scholarly journals START adolescents: study protocol of a randomised controlled trial to investigate the efficacy of a low-threshold group treatment programme in traumatised adolescent refugees

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e057968
Author(s):  
Esther Sobanski ◽  
Florian Hammerle ◽  
Andrea Dixius ◽  
Eva Möhler ◽  
Susanne Koudela-Hamila ◽  
...  

IntroductionNo evaluated therapeutic approaches, that can efficiently be established in routine mental healthcare, are currently available for traumatised adolescent refugees in Germany. This study evaluates the efficacy of the Stress-Traumasymptoms-Arousal-Regulation-Treatment (START) programme to reduce trauma-related symptoms and psychological distress in traumatised adolescent refugees based in Germany.Methods and analysisThis randomised, waiting-list-controlled, multicentre trial with a 12-week follow-up will include 174 refugee minors with partial or full post-traumatic stress disorder who are fluent in either Arabic, Dari, English, German or Somali. Eligible refugee minors will be randomised to the START or waiting-list control groups. The manualised 8-week START programme is based on techniques of dialectical behaviour therapy (DBT), fosters adaptive coping with emotional distress and traumatic symptoms and comprises eight therapy modules and a booster session. Study assessments are planned at baseline, post-treatment (ie, after programme participation or waiting time), booster session at week 12 or 12-week waiting time, and at the 12-week follow-up. Primary and coprimary outcomes are changes in psychological distress and traumatic symptoms at post-treatment and will be analysed as response variables in linear mixed regression models. Secondary outcomes are changes in further trauma-related and other psychopathological symptoms, emotion regulation and intermediate effects of the programme at follow-up. We will also assess effects of the programme with ecological momentary assessments and on neuroendocrine stress parameters using hair cortisol.Ethics and disseminationThis study has been approved by the lead ethics committee of Rhineland-Palatinate and the ethics committees of participating sites. The study results will be disseminated through peer-reviewed publications and scientific conferences.Trial registration numberDRKS00020771.

2020 ◽  
Author(s):  
Eyal Karin ◽  
Monique Francis Crane ◽  
Blake Farran Dear ◽  
Olav Nielssen ◽  
Gillian Ziona Heller ◽  
...  

BACKGROUND Missing cases present a challenge to our ability to evaluate the effects of web-based psychotherapy trials. As missing cases are often lost to follow up, less is known about their characteristics, their likely clinical outcomes, or the likely effect of the treatment being trialled. OBJECTIVE To explore the characteristics of missing cases, their likely treatment outcomes, and the ability of different statistical models to approximate missing post-treatment data. METHODS A sample of internet-delivered cognitive behavioural therapy participants, in routine care (n = 6701 with 36% missing cases at post-treatment), was used to identify predictors of dropping out of treatment and predictors that moderated clinical outcomes, such as psychological distress, anxiety and depressive symptoms. These variables were then incorporated into a range of statistical models that approximated replacement outcomes for missing cases, with the results compared using sensitivity and cross-validation analyses. RESULTS Treatment adherence, as measured by the rate of an individual’s progress through the treatment modules, and higher symptom scores at pre-treatment, were identified as the dominant predictors of missing cases probability (Nagelkerke R2 = 60.8%), as well as the rate of symptom change. Low treatment adherence, in particular, was associated with increased odds for presenting as missing cases during post-treatment assessment (eg, OR = 161.1:1) and at the same time, attenuate the rate of symptom change across anxiety (up to 28% of the total symptom 48% reduction effect), depression (up to 41% of the total 48% symptom reduction effect) and psychological distress symptom outcomes (up to 52% of the total 37% symptom reduction effect) at the end of an eight week window. Reflecting this pattern of results, statistical replacement methods that overlooked the features of treatment adherence, and baseline severity, underestimated missing case symptom outcomes by as much as 40% at post-treatment. CONCLUSIONS The treatment outcomes of the cases that were missing at follow up were distinct from the remaining observed sample. Thus, overlooking the features of missing cases is likely to result in an inaccurate estimate of the effect of treatment. CLINICALTRIAL


Author(s):  
Paolo Roma ◽  
Merylin Monaro ◽  
Marco Colasanti ◽  
Eleonora Ricci ◽  
Silvia Biondi ◽  
...  

The spread of coronavirus disease 2019 (COVID-19) has called for unprecedented measures, including a national lockdown in Italy. The present study aimed at identifying psychological changes (e.g., changes in depression, stress, and anxiety levels) among the Italian public during the lockdown period, in addition to factors associated with these changes. An online follow-up survey was administered to 439 participants (original sample = 2766), between 28 April and 3 May 2020. A paired sample t-test tested for differences in stress, anxiety, and depression over the period. Multivariate regression models examined associations between sociodemographic variables, personality traits, coping strategies, depression, and stress. Results showed an increase in stress and depression over the lockdown, but not anxiety. Negative affect and detachment were associated with higher levels of depression and stress. Higher levels of depression at the start of the lockdown, as well as fewer coping strategies and childlessness, were associated with increased depression at follow-up, whereas higher levels of stress at the start of the lockdown and younger age were associated with higher stress at follow-up. These results may help us to identify persons at greater risk of suffering from psychological distress as a result lockdown conditions, and inform psychological interventions targeting post-traumatic symptoms.


1998 ◽  
Vol 173 (3) ◽  
pp. 218-225 ◽  
Author(s):  
David M. Clark ◽  
Paul M. Salkovskis ◽  
Ann Hackmann ◽  
Adrian Wells ◽  
Melanie Fennell ◽  
...  

BackgroundHypochondriasis is generally considered difficult to manage. This study aimed to assess the effectiveness of cognitive therapy and to compare it with an equally credible, alternative treatment.MethodForty-eight patients with hypochondriasis were initially randomly assigned to either cognitive therapy, behavioural stress management or a no treatment waiting list control group. At the end of the waiting period, patients in the control group were randomly assigned to one of the two treatments. Assessments were at pre-, mid- and post-treatment or waiting list and at three-, six- and 12-month post-treatment follow-up.ResultsComparisons with the waiting list group showed both treatments were effective. Comparisons between the treatments showed that cognitive therapy was more effective than behavioural stress management on measures of hypochondriasis, but not general mood disturbance at mid-treatment and at post-treatment. One year after treatment patients who had received either treatment remained significantly better than before treatment, and on almost all measures the two therapies did not differ from each other.ConclusionsCognitive therapy is a specific treatment for hypochondriasis. Behavioural stress management is also effective but its specificity remains to be demonstrated.


2016 ◽  
Vol 46 (11) ◽  
pp. 2411-2421 ◽  
Author(s):  
P. A. J. M. de Bont ◽  
D. P. G. van den Berg ◽  
B. M. van der Vleugel ◽  
C. de Roos ◽  
A. de Jongh ◽  
...  

BackgroundIn patients with psychotic disorders, the effects of psychological post-traumatic stress disorder (PTSD) treatment on symptoms of psychosis, depression and social functioning are largely unknownMethodIn a single-blind randomized controlled trial (RCT) 155 outpatients in treatment for psychosis (61.3% schizophrenic disorder, 29% schizoaffective disorder) were randomized to eight sessions prolonged exposure (PE;n= 53) or eye movement desensitization and reprocessing (EMDR) (n= 55), or a waiting-list condition (WL,n= 47) for treatment of their co-morbid PTSD. Measures were performed on (1) psychosis: severity of delusions (PSYRATS-DRS), paranoid thoughts (GPTS), auditory verbal hallucinations (PSYRATS-AHRS), and remission from psychotic disorder (SCI-SR-PANSS); (2) depression (BDI-II); (3) social functioning (PSP). Outcomes were compared at baseline, post-treatment, 6-month follow-up and over all data points.ResultsBoth PE and EMDR were significantly associated with less severe paranoid thoughts post-treatment and at 6-month follow-up, and with more patients remitting from schizophrenia, at post-treatment (PE and EMDR) and over time (PE). Moreover, PE was significantly associated with a greater reduction of depression at post-treatment and at 6-month follow-up. Auditory verbal hallucinations and social functioning remained unchanged.ConclusionsIn patients with chronic psychotic disorders PE and EMDR not only reduced PTSD symptoms, but also paranoid thoughts. Importantly, in PE and EMDR more patients accomplished the status of their psychotic disorder in remission. Clinically, these effects are highly relevant and provide empirical support to the notion that delivering PTSD treatment to patients with psychotic disorders and PTSD deserves increasing recognition and acceptance among clinicians.


PLoS ONE ◽  
2021 ◽  
Vol 16 (11) ◽  
pp. e0259796
Author(s):  
Isabelle Carrard ◽  
Sophie Bucher Della Torre

Because of the serious consequences of eating disorders on young women’s lives and because of the lack of specialised care facilities, assessing and implementing evidence-based prevention interventions is necessary. Switzerland, like other Western countries, has high prevalence rates of eating disorders. However, no prevention interventions have been evaluated in this country so far. This paper presents the protocol of a preliminary study with the aim to evaluate the acceptability and effectiveness of two interventions, the Body Project (BP) and the Healthy Weight Program (HW), for female students from French-speaking Switzerland. These two interventions were chosen because they have been widely evaluated and they proved to be effective in various countries. They take place in groups and include four weekly sessions over one month. Because of the pandemic situation, the group sessions will take place online on an collaborative platform. The design is a three-arm randomised controlled study. Ninety female students aged 18–25 and presenting with at least moderate body dissatisfaction will be randomised into three groups: (1) one-month BP intervention, (2) one-month HW intervention, and (3) one-month waiting-list control group followed by the BP intervention. Assessments of body dissatisfaction, thin-ideal internalisation, dietary restraint, negative affect, and eating disorder psychopathology will be conducted before and after the interventions or waiting list and after a one-month follow-up. ANCOVA and ANOVA with repeated measures will be used to assess group differences and follow-up stability. Acceptability will be assessed with a questionnaire on participants’ satisfaction with the interventions, group discussion at the end of the intervention, and with participants’ rate of attendance to the group sessions. The study results will provide additional data on these two eating disorders prevention interventions and will suggest ways for their dissemination and further evaluation in Switzerland.


2020 ◽  
Vol 34 (4) ◽  
pp. 336-357
Author(s):  
Yvette N. Forbes ◽  
Robyn L. Moffitt ◽  
Marieke Van Bokkel ◽  
Caroline L. Donovan

ObjectiveThe aim of this study was to develop a 2-day intensive-format, Compassion-Focused Therapy (CFT) based group program targeting weight stigma in women with overweight and obesity, and to conduct a pilot study to determine the feasibility and acceptability of the intervention.MethodParticipants were 15 females aged 18–62 years (mean [M] = 43.60, standard deviation [SD] = 12.38), who participated in the program and completed measures of self-compassion, internalized weight stigma, psychological distress, life-satisfaction, loneliness, eating self-efficacy, body dissatisfaction, and body shame, at pre-treatment, post-treatment, and 3-month follow-up.ResultsSignificant improvements were found from pre-treatment to post-treatment for self-compassion and internalized weight stigma, with gains maintained at 3-month follow-up. Significant improvements were also found on measures of psychological distress, life satisfaction, loneliness, eating self-efficacy, and body dissatisfaction at the post-treatment assessment. Credibility ratings of the program were high.ConclusionsThis study has contributed to existing stigma research, being the first proof-of-concept study to demonstrate support for an intensive, CFT based group approach targeting the effects of weight stigma for women with overweight and obesity. The findings are discussed in terms of the potential of CFT to assist women develop resilience to the harmful effects of weight stigma, and possible future research directions to further develop and evaluate this approach.


2021 ◽  
Vol 24 (2) ◽  
pp. 292-305
Author(s):  
Behzad Salmani ◽  
◽  
Jaafar Hasani ◽  

Background & Aim: This study aimed at comparing efficacy of cognitive behavioral therapy, Zolpidem 10 mg, and waiting list group on illness perception and sleep efficiency in individuals with chronic insomnia disorder. Materials & Methods: Participants included 74 (female = 43) individuals with chronic insomnia disorder who were recruited from 2018 December to 2020 February by purposive sampling (inclusive & exclusive criteria). Then, patients randomly allocated to one of the three conditions, including cognitive behavioral therapy (N=25), pharmacotherapy (Zolpidem 10 mg.; N=29), and the waiting list (N=20). All patients were assessed three times at pretreatment, post-treatment, and 3-month follow-up by the Persian version of Brief Illness Perception Questionnaire and Sleep Efficiency Index. The data were analyzed by mixed analysis of variance with Bonferroni post-hoc test and repeated measure analysis of variance. Ethical Considerations: All stages of the research have been carried after taking supervising and approving of Kharazmi University's ethics in research committee. Findings: The patients who received cognitive behavioral therapy compared to patients in waiting list group, obtained significantly lower scores in illness perception and sleep efficiency during post-treatment and 3-month follow-up. Efficacy of pharmacotherapy only observed during post-treatment but there were no significant differences between pharmacotherapy and waiting list patients during 3-month follow-up. Conclusion: Cognitive behavioral therapy for insomnia reduced significantly illness perceptions and sleep efficiency during 3 months. All the treatment gains remain stable even 3 months later treatment ends. In addition, not receiving any treatment in waiting list and gradually discontinued the treatment in pharmacotherapy group leads to decreasing of sleep efficiency and increasing of illness perception.


2018 ◽  
Author(s):  
Shigetsugu Nakao ◽  
Atsuo Nakagawa ◽  
Yoshiyo Oguchi ◽  
Dai Mitsuda ◽  
Noriko Kato ◽  
...  

BACKGROUND Meta-analyses of a large number of randomized controlled trials have shown that cognitive behavioral therapy (CBT) has comparable efficacy to antidepressant medication, but therapist availability and cost-effectiveness is a problem. OBJECTIVE This study aimed to evaluate the effectiveness of a web-based CBT blended with face-to-face sessions that reduce therapist time in patients with major depression who were unresponsive to antidepressant medications. METHODS A 12-week, assessor-masked, parallel-group, waiting-list controlled, randomized trial was conducted in three medical institutions located in Tokyo. Outpatients aged 20–65 years with a primary diagnosis of major depression (taking one or more antidepressant medications at an adequate dose for ≥ 6 weeks, 17-item GRID-Hamilton Depression Rating Scale [GRID-HAMD] score ≥ 14) were randomly assigned (1:1) to blend CBT or waiting-list groups using a computer allocation system, stratified by the study site with the minimization method, to balance age and baseline GRID-HAMD score. The CBT intervention was given in a combined format, consisting of a web-based program and twelve 45-minute face-to-face sessions. Thus, across 12 weeks, a participant could receive up to 540 minutes of contact with a therapist, which was approximately two-thirds of the therapist contact time provided in the conventional CBT protocol, which typically provides sixteen 50-minute sessions. The primary outcome was the alleviation of depressive symptoms, as measured by a change in the total GRID-HAMD score from baseline (at randomization) to post-treatment (at 12 weeks). Additionally, in an exploratory analysis, we investigated whether the expected positive effects of the intervention were sustained during follow-up, 3 months after the post-treatment assessment. Analyses were performed on an intention-to-treat basis, and the primary outcome was analyzed using a mixed-effects model for repeated measures. RESULTS A total of 40 participants were randomized to either blend CBT (n=20) or waiting-list (n=20) groups. All patients completed the 12-week treatment protocol, and all were included in the intention-to-treat analyses. Participants in the blend CBT group had significantly alleviated depressive symptoms at week 12, as shown by greater least squares mean changes in GRID-HAMD score, than those in the waiting-list group (−8.9 points vs. −3.0 points; mean between-group difference = −5.95; 95% CI, −9.53 to −2.37; p =0.0002). The follow-up effects within the blend CBT group, as measured by GRID-HAMD score, was sustained at 3-months follow-up (week 24) after treatment (week 12) (post-treatment: 9.4 ± 5.2 vs. follow-up: 7.2 ± 5.7, p= 0.009). CONCLUSIONS Although our findings need to be confirmed in larger and longer-term studies with active controls, the present findings suggest that a combined form of CBT is effective in reducing depressive symptoms in patients with major depression who were unresponsive to antidepressant medications. CLINICALTRIAL Japanese Clinical Trials Registry UMIN Clinical Trials Registry Identifier: UMIN000009242.


2017 ◽  
pp. 50-55
Author(s):  
Duc Luu Ngo ◽  
Tu The Nguyen ◽  
Manh Hung Ho ◽  
Thanh Thai Le

Background: This study aims to survey some clinical features, indications and results of tracheotomy at Hue Central Hospital and Hue University Hospital. Patients and method: Studying on 77 patients who underwent tracheotomy at all of departments and designed as an prospective, descriptive and interventional study. Results: Male-female ratio was 4/1. Mean age was 49 years. Career: farmer 44.2%, worker 27.2%, officials 14.3%, student 7.8%, other jobs 6.5%. Respiratory condition before tracheotomy: underwent intubation 62.3%, didn’t undergo intubation 37.7%. Period of stay of endotracheal tube: 1-5 days 29.2%, 6-14 days 52.1%, >14 days 18.7%. Levels of dyspnea before tracheotomy: level I 41.4%, level II 48.3%, level III 0%, 10.3% of cases didn’t have dyspnea. Twenty cases (26%) were performed as an emergency while fifty seven (74%) as elective produces. Classic indications (37.7%) and modern indications (62.3%). On the bases of the site, we divided tracheostomy into three groups: high (0%), mid (25.3%) and low (74.7%). During follow-up, 44 complications occurred in 29 patients (37.7%). Tracheobronchitis 14.3%, tube obstruction 13%, subcutaneous empysema 10.4%, hemorrhage 5%, diffcult decannulation 5.2%, tube displacement 3.9%, canule watery past 2.6%, wound infection 1.3%. The final result after tracheotomy 3 months: there are 33 patients (42.9%) were successfully decannulated. In the 33 patients who were successfully decannulated: the duration of tracheotomy ranged from 1 day to 90 days, beautiful scar (51.5%), medium scar (36.4%), bad scar (12.1%). Conclusions: In tracheotomy male were more than female, adult were more than children. The main indication was morden indication. Tracheobronchitis and tube obstruction were more common than other complications. Key words: Tracheotomy


CJEM ◽  
2020 ◽  
Vol 22 (S1) ◽  
pp. S69-S69
Author(s):  
V. Tsang ◽  
K. Bao ◽  
J. Taylor

Introduction: Whole-body computed tomography scans (WBCT) are a mainstay in the work-up of polytrauma or multiple trauma patients in the emergency department. While incredibly useful for identifying traumatic injuries, WBCTs also reveal incidental findings in patients, some of which require further diagnostic testing and subsequent treatment. Although the presence of incidental findings in WBCTs have been well documented, there has been no systematic review conducted to organize and interpret findings, determine IF prevalence, and document strategies for best management. Methods: A systematic review was conducted using MEDLINE, PUBMED, and EMBASE. Specific journals and reference lists were hand-mined, and Google Scholar was used to find any additional papers. Data synthesis was performed to gather information on patient demographics, prevalence and type of incidental findings (IFs), and follow-up management was collected. All documents were independently assessed by the two reviewers for inclusion and any disagreements were resolved by consensus. Results: 1231 study results were identified, 59 abstracts, and 12 included in final review. A mean of 53.9% of patients had at least one IF identified, 31.5% had major findings, and 68.5% had minor findings. A mean of 2.7 IFs per patient was reported for articles that included number of total IFs. The mean age of patients included in the studies were 44 years old with IFs more common in older patients and men with more IFs than women. IFs were most commonly found in the abdominal/pelvic region followed by kidneys. Frequency of follow-up documentation was poor. The most common reported mechanisms of injury for patients included in the study were MVA and road traffic accidents (60.0%) followed by falls from >3m (23.2%). Conclusion: Although there is good documentation on the mechanism of injury, patient demographics, and type of IF, follow-up for IFs following acute trauma admission lacks documentation and follow-up and is an identified issue in patient management. There is great need for systematic protocols to address management of IFs in polytrauma patients.


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