Facilitating access to iCBT: a randomized controlled trial assessing a translated version of an empirically validated program using a minimally monitored delivery model

2019 ◽  
Vol 48 (2) ◽  
pp. 185-202
Author(s):  
Miguel Robichaud ◽  
France Talbot ◽  
Nickolai Titov ◽  
Blake F. Dear ◽  
Heather D. Hadjistavropoulos ◽  
...  
Keyword(s):  
Treatment Group ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Post Treatment ◽  
Effect Sizes ◽  
Anxiety And Depression ◽  
Control Group ◽  
Access To Treatment ◽  
Delivery Model

AbstractBackground:Despite its established efficacy, access to internet-delivered CBT (iCBT) remains limited in a number of countries. Translating existing programs and using a minimally monitored model of delivery may facilitate its dissemination across countries.Aims:This randomized control trial aims to evaluate the efficacy of an iCBT transdiagnostic program translated from English to French and offered in Canada using a minimally monitored delivery model for the treatment of anxiety and depression.Method:Sixty-three French speakers recruited in Canada were randomized to iCBT or a waiting-list. A French translation of an established program, the Wellbeing Course, was offered over 8 weeks using a minimally monitored delivery model. Primary outcome measures were the Generalized Anxiety Disorder-7 (GAD-7) and the Patient Health Questionnaire-9 (PHQ-9), which were obtained pre-treatment, post-treatment and at 3-month follow-up.Results:Mixed-effects models revealed that participants in the treatment group had significantly lower PHQ-9 and GAD-7 scores post-treatment than controls with small between-groups effect sizes (d = 0.34 and 0.37, respectively). Within-group effect sizes on primary outcome measures were larger in the treatment than control group. Clinical recovery rates on the PHQ-9 and GAD-7 were significantly higher among the treatment group (40 and 56%, respectively) than the controls (13 and 16%, respectively).Conclusions:The provision of a translated iCBT program using a minimally monitored delivery model may improve patients’ access to treatment of anxiety and depression across countries. This may be an optimal first step in improving access to iCBT before sufficient resources can be secured to implement a wider range of iCBT services.

scholarly journals Neurofeedback Training versus Treatment-as-Usual for Alcohol Dependence: Results of an Early-Phase Randomized Controlled Trial and Neuroimaging Correlates

2021 ◽  
pp. 1-14
Author(s):  
Leena Subramanian ◽  
Leon Skottnik ◽  
W. Miles Cox ◽  
Michael Lührs ◽  
Rachel McNamara ◽  
...  
Keyword(s):  
Treatment Group ◽  
Alcohol Dependence ◽  
Outcome Measures ◽  
Standard Care ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Salience Network ◽  
Neurofeedback Training

Introduction: Alcohol dependence is one of the most common substance use disorders, and novel treatment options are urgently needed. Neurofeedback training (NFT) based on real-time functional magnetic resonance imaging (rtf­MRI) has emerged as an attractive candidate for add-on treatments in psychiatry, but its use in alcohol dependence has not been formally investigated in a clinical trial. We investigated the use of rtfMRI-based NFT to prevent relapse in alcohol dependence. Methods: Fifty-two alcohol-dependent patients from the UK who had completed a detoxification program were randomly assigned to a treatment group (receiving rtfMRI NFT in addition to standard care) or the control group (receiving standard care only). At baseline, alcohol consumption was assessed as the primary outcome measure and a variety of psychological, behavioral, and neural parameters as secondary outcome measures to determine feasibility and secondary training effects. Participants in the treatment group underwent 6 NFT sessions over 4 months and were trained to downregulate their brain activation in the salience network in the presence of alcohol stimuli and to upregulate frontal activation in response to pictures related to positive goals. Four, 8, and 12 months after baseline assessment, both groups were followed up with a battery of clinical and psychometric tests. Results: Primary outcome measures showed very low relapse rates for both groups. Analysis of neural secondary outcome measures indicated that the majority of patients modulated the salience system in the desired directions, by decreasing activity in response to alcohol stimuli and increasing activation in response to positive goals. The intervention had a good safety and acceptability profile. Conclusion: We demonstrated that rtfMRI-neurofeedback targeting hyperactivity of the salience network in response to alcohol cues is feasible in currently abstinent patients with alcohol dependence.

scholarly journals The Effects of Anthocyanins in Purple Sweet Potato Extract to the Level MDA and NO Sputum Asymptomatic Smokers

2018 ◽  
Vol 38 (2) ◽  
pp. 64-74
Author(s):  
Ni Luh Putu Eka Arisanti ◽  
Helmia Hasan
Keyword(s):  
Oxidative Stress ◽  
Treatment Group ◽  
Sweet Potato ◽  
Airway Remodeling ◽  
Controlled Trial ◽  
Gene Mutations ◽  
Post Treatment ◽  
Control Group ◽  
Endogenous Nitric Oxide ◽  
Purple Sweet Potato

Backgrounds: Cigarette consist of 4000 chemical substances which can induce oxidative stress. In lungs, oxidative stress can cause lipid peroxidation, which produce MDA that leads to DNA damage, gene mutations, and loss of repair. Cigarette can also reduce the activity of endogenous Nitric Oxide (NO). Decrease of physiologic NO can cause dysfunction of the endothelium, pulmonary vasoconstriction, bronchospasm, mucous hypersecretion, reduction of mucociliary clearance, and airway remodeling. This damage can be prevented by antioxidant. The content of antosianin in purple cassava (purple sweet potato) is a potent antioxidant that can prevent oxidative stress. The aim of this study is to find out the effects of antosianin administration on MDA and NO sputum level in asymptomatic smoker. Methods: This study is an experimental study with randomized controlled trial pre–post test controlled group design, that performed on outpatient clinic of dr. Soetomo hospital. Results: The result of this study shows that MDA level in treatment group were significantly decrease P=0.0001 between pre (336,90 ng/ml) and post treatment (165,30 ng/ml) compare with control group that shows the opposite effect. In the control group, there was an increase of MDA level both before (416,00 ng/ml) and after placebo was given (476,00 ng/ml). The NO level in treatment group increase but it is not statistically significant between pre (40,80 ng/ml) and post treatment (78,30 ng/ml). The increase of NO level also occured in control group but it is not statistically significant between before (66,67 ng/ml) and after placebo was given (72,00 ng/ml), with the increment was higher in treatment group (6,66 ng/ml) compare with control group (0.53 ng/ml). Conclusions: The MDA sputum level were significantly decrease after the administration of antosianin extract from purple sweet potato in asymptomatic smoker. There were no significant increment of sputum NO level after the given of antosianin extract from purple sweet potato in asymptomatic smoker. (J Respir Indo 2018; 38(2): 64-74)

Does robot-assisted gait training improve ambulation in highly disabled multiple sclerosis people? A pilot randomized control trial

2016 ◽  
Vol 23 (5) ◽  
pp. 696-703 ◽  
Author(s):  
Alessandra Pompa ◽  
Giovanni Morone ◽  
Marco Iosa ◽  
Luca Pace ◽  
Sheila Catani ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Gait Training ◽  
Control Group ◽  
Robot Assisted ◽  
Robotic Training ◽  
Global Mobility ◽  
Pilot Randomized Control Trial

Background: Robotic training is commonly used to assist walking training in patients affected by multiple sclerosis (MS) with non-conclusive results. Objective: To compare the effect of robot-assisted gait training (RAGT) with that of conventional walking training (CWT) on gait competencies, global ability, fatigue and spasticity in a group of severely affected patients with MS. Methods: A pilot, single-blind randomized controlled trial was conducted in 43 severe (Expanded Disability Status Scale (EDSS) score of 6–7.5) and non-autonomous ambulant in-patients with MS. Experimental group performed 12 sessions of RAGT, whereas control group performed the same amount of CWT. Primary outcome measures were gait ability assessed by 2 minutes walking test and Functional Ambulatory Category; secondary outcomes were global ability (modified Barthel Index), global mobility (Rivermead Mobility Index), severity of disease (EDSS) and subjectively perceived fatigue (Fatigue Severity Scale). Results: The number of subjects who achieved a clinical significant improvement was significantly higher in RAGT than in CWT ( p < 0.05 for both primary outcome measures). RAGT also led to an improvement in all the other clinical parameters (global ability: p < 0.001, global mobility: p < 0.001, EDSS: p = 0.014 and fatigue: p = 0.001). Conclusions: RAGT improved the walking competencies in non-autonomous ambulant patients with MS, with benefits in terms of perceived fatigue.

scholarly journals Mindfulness-Based Program Plus Amygdala and Insula Retraining (MAIR) for the Treatment of Women with Fibromyalgia: A Pilot Randomized Controlled Trial

2020 ◽  
Vol 9 (10) ◽  
pp. 3246
Author(s):  
Juan P. Sanabria-Mazo ◽  
Jesus Montero-Marin ◽  
Albert Feliu-Soler ◽  
Virginia Gasión ◽  
Mayte Navarro-Gil ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Post Treatment ◽  
Effect Sizes ◽  
Control Group ◽  
Active Control Group ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

The lack of highly effective treatments for fibromyalgia (FM) represents a great challenge for public health. The objective of this parallel, pilot randomized controlled trial (RCT) was two-fold: (1) to analyze the clinical effects of mindfulness plus amygdala and insula retraining (MAIR) compared to a structurally equivalent active control group of relaxation therapy (RT) in the treatment of FM; and (2) to evaluate its impact on immune-inflammatory markers and brain-derived neurotrophic factor (BDNF) in serum. A total of 41 FM patients were randomized into two study arms: MAIR (intervention group) and RT (active control group), both as add-ons of treatment as usual. MAIR demonstrated significantly greater reductions in functional impairment, anxiety, and depression, as well as higher improvements in mindfulness, and self-compassion at post-treatment and follow-up, with moderate to large effect sizes. Significant decreases in pain catastrophizing and psychological inflexibility and improvements in clinical severity and health-related quality of life were found at follow-up, but not at post-treatment, showing large effect sizes. The number needed to treat was three based on the criteria of ≥50% Fibromyalgia Impact Questionnaire (FIQ) reduction post-treatment. Compared to RT, the MAIR showed significant decreases in BDNF. No effect of MAIR was observed in immune-inflammatory biomarkers (i.e., TNF-α, IL-6, IL-10, and hs-CRP). In conclusion, these results suggest that MAIR, as an adjuvant of treatment-as-usual (TAU), appears to be effective for the management of FM symptoms and for reducing BDNF levels in serum.

Psychodynamic therapy for adolescents suffering from co-morbid disorders of conduct and emotions in an in-patient setting: a randomized controlled trial

2013 ◽  
Vol 44 (10) ◽  
pp. 2213-2222 ◽  
Author(s):  
S. Salzer ◽  
C. Cropp ◽  
U. Jaeger ◽  
O. Masuhr ◽  
A. Streeck-Fischer
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Controlled Trial ◽  
Academic Failure ◽  
Psychodynamic Therapy ◽  
Post Treatment ◽  
Control Group ◽  
Global Severity Index ◽  
Randomized Controlled

BackgroundCo-morbid disorders of conduct and emotions can be regarded as childhood antecedents of further negative developments (e.g. manifestation of personality disorders in adulthood). We evaluated a manualized psychodynamic therapy (PDT) for adolescents with these co-morbid disorders.MethodIn a randomized controlled trial (RCT), 66 adolescents diagnosed with mixed disorders of conduct and emotions (F92 in ICD-10) were randomly assigned to a manualized in-patient PDT group or a waiting list/treatment-as-usual (WL/TAU) control condition. Diagnoses according to DSM-IV were also documented. Patients were compared using rates of remission as the primary outcome. The Global Severity Index (GSI) and the Strengths and Difficulties Questionnaire (SDQ) were used as secondary measures. Assessments were performed at baseline, post-treatment and at the 6-month follow-up.ResultsThe sample consisted of severely impaired adolescents with high rates of further co-morbid disorders and academic failure. Patients in the treatment group had a significantly higher rate of remission [odds ratio (OR) 26.41, 95% confidence interval (CI) 6.42–108.55, p < 0.001]. Compared with the control group, the PDT group resulted in significantly better outcomes on the SDQ (p = 0.04) but not the GSI (p = 0.18), with small between-group effect sizes (SDQ: d = 0.38, GSI: d = 0.18). However, the scores of patients treated with PDT were post-treatment no longer significantly different from normative data on the GSI and within the normal range on the SDQ. The effects in the treatment group were stable at follow-up. Furthermore, most patients were reintegrated into educational processes.ConclusionPDT led to remarkable improvement and furthered necessary preconditions for long-term stabilization. In future, PDT should be compared to other strong active treatments.

Electroacupuncture for post-stroke overactive bladder: a multi-centre pilot randomized controlled trial

2020 ◽  
pp. 096452842092548
Author(s):  
Haiyong Chen ◽  
Changde Wang ◽  
Minjie Zhou ◽  
Pui Yan Chan ◽  
Lo Lo Yam ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Overactive Bladder ◽  
Controlled Trial ◽  
Post Treatment ◽  
Secondary Outcome ◽  
Control Group ◽  
Bladder Diary ◽  
Post Stroke ◽  
Randomized Controlled

Background Although acupuncture has been shown to be effective at treating overactive bladder (OAB) following stroke, to our knowledge, no randomized controlled trial (RCT) examining the effects of acupuncture on patients with post-stroke OAB has been conducted. The aim of this preliminary study was to explore the effects of electroacupuncture (EA) in the treatment of post-stroke OAB. Methods This study was a multi-site randomized, assessor-blind, controlled pilot trial of patients with post-stroke OAB. In all, 34 post-stroke subjects (mean age: 71.0 years; 32.4% female) with OAB symptoms were randomly assigned to the treatment group or control group in a 1:1 ratio. The subjects in the treatment group were treated with six sessions of EA for 4 weeks, while the subjects in the control group received usual care. The primary outcome measure was the overactive bladder symptom scale (OABSS). Secondary outcome measures included a three day bladder diary and the stroke-specific quality-of-life scale (SSQoL). Results EA showed a moderate effect size (ES) on the perceived severity of OAB symptoms as measured by the OABSS at week 5 (one week post-treatment, ES 0.57; p = 0.034) and week 8 (three weeks post-treatment, ES 0.60; p = 0.021), although the results did not remain statistically significant after Bonferroni correction for multiple testing. No significant differences in bladder diary parameters or SSQoL score were found. The EA treatment was well tolerated by the post-stroke subjects. Conclusion A six-session EA treatment was feasible and appeared to reduce OAB symptoms in post-stroke patients. Further fully powered trials are warranted to confirm the efficacy of EA for those with post-stroke OAB.

scholarly journals The Efficacy of Zemedy, a Mobile Digital Therapeutic for the Self-Management of Irritable Bowel Syndrome: a Cross-Over, Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Melissa Hunt ◽  
Sofia Miguez ◽  
Benji Dukas ◽  
Obinna Onwude ◽  
Sarah White
Keyword(s):  
Irritable Bowel Syndrome ◽  
Treatment Group ◽  
Controlled Trial ◽  
Post Treatment ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomized Controlled ◽  
Irritable Bowel ◽  
Intent To Treat

BACKGROUND Patients with irritable bowel syndrome (IBS) experience abdominal pain, altered bowel habits, and defecation-related anxiety which can result in reduced productivity and impaired health related quality of life (HRQL). Cognitive-behavioral therapy (CBT) has been shown to reduce symptoms of IBS and to improve HRQL, but access to qualified therapists is limited. Smartphone-based digital therapeutic interventions have the potential to increase access to guided CBT at scale but require careful study to assess their benefits and risks. OBJECTIVE To test the efficacy of a novel app, Zemedy - a mobile digital therapeutic that delivers a comprehensive CBT program to individuals with IBS. METHODS This was a cross-over randomized controlled trial (registration number NCT04170686). Participants were recruited online. Patients were randomly allocated to either immediate treatment (N = 62) or waitlist control (N = 59). The Zemedy app consists of 8 modules focusing on psychoeducation, relaxation training, exercise, the cognitive model of stress management, applying CBT to IBS symptoms, reducing avoidance through exposure therapy and behavioral experiments, and information about diet. Users interact with a chatbot that presents the information and encourages specific plans, homework and exercises. The treatment was fully automated, with no therapist involvement or communication. At baseline and after 8 weeks, participants were asked to complete the battery of primary (Irritable Bowel Syndrome Quality of Life (IBS-QoL), Gastrointestinal Symptom Rating Scale (GSRS)) and secondary outcome measures (the Fear of Food Questionnaire (FFQ), the Visceral Sensitivity Index (VSI), the GI Cognition Questionnaire (GI-COG), the Depression, Anxiety Stress Scale (DASS) and the Patient Health Questionnaire (PHQ-9)). Waitlist controls were then offered the opportunity to cross over. All participants were assessed one more time at 3 months post-treatment completion. RESULTS Both intent-to-treat and completer analyses at post-treatment revealed significant improvement for the immediate treatment group compared to the waitlist control group on both primary and secondary outcome measures. Gains were generally maintained at 3 months post-treatment. Scores on the GSRS, IBS-QoL, GI-COG, and VSI all improved significantly more in the treatment group [F(1,79) = 20.49, P < .001, Cohen’s d = 1.01; F(1,79) = 20.12, P < .001, d = 1.25; F(1,79) = 34.71, P < .001, d = 1.47 and F(1,79) = 18.7, P < .001, d = 1.07]. Fear of food also decreased for the treatment group relative to the control group [F(1,79) = 12.13, P = .001, d = .62]. Depression improved significantly as measured by both the PHQ9 [F(1,79) = 10.5, P = .002, d = 1.07] and the DASS Depression Subscale [F(1,79) = 6.03, P = .016, d = .83], as did the stress subscale of the DASS [F(1,79) = 4.47, P = .04, d = .65] in the completer analysis but not the intent-to-treat analysis. The impact of treatment on HRQL was mediated by reductions in catastrophizing and visceral sensitivity. CONCLUSIONS Despite its relatively benign physical profile, IBS can be an extraordinarily debilitating condition. Zemedy is an effective modality to deliver CBT for individuals with IBS, and could increase accessibility of this evidence based treatment. CLINICALTRIAL This trial was registered at ClinicalTrials.gov as NCT04170686

scholarly journals A randomized controlled trial of an internet-delivered treatment: Its potential as a low-intensity community intervention for adults with symptoms of depression

2016 ◽  
Vol 33 (S1) ◽  
pp. S112-S112
Author(s):  
D. Richards ◽  
L. Timulak ◽  
N. Vigano ◽  
E. O’Brien ◽  
G. Doherty ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Treatment Group ◽  
Primary Outcome ◽  
Community Intervention ◽  
Controlled Trial ◽  
Control Group ◽  
Behavioural Intervention ◽  
Symptoms Of Depression ◽  
Randomized Controlled

IntroductionInternet-delivered treatments for depression have proved successful, with supported programs offering the potential for improved adherence and outcomes. Internet interventions are particularly interesting in the context of increasing access to interventions, and delivering interventions population-wide.ObjectiveInvestigate the potential feasibility and effectiveness of an online intervention for depression in the community.AimsEstablish the effectiveness of a supported online delivered cognitive behavioural intervention for symptoms of depression in adults in the community.MethodsThe study was a randomized controlled trial of an 8-module internet-delivered cognitive behavioral therapy (iCBT) program for adults with depressive symptoms (n = 96) compared to a waiting-list control group (n = 92). Participants received weekly support from a trained supporter. The primary outcome was depressive symptoms as measured by the Beck Depression Inventory (BDI-II). The program was made available nationwide from an established and recognized charity for depression.ResultsFor the treatment group, post-treatment effect sizes reported were large for the primary outcome measure (d = 0.91). The between-group effects were moderate to large and statistically significant for the primary outcomes (d = 0.50) favoring the treatment group. Gains were maintained at 6-month follow-up.ConclusionThe study has demonstrated the efficacy of the online delivered space from depression treatment. Participants demonstrated reliable and statistically significant changes in symptoms from pre- to post-intervention. The study supports a model for delivering online depression interventions population-wide using trained supporters.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Saving clinicians' time by delegating routine aspects of therapy to a computer: a randomized controlled trial in phobia/panic disorder

2004 ◽  
Vol 34 (1) ◽  
pp. 9-17 ◽  
Author(s):  
I. M. MARKS ◽  
M. KENWRIGHT ◽  
M. McDONOUGH ◽  
M. WHITTAKER ◽  
D. MATAIX-COLS
Keyword(s):  
Panic Disorder ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Exposure Therapy ◽  
Controlled Trial ◽  
Dropout Rate ◽  
Post Treatment ◽  
Exposure Group ◽  
Drop Outs

Background. The demand for time-consuming psychotherapy of phobia/panic exceeds the supply of trained therapists. Delegating routine therapy aspects to a computer might ease this problem.Method. Ninety-three out-patients with phobia or panic disorder were randomized in a 2[ratio ]2[ratio ]1 ratio to have self-exposure therapy guided either mainly by a stand-alone computer system (FearFighter) or entirely face-to-face by a clinician, or to have mainly computer-guided self-relaxation as a placebo. Both computer groups (FearFighter and relaxation) had brief back-up advice from a clinician. Primary outcome measures were self- and blind-assessor ratings of Main Problem and Goals, and Global Phobia.Results. Drop-outs occurred significantly more often in the two self-exposure groups (43% if mainly computer-guided, 24% if entirely clinician-guided) than with self-relaxation (6%); the difference between the two self-exposure groups was not significant. Even with all drop-outs included, the mainly computer-guided exposure group and the relaxation group had 73% less clinician time per patient than did the entirely clinician-guided exposure group. The two self-exposure groups had comparable improvement and satisfaction at post-treatment and at 1-month follow-up, while relaxation was ineffective. Mean improvement on the primary outcome measures (self- and assessor-rated) was 46% computer, 49% clinician, 9% relaxation at post-treatment (week 10) and 58% computer, 53% clinician and −4% relaxation at 1-month follow-up (week 14). Mean effect sizes on the primary outcome measures were 2·9 computer, 3·5 clinician and 0·5 relaxation at post-treatment; and 3·7 computer, 3·5 clinician and 0·5 relaxation at 1-month follow-up. The assessor did not rate patients at follow-up.Conclusions. Despite its (non-significantly) higher dropout rate, self-exposure therapy for panic/phobia cut clinician time per patient by 73% without losing efficacy when guided mainly by a computer rather than entirely by a clinician. The finding needs confirmation at a follow-up that is longer and includes a blind assessor. Self-relaxation had the highest rate of completers but was ineffective.

Solution-Focused Brief Therapy With Substance-Using Individuals

2016 ◽  
Vol 28 (4) ◽  
pp. 452-462 ◽  
Author(s):  
Johnny S. Kim ◽  
Jody Brook ◽  
Becci A. Akin
Keyword(s):  
Substance Use ◽  
Linear Models ◽  
Brief Therapy ◽  
Controlled Trial ◽  
Addiction Severity Index ◽  
Self Report ◽  
Effect Sizes ◽  
Control Group ◽  
Solution Focused Brief Therapy ◽  
Solution Focused

Objective: This study examined the effectiveness of solution-focused brief therapy (SFBT) intervention on substance abuse and trauma-related problems. Methods: A randomized controlled trial design was used to evaluate the effectiveness of SFBT in primary substance use treatment services for child welfare involved parents in outpatient treatment for substance use disorders. Mixed linear models were used to test within- and between-group changes using intent-to-treat analysis ( N = 64). Hedges’s g effect sizes were also calculated to examine magnitude of treatment effects. Results: Both groups decreased on the Addiction Severity Index-Self-Report and the Trauma Symptom Checklist-40. The between group effect sizes were not statistically significant on either measures, thus SFBT produced similar results as the research supported treatments the control group received. Conclusion: Results support the use of SFBT in treating substance use and trauma and provide an alternative approach that is more strengths based and less problem focused.

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