A RCT to explore the effectiveness of supporting adherence to nebuliser medication in adults with cystic fibrosis: fidelity assessment of study interventions.

BACKGROUND: A multi-component self-management intervention 'CFHealthHub' was developed to reduce pulmonary exacerbations in adults with Cystic Fibrosis (CF) by supporting adherence to nebuliser medication. It was evaluated in a randomized controlled trial (RCT) involving 19 CF centres, with 32 interventionists, 305 participants in the intervention group, and 303 participants in the standard care arm. Ensuring treatment fidelity of intervention delivery was crucial to ensure that the intervention produced the expected outcomes. METHODS: Fidelity of the CFHealthHub intervention and standard care was assessed using different methods for each of the five fidelity domains defined by the Borrelli framework: study design, training, treatment delivery, receipt, and enactment. Study design ensured that the groups received the intended intervention or standard care. Interventionists underwent training and competency assessments to be deemed certified to deliver the intervention. Audio-recorded intervention sessions were assessed for fidelity drift. Receipt was assessed by identifying whether participants set Action and Coping Plans, while enactment was assessed using click analytics on the CFHealthHub digital platform. RESULTS: Design: There was reasonable agreement (74%, 226/305) between the expected versus actual intervention dose received by participants in the CFHealthHub intervention group. The standard care group did not include focused adherence support for most centres and participants. Training: All interventionists were trained. Treatment delivery: The trial demonstrated good fidelity (overall fidelity by centre ranged from 79 to 97%), with only one centre falling below the mean threshold (> 80%) on fidelity drift assessments. Receipt: Among participants who completed the 12-month intervention, 77% (205/265) completed at least one action plan, and 60% (160/265) completed at least one coping plan. Enactment: 88% (268/305) of participants used web/app click analytics outside the intervention sessions. The mean (SD) number of web/app click analytics per participant was 31.2 (58.9). Additionally, 64% (195/305) of participants agreed to receive notifications via the mobile application, with an average of 53.6 (14.9) notifications per participant. CONCLUSIONS: The study demonstrates high fidelity throughout the RCT, and the CFHealthHub intervention was delivered as intended. This provides confidence that the results of the RCT are a valid reflection of the effectiveness of the CFHealthHub intervention compared to standard care. TRIAL REGISTRATION: ISRCTN registry: ISRCTN55504164 (date of registration: 12/10/2017).

Ensuring treatment fidelity in intervention studies: Developing a checklist and scoring system within a behaviour change paradigm.

BACKGROUND: Treatment fidelity refers to the degree to which an intervention is implemented as intended. Promoting treatment fidelity is important to achieve a valid comparison in intervention research. However, it is often underreported: few studies detail the use and development of fidelity measures. This study aims to promote the treatment fidelity of a modified version of the Derbyshire Language Scheme (M-DLS), a manualised intervention for children with language difficulties, by exploring participants' opinions on training and intervention delivery. Results inform development of a checklist and scoring system to monitor and promote treatment fidelity in a comparison trial. METHOD: Ten student speech and language therapists (SLTs) and two research assistants (RAs) participated in the study. All received training on the M-DLS, and 10 were video-recorded completing role-plays of an M-DLS session in small groups. Feedback was gathered after training and role-plays in focus groups and interviews. Feedback was interpreted using the constructs of the Theoretical Domains Framework (TDF). A treatment fidelity checklist was then developed using the feedback. The first author and two RAs rated role-play videos using the checklist to trial it to inform amendments and to promote interrater reliability. Interrater agreement was calculated using Spearman's test of correlation. RESULTS: Participants discussed the importance of having clear materials and time to practise sessions. They suggested amendments to the materials and training to promote treatment fidelity. The checklist and scoring system accounted for participants' suggestions, with amendments detailed in a log. Spearman's correlation results suggested agreement between the raters was strong. CONCLUSIONS: Results emphasise the importance of training quality, practice and reflective opportunities and clear materials to promote treatment fidelity. The construction of the checklist and scoring system was described in detail, informing the development of future checklists. After further trialling, the checklist can be used to ensure the M-DLS is delivered with high treatment fidelity in the comparison trial. WHAT THIS PAPER ADDS: What is already known on this subject Treatment fidelity is an essential component of intervention effectiveness and efficacy studies, ensuring the intervention is delivered as intended. It is also an essential component of evidence-based clinical practice. However, few research studies report the treatment fidelity process or publish the checklists used, depriving clinicians of useful information for implementation. What this study adds This study describes in detail the iterative process of treatment fidelity checklist development, engaging those implementing the intervention in development. This ensured clarity and interrater reliability of the checklist. Furthermore, a novel scoring system was developed so that accuracy of implementation can be easily compared across users and across practice attempts. What are the clinical implications of this work? The importance of treatment fidelity when implementing effective and efficacious interventions cannot be overstated. The treatment fidelity checklist developed for research can be easily adopted to support accurate implementation in clinical practice through an audit process.

Stigma and Social Determinants of Health Associated With Fidelity to Guideline-Concordant Therapy in Patients With Breast Cancer Living With and Without HIV in Botswana.

BACKGROUND: Patients with breast cancer in sub-Saharan Africa (SSA) experience a disproportionate burden of mortality. Fidelity to treatment guidelines, defined as receiving optimal dose and frequency of prescribed treatments, improves survival. We sought to identify patient factors associated with treatment fidelity and how this may differ for people with HIV (PWH) and breast cancer. METHODS: We conducted a qualitative study of women who initiated outpatient treatment for stages I-III breast cancer in Botswana, with deviance sampling of high- and low-fidelity patients. One-on-one interviews were conducted using semi-structured guides informed by the Theory of Planned Behavior. The sample size was determined by thematic saturation. Transcribed interviews were double coded with an integrated analytic approach. RESULTS: We enrolled 15 high- and 15 low-fidelity participants from August 25, 2020 to December 15, 2020, including 10 PWH (4 high, 6 low fidelity). Ninety-three percent had stage III disease. Barriers to treatment fidelity included stigma, social determinants of health (SDOH), and health system barriers. Acceptance and de-stigmatization, peer and other social support, increased knowledge and self-efficacy were identified as facilitators. The COVID-19 pandemic amplified existing socioeconomic stressors. Unique barriers and facilitators identified by PWH included intersectional stigma, and HIV and cancer care integration, respectively. CONCLUSION: We identified multilevel modifiable patient and health system factors associated with fidelity. The facilitators provide opportunities for leveraging existing strengths within the Botswana context to design implementation strategies to increase treatment fidelity to guideline-concordant breast cancer therapy. However, PWH experienced unique barriers, suggesting that interventions to address fidelity may need to be tailored to specific comorbidities.

How does training format and clinical education model impact fidelity and confidence in a speech-language pathology rotation?

Clinical education rotations typically involve an initial training phase followed by supervised clinical practice. However, little research has explored the separate contributions of each component to the development of student confidence and treatment fidelity. The dual purpose of this study was to compare the impact of clinical training format (synchronous vs. asynchronous) and education model (traditional vs. collaborative) on student confidence and treatment fidelity. Thirty-six speech-language pathology graduate students completed this two-phase study during a one-term clinical rotation. Phase 1 investigated the impact of training condition (synchronous, asynchronous guided, asynchronous unguided) on student confidence and treatment fidelity. Phase 2 explored the impact of education model (traditional vs. collaborative) on student confidence and treatment fidelity. Treatment fidelity was measured at the conclusion of Phases 1 and 2. Students rated their confidence at six-time points throughout the study. Our results indicate that training condition did not differentially impact student confidence or treatment fidelity; however, education model did: students in the collaborative education model reported increased confidence compared to students in the traditional education model. Students in the collaborative education model also trended towards having higher treatment fidelity than students in the traditional education model. These results demonstrate that pre-clinical trainings can be effective in several different formats provided they cover the discrete skills needed for the clinical rotation. While preliminary, our results further suggest that students may benefit from working with peers during their clinical rotations.

The Long and the Short of It: A Comparison of the Effectiveness of Parent-Child Care (PC-CARE) and Parent-Child Interaction Therapy (PCIT).

Research shows that parenting interventions struggle with keeping clients in treatment. The purpose of this study was to compare attrition and rates of improvement in caregiver-child dyads participating in either Parent-Child Care (PC-CARE), a brief, 7-session parenting intervention or Parent-Child Interaction Therapy (PCIT) over a 7-week period. Participants were 204 caregiver-child dyads referred to either PC-CARE (N = 69) or PCIT (N = 135) between 2016 and 2019. Children were aged 2-7 years, referred for treatment by county Behavioral Health Services, and Medicaid funded. Findings showed that PC-CARE participants were 2.5 times more likely than PCIT participants to complete 7 sessions, all other things being equal, and showed significantly greater rates of improvement during this timeframe in reported child behavior problems and parenting stress. In conclusion, compared with PCIT, PC-CARE showed greater retention and rate of improvement in child and parent outcomes over a comparable time period.

Implementation of a hospital-wide multidisciplinary blunt chest injury care bundle (ChIP): Fidelity of delivery evaluation.

BACKGROUND: Ineffective intervention for patients with blunt chest wall injury results in high rates of morbidity and mortality. To address this, a blunt chest injury care bundle protocol (ChIP) was developed, and a multifaceted plan was implemented using the Behaviour Change Wheel. OBJECTIVE: The purpose of this study was to evaluate the reach, fidelity, and dose of the ChIP intervention to discern if it was activated and delivered to patients as intended at two regional Australian hospitals. METHODS: This is a pretest and post-test implementation evaluation study. The proportion of ChIP activations and adherence to ChIP components received by eligible patients were compared before and after intervention over a 4-year period. Sample medians were compared using the nonparametric median test, with 95% confidence intervals. Differences in proportions for categorical data were compared using the two-sample z-test. RESULTS/FINDINGS: Over the 19-month postimplementation period, 97.1% (n = 440) of eligible patients received ChIP (reach). The median activation time was 134 min; there was no difference in time to activation between business hours and after-hours; time to activation was not associated with comorbidities and injury severity score. Compared with the preimplementation group, the postimplementation group were more likely to receive evidence-based treatments (dose), including high-flow nasal cannula use (odds ratio [OR] = 6.8 [95% confidence interval {CI} = 4.8-9.6]), incentive spirometry in the emergency department (OR = 7.5, [95% CI = 3.2-17.6]), regular analgesia (OR = 2.4 [95% CI = 1.5-3.8]), regional analgesia (OR = 2.8 [95% CI = 1.5-5.3]), patient-controlled analgesia (OR = 1.8 [95% CI = 1.3-2.4]), and multiple specialist team reviews, e.g., surgical review (OR = 9.9 [95% CI = 6.1-16.1]). CONCLUSIONS: High fidelity of delivery was achieved and sustained over 19 months for implementation of a complex intervention in the acute context through a robust implementation plan based on theoretical frameworks. There were significant and sustained improvements in care practices known to result in better patient outcomes. Findings from this evaluation can inform future implementation programs such as ChIP and other multidisciplinary interventions in an emergency or acute care context.

Treatment fidelity in eating disorders and psychological research: Current status and future directions.

OBJECTIVE: The evaluation and use of treatment fidelity procedures are rare in the development and implementation of psychological interventions. This article aims to review the construct of treatment fidelity, highlight limitations to currently available measures, and introduce a conceptual framework for studying and adapting fidelity measures in clinical research and practice using eating disorders as an example. METHOD: As treatment fidelity assesses whether an intervention was delivered as intended, we operationalized this construct as: (a) treatment adherence, (b) therapist competence, and (c) treatment differentiation. RESULTS: There is a significant gap in the literature assessing and documenting treatment fidelity. Available studies indicate that existing adherence measures can be time consuming, costly, and are not widely used in the field. Furthermore, therapist competence is a complex and context-dependent construct that is challenging to measure. Finally, treatment differentiation is often inferred by ensuring adherence. DISCUSSION: The development of simplified formal tests of treatment fidelity would help draw conclusions about treatment efficacy and improve the dissemination and implementation of interventions to promote optimal clinical outcomes.

Psychoeducational Interventions for Problematic Anger in Chronic Moderate to Severe Traumatic Brain Injury: A Study of Treatment Enactment.

OBJECTIVES: Treatment enactment, a final stage of treatment implementation, refers to patients' application of skills and concepts from treatment sessions into everyday life situations. We examined treatment enactment in a two-arm, multicenter trial comparing two psychoeducational treatments for persons with chronic moderate to severe traumatic brain injury and problematic anger. METHODS: Seventy-one of 90 participants from the parent trial underwent a telephone enactment interview at least 2 months (median 97 days, range 64-586 days) after cessation of treatment. Enactment, quantified as average frequency of use across seven core treatment components, was compared across treatment arms: anger self-management training (ASMT) and personal readjustment and education (PRE), a structurally equivalent control. Components were also rated for helpfulness when used. Predictors of, and barriers to, enactment were explored. RESULTS: More than 80% of participants reported remembering all seven treatment components when queried using a recognition format. Enactment was equivalent across treatments. Most used/most helpful components concerned normalizing anger and general anger management strategies (ASMT), and normalizing traumatic brain injury-related changes while providing hope for improvement (PRE). Higher baseline executive function and IQ were predictive of better enactment, as well as better episodic memory (trend). Poor memory was cited by many participants as a barrier to enactment, as was the reaction of other people to attempted use of strategies. CONCLUSIONS: Treatment enactment is a neglected component of implementation in neuropsychological clinical trials, but is important both to measure and to help participants achieve sustained carryover of core treatment ingredients and learned material to everyday life.

Implementation, feasibility, and acceptability of quality of life therapy to improve positive emotions among patients with implantable cardioverter defibrillators.

Implantable cardioverter defibrillators (ICDs) save lives, but often induce significant psychological distress among patients. Positive psychological constructs are associated with improved outcomes among cardiac patients. In this NHLBI-funded randomized controlled trial, one aim was to evaluate the feasibility and acceptability of a positive psychology intervention (Quality of Life Therapy; QOLT, n = 11), compared to a Heart Healthy Education (HHE) control (n = 10), among ICD patients. A majority of participants across groups attended all 12 sessions (71%) and completed homework assignments (80%). Agreement on participant engagement and interventionist protocol adherence were high, with no differences between groups (ps > 0.20). A greater proportion of QOLT participants rated their sessions was "very" helpful compared to HHE participants (63% vs. 10%, p = 0.19). These initial data support the feasibility and acceptability of QOLT. A larger-scale trial using positive psychology interventions among ICD patients is indicated to determine potential mechanisms underlying the relationship between positive psychological constructs and cardiovascular health.

Pain-related fear in adolescents with chronic musculoskeletal pain: process evaluation of an interdisciplinary graded exposure program.

BACKGROUND: For studying the effectiveness of treatment, it is important to check whether a new treatment is performed as originally described in the study-protocol. OBJECTIVES: To evaluate whether an interdisciplinary graded exposure program, for adolescents with chronic musculoskeletal pain reporting pain-related fear, was performed according to protocol, and whether it is feasible to implement the program in rehabilitation care. METHODS: A process evaluation where quantitative and qualitative data on participant characteristics (adolescents, parents and therapists), attendance and participants' opinion on the program were collected, by means of registration forms, questionnaires and group interviews. To evaluate treatment fidelity, audio and video recordings of program sessions were analyzed. RESULTS: Thirty adolescents were offered the program, of which 23 started the program. Adolescents attended on average 90% of the sessions. At least one parent per adolescent participated in the program. Analysis of 20 randomly selected recordings of treatment sessions revealed that treatment fidelity was high, since 81% of essential treatment elements were offered to the adolescents. The program was considered client-centered by adolescents and family-centered by parents. Treatment teams wished to continue offering the program in their center. CONCLUSION: The interdisciplinary graded exposure program was performed largely according to protocol, and therapists, adolescents and their parents had a favorable opinion on the program. Implementation of the program in rehabilitation care is considered feasible. TRIAL REGISTRATION: Clinicaltrials.gov ID: NCT02181725 (7 February 2014).

Application of treatment fidelity in tailored caregiver interventions.

OBJECTIVES: Demonstrations of the effectiveness of interventions requires evidence that the model can be implemented with fidelity. Caregiving interventions that are tailored to the individual or family require flexibility, which adds some challenges to the assessment of fidelity. This paper outlines the components necessary for examining treatment fidelity and common barriers to implementing fidelity studies, offers considerations for designing fidelity studies with tailored caregiver interventions, and aims to provide a set of procedures that can be used to guide future fidelity studies. METHOD: Case study methods are used to illustrate the processes and findings, drawing on two research studies of fidelity in tailored caregiver interventions. RESULTS: Fidelity studies consist of core components (i.e. training on intervention delivery, adherence to the intervention, therapist competence, acceptability and outcomes) that should be maintained and monitored throughout the study to elucidate the relationship between the intervention and outcomes. These components are applicable to tailored caregiver interventions and can be implemented with the consideration of some key issues that are addressed prior to the evaluation. The two cases presented utilized similar methods to evaluate fidelity of two different tailored caregiver interventions. CONCLUSION: Treatment fidelity can be assessed for tailored caregiving interventions, which increases confidence about the potency of the active ingredients in the interventions. Standard fidelity guidelines can be implemented with minor additional considerations.

Development and validation of the Gestalt Therapy Fidelity Scale.

Objective: Three studies were conducted to develop and validate the Gestalt Therapy Fidelity Scale (GTFS), a 21-item measure of treatment adherence for Gestalt Therapy (GT).Method: Thirty five items for possible inclusion in the GTFS were generated on the basis of a literature review. In Study 1, a Delphi methodology consulting 63 international GT experts was used to select items for the GTFS. In Study 2, six experts used the scale to rate video-based sessions of GT, and provided feedback on the usability of the scale. In Study 3, 176 participants from 18 countries used the GTFS to rate GT and not-GT video recorded sessions.Results: The Delphi study consensus method resulted in 25 items for consideration in the GTFS. The scoring system and items were subsequently revised following further feedback from experts (Study 2). The GTFS was found to significantly discriminate between GT and not-GT based sessions (Study 3): raters scored GT sessions significantly higher than not-GT sessions. High levels of internal and inter-rater reliability were found.Conclusion: The GTFS is supported as a psychometrically sound measure of treatment adherence for GT, and hence can be used to assess the degree to which therapists are administering GT.

Measuring clinical competencies in facilitating group-based rehabilitation interventions: development of a new competency checklist.

OBJECTIVE: Group-based intervention formats are common in rehabilitation, but no tool for objectively measuring clinical competencies in group facilitation currently exists. We aimed to develop a psychometrically sound group facilitation competency checklist for use in clinical, training, and research settings. METHOD: The Delphi method of expert consensus was used to establish checklist items that clearly describe competencies considered important for effective group facilitation. Inter-rater reliability was determined with two experienced psychologists who used the checklist to rate the competencies of psychology trainees facilitating a memory skills group. RESULTS: After two Delphi rounds, consensus was reached on 17 items, defined as at least 80% agreement among the panel of 15 experts. The four checklist item categories were (a) Facilitating focused group discussion, (b) Communication skills, (c) Interpersonal style, and (d) Session structure. One item was removed after piloting. Inter-rater reliability was excellent (88% agreement) using a simple coding method (competent/incompetent). When using a detailed coding method that discriminated between 'done adequately' and 'done well', inter-rater reliability was weaker (κ = 0.481, 55% agreement); however, it improved to almost perfect after the raters calibrated their standards. CONCLUSION: The new group facilitation competency checklist is fit for purpose for measuring clinical competencies in delivering group-based rehabilitation interventions and can be used in the training of effective group facilitators.

Treatment fidelity evidence for BE-ACTIV - a behavioral intervention for depression in nursing homes.

Objectives: Evidence-based depression therapies are difficult to implement in nursing homes. We present data for BE-ACTIV, a 10-week depression treatment designed for implementation in nursing homes, to address questions of treatment fidelity (delivery, receipt, and enactment) in that context. Method: Participants were 41 patients from 13 nursing homes in the treatment arm of a clinical trial, treated by graduate student therapists. Therapists and their supervisor rated their audio-recorded sessions for adherence to treatment protocol and session quality. Results: Delivery of core program elements averaged from 80-94% across all sessions; mean quality was 5.6 (SD 0.61) out of 6 points. Delivery of core components to nursing home activities staff who collaborated in the treatment was similarly high. Patients received an average of 7.32 sessions (SD 3.39); 17 completed 10 sessions. The theoretical basis of BE-ACTIV is behavioral activation; therapist-client dyads planned new pleasant events weekly, from a mean of 3.66 (SD 1.35) after the first session to a mean of between 5 and 6 activities a week across sessions 6-9, with a similar progression in percent activities completed. Activities enactment was significantly related to the likelihood of remission at post-treatment, and of maintaining improvement at 3-month follow-up. Treatment receipt and enactment were also related to improved mood from baseline to 3 months. Conclusion: Results demonstrate delivery, receipt, and successful enactment of BE-ACTIV core components in diverse nursing homes and patients, and support the theoretical premise of the intervention. These findings support further implementation work for the BE-ACTIV intervention.

An Open Trial of Parent-Child Care (PC-CARE)-A 6-Week Dyadic Parenting Intervention for Children with Externalizing Behavior Problems.

Research shows that parenting interventions are plagued with the problem of early treatment termination. A brief 6-week intervention, parent-child care (PC-CARE) was developed to minimize the time investment for parents while maximizing the probability of improving behavioral problems of their 1-10 year old children. The purpose of this study was to determine the feasibility of PC-CARE and examine preliminary outcomes. The data were collected as part of an open trial in a community mental health clinic and included pre- and post-treatment performance outcomes, weekly measures of treatment progress, and assessments of treatment fidelity. Participants were 64 children and their primary caregivers, referred by physicians, social workers, or self-referred for help with their children's difficult behaviors. The retention rate was 94%. Results of analyses pre- to post-intervention scores showed significant improvements in child behavioral problems as well as improvements in parenting stress and positive parenting skills. The findings suggest that PC-CARE may be a beneficial treatment for children with disruptive behaviors, encourage future research into the efficacy of this brief parenting intervention, and its effectiveness in other populations and contexts.

Fidelity Failures in Brief Strategic Family Therapy for Adolescent Drug Abuse: A Clinical Analysis.

As evidence-based family treatments for adolescent substance use and conduct problems gain traction, cutting edge research moves beyond randomized efficacy trials to address questions such as how these treatments work and how best to disseminate them to community settings. A key factor in effective dissemination is treatment fidelity, which refers to implementing an intervention in a manner consistent with an established manual. While most fidelity research is quantitative, this study offers a qualitative clinical analysis of fidelity failures in a large, multisite effectiveness trial of Brief Strategic Family Therapy (BSFT) for adolescent drug abuse, where BSFT developers trained community therapists to administer this intervention in their own agencies. Using case notes and video recordings of therapy sessions, an independent expert panel first rated 103 cases on quantitative fidelity scales grounded in the BSFT manual and the broader structural-strategic framework that informs BSFT intervention. Because fidelity was generally low, the panel reviewed all cases qualitatively to identify emergent types or categories of fidelity failure. Ten categories of failures emerged, characterized by therapist omissions (e.g., failure to engage key family members, failure to think in threes) and commissions (e.g., off-model, nonsystemic formulations/interventions). Of these, "failure to think in threes" appeared basic and particularly problematic, reflecting the central place of this idea in structural theory and therapy. Although subject to possible bias, our observations highlight likely stumbling blocks in exporting a complex family treatment like BSFT to community settings. These findings also underscore the importance of treatment fidelity in family therapy research.

A medida que los tratamientos familiares factuales para el consumo de sustancias y los problemas de conducta en los adolescentes ganan terreno, la investigación de vanguardia trasciende los ensayos aleatorizados de eficacia teórica para abordar preguntas, por ejemplo, cómo funcionan estos tratamientos y cómo difundirlos mejor en entornos comunitarios. Un factor clave para la difusión eficaz es la fidelidad al tratamiento, que se refiere a implementar una intervención de una manera consecuente con un manual establecido. Si bien la mayor parte de la investigación de fidelidad es cuantitativa, el presente estudio ofrece un análisis clínico cualitativo de fallas de la fidelidad en un ensayo grande multicéntrico de eficacia real de Terapia Familiar Breve y Estratégica (BSFT) para el abuso de drogas en los adolescentes, donde los desarrolladores de la BSFT capacitaron a terapeutas de la comunidad para que apliquen esta intervención en sus propias agencias. Utilizando informes de casos y grabaciones de vídeo de sesiones de terapia, un panel independiente de expertos evaluó primero 103 casos con escalas de fidelidad cuantitativa basadas en el manual de BSFT y el marco estratégico estructural más amplio que respalda la intervención de la BSFT. Como la fidelidad fue generalmente baja, el panel revisó todos los casos cualitativamente para reconocer tipos o categorías emergentes de fallas de la fidelidad. Surgieron diez categorías de fallas caracterizadas por omisiones del terapeuta (p. ej.: el terapeuta no hizo participar a familiares clave, no pensó en grupos de tres) y licencias (p. ej.: desvío del modelo, formulaciones/intervenciones no sistémicas). De estas opciones, la falla en "no pensar en grupos de tres" pareció básica y particularmente problemática, lo cual refleja el lugar fundamental de esta idea en la teoría y la terapia estructural. Aunque nuestras observaciones estén sujetas a un posible sesgo, estas ponen de manifiesto posibles obstáculos a la hora de exportar un tratamiento familiar complejo como la BSFT a entornos comunitarios. Estos resultados también subrayan la importancia de la fidelidad al tratamiento en la investigación sobre terapia familiar.

Intervention fidelity in Qigong randomized controlled trials: A method review.

Intervention fidelity has important implications for the reliability and validity of a study. Despite the widely reported health benefits of Qigong exercise interventions, the quality of intervention fidelity is less clear. The purpose of this paper is to use a valid intervention fidelity assessment tool to evaluate how intervention fidelity has been addressed in five areas-design, training, delivery, receipt, and enactment-in Qigong randomized controlled studies. A total of 86 articles were drawn from CINAHL, PubMed, AMED, and Scopus, and 32 were selected for the review. The adherence to intervention fidelity strategies within the intervention design, training, delivery, receipt, and enactment was 0.66, 0.32, 0.22, 0.12, and 0.21, respectively. The findings suggest that intervention fidelity is inadequately implemented or reported in published Qigong studies. Developing a consistent intervention fidelity plan for Qigong interventions is needed. To this aim, we propose a treatment fidelity plan specific to Qigong research.

Collaborative Care for Depression and Posttraumatic Stress Disorder: Evaluation of Collaborative Care Fidelity on Symptom Trajectories and Outcomes.

BACKGROUND: Despite the growing consensus that collaborative care is effective, limited research has focused on the importance of collaborative care fidelity as it relates to mental health clinical outcomes. OBJECTIVE: To assess the relationship of collaborative care fidelity on symptom trajectories and clinical outcomes among military service members enrolled in a multi-site randomized controlled trial for the treatment of depression and posttraumatic stress disorder (PTSD). DESIGN: Study data for our analyses came from a two-parallel arm randomized trial that evaluated the effectiveness of a centralized collaborative care model compared to the existing collaborative care model for the treatment of PTSD and depression. All patients were included in the analyses to evaluate how longitudinal trajectories of PTSD and depression scores differed across various collaborative care fidelity groupings. PARTICIPANTS: A total of 666 US Military Service members screening positive for probable PTSD or depression through primary care. MAIN MEASURES: Disease registry data from a web-based clinical management support tool was used to measure collaborative care fidelity for patients enrolled in the trial. Participant depression and PTSD symptoms were collected independently from research survey assessments at four time points across the 1-year trial period. Treatment utilization records were acquired from the Military Health System administrative records to determine mental health service use. KEY RESULTS: Consistent and late fidelity to the collaborative care model predicted an improving symptom trajectory over the course of treatment. This effect was more pronounced for patients with depression than for patients with PTSD. CONCLUSIONS: Long-term fidelity to key collaborative care elements throughout care episodes may improve depression outcomes, particularly for patients with elevated symptoms. More controlled research is needed to further understand the influence of collaborative care fidelity on clinical outcomes. TRIAL REGISTRATION: Clinicaltrials.gov Identifier NCT01492348.

The implementation of web-based cognitive rehabilitation in adult cancer survivors: examining participant engagement, attrition and treatment fidelity.

PURPOSE: Low engagement and high attrition are common challenges in web-based interventions. Typical measures of engagement reported in the literature are not meaningful for describing participant activity within the intervention and can be misleading. This research aimed to develop a more meaningful method of measuring engagement in an online cognitive rehabilitation program whilst monitoring treatment fidelity. METHODS: A pilot study and randomised controlled trial (RCT) were conducted. Data from 60 participants were analysed from three intervention groups: pilot cancer group, pilot non-cancer group and RCT cancer group. Groups completed the 4-week eReCog program comprised of four online modules. Engagement scores were calculated based on activities completed in each module. Attrition, interaction with the program facilitator and correlations with outcome measures were analysed. RESULTS: Overall engagement in the intervention was high. The non-cancer group participated significantly less than the cancer groups (p = < 0.001), whereby the percentage of activity items completed was 92, 87 and 78% in the pilot cancer, RCT cancer and pilot non-cancer groups, respectively. Attrition was higher in the pilot non-cancer group (24%) compared to the pilot cancer group (8%) and the RCT cancer group (16%). Total engagement was correlated with fewer prospective memory problems on instrumental activities of daily living (p = 0.018). CONCLUSIONS: Measuring completed activities in online interventions appears a more meaningful measure of engagement than other conventional methods described in the literature and has the potential to increase treatment fidelity in web-based research.

Treatment integrity of elaborated semantic feature analysis aphasia therapy delivered in individual and group settings.

BACKGROUND & AIMS: This study ran within the framework of the Thales Aphasia Project that investigated the efficacy of elaborated semantic feature analysis (ESFA). We evaluated the treatment integrity (TI) of ESFA, i.e., the degree to which therapists implemented treatment as intended by the treatment protocol, in two different formats: individual and group therapy. METHODS & PROCEDURES: Based on the ESFA manual, observation of therapy videos and TI literature, we developed two ESFA integrity checklists, for individual and group therapy, and used them to rate 15 videos of therapy sessions, delivered by three speech-language therapists (SLTs). Thirteen people with aphasia (PwA) were involved in this study. Reliability of the checklists was checked using Kappa statistics. Each session's TI was calculated. Differences in TI scores between the two therapy approaches were calculated using independent sample t-tests. Treating SLTs' views on what facilitates TI were also explored through a survey. OUTCOMES & RESULTS: Inter- and intra-rater reliability were excellent (.75 ≤ κ ≤ 1.00) for all but one video (κ = .63). Overall, a high TI level (91.4%) was achieved. Although both approaches' TI was high, TI for individual therapy sessions was significantly higher than for group sessions (94.6% and 86.7% respectively), t(13) = 2.68, p = .019. SLTs found training, use of the treatment manual, supervision and peer support useful in implementing ESFA therapy accurately. CONCLUSIONS & IMPLICATIONS: ESFA therapy as delivered in Thales is well described and therapists can implement it as intended. The high TI scores found enhance the internal validity of the main research project and facilitate its replication. The need for more emphasis on the methodological quality of TI studies is discussed.