Waitlist Control Condition Research Articles

The overestimation of the effect sizes of psychotherapies for depression in waitlist controlled trials: a meta-analytic comparison with usual care controlled trials.

There is considerable evidence that waiting list (WL) control groups overestimate the effect sizes of psychotherapies for depression. It is not clear, however, what are the exact causes for this overestimation. We decided to conduct a meta-analytic study to compare trials on psychotherapy for depression with a WL control group against trials with a care-as-usual (CAU) control group. We used an existing meta-analytic database of randomized trials comparing psychological treatments of adult depression with control groups and selected trials using a WL or a CAU control group. We used subgroup and meta-regression analyses to examine differences in effect sizes between WL and CAU controlled trials. We included 333 randomized controlled trials (472 comparisons; total number participants: 41,480), 141 with a WL and 195 with a CAU control group (3 included both). We found several significant differences between WL and CAU controlled trials (in type of therapy examined, treatment format, recency, target group, recruitment strategy, number of treatment arms and number of depression outcome measures). The overall effect size indicating the difference between treatment and control at post-test for all comparisons was g = 0.77 (95% confidence interval [CI]: 0.71; 0.84) with high heterogeneity (I2 = 84; 95% CI: 82; 85). A highly significant difference was observed between studies with a CAU control group (g = 0.63; 95% CI: 0.55; 0.71; I2 = 85; 95% CI: 83; 86) and studies with a WL (g = 0.95; 95% CI: 0.85; 1.04; I2 = 80; 95% CI: 78; 82; p for difference < 0.001). This difference remained significant in all sensitivity analyses, including a meta-regression analysis in which we adjusted for all differences in characteristics of studies with a WL versus CAU control group. We also found that pre-post effect sizes in WL control conditions (g = 0.37; 95% CI: 0.28; 0.46) were significantly smaller than change within CAU conditions (g = 0.64; 95% CI: 0.50; 0.78). We found few indications that pre-post effect sizes within therapy conditions differed between WL and CAU controlled trials. WL control conditions considerably overestimate the effect sizes of psychological treatments, compared to trials using CAU control conditions. This overestimation is probably caused by a smaller improvement within the WL condition compared to the improvement in the CAU condition. WL control conditions should be avoided in randomized trials examining psychological treatments of adult depression.

Reducing emotion dysregulation online in nonclinical population with compassion focused therapy and emotional competencies program: A randomized controlled trial

AbstractObjectivesThe present randomized controlled study aimed to evaluate the effects of two interventions on emotional dysregulation as a primary outcome and on depression, anxiety, stress, well‐being, self‐compassion and emotional competencies as secondary outcomes. Finally, the mediating role of emotional dysregulation as a core process in the effect of interventions on anxiety‐depressive and stress symptoms was evaluated.MethodsOne hundred and seventy‐nine individuals aged 18–68 years (M = 39, SD = 12.4; 83.9% females) with emotion regulation difficulties were randomly assigned to one of the three 12‐weeks online programs: Compassion Focused Program (CFP), an Emotional Competencies Program (ECP) or a Waitlist control condition (WL). Participants completed pre‐, post‐ and 3 months follow‐up measures of each outcome. Mixed effect linear models compared groups on primary and secondary outcomes.ResultsResults showed that (1) perceived credibility and expectancy and satisfaction did not differ between the two interventions, (2) both interventions reduced emotion regulation difficulty, depression, anxiety and stress symptoms, and enhanced well‐being, self‐compassion, and emotional competencies; (3) ECP was more effective to enhance well‐being than CFP; (4) CFP was more effective to enhance emotional competencies than ECP, and (5) emotion regulation difficulty mediated the effect of the interventions on depression, anxiety, and stress symptoms.ConclusionsFindings offer preliminary support for the usefulness of online CFP and ECP to reduce emotion dysregulation, symptoms of depression, anxiety, and stress and to increase well‐being, self‐compassion and emotional competencies. These results are discussed regarding clinical practice and the transdiagnostic role of emotional dysregulation.

Aerobic exercise and CogniTIVe functioning in women with breAsT cancEr (ACTIVATE): A randomized controlled trial.

As the prevalence of chemotherapy-related cognitive impairment rises, investigation into treatment options is critical. The objectives of this study were to test the effects of an aerobic exercise intervention initiated during chemotherapy compared to usual care (wait list control condition) on (1) objectively measured cognitive function and self-reported cognitive function, as well as on (2) the impact of cognitive impairment on quality of life (QOL) postintervention (commensurate with chemotherapy completion). The Aerobic exercise and CogniTIVe functioning in women with breAsT cancEr (ACTIVATE) trial was a two-arm, two-center randomized controlled trial conducted in Ottawa and Vancouver (Canada). Fifty-seven women (Mage,48.8±10 years) diagnosed with stage I-III breast cancer and awaiting chemotherapy were randomized to aerobic exercise initiated with chemotherapy (nEX=28) or usual care during chemotherapy with aerobic exercise after chemotherapy completion (nUC=29). The intervention lasted 12-24 weeks and consisted of supervised aerobic training and at-home exercise. The primary outcome was objective cognitive function measured via 13 neuropsychological tests (standardized to M ± SD,0±1); secondary outcomes of self-reported cognitive function and its impact on QOL were assessed via questionnaires. Data collected pre- and postintervention (the primary end point) were analyzed. Although no significant differences between groups were found for objective cognitive function outcomes postintervention after accounting for multiple testing, four of six self-reported cognitive function outcomes showed significant differences favoring the aerobic exercise group. Among women initiating chemotherapy for breast cancer, aerobic exercise did not result in significant differences in objective cognitive function postintervention after chemotherapy completion; however, the results do support the use of this intervention for improving self-reported cognitive function and its impact on QOL.

A Technology-Supported Psychoeducational Intervention for Older Adults and Their Families to Improve Social Isolation, Loneliness, and Intergenerational Connectedness-A Randomized Controlled Study.

Information and communication technologies (ICT) provide digital tools to support and facilitate social engagement. However, the extent to which new ICTs, such as instant messaging, and training on its use, enhance intergenerational family interactions and reduce social isolation and loneliness needs further exploration. In the present study, we developed a brief psychoeducational intervention to promote older adults and their family members (N = 64) to use new technologies to increase communication with each other. With a randomized controlled trial design, we evaluated the effectiveness of the intervention in changing primarily participants' intergenerational interactions, perceived social isolation, and loneliness. Through repeated-measures analysis of variance, an overall condition by time effect was found in younger family members such that contact frequency improved in the intervention condition compared with the waitlist control condition. Using a dyadic framework, we further investigated the role of the intervention in fostering interactions among family members. Dyadic analyses showed a partner effect with contact frequency in younger adults at pre-assessment predicting contact frequency of older adults at post-assessment. This suggests that support and encouragement from younger family members could increase intergenerational interactions and technology adoption among older adults. Moreover, online phone calls served as a promising tool to enhance intergenerational communication; higher user satisfaction was associated with increased ICT use, perceived usefulness, and fewer barriers to technology. This study provides preliminary findings on the effectiveness of ICT-based interventions for engaging older adults and their family members in the use of newer technologies to promote intergenerational interactions and reduce social isolation.

Long-term treatment outcomes of mindfulness-based cognitive therapy for fatigue in patients with inflammatory bowel disease: Results of a randomized controlled trial

ObjectivesFatigue is prevalent in patients with inflammatory bowel disease (IBD) in remission. Previously, we showed that fatigued IBD patients experienced a significant decrease in fatigue after receiving mindfulness-based cognitive therapy (MBCT). The current study examined to what extent these short-term beneficial effects of MBCT on fatigue were maintained over nine months follow-up, and whether patient characteristics were associated with clinically relevant improvement in fatigue. MethodsA randomized controlled trial, including an MBCT and waiting-list control condition, was performed in fatigued IBD patients in remission. For this study, we analysed long-term outcomes of 108 patients who received MBCT (either directly or after three months waiting). The primary outcome was fatigue, assessed with the Checklist Individual Strenght-20. Secondary outcomes included fatigue interference, depression, anxiety, and quality of life. ResultsThe reduced level of fatigue post-treatment did not change significantly during follow-up (F(2,76) = 1.68, p = 0.19). In total, 29% of patients reported clinically relevant improvement from pre-treatment to nine months follow-up. We found few significant differences in baseline characteristics between those reporting clinically relevant improvement and those not, except that patients who improved were significantly more often unemployed (χ2(1, n = 73) = 4.40, p = 0.04). Secondary outcomes, which did not change significantly during MBCT, also remained stable during follow-up. ConclusionFindings suggest that reductions in IBD-related fatigue after receiving MBCT are sustained over nine months follow-up, with around one-third of patients reporting clinically relevant improvement from pre-treatment to follow-up. Employment status might be related to improvements in fatigue. Future research is needed to confirm these long-term outcomes. PreregistrationClinicalTrials.gov ID: NCT03162575.

Protocol of a randomized controlled trial into guided internet-delivered cognitive behavioral therapy for insomnia in autistic adults (i-Sleep Autism)

BackgroundSleep problems, especially insomnia, are prevalent among autistic adults, affecting about 60 %, and significantly impact their quality of life. Internet-based cognitive behavioral therapy for insomnia (iCBT-I) could provide accessible and scalable treatment. Given the unique sensory- and information processing, and social challenges at play in autism, a tailored treatment approach may be essential to tackle sleep problems. Yet, interventions developed and tested specifically for autistic adults were scarce. Addressing this gap is crucial to meet the urgent need for effective insomnia treatments in this population. MethodsWith this two-arm, parallel, superiority randomized controlled trial, we will assess the effectiveness of a guided iCBT-I intervention for adults (N = 160) with autism and insomnia (i-Sleep Autism). In co-creation, i-Sleep Autism has been adjusted from an existing intervention (i-Sleep). Inclusion criteria are: age ≥ 18, an ASD diagnosis, and at least sub-threshold insomnia (Insomnia Severity Index ≥10). Participants are randomly assigned to either i-Sleep Autism or an information only waitlist control condition (online psychoeducation and sleep hygiene). After 6 weeks, the control group receives the intervention. Insomnia severity is the primary outcome. Secondary outcomes include pre-sleep arousal, general mental health, depression, anxiety, daily functioning, and quality of life. Assessments will occur at baseline, mid-intervention (3 weeks), post-intervention (6 weeks), and at 6-month follow-up (the intervention group). Linear mixed-effect regression models are employed to evaluate the effectiveness of i-Sleep Autism, alongside exploration of potential moderators and mediators. ConclusionThis trial can reveal whether autistic adults with insomnia benefit from a guided e-health intervention.Trial registration: NL-OMON56692.

Internet-based therapist-supported interpersonal psychotherapy for depression: A randomized controlled trial

BackgroundDepression is a common disorder for which there are several treatments options including different psychological treatments. The aim of this study was to investigate the effects of internet-based interpersonal psychotherapy (IPT) for symptoms of depression in randomized controlled trial. MethodsFollowing recruitment via advertisement a total of 113 participants with mild to moderate symptoms of depression were included and randomized to either a ten-week internet-based IPT with weekly therapist guidance or a waitlist control condition. The primary outcome was symptoms of depression measured weekly with the Montgomery Åsberg Depression Rating Scale (MADRS-S) and at pre- and post-treatment assessment with the Beck's Depression Inventory (BDI-II). Secondary outcomes were self-rated quality of life and symptoms of generalized anxiety disorder. We also measured therapeutic alliance and treatment credibility. Outcomes were evaluated with a latent growth curve model (for MADRS-S) and robust linear regression models (for the other measures). The trial was conducted during the Covid-19 pandemic in the spring of 2021. ResultsSignificant differences favoring the treatment group were found on three of the four outcomes: BDI-II, quality of life ratings, and ratings of generalized anxiety. Between-group effect sizes for these outcomes were moderate (BDI-II, quality of life) or small (generalized anxiety). The latent growth curve model did not indicate a significant difference on the weekly MADRS-S ratings. Exploratory analyses did not show an association between therapeutic alliance, treatment credibility and outcome. LimitationsMissing data at post-treatment was high in the treatment group (37 %), though the missingness was not significantly related to observed ratings at pre-treatment or estimated trajectories during the treatment. Few participants completed all modules. The Covid-19 pandemic situation may have affected both effects and dropout rates. ConclusionsInternet-based IPT can lead to significant improvements, though the reductions in symptoms of depression were not consistent across the two measures used. Completion rates and dropout patterns suggest a need for improved acceptability. Trial registrationThe trial was preregistered at Clinicaltrials.gov (Identifier: NCT04721678). Registered January 2021.https://clinicaltrials.gov/study/NCT04721678

Parent Training for Disruptive Behaviors in Referred Children with Autism Spectrum Disorder: A Randomized Controlled Trial.

The purpose of this study was to investigate whether face-to-face and therapist-assisted online (i.e., blended) behavioral parent training are effective on reducing disruptive behaviors in children with autism spectrum disorder (ASD) in routine mental health care. Ninety-seven children with ASD (4-13years; 76 boys) were randomized to face-to-face parent training, blended parent training, or a waitlist control condition. We assessed treatment effects on parent-rated child noncompliance (primary outcome) and irritability (secondary outcome). This involved comparing both formats separately to the control condition using linear regression models. Child behaviors at 6months follow-up were also examined. Children in the face-to-face parent training condition improved significantly more on noncompliance and irritability than children in the waitlist condition and improvements sustained to 6months follow-up. Children in the blended condition did not improve more than children in the waitlist condition and attrition was high. Our results extend findings from efficacy studies to routine mental health care and advocate the use of face-to-face parent training for disruptive behaviors in children with ASD. More research into blended parent training programs for children with ASD and disruptive behaviors in routine mental health care should be conducted to draw more definite conclusions about the value of blended parent training for these children. Trial registration number NL4712; date of registration 22-10-2014.

Interpersonal and individual effects of an app-based Christian and Islamic heart meditation intervention in healthy adults: protocol of a stratified randomised controlled trial

BackgroundThe academic development and widespread adoption of meditation practices for well-being and therapy have predominantly focused on secularised adaptations of Buddhist and Hindu techniques. This study aims to expand the field by investigating Christian and Islamic meditation that emphasize the spiritual significance of the heart through elements of visualisation and recitation. It compares the effects of spiritual heart-centred meditation with mindfulness meditation and a waitlist control, focusing on dimensions of social functioning, psychophysiology, cognition, and mental health.MethodThis study employs a stratified 3-arm randomised controlled method with mixed-method repeated measures across three assessment time points: before intervention (T1), after an 8-week intervention (T2), and at a 3-month follow up (T3). The three conditions include spiritual meditation (either Christian or Islamic), mindfulness meditation (Mindfulness-Based Stress Reduction – MBSR), and a waitlist. Participants will be stratified into Christian and Muslim samples and randomly allocated to the spiritual meditation, MBSR, or waitlist control conditions. Importantly, participants assigned to the spiritual meditation condition will be matched to the spiritual meditation program corresponding to their religion. The intervention will be administered through a mobile phone app with daily 20-minute guided meditation sessions for eight weeks. Primary outcomes pertain to the domain of interpersonal functioning, focusing on prosociality, forgiveness, empathy, and perspective taking. Secondary outcomes include physiology: pain tolerance, pain intensity, stress reactivity assessed via heart rate (HR) and heart rate variability (HRV), psychophysiological reactivity associated with a forgiveness task as measured through HR and HRV, attention (alerting, orienting, and executive attention networks), and mental health (stress, depression, anxiety, subjective well-being, positive and negative affect).DiscussionThis trial aims to test the effects of an app-based Christian and Islamic meditation, compared to secular mindfulness and a waitlist, using a randomised controlled trial. If the results yield positive outcomes, this study will support the efficacy of these contemplations, offering practitioners a way to enhance their well-being within their religious framework.Trial registrationClinicalTrials.gov, NCT06136676. Registered on 18 November 2023.https://clinicaltrials.gov/study/NCT06136676.

Telehealth-delivered recovery-orientated well-being plan group program for bipolar disorder: a pilot randomised feasibility and acceptability study.

Psychological interventions may assist in the management of bipolar disorder, but few studies have assessed the use of group therapy programs using telehealth. The present study aimed to assess the feasibility and acceptability of a well-being group program for people living with bipolar disorder designed to be delivered via telehealth (Zoom platform) using a randomised controlled pilot design. Participants were randomly assigned to either the 8-week well-being plan treatment condition or the wait-list control condition. They were administered a structured diagnostic instrument to confirm bipolar disorder diagnosis followed by a set of self-report questionnaires relating to mood, quality of life, personal recovery, and stigma. A total of 32 participants (16 treatment; 16 control) were randomised with 12 participants completing the intervention, and 13 the control condition. The program appeared acceptable and feasible (75% retention rate) with a mean attendance being reported of 7.25 sessions attended out of a possible 8 sessions. Participants reported high levels of satisfaction overall with the intervention, with a mean score of 9.18 out of 10. Preliminary evidence suggests that delivery of the group program online is feasible and acceptable for participants living with bipolar disorder. As the program was designed to prevent relapse over time, further research is needed to determine if the program may be helpful in improving symptom outcomes over a longer follow-up period.

The reROOT Coaching Program: A Pilot Randomized Controlled Trial Evaluating Its Impact on Coaching Style and Athlete Sports Development

The reROOT program teaches coaches 40 behaviors belonging to a need-supportive coaching style (including structure, involvement, and autonomy support), as defined by self-determination theory. This pilot randomized controlled trial, conducted during the COVID-19-related lockdown, evaluated the impact of this 18-hr program on coaching style (e.g., Problems in Sports Questionnaire) and on athlete motivation (Motivation Underlying Achievement Goals Questionnaire), performance (tactical, technical, physical, and psychological skills), and well-being (Satisfaction with Life Scale; Positive and Negative Affect Schedule). Twenty-three sports teams from two universities were randomized in the experimental or the wait-list control condition. Coaches in the experimental condition evaluated autonomy-supportive coaching styles more favorably than those in the control condition at the 1-year follow-up, but not 2 months after the end of the program. Athletes whose coaches participated in the program did not rate them as having a higher need-supportive coaching style, but experienced greater autonomous motivation and (potentially) performance, and under certain circumstances greater well-being and less controlled motivation 2 months after the end of the program compared with the wait-list condition. These findings suggest that the reROOT program could potentially improve readiness to rely on more autonomy-supportive skills and promote some aspects of sports development in athletes.

Effects of a mobile-app-based self-compassion intervention on psychological health and maladaptive cognitive traits: findings from a randomized controlled trial

AbstractCollege students are at risk of poor mental health and other maladaptive traits such as academic worry, perfectionism, and rumination. This study aimed to examine the effects of a seven-week mobile app-based self-compassion intervention on psychological symptoms and maladaptive cognitive traits in a sample of college students based in Singapore. Using a randomized controlled trial design, a total of 63 participants (mean age = 21.2; 64.2% female) were recruited and randomly assigned to either the self-compassion program (n = 31) or a waitlist control condition (n = 32). The online self-compassion program was administered via the mobile app 29k, which consists of weekly lessons each lasting 30 to 60 min. Outcome measures were administered a week before and after the intervention program. Analyses indicated that compared to participants in the waitlist control condition, participants in the intervention condition reported significantly greater decreases in depressive symptoms, anxiety, and stress. There was also a trend for greater decreases in academic worry in the intervention condition. No significant between-group differences were found on changes in trait self-compassion, perfectionism, or rumination. The results are promising in indicating that app-based self-compassion programs may be effective in improving selected aspects of college students’ mental health. Future research could investigate additional features that could be incorporated into mobile app-based interventions, such as synchronous sessions with a trained facilitator, and more targeted content for college students.

The efficacy of the TEACH e-Learning course at improving early childhood educators’ physical activity and sedentary behaviour self-efficacy, knowledge, intentions, and perceived behavioural control: a randomized controlled trial

BackgroundEarly childhood educators play a critical role in promoting physical activity and reducing sedentary time in childcare centres. However, early childhood educators receive limited specialised pre- and in-service learning opportunities relating to these behaviours and may lack the capacity to effectively engage children in healthy movement behaviours. This study aimed to examine the efficacy of an e-Learning course on increasing early childhood educators’ physical activity and sedentary behaviour-related capacities.MethodsA two-group parallel randomized controlled trial was conducted with early childhood educators in Canada (Mage = 41.78, 97% female). Participants randomized to the intervention group were asked to complete a physical activity and sedentary behaviour e-Learning course within a 4-week period. Participants randomized to the waitlist control condition were assigned to a waitlist to receive the intervention after the testing period. Participants reported on their self-efficacy, knowledge, intentions, and perceived behavioural control relating to physical activity and sedentary behaviours at baseline, post-intervention, and 3 months follow-up. Linear mixed effects models were estimated to determine difference in changes in outcomes from baseline to post-intervention, and follow-up.ResultsA total of 209 early childhood educators participated in the study (intervention n = 98; control n = 111). The TEACH e-Learning course was found to be efficacious at improving all of the examined outcomes, with standardized effect sizes ranging from d = 0.58 to d = 0.65 for self-efficacy outcomes, d = 0.66 to d = 1.20 for knowledge outcomes, d = 0.50 to d = 0.65 for intention outcomes, and d = 0.33 to d = 0.69 for perceived behavioural control outcomes post-intervention. The intervention effects were sustained at follow-up for all outcomes apart from perceived behavioural control to limit screen time. Additionally, the magnitude of the effect for knowledge outcomes decreased at follow-up, with standardized effect sizes ranging from d = 0.49 to d = 0.67.ConclusionsThe e-Learning course was highly successful at improving early childhood educators’ capacity pertaining to physical activity and sedentary behaviours. Providing training content through e-Learning may be an efficacious approach to providing continual professional learning opportunities relating to physical activity and sedentary time to early childhood educators on a large scale.

Impact of a mindfulness-based intervention on well-being and mental health of elementary school children: results from a randomized cluster trial

Prevention programs, such as mindfulness-based interventions (MBIs), are often implemented in schools to prevent psychological disorders from emerging in children and to support their mental health. This study used a randomized cluster design to evaluate the impact of a MBI, called Mission Méditation, on the well-being and the mental health of elementary school children’s. 13 classrooms of an elementary school were randomly allocated to the experimental condition (7 classrooms, n = 127 students) or the waitlist control condition (6 classrooms, n = 104 students). Participants in the experimental condition received a 10-week MBI. Regression analyses revealed significant differences between conditions for inattention. Participants in the MBI condition reported no change in pre- to post-intervention, whereas participants in the control condition reported pre- to post-intervention increases. Results also showed significant differences in perceived competence. Participants in the MBI condition reported a non-significant decrease in perceive competence, whereas participants in the control condition reported significantly higher perceive competence scores from pre- to post-intervention. Results do not indicate that the MBI had a significant impact on participant’s well-being and mental health. This suggests that MBIs may not have an added value when compared to other preventive interventions geared towards well-being and mental health promotion in school settings.

Treating young adult cannabis use disorder with text message-delivered peer network counseling

BackgroundApproximately 16.5% of U.S. young adults have a cannabis use disorder (CUD) and are at risk for negative outcomes. Treatment can reduce cannabis use, but young adults are less likely to seek help than older adults. Peer Network Counseling-txt (PNC-txt) is a brief, text-delivered, Motivational Interviewing-informed substance use intervention focusing on peer relations and activity spaces as mechanisms for behavioral change. PNC-txt has shown evidence of reducing tobacco and cannabis use with adolescents and young adults, but it has not been tested in the context of legal cannabis use. The current randomized controlled trial sought to expand the evidence regarding the context of PNC-txt effects, comparing one state in which cannabis is legal (Colorado) and one state in which it is not (Tennessee). We hypothesized that participants randomized to PNC-txt would show significant reductions in cannabis use compared to controls, with larger reductions for females and those in Colorado, and that peer relations and activity space would mediate effects. MethodsOne thousand, seventy eight 18–25 year olds (CO: 551; TN: 527) who met screening criteria for CUD and biologically-verified cannabis use were randomly assigned to PNC-txt or waitlist control condition. Every other day for 4 weeks, participants assigned to PNC-txt received pre-programmed text conversations, tailored via data from the baseline assessment. Self-report and biological indicators of cannabis use were measured at 1-, 3-, and 6-months. DiscussionData analysis is underway. Results will provide evidence regarding whether, and how, PNC-txt reduces cannabis use in young adults with CUD. Trial registrationThis trial was prospectively registered on September 28, 2020 with ClinicalTrials.gov (NCT04567394).

Effectiveness of a positive psychology and mindfulness-based app on mental health for parents of children with a neurodevelopmental disorder: study protocol of a pragmatic international randomized controlled trial

IntroductionParents of children with a neurodevelopmental disorder (NDD) experience more stress than parents of typically developing children. In a cocreation process with experts and parents, a low-threshold application that uses exercises based on the principles of positive psychology and mindfulness was developed. This application, called “Adappt,” aims at enhancing the ability to adapt of the parents and caregivers of children with NDDs and at supporting their mental health. This protocol describes the evaluation study of the effectiveness of Adappt, its core working mechanisms and user experiences.MethodA pragmatic international multicenter randomized controlled trial will compare the effectiveness of Adappt with a (delayed) waitlist control condition. At least 212 parents or primary caregivers of children younger than 18 years diagnosed with or suspected of a NDD will be randomly assigned to the intervention or waitlist control condition. Participants are excluded if they have severe anxiety or depression levels or are in treatment for mental health issues. Measures will be collected online at baseline, post-intervention (1 month after baseline), and 4 and 7 months after baseline. The primary outcome is the improvement in generic sense of ability to adapt as measured with the Generic Sense of Ability to Adapt Scale (GSAAS; (Front Psychol 14:985408, 2023)) at 4-month follow-up. Secondary outcomes are mental well-being, (parental) distress, and client satisfaction with “Adappt.”DiscussionResults of this study will contribute to knowledge on the effectiveness of a low-threshold application for parents of children with a NDD in multiple countries. If the application is found to be effective in improving mental health, recommendations will be made for implementation in health care.Trial registrationThis study is registered on clinicaltrials.gov (NCT06248762) on February 8, 2024, and the Open Science Framework (https://osf.io/5znqv).

Promoting Psychological Well-being in Preschoolers Through Mindfulness-based Socio-emotional Learning: A Randomized-controlled Trial.

Mental health issues in children and young people are frequent and can have enduring negative consequences. Preventive early interventions delivered at school may foster psychological well-being, and preliminary evidence suggests that mindfulness-based social and emotional learning (SEL) interventions have positive effects on children's mental health. The aim of this study was to evaluate a mindfulness-based SEL curriculum including a French adaptation of the Kindness Curriculum (KC), delivered by pre-kindergarten teachers, in a cluster randomized control trial. Sixty-four classes (761 children, aged 38-58 months) from a socio-economically disadvantaged area in France were randomly assigned to either intervention or waiting-list control conditions. Indicators of children's mental health, self-management, positive relationships with teachers and peers, emotional processing and executive functioning were collected through teacher-rated questionnaires, standardized observations, and behavioral tasks. Results in the whole sample indicated a positive effect of the intervention on children's mental health, including a reduction in emotional, conduct and peer relationship problems, and a reduction in teacher-child conflicts. No significant effects were found on the other indicators. Heterogeneity analyses revealed stronger effects of the intervention on several indicators for children who had a teacher with lower level of teaching experience, for children with lower baseline mental health and for older children. This program therefore appears as a promising early school-based intervention promoting mental health and positive relationships, especially in a subgroup of at-risk preschool-aged children.

Does Web-Based Relationship Education Improve Sexual Intimacy? Initial Examination, Replication, and Exploration of Moderation in a Low-Income Sample.

Sexual intimacy, characterized as the experience between individuals of sharing general affection and sexual activity with one another within the Personal Assessment of Intimacy in Relationships inventory, is positively related to relationship satisfaction and stability. However, many studies of couple therapy have shown that it only results in small-sized (and often non-significant) improvements in sexual intimacy. Furthermore, there are numerous financial, logistical, and psychological barriers to couple therapy. Thus, the current study sought to examine whether two brief online relationship education programs (OurRelationship and ePREP) could overcome these barriers and yield similar-sized effects to more intensive couple therapy. In two independently collected samples of low-income couples (NSample 1 = 742 Couples; M AgeSample 1 = 33.19; NSample 2 = 671 Couples; M AgeSample 2 = 33.48), the current study found that: OurRelationship (d = 0.24-0.28) and ePREP (d = 0.26-0.34) produced small-sized changes in sexual intimacy relative to a waitlist control condition in both samples, the magnitude of the effect size replicated in a second sample and, with rare exception, these changes were generally not moderated by key variables of interest. Given that web-based relationship education is significantly shorter, less expensive, and more accessible than in-person couple interventions, web-based relationship education could be considered a viable candidate for couples experiencing concerns with sexual intimacy.

Web-Based Imagery Behavioral Activation (WIMBA): Study Protocol for a Randomized Controlled Trial Testing the Effects, Acceptability, and Feasibility of a Mental Imagery Activity Scheduling Training Delivered Online.

Behavioral activation (BA) is an effective and efficacious treatment for depression. Activity scheduling is the central treatment component of BA and involves planning of potentially enjoyable and rewarding activities. Evidence from non-clinical studies suggests that mental imagery simulations of planned activities can increase motivation and anticipated pleasure for these activities. We describe a randomized controlled trial testing a mental imagery activity scheduling training delivered online in four weekly sessions (total training duration approximately 90 minutes) in a sample meeting diagnostic criteria of a major depressive episode, as indicated by the Diagnostic Short-Interview for Mental Disorders (Mini-DIPS), and not currently receiving treatment. Participants (N = 140) will be randomized to either mental imagery activity scheduling or a wait-list control condition. Depressive symptoms (BDI-II) and behavioral activation (BADS) are the primary outcomes; BDI-II will be measured at Session 1, Session 4, and at two-week follow-up, BADS at Sessions 1-4 and at two-week follow-up. It is discussed how the expected results may reflect mechanisms and effects of a mental imagery activity scheduling training delivered online in a sample of individuals with depression. Concluding we outline next steps for future research and highlight the potential of this novel treatment for dissemination in the wider community and integration into routine care.

The effects of psychotherapy for anhedonia on subcortical brain volumes measured with ultra-high field MRI

BackgroundAnhedonia is a transdiagnostic symptom often resistant to treatment. The identification of biomarkers sensitive to anhedonia treatment will aid in the evaluation of novel anhedonia interventions. MethodsThis is an exploratory analysis of changes in subcortical brain volumes accompanying psychotherapy in a transdiagnostic anhedonic sample using ultra-high field (7-Tesla) MRI. Outpatients with clinically impairing anhedonia (n = 116) received Behavioral Activation Treatment for Anhedonia, a novel psychotherapy, or Mindfulness-Based Cognitive Therapy (ClinicalTrials.gov Identifiers NCT02874534 and NCT04036136). Subcortical brain volumes were estimated via the MultisegPipeline, and regions of interest were the amygdala, caudate nucleus, hippocampus, pallidum, putamen, and thalamus. Bivariate mixed effects models estimated pre-treatment relations between anhedonia severity and subcortical brain volumes, change over time in subcortical brain volumes, and associations between changes in subcortical brain volumes and changes in anhedonia symptoms. ResultsAs reported previously (Cernasov et al., 2023), both forms of psychotherapy resulted in equivalent and significant reductions in anhedonia symptoms. Pre-treatment anhedonia severity and subcortical brain volumes were not related. No changes in subcortical brain volumes were observed over the course of treatment. Additionally, no relations were observed between changes in subcortical brain volumes and changes in anhedonia severity over the course of treatment. LimitationsThis trial included a modest sample size and did not have a waitlist-control condition or a non-anhedonic comparison group. ConclusionsIn this exploratory analysis, psychotherapy for anhedonia was not accompanied by changes in subcortical brain volumes, suggesting that subcortical brain volumes may not be a candidate biomarker sensitive to response to psychotherapy.