Patient and public involvement in health research in Norway: a survey among researchers and patient organisations.

BACKGROUND: Patient and public involvement (PPI) in health research may improve both the relevance and quality of the research. There is however a lack of research investigating the experiences, attitudes and barriers towards PPI in clinical research in Norway. The Norwegian Clinical Research Infrastructure Network therefore conducted a survey among researchers and PPI contributors aiming to investigate experiences with PPI and identify current challenges for successful involvement. METHODS: Two survey questionnaires were developed and distributed in October and November 2021. The survey targeting 1185 researchers was distributed from the research administrative system in the Regional Health Trusts. The survey targeting PPI contributors was distributed through Norwegian patient organisations, regional and national competence centers. RESULTS: The response rate was 30% among researchers and was unobtainable from PPI contributors due to the survey distribution strategy. PPI was most frequently used in the planning and conduct of the studies, and less utilized in dissemination and implementation of results. Both researchers and user representatives were generally positive to PPI, and agreed that PPI might be more useful in clinical research than in underpinning research. Researchers and PPI contributors who reported that roles and expectations were clarified in advance, were more likely to experience a common understanding of roles and responsibilities in the research project. Both groups pointed to the importance of earmarked funding for PPI activities. There was a demand for a closer collaboration between researchers and patient organisations to develop accessible tools and effective models for PPI in health research. CONCLUSIONS: Surveys among clinical researchers and PPI contributors indicate overall positive attitudes towards PPI in clinical research. However, more resources, such as budget, time, and accessible tools, are needed. Clarifying roles and expectations, and creating new PPI models under resource constraints can enhance its effectiveness. PPI is underutilized in disseminating and implementing research results, presenting an opportunity for improving healthcare outcomes.

Patient and public involvement (PPI) in health research can make the research more relevant and of better quality. However, in Norway, there has not been much research on the experiences, attitudes, and barriers related to PPI in clinical research. To address this gap, we conducted a survey among researchers and PPI contributors to understand their experiences and identify current challenges. We found that PPI was most common during planning and execution of studies. PPI was less used in the process of sharing the results from the studies, and in the process of putting the findings into practice. Those who reported that roles and expectations were clarified in advance were more likely to have a shared understanding of their roles and responsibilities in the research project. Both groups emphasized the importance of funding for PPI activities. There was also a desire for closer collaboration between researchers and patient organisations to develop accessible tools and for PPI. In summary, the survey revealed a generally positive attitude towards PPI in health research. However, more resources, such as budget, time, and accessible tools, are needed. Clarification of roles and expectations also stand out a crucial part of the PPI process, and should receive much attention in all research projects where PPI is used.

Adherence, Competence, and Alliance as Predictors of Long-term Outcomes of Cognitive Behavioral Therapy for Youth Anxiety Disorders.

The present study investigated therapist adherence, therapist competence, and patient-therapist alliance as predictors of long-term outcomes of cognitive behavioral therapy (CBT) for anxiety disorders in youth. Potential differential effects for group versus individual CBT, for therapists with or without formal CBT training, and based on youth symptom severity were examined. Videotapes (n = 181) from treatment sessions in a randomized controlled effectiveness trial comprising youth (N = 170, M age = 11.6 years, SD = 2.1) with anxiety disorders were assessed for therapist adherence and competence. Alliance was rated by therapists and youth. Participants completed a diagnostic interview and an anxiety symptom measure at pre-treatment, post-treatment, one-year follow-up, and long-term follow-up (M = 3.9 years post-treatment, SD = 0.8, range = 2.2-5.9 years). The change in anxiety symptoms or diagnostic status from pre-treatment to long-term follow-up was not significantly related to any predictor variables. However, several interaction effects were found. For loss of principal diagnosis, therapist competence predicted positive outcome when therapist adherence also was high. Adherence was found to predict positive outcome if CBT was provided individually. Therapist-rated alliance was related to both loss of principal diagnosis and loss of all diagnoses when CBT was provided in groups. Interaction effects suggested that therapists displaying both high adherence and high competence produced better long-term outcomes. Further, the alliance may be particularly important for outcomes in group CBT, whereas adherence may be particularly important for outcomes in individual CBT.

Effect of early intervention for anxiety on sleep outcomes in adolescents: a randomized trial.

The potential effect of early intervention for anxiety on sleep outcomes was examined in a sample of adolescents with anxiety (N = 313, mean 14.0 years, SD = 0.84, 84% girls, 95.7% Norwegians). Participants were randomized to one of three conditions: a brief or a standard-length cognitive-behavioral group-intervention (GCBT), or a waitlist control-group (WL). Interventions were delivered at schools, during school hours. Adolescents with elevated anxiety were recruited by school health services. Questionnaires on self-reported anxiety symptoms, depressive symptoms, and sleep characteristics were administered at pre- and post-intervention, post-waitlist, and at 1-year follow-up. Adolescents reported reduced insomnia (odds ratio (OR) = 0.42, p < 0.001) and shorter sleep onset latency (d = 0.27, p <  0.001) from pre- to post-intervention. For insomnia, this effect was maintained at 1-year follow-up (OR = 0.54, p = 0.020). However, no effect of GCBT on sleep outcomes was found when comparing GCBT and WL. Also, no difference was found in sleep outcomes between brief and standard-length interventions. Adolescents defined as responders (i.e., having improved much or very much on anxiety after GCBT), did not differ from non-responders regarding sleep outcomes. Thus, anxiety-focused CBT, delivered in groups, showed no effect on sleep outcomes. Strategies specifically targeting sleep problems in adolescents should be included in GCBT when delivered as early intervention for adolescents with elevated anxiety.Trial registry Clinical trial registration: School Based Low-intensity Cognitive Behavioral Intervention for Anxious Youth (LIST); http://clinicalrials.gov/ ; NCT02279251, Date: 11.31. 2014.

Competence and Adherence Scale for Cognitive Behavioural Therapy (CAS-CBT) for anxiety disorders in youth: reliability and factor structure.

BACKGROUND: There has been increased research interest into the concept of treatment integrity within psychotherapy research. The Competence and Adherence Scale for Cognitive Behavioural Therapy (CAS-CBT) was developed to measure therapists' competence and adherence in cognitive behavioural therapy (CBT), when delivered to children and youth with anxiety disorders. AIMS: The aim of this study was to evaluate the psychometric properties of the CAS-CBT in a naturalistic treatment setting. METHOD: Ratings of 212 randomly selected sessions from a clinical effectiveness trial for children with anxiety disorders (n = 165, mean age = 10.46 years, SD = 1.49) were analysed to assess the psychometric properties of CAS-CBT. Therapy format included both individual sessions and group sessions. RESULTS: Internal consistency for the CAS-CBT was excellent (Cronbach's alpha = .88). Factor analysis suggested a two-factor solution for the total sample, where the first factor was related to CBT structure and session goals, and the second factor was associated with process and relational skills. The individual CBT treatment condition (ICBT) and group CBT treatment condition (GCBT) showed the same factor solution. CONCLUSION: The CAS-CBT is a feasible and reliable measure for assessing competence and adherence to CBT in the treatment of anxious children. Future research is needed to further assess the generalizability of this scale, its psychometric properties in different treatment populations and with other treatment approaches, and ideally with larger sample sizes.

Sleep Duration and Insomnia in Adolescents Seeking Treatment for Anxiety in Primary Health Care.

There is limited knowledge about sleep in adolescents with elevated levels of anxiety treated within primary health care settings, potentially resulting in sleep problems not being sufficiently addressed by primary health care workers. In the current study self-reported anxiety, insomnia, sleep onset latency, sleep duration, and depressive symptoms were assessed in 313 adolescents (12-16 years; mean age 14.0, SD = 0.84, 84.0% girls) referred to treatment for anxiety within primary health care. Results showed that 38.1% of the adolescents met criteria for insomnia, 34.8% reported short sleep duration (<7 h), and 83.1% reported long sleep onset latency (≥30 min). Total anxiety symptoms were related to all sleep variables after controlling for age and sex. Furthermore, all anxiety symptom sub-types were associated with insomnia and sleep onset latency, whereas most anxiety subtypes were associated with sleep duration. Adolescents' depressive symptoms accounted for most of the anxiety-sleep associations, emphasizing the importance of depressive symptoms for sleep. However, anxiety was associated with insomnia and sleep onset latency also among youth with low levels of depressive symptoms. The findings suggests that primary health care workers should assess sleep duration, sleep onset latency, and insomnia in help-seeking adolescents with anxiety.

"Less stress": a pilot study on a cognitive behavioral treatment program for anxiety in children with autism spectrum disorders.

BACKGROUND: Comorbid anxiety disorders are prevalent in children with autism spectrum disorders (ASD), but only a minority receives adequate treatment for anxiety. Cognitive behavioral therapy (CBT) has been shown to be effective in treating anxiety disorders. The objectives of the present pilot study were to test the feasibility of the CBT program "Less stress" for comorbid anxiety disorders in children with ASD and explore whether an improvement in diagnostic outcomes for anxiety disorders and symptoms of anxiety was found after treatment. METHODS: Participants were ten children diagnosed with ASD and anxiety disorders (eight boys, mean age = 9.5 years, range 8 - 12 years). The "Less Stress" program includes three months of weekly treatment sessions followed by three monthly booster sessions. Five therapists participated. A standardized semi-structured diagnostic interview with the mothers was used to assess comorbid disorders. Child anxiety symptoms were measured with the Revised Child Anxiety and Depression Scale (RCADS). RESULTS: The therapists found the manual easy to use but adaptations were necessary, particularly shorter sessions due to frequent (n = 7) comorbid Attention-Deficit/Hyperactivity Disorder. The participants found the program useful and the parents noted that they had learned methods they could continue using after the end of the program.Eight of ten children completed the treatment. Seven of the eight completers benefited from the program. Five of those seven children were free from all anxiety disorders, while two had fewer anxiety disorders. On a group level, a significant mean reduction of anxiety symptoms (RCADS) was found after treatment. CONCLUSION: The therapists found the "Less stress" program to be a feasible intervention in a sample of children with ASD and comorbid anxiety. The significant reduction of anxiety after treatment is promising, but a replication in a larger and more rigorous study is needed to investigate the effectiveness of the intervention.

Effectiveness of Brief and Standard School-Based Cognitive-Behavioral Interventions for Adolescents With Anxiety: A Randomized Noninferiority Study.

OBJECTIVE: We examined the effectiveness of targeted school-based cognitive-behavioral therapy (CBT) for adolescents (12-16 years of age) with anxiety, and tested whether brief CBT was noninferior to standard duration CBT. METHOD: A randomized controlled study of 313 adolescents (mean 14.0 years, SD = 0.84, 84% girls) were recruited through school health services to 10 weeks CBT group interventions. Groups of 5 to 8 adolescents were randomly allocated to brief (5 sessions, comprising 5.5 hours) or standard CBT (10 sessions, comprising 15 hours), or 10 weeks waitlist (WL). Self-reported and parent-reported youth anxiety symptoms, impairment from anxiety, depressive symptoms,and clinical severity were assessed pre- and postintervention, after WL, and at 1-year follow-up. RESULTS: Targeted school based CBT significantly reduced adolescents' anxiety symptoms with small to moderate effect sizes compared to WL (Cohen d = 0.34 for youth report and d = 0.53 for parent report). According to the parents, also adolescents' impairment from anxiety was significantly reduced compared to WL (d = 0.51). Pre to post changes in anxiety symptoms were small to moderate (within-group effect sizes between d = 0.41 and d = 0.67). Although no significant differences in effects were found between brief and standard CBT, brief CBT was not noninferior to standard CBT. Outcomes from both interventions were sustained at 1-year follow-up. CONCLUSION: Targeted school-based CBT interventions reduced anxiety, impairment, and depressive symptoms in adolescents. Both brief and standard CBT demonstrated efficacy, but brief CBT was not noninferior to standard CBT. By administering school-based CBT to youths with anxiety symptoms, we may reach young people with effective interventions at an earlier phase in their lives. CLINICAL TRIAL REGISTRATION INFORMATION: School Based Low-intensity Cognitive Behavioral Intervention for Anxious Youth (LIST); http://clinicalrials.gov/; NCT02279251.

Attitudes toward standardized assessment tools and their use among clinicians in a public mental health service.

The aim of the present study was to investigate the use and attitudes toward standardized assessment tools among clinicians in a public mental health service in Norway. A total of 606 clinicians provided feedback on their use and attitudes regarding psychometric qualities of such tools, their practicality, and their benefit over clinical judgment alone using the Attitudes toward Standardized Assessment (ASA) Scales. Clinicians working in the adult mental health field scored significantly higher on use of diagnostic interviews, pre-post evaluations, and ongoing evaluations, whereas clinicians working in the child/adolescent mental health field scored significantly higher on use of screening instruments and held more positive attitudes towards using standardized assessment tools. Attitudes toward standardized assessment tools predicted use of such tools, and results were found to be similar to a study on US clinicians. Whereas the US study only found attitudes regarding the practicality of using such instrument as an independent predictor of assessment use, the current study found that attitudes regarding psychometric qualities of such tools, their practicality, and their benefit over clinical judgment alone were independent predictors of use.

Quality of life in anxious adolescents.

PURPOSE: To examine associations between health-related quality of life (HRQoL) and anxiety symptoms across anxiety domains (obsessions/compulsions, social anxiety, panic disorder, agoraphobia, separation anxiety, physical injury fears, generalised anxiety, and posttraumatic stress) in a general adolescent population. Expanded knowledge about these associations can provide valuable information for improving interventions and prevention strategies for adolescent anxiety. METHODS: Cross-sectional data about anxiety were collected via a school survey from a community sample of Norwegian adolescents aged 12-17 (N = 1719). Based on scores from the Spence Children's Anxiety Scale (SCAS), each adolescent was categorized as reporting a low, medium, or high level of anxiety. Each adolescent's HRQoL was then measured using the Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents Revised Version (KINDL-R). Hierarchical regression analyses were performed to determine any relationship between anxiety symptoms and HRQoL. RESULTS: Across domains of anxiety, anxiety symptoms were inversely associated with overall HRQoL. All HRQoL-dimensions were inversely associated with overall level of anxiety symptoms. In adolescents with medium and high anxiety symptoms, poor HRQoL was documented in all HRQoL dimensions with the exception of the family dimension. CONCLUSIONS: The strong association between elevated levels of anxiety symptoms and poor HRQoL demonstrate the importance of improved mental health interventions and prevention initiatives targeting anxious adolescents.

Negative Life Events, Social Support, and Self-Efficacy in Anxious Adolescents.

PURPOSE: To examine the prevalence and correlates of anxiety in a community sample of adolescents. Knowing the prevalence and characteristics of anxious adolescents is valuable to improve anxiety prevention strategies and interventions. DESIGN: Cross-sectional data about anxiety were collected via a school survey from a community sample of Norwegian adolescents aged 12-17 (N = 1719). METHODS: Based on scores from the Spence Children's Anxiety Scale, the adolescents were categorized as not anxious or anxious. Logistic regression analysis was performed to access the impact of each factor on the likelihood that participants would report an elevated level of anxiety. RESULTS: A total of 22% of the adolescents were categorized as anxious. Female gender, experienced negative life events, low social support, and low self-efficacy were associated with elevated level of anxiety. CONCLUSIONS: The high prevalence of anxiety in adolescents demonstrates the importance of improved prevention interventions targeting anxious adolescents. We argue that addressing is the responsibility of not only the individual adolescents and their families but also schools, school health services, and policy makers. School-based interventions that increase social support and self-efficacy would probably be particularly beneficial for anxious adolescents.

School-based cognitive behavioral interventions for anxious youth: study protocol for a randomized controlled trial.

BACKGROUND: Anxiety disorders are prevalent among adolescents and may have long-lasting negative consequences for the individual, the family and society. Cognitive behavioral therapy (CBT) is an effective treatment. However, many anxious youth do not seek treatment. Low-intensity CBT in schools may improve access to evidence-based services. We aim to investigate the efficacy of two CBT youth anxiety programs with different intensities (i.e., number and length of sessions), both group-based and administered as early interventions in a school setting. The objectives of the study are to examine the effects of school-based interventions for youth anxiety and to determine whether a less intensive intervention is non-inferior to a more intensive intervention. METHODS/DESIGN: The present study is a randomized controlled trial comparing two CBT interventions to a waitlist control group. A total of 18 schools participate and we aim to recruit 323 adolescents (12-16 years). Youth who score above a cutoff on an anxiety symptom scale will be included in the study. School nurses recruit participants and deliver the interventions, with mental health workers as co-therapists and/or supervisors. Primary outcomes are level of anxiety symptoms and anxiety-related functional impairments. Secondary outcomes are level of depressive symptoms, quality of life and general psychosocial functioning. Non-inferiority between the two active interventions will be declared if a difference of 1.4 or less is found on the anxiety symptom measure post-intervention and a difference of 0.8 on the interference scale. Effects will be analyzed by mixed effect models, applying an intention to treat procedure. DISCUSSION: The present study extends previous research by comparing two programs with different intensity. A brief intervention, if effective, could more easily be subject to large-scale implementation in school health services. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02279251 . Registered on 15 October 2014. Retrospectively registered.

Predictors of treatment outcome in an effectiveness trial of cognitive behavioral therapy for children with anxiety disorders.

A substantial number of children with anxiety disorders do not improve following cognitive behavioral therapy (CBT). Recent effectiveness studies have found poorer outcome for CBT programs than what is typically found in efficacy studies. The present study examined predictors of treatment outcome among 181 children (aged 8-15 years), with separation anxiety, social phobia, or generalized anxiety disorder, who participated in a randomized, controlled effectiveness trial of a 10-session CBT program in community clinics. Potential predictors included baseline demographic, child, and parent factors. Outcomes were as follows: a) remission from all inclusion anxiety disorders; b) remission from the primary anxiety disorder; and c) child- and parent-rated reduction of anxiety symptoms at post-treatment and at 1-year follow-up. The most consistent findings across outcome measures and informants were that child-rated anxiety symptoms, functional impairment, a primary diagnosis of social phobia or separation anxiety disorder, and parent internalizing symptoms predicted poorer outcome at post-treatment. Child-rated anxiety symptoms, lower family social class, lower pretreatment child motivation, and parent internalizing symptoms predicted poorer outcome at 1-year follow-up. These results suggest that anxious children with more severe problems, and children of parents with elevated internalizing symptom levels, may be in need of modified, additional, or alternative interventions to achieve a positive treatment outcome.

Competence and Adherence Scale for Cognitive Behavioral Therapy (CAS-CBT) for anxiety disorders in youth: Psychometric properties.

The aim of the present study was to evaluate the psychometric properties of the Competence and Adherence Scale for Cognitive Behavioral Therapy (CAS-CBT). The CAS-CBT is an 11-item scale developed to measure adherence and competence in cognitive-behavioral therapy (CBT) for anxiety disorders in youth. A total of 181 videotapes from the treatment sessions in a randomized controlled effectiveness trial (Wergeland et al., 2014) comprising youth (N = 182, M age = 11.5 years, SD = 2.1, range 8-15 years, 53% girls, 90.7% Caucasian) with mixed anxiety disorders were assessed with the CAS-CBT to investigate interitem correlations, internal consistency, and factor structure. Internal consistency was good (Cronbach's alpha = .87). Factor analysis suggested a 2-factor solution with Factor 1 representing CBT structure and session goals (explaining 46.9% of the variance) and Factor 2 representing process and relational skills (explaining 19.7% of the variance). The sum-score for adherence and competence was strongly intercorrelated, r = .79, p < .001. Novice raters (graduate psychology students) obtained satisfactory accuracy (ICC > .40, n = 10 videotapes) and also good to excellent interrater reliability when compared to expert raters (ICC = .83 for adherence and .64 for competence, n = 26 videotapes). High rater stability was also found (n = 15 videotapes). The findings suggest that the CAS-CBT is a reliable measure of adherence and competence in manualized CBT for anxiety disorders in youth. Further research is needed to investigate the validity of the scale and psychometric properties when used with other treatment programs, disorders and treatment formats. (PsycINFO Database Record

An effectiveness study of individual vs. group cognitive behavioral therapy for anxiety disorders in youth.

OBJECTIVE: Conducted a randomized controlled trial to investigate the effectiveness of cognitive behavioral therapy (CBT), and compared the relative effectiveness of individual (ICBT) and group (GCBT) treatment approaches for anxiety disorders in children and adolescents. METHODS: Referred youth (N = 182, M age = 11.5 years, range 8-15 years, 53% girls) with separation anxiety, social phobia, or generalized anxiety disorder were randomly assigned to ICBT, GCBT or a waitlist control (WLC) in community clinics. Pre-, post-, and one year follow-up assessments included youth and parent completed diagnostic interview and symptom measures. After comparing CBT (ICBT and GCBT combined) to WLC, ICBT and GCBT were compared along diagnostic recovery rates, clinically significant improvement, and symptom measures scores using traditional hypothesis tests, as well as statistical equivalence tests. RESULTS: Significantly more youth lost all anxiety disorders after CBT compared to WLC. Full diagnostic recovery rate was 25.3% for ICBT and 20.5% in GCBT, which was not significantly different. There was continued lack of significant differences between ICBT and GCBT at one year follow-up. However, equivalence between GCBT and ICBT could only be demonstrated for clinical severity rating of the principal anxiety disorder and child reported anxiety symptoms post-treatment. CONCLUSION: Findings support the effectiveness of CBT compared to no intervention for youth with anxiety disorders, with no significant differences between ICBT and GCBT. However, the relatively low recovery rates highlight the need for further improvement of CBT programs and their transportability from university to community settings.