicating that the experimental manipulation was successful.

Efficacy of Self-Natural Posture Exercise (SNPE) programs on chronic low back pain: A randomized controlled feasibility trial with waitlist control.

Low back pain (LBP) is a significant source of disability and decreased quality of life. The Self-Natural Posture Exercise (SNPE) intervention can be used effectively in many cases, but feasibility and impact has not been fully explored. The current study explores the feasibility and efficacy of face-to-face (FtF) and virtual (Vir) SNPE programs on chronic low back pain. This is a randomized single-blinded waitlist control study with 10participants in the FtF group (age 45.8 ± 2.89) and 9 in the Vir group (age 52.2 ± 2.3). Participants had low to moderate low back pain for > 3months. Those who would eventually become the Vir group served initially as a waitlist control (Con) group. The FtF group received 12weeks of in-person exercise training sessions conducted and the Vir group received weekly recorded training videos created by and featuring the same instructor. Measured outcomes included feasibility assessed by rate of retention and rate of attendance, level of low back pain (Oswestry Disability Index, Visual Analogue Scale), quality of life (36-Item Short Form Health Survey 1.0), muscular pressure pain threshold, and muscle tone. Analysis was done via repeated measures ANOVA and Wilcoxon tests. Rates of retention were 80% in the FtF group and 78% in the Vir group. Attendance rates were 88% in the FtF group and 60% in the Vir group. ODI, VAS, and some SF-36 domains improved in both the FtF and Vir groups. Overall, the FtF group improved in more domains and by a larger degree than the Vir group and both groups improved relative to Con. A 12-week SNPE program, done virtually or in person, shows promise in improving ODI, VAS, and some SF-36 domains. FtF appears to be more effective. Future studies would benefit from sampling a larger and more diverse population.

Effects of mindfulness meditation training offered in-person and via a virtual world on self-compassion: A study with U.S. military active duty and veterans.

Mindfulness-based, in-person programs are effective at reducing stress and enhancing resilience in military and civilian samples, yet few studies have examined or compared training offered via real-time, interactive social media. Such a program would have a wider-reach and could include those unable to attend in-person. There is also interest in resolving ambiguity about the effects of mindfulness training on individual difference variables, such as self-compassion. The purpose of this research was to compare pre/post self-compassion for three interventions; Mindfulness-based Stress Reduction delivered in-person (IP), mindfulness meditation training delivered via a Virtual World (VW), and a wait-list Control Group (CG) among active duty and veteran U.S. military. A 2 (pre/post)×3 (group) factorial design was conducted with 250 active duty and veteran U.S. Military service members, with self-compassion measures as dependent variables. Self Compassion improved 10% for the IP group and 14% for the VW group, while the CG group did not improve. Combined treatment groups yielded a 10.3% improvement in self-compassion compared with no change in the CG and with a group×time interaction effect (p < 0.01). Participants with lower initial self-compassion experienced greater benefits than those with higher baseline self-compassion (p < 0.01). IP and VW Mindfulness Meditation training were equally effective in increasing self-compassion. Adding effective on-line mindfulness delivery will promote self-compassion among a more extensive audience, likely yielding improved coping, confidence, connectedness, cheerfulness, steadiness, and self-satisfaction, while lessening anxiety, fear-of-failure, and stress among participants.

Lifestyle Intervention Modulates the CD4+ T Cell Profile in the Blood of Crohn's Disease Patients.

Crohn's disease (CD) significantly affects patients' well-being and is influenced by stress and lifestyle factors, highlighting the importance of improving quality of life in CD management. An imbalance between pro- and anti-inflammatory CD4+ T cell responses is a key factor in CD, and stress has been shown to alter the function of CD4+ T cells. Therefore, this study aimed to evaluate the effect of a mind-body medicine stress management and lifestyle modification (MBM) program on the CD4+ T cell profile in CD patients. Circulating CD4+ T cells from CD patients were analyzed by flow cytometry following the MBM program. Patients were randomly assigned to either a guided intervention group (IG) or a self-guided waitlist control group (CG) over a 9-month trial and compared with healthy blood donors. Lifestyle intervention reduced regulatory T cell (Treg) frequencies in the blood of CD patients. Notably, we observed a significant correlation between the quality of life improvement and Treg frequencies in the IG but not in the CG. Furthermore, differential activation and expression of the gut-homing molecules G protein-coupled receptor 15 and CCR9 on circulating Tregs and CD4+ effector T cells were detected in both the IG and CG. The MBM program, whether guided or self-directed, has the potential to restore the CD4+ T cell profile of CD patients to levels comparable to healthy blood donors. Lifestyle interventions may benefit CD progression, symptoms, and immunological status, but further analysis is needed to substantiate these findings and to fully understand their clinical implications. (ClinicalTrials.gov: NCT05182645).

Beyond HIV Shame: Effects of Self-Forgiveness in Improving Mental Health in HIV-Positive Individuals in Poland.

Guided by the bio-psycho-socio-spiritual approach, this randomized controlled trial assessed the efficacy of a self-forgiveness intervention among 60 HIV-positive individuals in Poland. Participants underwent a 90-min "Restore: The Journey Toward Self-Forgiveness" session, in contrast to a wait-list control group. The intervention significantly enhanced self-forgiveness, spirituality, mental well-being, and heart rate variability in response to a cognitive stressor (i.e., a mental arithmetic challenge). Significant effects were observed in both between-group and within-subject comparisons. These results support the incorporation of self-forgiveness into psychological rehabilitation programs for HIV to improve quality of life and health outcomes.

Effectiveness of a group psychological intervention to reduce psychosocial distress in adolescents in Pakistan: a single-blind, cluster randomised controlled trial

Emotional problems in adolescents living in low-income and middle-income countries (LMICs) remain largely unaddressed; key reasons include a scarcity of trained mental health professionals and unavailability of evidence-based, scalable psychological interventions. We aimed to evaluate the effectiveness of a non-specialist-delivered, group psychological intervention to reduce psychosocial distress in school-going adolescents in Pakistan. In a two-arm, single-blind, cluster randomised controlled trial, eligible public school clusters from a rural subdistrict of Gujar Khan, Rawalpindi, Pakistan, were randomised (1:1, stratified by sex) using permuted block randomisation into intervention (n=20) and wait-list control (n=20) groups. Adolescents aged 13-15 years who provided informed assent and caregivers' consent were screened for psychosocial distress using the youth-reported Pediatric Symptoms Checklist (PSC; total psychosocial distress scores from 0 to 70), and those scoring 28 or more and their caregivers were enrolled into the trial. Adolescents in the intervention group received seven weekly group sessions and their caregivers received three biweekly group sessions in school settings from trained non-specialists. The primary outcome was change from baseline in the total PSC scores at 3 months post-intervention. The trial was registered prospectively with the International Standard Randomised Controlled Trial Number registry, ISRCTN17755448. From the 40 school clusters that were included, 282 adolescents in the intervention group and 284 adolescents in the wait-list control group were enrolled between Nov 2 and Nov 30, 2021. At 3 months, adolescents in the intervention group had significantly lower mean total score on the PSC compared with adolescents in the control group (mean difference in change from baseline 3·48 [95% CI 1·66-5·29], p=0·0002, effect size 0·38 [95% CI 0·18-0·57]; adjusted mean difference 3·26 (95% CI 1·46-5·06], p=0·0004, effect size 0·35 (0·16-0·55). No adverse events were reported in either group. The group psychological intervention most likely represents a feasible and effective option for adolescents with psychosocial distress in school settings. UK Medical Research Council, Foreign Commonwealth and Development Office, Department of Health and Social Care. For the Urdu translation of the abstract see Supplementary Materials section.

Effects of a tailor-made yoga program on upper limb function and sleep quality in women with breast cancer: A pilot randomized controlled trial

PurposeUpper limb dysfunction and sleep disturbance are common and serious health problems in women with breast cancer. Yoga is a mind-body intervention which is shown to improve physical and psychological health. The aim of this study is to evaluate the effectiveness of a tailor-made yoga program on upper limb function and sleep quality in women with breast cancer. MethodsA pilot randomized controlled trial (RCT) study design was used. Participants were randomly allocated to either the yoga intervention group (YG; eight weekly 60-min group-based yoga sessions) or the wait-list control group (CG). The primary outcome measures were upper limb function and sleep quality, which were assessed by the self-reported questionnaires – the shortened version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH) and the Pittsburgh Sleep Quality Index (PSQI), respectively. The secondary outcome measures were upper limb muscle strength and mobility, heart rate variability (HRV), anxiety and depression, fatigue, and health-related quality of life. All participants underwent assessment at four time-points (baseline, mid-intervention, post-intervention, and 1-month follow-up). The effectiveness of the intervention was tested by two-way mixed-design repeated-measures analysis of covariance. ResultsFor the primary outcomes, there was no significant between-group difference in the upper limb function. The YG demonstrated significantly shorter sleep latency and higher HRV, and less sleep disturbance than the CG at post-intervention, and 1-month follow-up, respectively. For the secondary outcomes, the YG demonstrated significantly improved shoulder muscle strength and arm symptoms compared to the CG from mid-intervention until the 1-month follow-up. ConclusionThis pilot trial revealed that the yoga program was feasible to be implemented for women with primary stage breast cancer. Although yoga was not found to be effective in improving the upper limb function, it improved sleep latency, HRV, shoulder muscle strength and arm symptoms of women with breast cancer.

Effects of an online mindfulness-based intervention on brain haemodynamics: a pilot randomized controlled trial using functional near-infrared spectroscopy.

Although many neuroimaging studies have evaluated changes in the prefrontal cortex during mindfulness-based interventions, most of these studies were cross-sectional studies of skilled participants or involved pre-post comparisons before and after a single session. While functional near-infrared spectroscopy is a useful tool to capture changes in the hemodynamic response of the prefrontal cortex during continuous mindfulness-based intervention, its ability to detect the accumulated effects of continuous mindfulness-based intervention is currently unclear. We investigated whether a 12-wk online mindfulness-based intervention changed the hemodynamic response of the prefrontal cortex during a verbal fluency task. Eighty-two healthy university students were randomly allocated to a 12-wk online mindfulness-based intervention group or a wait-list control group. The integral values of oxygenated hemoglobin measured using functional near-infrared spectroscopy before and after the intervention were compared to the values in the wait-list group. The intervention condition showed significantly greater functional near-infrared spectroscopy signal activation than the control condition; however, the effect sizes before and after the intervention were small. Thus, continuous mindfulness-based intervention could alter prefrontal cortex function, and functional near-infrared spectroscopy could be useful for measuring the accumulated effects of continuous mindfulness-based interventions. With a better understanding of the association between mindfulness and functional near-infrared spectroscopy signals, functional near-infrared spectroscopy can be used for biofeedback analyses.

Multicomponent versus aerobic exercise intervention: Effects on hemodynamic, physical fitness and quality of life in adult and elderly cardiovascular disease patients: A randomized controlled study

ObjectiveCardiovascular diseases (CVDs) remain a leading cause of mortality globally, emphasizing the need for effective preventive measures. This study aimed to investigate the effects of a multicomponent compared to an aerobic training program on the hemodynamic parameters, physical fitness, psychophysical health status and quality of life (QoL) of adults and elderly with stabilized CVDs. MethodsThirty-three subjects (19M and 14F; age 69.5 ± 4.9 years; BMI 27.34 ± 4.95 kg/m2) suffering from CVDs voluntarily participated in this 10-week randomized controlled study and were allocated into three groups: multicomponent training group (MTG; 6M, 6F; cardiorespiratory, resistance, flexibility and breathing exercises; 60′, 2d·wk-1), aerobic training group (ATG; 7M, 5F; aerobic-only training; 60′, 2d·wk-1) or a wait-list control group (CG; 6M, 3F; no PA). Hemodynamic parameters were assessed through resting hearth rate (RHR) and peripheral-systolic and diastolic blood pressure (P-SBP/P-DBP). Physical fitness was assessed via a 30” chair stand test (30CST), timed up and go (TUG) test, handgrip strength (HGS) test, and 2’ step test (TMST). The health status, QoL and enjoyment were evaluated with short form-12 (SF-12), world health organization quality of life-bref (WHOQoL-bref) and physical activity enjoyment scale (PACES), respectively. ResultsAfter the intervention, MTG showed significant improvements in hemodynamic parameters (95 % CI, RHR: 2.76 to 9.07; P-SBP: 3.28 to 13.71; P-DBP: 3.56 to 8.94; p < 0.001), physical fitness (95 % CI, 30CST: 4.42 to −1.90; TUG: 0.56 to 1.58; TMST: 35.24 to −18.58; Dominant HGS: 4.00 to −1.65; Undominant HGS: 2.87 to −0.79, p < 0.001) and enjoyment (PACES: 15.18 to −5.48, p < 0.001) compared to CG; ATG showed significant improvement in hemodynamic parameters (95 % CI, RHR: 1.76 to 8.07; P-SBP: 3.19 to 13.63; P-DBP: 4.47 to 9.85, p < 0.001), physical fitness (95 % CI, 30CST: 2.59 to −0.07; TUG: 0.03 to 1.05; Dominant HGS: 2.42 to −0.07, p < 0.05; TMST: 36.08 to −19.41, p < 0.001) and enjoyment (PACES: 14.68 to −4.98, p < 0.001) compared to CG. No significant changes were observed in QoL and SF-12 (p > 0.05). Significant differences between MTG and ATG were only found in physical fitness variables (95 % CI, 30CST: 3.21 to −0.45, p < 0.01; Dominant HGS: 0.00 to 3.00, p < 0.05). ConclusionsFindings showed significant improvements in hemodynamic parameters and physical fitness suggesting the effectiveness of the multicomponent exercise program, similar to aerobic-only training, and greater efficacy for lower limb strength and dominant hand grip strength in adults and elderly with stabilized CVDs. Both exercise groups showed similar levels of enjoyment.

Group psychological counseling to contrast academic burnout: a research protocol for a randomized controlled trial.

Academic burnout is a condition characterized by exhaustion, cynicism, a distant attitude toward studying, and diminished self-efficacy in academic activities. Preliminary scientific findings indicate that interventions designed to alleviate work burnout also hold promise for mitigating academic burnout, however clear evidence based on randomized controlled trials is still missing. This research protocol describes a randomized controlled trial aimed at evaluating the efficacy of an online group psychological intervention to contrast academic burnout. Participants with high levels of burnout will be assigned to a psychological counseling group or a waiting list control group. The research comprises several phases: (T0) Screening, Recruitment, and Randomization; (T1) Baseline assessment (pre-intervention); (T2) Outcome Assessment (post-intervention); and (T3) Follow-up Assessment (3 months post-intervention). The primary outcomes include burnout symptoms, general wellbeing, and academic achievement. Additionally, secondary variables such as effort-reward imbalances, satisfaction/frustration of basic psychological needs, intrapersonal and interpersonal emotion regulation, coping strategies, and social support will be examined. The psychological intervention strategies will encompass psychoeducation, self-awareness enhancement, cognitive restructuring, and promotion of social support. This research protocol is an initial step toward evidence-based psychological interventions to treat academic burnout.

Programa de estimulación cognitiva en línea para pacientes adultos mayores con deterioro cognitivo leve: estudio de factibilidad

BackgroundMild Cognitive Impairment (MCI) is considered a decline in cognitive functions, which becomes more pronounced with age. These patients may benefit from cognitive treatments that help attenuate or slow down a potential progression towards dementia. ObjectiveTo assess the feasibility, fidelity, satisfaction, and effectiveness of the Memory Training and Cognitive Stimulation Program (PEMEC, by its Spanish acronym) in individuals with MCI in an online setting. MethodA non-probabilistic convenience sample of 14 patients with MCI received the PEMEC (PEMEC online) through an electronic device, were assessed with MoCA, NEUROPSI Brief, Yesavage Geriatric Depression Scale before and after treatment, comparing these measurements with those of a waiting list control group. Results92,85% completed the treatment; with an average of 92% fidelity to the original intervention, an average of 91,61% for satisfaction with the activities of each session and the perceived usefulness was 97,98%. Statistically significant differences were found in the NEUROPSI Brief and the MoCA, before and after treatment in the intervention group and, when comparing the scores with the waiting list control group, a statistically significant difference was found in the MoCA scores. ConclusionFollowing the cultural adaptation of the program (from a Spanish to a Mexican treatment group), these results establish a precedent that systematic group cognitive interventions are feasible and effective in virtual tele-neuropsychology contexts for older adults.

The impact of an animal assisted activity on healthcare worker well-being in the inpatient hospital setting

Chronic stress and burnout experienced by healthcare workers has been exacerbated by the COVID-19 pandemic. Animal-assisted activities, traditionally patient-focused, have the potential to benefit healthcare worker well-being. With limited evidence to support animal assisted activities for healthcare workers within inpatient hospital settings, the purpose of this study was to evaluate the acceptability and impact of an animal assisted activity using therapy dogs on healthcare worker stress, burnout, work engagement, and mood. Using a quasi-experimental, waitlist control design, healthcare workers from paired medical intensive care and medical-surgical units served as intervention and waitlist control groups and were offered the animal assisted activity three times a week for eight weeks. Visits ranged from 20 to 60 minutes. Measures of stress, burnout, and work engagement were measured pre- and post-intervention. Self-reported mood was collected before and after each intervention with participants reporting weekly participation. Intervention acceptability was measured post-intervention. Differences between pre- and post-intervention measures of stress, burnout, work engagement, and mood were assessed with paired and independent samples t-tests; participation and acceptability were measured descriptively. Acceptability of the animal-assisted activity, rated on a scale of 1 to 10, was similar for both intervention (M=8.92; SD=1.256) and waitlist control (M=9.57; SD=.787) groups. Weekly participation for both groups averaged one to two per week. There were no significant improvements in stress, burnout, or work engagement. Self-reported mood increased significantly for the intervention group (p=.05). Our findings suggest that an animal assisted activity, available for healthcare workers within busy inpatient settings, may offer immediate benefits through improved mood. Further research is needed to better understand short and and long-term effects of animal assisted activity on healthcare worker, patient, and organizational outcomes.

Testing the Effectiveness of a Mindfulness- and Acceptance-Based Smartphone App for Nurses Traumatized by the COVID-19 Pandemic: A Pilot Study

A significant proportion of frontline nurses developed post-traumatic stress disorder (PTSD) symptoms as a result of working during the COVID-19 pandemic. This study aimed to determine the efficacy of a mindfulness- and acceptance-based smartphone app intervention among nurses traumatized by the COVID-19 pandemic. This was a two-arm, randomized controlled trial. We randomly assigned 60 frontline nurses working in various clinical settings in the United States during the pandemic to either the intervention group (i.e. participants used the mindfulness app for 6 wk) or the wait-list control group. We assessed the app’s efficacy through outcome measures of PTSD symptom severity, experiential avoidance, rumination, mindfulness, and resilience, measured at pre-, mid-, and post-intervention periods and a 1-month follow-up. Intervention satisfaction and perceived usability of the app were assessed within the intervention group. There was strong evidence of within-between interaction for PTSD, experiential avoidance, and rumination, implying significant improvement of these outcomes for the intervention group as compared to the control group. We only found a within-group interaction effect for mindfulness, indicating significant improvement of mindfulness within the intervention group only. Participants in the intervention group reported high satisfaction levels and perceived usability with the app. Findings highlight that mindfulness- and acceptance-based smartphone apps can improve PTSD symptoms of nurses traumatized by the pandemic. Healthcare organizations should provide nurses with accessible interventions (e.g. mindfulness apps) to treat and prevent secondary behavioral consequences of the pandemic, such as PTSD.

Complex decongestive therapy improves finger tapping score in patients with breast cancer-related lymphedema.

Breast cancer-related lymphedema (BCRL) impairs upper limb function and cognitive performance. This study aimed to evaluate the effects of fifteen sessions of complex decongestive therapy (CDT) on fine motor performance and information processing speed in women with BCRL. Thirty-eight women with BCRL (54.97 ± 10.78years) were recruited in the study. Participants either received five times weekly CDT consisting of manual lymphatic drainage, skin care, compression bandaging, and remedial exercises (n = 19) or served as a wait-list control group (n = 19). We used the Finger Tapping Task to assess fine motor performance and the Digit Symbol Substitution Test to assess information processing speed. ANCOVA was performed to analyze the effect of CDT on the dependent variables, adjusting for covariates and baseline values. CDT significantly improved finger tapping score (p < 0.001) compared to the wait-list to the control group, whereas information processing speed did not significantly change (p = 0.673). The findings suggest that CDT is an effective conservative therapeutic approach to improve upper extremity fine motor function in women with BCRL. Future studies are needed to investigate the effect of CDT on different cognitive domains.

The use of the "group traumatic episode protocol (G-TEP) " in an outpatient randomized and hospital setting: Implementation and effects in heterogeneous patient samples.

The resource-based eye movement desensitization and reprocessing group intervention group traumatic episode protocol G-TEP showed promising results in reducing posttraumatic stress disorder, depression, and anxiety. Using a high structured G-TEP worksheet, the patients conduct self-bilateral stimulation while (re)processing their targets. We examined the effectiveness on multiple symptoms and practicability of G-TEP in an outpatient setting and its feasibility in hospital treatment. Study A: Forty-four patients suffering from different symptoms and diagnoses received four ambulatory G-TEP sessions within three eye movement desensitization and reprocessing-G-TEP sessions in a randomized delayed waitlist control group design. We investigate the improvements in symptoms and advantages of G-TEP as an upstream treatment. Study B: The targeted changes in symptom burden in 23 patients and the implementation process of G-TEP as an additional treatment option in a psychiatric hospital were examined. The measures used were Impact of Event Scale-Revised, Beck Depression Inventory-II, Brief Symptom Check List, and the Questionnaire on Dissociative Symptoms at pre- and posttreatment and follow-up. Both studies showed significant and long-lasting reductions in subjective distress and concomitant impairments. The distressing experiences became more "ego-syntonic," levels of avoidance decreased, abilities to manage negative emotions got strengthened, and they gained hope. All effects had a positive impact on subsequent treatment processes; some patients already went free of symptoms only with this short G-TEP treatment. G-TEP effectively alleviates symptoms caused by stressful experiences. G-TEP can be used as a stand-alone intervention in outpatients and can easily be integrated into the offer of multimodal therapy in a psychiatric ward. It can prevent the exacerbation of symptoms and chronification of disease and should be implemented into the (German) health system. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Evaluation of the Teaching Recovery Techniques intervention among newcomer students in Swedish schools: a randomised controlled trial turned into a feasibility study

BackgroundDuring recent years, Europe has faced the arrival of migrants whereof a considerable group of youth present mental health problems, such as symptoms of post-traumatic stress disorder (PTSD). Schools offer a safe environment for mental health interventions to these groups, yet there is limited research on the impact of school-based interventions addressing mental health problems in newcomer youths, especially in the Swedish context. This cluster randomized controlled trial (RCT) aimed to explore the effectiveness of the Teaching Recovery Techniques (TRT) intervention among newcomer students with PTSD symptoms in Swedish secondary schools.MethodsNine schools were randomly assigned to TRT or a wait list control group prior to the baseline assessment. Follow-up data were collected immediately following the intervention and three months post-intervention. In total, 531 students were approached, of which 61 gave consent and were eligible to be included in the study: 55 in TRT and 6 in the control condition. Given the low number of participants in the control condition, we merely analyzed students who had received TRT.ResultsWe report on feasibility of recruitment, data collection, intervention delivery and intervention effectiveness. In terms of intervention effectiveness, within subjects ANOVAs revealed significant reductions in PTSD symptoms and general mental health problems from baseline to the three months-follow-up (p < 0.001).ConclusionsOur results indicate that TRT is a promising school-based intervention for newcomer students with PTSD symptoms. For a successful implementation of TRT in the school context, schools need to be engaged and the implementation should be managed by a local coordinator.Trial registrationISRCTN, ISRCTN48178969, Retrospectively registered 20/12/2019.

Hope Groups: a protocol for a cluster randomized controlled trial of psychosocial, mental health, and parenting support groups for Ukrainian caregivers during war and conflict

BackgroundIn 2021, more than two-thirds of the world’s children lived in a conflict-affected country. In 2022, 13 million Ukrainians were forced to flee their homes after Russia’s full-scale invasion. Hope Groups are a 12-session psychosocial, mental health, and parenting support intervention designed to strengthen parents, caregivers, and children affected by war and crisis. The primary objective of this study is to evaluate the effectiveness of Hope Groups among Ukrainians affected by war, compared to a wait-list control group. This protocol describes a promising decentralized intervention delivery model and an innovative research design, which estimates the causal effect of Hope Groups while prioritizing prompt delivery of beneficial services to war-affected participants.MethodsThis protocol describes a pragmatic cluster randomized controlled trial (RCT) among Ukrainians externally displaced, internally displaced within Ukraine, and living at home in war-affected areas. This study consists of 90 clusters with 4–7 participants per cluster, totaling approximately n = 450 participants. Intervention clusters will receive 12-session Hope Groups led by peer facilitators, and control clusters will be wait-listed to receive the intervention after the RCT concludes. Clusters will be matched on the facilitator performing recruitment and intervention delivery. Primary outcomes are caregiver mental health, violence against children, and positive parenting practices. Secondary outcomes include prevention of violence against women and caregiver and child well-being. Outcomes will be based on caregiver report and collected at baseline and endline (1-week post-intervention). Follow-up data will be collected among the intervention group at 6–8 weeks post-intervention, with aims for quasi-experimental follow-ups after 6 and 12 months, pending war circumstances and funding. Analyses will utilize matching techniques, Bayesian interim analyses, and multi-level modeling to estimate the causal effect of Hope Groups in comparison to wait-list controls.DiscussionThis study is the first known randomized trial of a psychosocial, mental health, and parenting intervention among Ukrainians affected by war. If results demonstrate effectiveness, Hope Groups hold the potential to be adapted and scaled to other populations affected by war and crisis worldwide. Additionally, methodologies described in this protocol could be utilized in crisis-setting research to simultaneously prioritize the estimation of causal effects and prompt delivery of beneficial interventions to crisis-affected populations.Trial registrationThis trial was registered on Open Science Framework on November 9, 2023. Registration: OSF.IO/UVJ67.