Pilot Randomized Controlled Trial of the Emotion Detectives In-Out: A Blended Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children.
Aug 2026· Child Psychiatry and Human Development· 0 citations· 55 references
Medicine
Abstract
Anxiety disorders are highly prevalent in childhood, and increasing demand for services highlights the need for scalable and accessible interventions. This pilot randomized controlled equivalence trial examined the feasibility and preliminary efficacy of a blended adaptation of the Unified Protocol for Children ("Emotion Detectives In-Out"), integrating face-to-face group sessions with self-guided and therapist-supported online components. The intervention was compared with Coping Cat, a well-established cognitive-behavioral group program for childhood anxiety. Seventy-seven children aged 6-13 years with a primary anxiety disorder were randomized to either condition. Outcomes included clinician-rated severity and improvement, child- and parent-reported anxiety and depressive symptoms, and anxiety-related interference in daily life. Both interventions were associated with significant improvements over time across most outcomes. No significant between-group differences were observed for clinician-rated severity or improvement, and remission and treatment response rates were comparable. Significant group-by-time interaction effects favoring the blended intervention emerged for child-reported generalized anxiety, total anxiety and overall symptom scores. Between-group differences were limited, although Coping Cat was associated with significantly lower parent-reported family interference at post-treatment. Equivalence analyses yielded mixed findings, with some primary outcomes meeting the prespecified equivalence criteria. Findings provide preliminary evidence supporting the potential clinical utility of a blended transdiagnostic group intervention. Although several outcomes demonstrated statistical equivalence with Coping Cat, equivalence findings were mixed and should be interpreted cautiously given the pilot nature of the trial. Larger, adequately powered randomized controlled trials are needed to determine whether the interventions achieve clinically equivalent outcomes. Trial registration number: https://doi.org/10.17605/OSF.IO/62N4X (retrospectively registered at November 18, 2025).
The objective of this study was to compare the effectiveness of Emotion-Focused Couple Therapy and Cognitive-Behavioral Couple Therapy in reducing anxiety and depression and improving relationship quality among couples with a history of childhood trauma. This study employed a randomized controlled trial with a pretest–posttest and three-month follow-up design. The sample consisted of 45 couples (90 individuals) recruited from counseling centers in Tehran and Karaj and randomly assigned to EFT, CBT, or control groups. The intervention groups received structured weekly therapy sessions based on their respective protocols, while the control group received no intervention. Anxiety, depression, and relationship quality were assessed at three time points using standardized measures. Data were analyzed using repeated measures analysis of variance and Bonferroni post-hoc tests in SPSS version 27. The results indicated significant main effects of time and group, as well as significant time-by-group interaction effects for anxiety, depression, and relationship quality. Both EFT and CBT led to significant reductions in anxiety and depression and significant improvements in relationship quality compared to the control group. However, EFT demonstrated significantly greater effectiveness than CBT in improving relationship quality and reducing depressive symptoms, with treatment gains maintained at the three-month follow-up. Both therapeutic approaches are effective for trauma-exposed couples, but Emotion-Focused Couple Therapy appears to be more effective in producing deeper and more sustained improvements in relationship quality and depressive symptoms, highlighting the importance of emotionally and attachment-oriented interventions in this population.
Nasrin Shayganfar, Sophia Khaneghahi, Gholamreza Sanagouye Moharer· Health Psychology and Behavi...· 0 citations
OBJECTIVES
Mindfulness is increasingly being implemented in child and adolescent therapy. However, little is known about its effectiveness in individual settings within a clinical outpatient context. We investigated the effects of session-introducing mindfulness interventions (IG-M) compared to session-introducing relaxation interventions (CG-R) and no standardized session-introduction (CG) on symptomatic outcome and therapeutic alliance in cognitive-behavioral therapy using a randomized controlled design.
METHOD
One thousand four hundred and seventy-eight of 90 outpatient adolescents (11-19 years) diagnosed with depression, an anxiety disorder, or a hyperkinetic disorder were assessed. Symptomatic outcome was assessed by the German version of the Youth Self-Report 11-18R at five measurement time points (pre, 3rd, 10th, 17th therapy session, post), therapeutic alliance was assessed by the German version of the Therapeutic Alliance Scales for Children after every therapy session (1st-24th therapy session). Statistical analyses were conducted using multilevel modeling. The RCT was registered at ClinicalTrials.gov (NCT04034576).
RESULTS
Multilevel modeling revealed a significant decrease of symptomatic outcome in IG-M compared to CG, but not compared to CG-R, over time. A significant increase in therapeutic alliance over time was observed from the therapists' perspective with no group differences. Therapeutic alliance from patients' perspective significantly increased in IG-M and significantly decreased in CG. There was no statistically meaningful change in therapeutic alliance from the patients' perspective in CG-R.
CONCLUSION
IG-M had positive effects on symptomatic outcome and therapeutic alliance compared to CG, but did not outperform CG-R. Future studies that control confounding variables are highly relevant to understand the role of mindfulness in individual youth psychotherapy.
Julia Kalmar, Ines Baumann, Elena Schleiting et al.· Journal of Clinical Psycholo...· 0 citations
BACKGROUND
Mindfulness-based approaches show promise for reducing tic severity, yet little is known about their effect on comorbid symptoms.
OBJECTIVES
The objective was to evaluate secondary outcomes from a pilot randomized controlled trial comparing mindfulness-based intervention for tics (MBIT) with psychoeducation, relaxation, and supportive therapy (PRST).
METHODS
Twenty-eight adults with Tourette's syndrome or persistent tic disorder were randomized to MBIT or PRST and completed measures of obsessive-compulsive (OC) symptoms, attention-deficit/hyperactivity disorder (ADHD) symptoms, depression, anxiety, stress, and functional impairment at baseline, posttreatment, 1-month, and 6-month follow-up.
RESULTS
A significant group-by-time interaction emerged for OC symptoms, indicating a significantly greater reduction in OC symptoms in MBIT compared to PRST at posttreatment. No significant group-by-time interactions emerged for the remaining outcomes at posttreatment. Outcomes at 1- and 6-month follow-ups are reported descriptively.
CONCLUSIONS
MBIT, relative to PRST, led to significantly greater reductions in OC symptoms. Larger clinical trials are necessary to test these initial findings.
Kiran Kaur, W. A. Brown, Susanne S. Hoeppner et al.· Movement Disorders Clinical...· 0 citations
BACKGROUND
To evaluate the effectiveness of mentalization-based treatment (MBT) for borderline personality disorder (BPD) compared to structured clinical management (SCM) in a South Korean clinical setting.
METHODS
This single-blind pilot randomized controlled trial included 64 individuals with a primary diagnosis of BPD who underwent either MBT (n = 37) or SCM (n = 27) in an outpatient setting over 12 months. Both interventions included weekly individual and group sessions. The primary outcome measure was the number of suicide attempts. Secondary outcomes included depressive symptoms, suicide risk, hospitalization frequency and duration, mentalization difficulties, adult attachment styles, BPD symptom severity, and resilience. Outcomes were assessed at baseline and 6 and 12 months. Analyses were conducted using generalized estimating equations, following the intention-to-treat principle.
RESULTS
Both treatment groups demonstrated a significant reduction in suicide attempts over 12 months, with no significant between-group differences in the primary outcome. However, participants receiving MBT showed consistent and sustained improvements in depressive symptoms, mentalization difficulties, and resilience. MBT was also associated with a significant reduction in attachment anxiety at 12 months, whereas the SCM produced earlier reductions in suicide risk and improvements in psychic equivalence. No significant changes were observed in attachment avoidance or in the hasty and incomplete mentalizing domains in either group.
CONCLUSIONS
This pilot trial provides preliminary evidence that both MBT and SCM were effective in reducing suicidal behaviors and enhancing psychological functioning among Koreans with BPD. MBT demonstrated greater long-term benefits in emotion regulation and adaptability, suggesting that it may serve as a culturally scalable intervention in non-Western clinical settings.
Hyunkyung Shin, Wonjun Choi, Y. Chung et al.· Borderline Personality Disor...· 0 citations
Background Behavioral parent training (BPT) programs are effective for reducing disruptive behavior of many children with emotional and behavioral disorders (EBD) and improving skills and competencies of their parents. However, these interventions are not sufficiently effective for parents who themselves have depression. This study assessed the feasibility of the Addressing Depression and Positive Parenting Techniques (ADAPT) Program—a novel BPT that includes aspects of cognitive behavioral therapy and dialectical behavior therapy. We identified whether recruitment was possible, attendance was acceptable, participants were satisfied, and facilitators adhered to the protocol. Additionally, we measured trends in changes in parent and child outcomes with intervention. Methods Participants were 28 parents and their children with EBD, referred to two hospital-based clinics. Parents were eligible if they (1) had a child aged 6–10 experiencing emotional and behavioral difficulties and (2) were experiencing elevated depressive symptoms. ADAPT took place virtually over 10 weeks. Participants completed measures before, weekly and after treatment. Clinicians recorded attendance and completed weekly treatment fidelity checklists. Results We found that recruitment was possible, the intervention showed high parental satisfaction, and facilitators reported high program fidelity. Further, secondary outcome measures showed evidence of sensitivity to change in the intended direction. Conclusion Given that a priori progression criteria were met and we found preliminary indication of efficacy, we conclude that an RCT of ADAPT to determine efficacy is warranted.
Brendan F. Andrade, Sabrina Brodkin, Aliza Israel et al.· PLoS ONE· 0 citations
Abstract Background Depressive disorders are a leading cause of disability among women worldwide, yet existing interventions often fail to account for the biological and sociocultural factors shaping women’s risk and symptom presentation. Objective In response, this randomized, single-blind, controlled trial will evaluate the efficacy of the 3D Program—a gender-sensitive, guided internet-based cognitive behavioral therapy (iCBT) intervention for women with moderate depressive symptoms. Methods A total of 120 women presenting with moderate depressive symptoms (17-item Hamilton Depression Rating Scale score 17‐23), aged 18 to 45 years, will be randomized to receive either the 10-week 3D Program or informational video content, with both groups continuing treatment as usual. The 3D Program will integrate personalized therapist support, self-guided digital modules, and a moderated online group, with content cocreated alongside women with lived experience of depressive symptoms. The primary outcome will be the change in depressive symptom severity, measured by the 17-item Hamilton Depression Rating Scale at 12- and 26-week postbaseline assessments. Secondary outcomes will include functioning, quality of life, perceived stress, and menstrual-related distress. Additionally, the study will explore potential biological predictors of treatment response, analyzing metabolic markers related to tryptophan metabolism and adrenal steroid pathways across multiple biological matrices. Data analyses will use linear mixed-effects models and multivariate techniques to examine treatment effects and possible biomarker associations. Results The trial was funded in October 2023 (grant PI23/00257, Spanish Ministry of Economy and Competitiveness), and ethical approval was obtained in February 2024. The trial was registered in July 2025 (ClinicalTrials.gov NCT07060690). Data collection began in March 2026 and is projected to conclude in August 2027. As of April 2026, a total of 8 participants have been enrolled. Data analysis has not yet commenced. The results are expected to be published in the summer of 2028. Conclusions This trial aims to address critical gaps in accessible, personalized, and gender-sensitive mental health care. If effective, the 3D Program may serve as a scalable, cost-efficient adjunct to routine care for women with depressive symptoms in public health systems, while biomarker findings may lay the groundwork for future trials examining predictors of response.
N. Angarita-Osorio, A. García-Estela, L. Terraneo et al.· JMIR Research Protocols· 0 citations
