scholarly journals Stabilising sleep for patients admitted at acute crisis to a psychiatric hospital (OWLS): an assessor-blind pilot randomised controlled trial

2017 ◽  
Vol 48 (10) ◽  
pp. 1694-1704 ◽  
Author(s):  
Bryony Sheaves ◽  
Daniel Freeman ◽  
Louise Isham ◽  
Josephine McInerney ◽  
Alecia Nickless ◽  
...  
Keyword(s):  
Sleep Problems ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Severity Index ◽  
Behavioural Therapy ◽  
Mean Difference ◽  
Mental Wellbeing ◽  
Intention To Treat ◽  
Sleep Treatment ◽  
Acute Crisis

AbstractBackgroundWhen patients are admitted onto psychiatric wards, sleep problems are highly prevalent. We carried out the first trial testing a psychological sleep treatment at acute admission (Oxford Ward sLeep Solution, OWLS).MethodsThis assessor-blind parallel-group pilot trial randomised patients to receive sleep treatment at acute crisis [STAC, plus standard care (SC)], or SC alone (1 : 1). STAC included cognitive–behavioural therapy (CBT) for insomnia, sleep monitoring and light/dark exposure for circadian entrainment, delivered over 2 weeks. Assessments took place at 0, 2, 4 and 12 weeks. Feasibility outcomes assessed recruitment, retention of participants and uptake of the therapy. Primary efficacy outcomes were the Insomnia Severity Index and Warwick–Edinburgh Mental Wellbeing Scale at week 2. Analyses were intention-to-treat, estimating treatment effect with 95% confidence intervals.ResultsBetween October 2015 and July 2016, 40 participants were recruited (from 43 assessed eligible). All participants offered STAC completed treatment (mean sessions received = 8.6,s.d.= 1.5). All participants completed the primary end point. Compared with SC, STAC led to large effect size (ES) reductions in insomnia at week 2 (adjusted mean difference −4.6, 95% CI −7.7 to −1.4, ES −0.9), a small improvement in psychological wellbeing (adjusted mean difference 3.7, 95% CI −2.8 to 10.1, ES 0.3) and patients were discharged 8.5 days earlier. One patient in the STAC group had an adverse event, unrelated to participation.ConclusionsIn this challenging environment for research, the trial was feasible. Therapy uptake was high. STAC may be a highly effective treatment for sleep disturbance on wards with potential wider benefits on wellbeing and admission length.

scholarly journals O028 Effectiveness of digital brief behavioural therapy for insomnia with wearable technology: pilot randomized controlled trial

2021 ◽  
Vol 2 (Supplement_1) ◽  
pp. A13-A13
Author(s):  
C Gordon ◽  
M Aji ◽  
N Glozier ◽  
D Bartlett ◽  
R Calvo ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Pilot Trial ◽  
Sleep Onset ◽  
Severity Index ◽  
Sleep Time ◽  
Behavioural Therapy ◽  
Wearable Device ◽  
User Engagement ◽  
Sleep Onset Latency ◽  
Significant Difference

Abstract Objective This pilot trial aimed to test the effectiveness of integration of a wearable device with digital brief behavioural therapy for insomnia (dBBTi) on insomnia symptom severity, sleep metrics and therapy engagement. Participants and Methods One hundred and twenty-eight participants with insomnia symptoms were randomised to a 3-week dBBTi program with a wearable device enabling sleep data synchronization (dBBTi+wearable group; n = 62) or dBBTi alone (n = 66). We assessed the Insomnia Severity Index (ISI) and modified Pittsburgh Sleep Quality Index (PSQI; wake-after-sleep-onset (WASO), sleep-onset-latency (SOL), and total sleep time (TST)) at baseline and weeks 1, 2, 3, 6 and 12. Engagement was measured by the number of daily sleep diaries. Results There was no significant difference in ISI scores between the groups (d = 0.7, p = 0.061). The dBBTi+wearable group showed greater improvements in WASO (d = 0.8, p = 0.005) and TST (d = 0.3, p = 0.049) compared to the dBBTi group after 6 weeks. There was significantly greater engagement in the dBBTi+wearable group compared to the dBTi group (d =0.7, p = 0.010). Conclusions This pilot trial found that wearable device integration with a digital insomnia therapy led to improvements in WASO and TST and enhanced user engagement. We suggest that incorporation of adjunctive wearable technologies may improve digital insomnia therapy.

scholarly journals Randomised controlled trial of a self-guided online fatigue intervention in multiple sclerosis

2018 ◽  
Vol 89 (9) ◽  
pp. 970-976 ◽  
Author(s):  
Jana Pöttgen ◽  
Rona Moss-Morris ◽  
Janina-Maria Wendebourg ◽  
Lena Feddersen ◽  
Stefanie Lau ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Controlled Trial ◽  
Treatment Options ◽  
Behavioural Therapy ◽  
Mean Difference ◽  
Control Group ◽  
Effective Treatment Option ◽  
Intention To Treat ◽  
Cost Effective Treatment ◽  
Treat Analysis

ObjectiveFatigue is a major disabling symptom in many chronic diseases including multiple sclerosis (MS), but treatment options are limited.Here, we tested the effectiveness of a self-guided , interactive, online fatigue management programme (ELEVIDA) based on principles of cognitive behavioural therapy (CBT) and related psychotherapeutic approaches (eg, mindfulness) for reducing fatigue in MS.MethodsPatients with MS and self-reported fatigue were recruited via the website of the German MS Society and assigned via an automated randomisation generator (1:1, no blocking or stratification) to a 12-week online intervention (ELEVIDA, n=139, 82% female, mean age 40.8, median patient determined disease steps (PDDS) 3.0) or a waitlist control group (n=136, 79% female, mean age 41.9, median PDDS 3.0). The primary outcome was the Chalder Fatigue Scale. Outcomes were assessed at baseline, at week 12 (postintervention) and at follow-up (week 24).ResultsCompared with the control group, significantly greater reductions in Chalder Fatigue Scale scores were seen in the ELEVIDA group at week 12 (primary endpoint, intention-to-treat analysis: between-group mean difference 2.74 points; 95% CI 1.16 to 4.32; p=0.0007; effect size d=0.53), with effects sustained at week 24 (intention-to-treat analysis: between-group mean difference 2.19 points; 95% CI 0.57 to 3.82; p=0.0080).ConclusionsOur trial provides evidence for the effectiveness of a self-guided , internet-based intervention to reduce fatigue in MS. Interventions such as ELEVIDA may be a suitable low barrier, cost-effective treatment option for MS fatigue.Trial registration numberISRCTN registry (number ISRCTN25692173).

scholarly journals Cognitive Behavioural Therapy for Nightmares for Patients with Persecutory Delusions (Nites): An Assessor-Blind, Pilot Randomized Controlled Trial

2019 ◽  
pp. 070674371984742 ◽  
Author(s):  
Bryony Sheaves ◽  
Emily A. Holmes ◽  
Stephanie Rek ◽  
Kathryn M. Taylor ◽  
Alecia Nickless ◽  
...  
Keyword(s):  
Suicidal Ideation ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Behavioural Therapy ◽  
Serious Adverse Events ◽  
Persecutory Delusions ◽  
Treatment As Usual ◽  
Cognitive Behavioural

Objective:Nightmares are relatively common in patients experiencing psychosis but rarely assessed or treated. Nightmares may maintain persecutory delusions by portraying fears in sensory-rich detail. We tested the potential benefits of imagery-focused cognitive behavioural therapy (CBT) for nightmares on nightmare severity and persecutory delusions.Method:This assessor-blind parallel-group pilot trial randomized 24 participants with nightmares and persecutory delusions to receive CBT for nightmares delivered over 4 weeks in addition to treatment as usual (TAU) or TAU alone. Assessments were at 0, 4 (end of treatment), and 8 weeks (follow-up). Feasibility outcomes assessed therapy uptake, techniques used, satisfaction, and attrition. The primary efficacy outcome assessed nightmare severity at week 4. Analyses were intention to treat, estimating treatment effect with 95% confidence intervals (CIs).Results:All participants offered CBT completed therapy (mean [SD], 4.8 [0.6] sessions) with high satisfaction, and 20 (83%) participants completed all assessments. Compared with TAU, CBT led to large improvements in nightmares (adjusted mean difference = −7.0; 95% CI, –12.6 to –1.3; d = –1.1) and insomnia (6.3; 95% CI, 2.6 to 10.0; d = 1.4) at week 4. Gains were maintained at follow-up. Suicidal ideation was not exacerbated by CBT but remained stable to follow-up, compared with TAU, which reduced at follow-up (6.8; 95% CI, 0.3 to 3.3; d = 0.7). CBT led to reductions in paranoia (–20.8; 95% CI, –43.2 to 1.7; d = –0.6), although CIs were wide. Three serious adverse events were deemed unrelated to participation (CBT = 2, TAU = 1).Conclusions:CBT for nightmares is feasible and may be efficacious for treating nightmares and comorbid insomnia for patients with persecutory delusions. It shows promise on paranoia but potentially not on suicidal ideation.

scholarly journals Cost-effectiveness of cell salvage and donor blood transfusion during caesarean section: results from a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e022352 ◽  
Author(s):  
Carol McLoughlin ◽  
Tracy E Roberts ◽  
Louise J Jackson ◽  
Philip Moore ◽  
Matthew Wilson ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Caesarean Section ◽  
Blood Transfusion ◽  
Controlled Trial ◽  
Mean Difference ◽  
Cell Salvage ◽  
Donor Blood ◽  
Intention To Treat ◽  
The Mean ◽  
Randomised Controlled

ObjectivesTo evaluate the cost-effectiveness of routine use of cell salvage during caesarean section in mothers at risk of haemorrhage compared with current standard of care.DesignModel-based cost-effectiveness evaluation alongside a multicentre randomised controlled trial. Three main analyses were carried out on the trial data: (1) based on the intention-to-treat principle; (2) based on the per-protocol principle; (3) only participants who underwent an emergency caesarean section.Setting26 obstetric units in the UK.Participants3028 women at risk of haemorrhage recruited between June 2013 and April 2016.InterventionsCell salvage (intervention) versus routine care without salvage (control).Primary outcome measuresCost-effectiveness based on incremental cost per donor blood transfusion avoided.ResultsIn the intention-to-treat analysis, the mean difference in total costs between cell salvage and standard care was £83. The estimated incremental cost-effectiveness ratio (ICER) was £8110 per donor blood transfusion avoided. For the per-protocol analysis, the mean difference in total costs was £92 and the ICER was £8252. In the emergency caesarean section analysis, the mean difference in total costs was £55 and the ICER was £13 713 per donor blood transfusion avoided. This ICER is driven by the increased probability that these patients would require a higher level of postoperative care and additional surgeries. The results of these analyses were shown to be robust for the majority of deterministic sensitivity analyses.ConclusionsThe results of the economic evaluation suggest that while routine cell salvage is a marginally more effective strategy than standard care in avoiding a donor blood transfusion, there is uncertainty in relation to whether it is a less or more costly strategy. The lack of long-term data on the health and quality of life of patients in both arms of the trial means that further research is needed to fully understand the cost implications of both strategies.Trial registration numberISRCTN66118656.

Development and assessment of a mobile phone-based intervention to reduce maternal depression and improve child health

2016 ◽  
Vol 33 (S1) ◽  
pp. S608-S609
Author(s):  
N. Husain ◽  
T. Kiran ◽  
B. Fatima ◽  
I.B. Chaudhry ◽  
Q. Saeed ◽  
...  
Keyword(s):  
Child Health ◽  
Mobile Phone ◽  
Real Time ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Pilot Trial ◽  
Cost Effective ◽  
Behavioural Therapy ◽  
Negative Consequences ◽  
Post Intervention

IntroductionPostnatal depression is known to cause disability and suffering in women and negative consequences both for their infants and their families, with huge costs globally. Several studies from low and middle income countries (LAMIC) have demonstrated that effectively delivered psychological interventions are cost effective for improving maternal and child health, but access to these interventions is limited in both the low and high income countries.ObjectiveThe objective of the study is to develop and test a mobile phone-based intervention (TechMotherCare), which will include components of cognitive behavioural therapy (CBT) and child development related psychoeducation.AimThe aim of the study is to examine the feasibility and acceptability of the TechMotherCare intervention.MethodsA total of 36 participants will be recruited from health centers in Karachi, Pakistan for this 2-arm randomized pilot study. The TechMotherCare App intervention will be based on principles of CBT and learning-through-play (LTP) a parenting intervention and will assess the real-time depressive symptoms of participants and respond, using intelligent real time therapy (iRTT) dependent on symptoms reported by participants.ResultsOutcome assessments will be completed after 3 months (end of intervention). In-depth qualitative interviews will also be conducted with participants pre- and post-intervention. The trial is ongoing and we will present both the qualitative and quantitative results.ConclusionsThe results of this pilot trial will inform the design of a larger randomised controlled trial using a mobile based technology platform to address the huge treatment gap in LAMICs.Disclosure of interestThe authors have not supplied their declaration of competing interest.

scholarly journals Recovery-focused cognitive–behavioural therapy for recent-onset bipolar disorder: Randomised controlled pilot trial

2015 ◽  
Vol 206 (1) ◽  
pp. 58-66 ◽  
Author(s):  
Steven H. Jones ◽  
Gina Smith ◽  
Lee D. Mulligan ◽  
Fiona Lobban ◽  
Heather Law ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Behavioural Therapy ◽  
Personal Recovery ◽  
Recent Onset ◽  
Cognitive Behavioural ◽  
Randomised Controlled

BackgroundDespite evidence for the effectiveness of structured psychological therapies for bipolar disorder no psychological interventions have been specifically designed to enhance personal recovery for individuals with recent-onset bipolar disorder.AimsA pilot study to assess the feasibility and effectiveness of a new intervention, recovery-focused cognitive–behavioural therapy (CBT), designed in collaboration with individuals with recent-onset bipolar disorder intended to improve clinical and personal recovery outcomes.MethodA single, blind randomised controlled trial compared treatment as usual (TAU) with recovery-focused CBT plus TAU (n = 67).ResultsRecruitment and follow-up rates within 10% of pre-planned targets to 12-month follow-up were achieved. An average of 14.15 h (s.d. = 4.21) of recovery-focused CBT were attended out of a potential maximum of 18 h. Compared with TAU, recovery-focused CBT significantly improved personal recovery up to 12-month follow-up (Bipolar Recovery Questionnaire mean score 310.87, 95% CI 75.00–546.74 (s.e. = 120.34), P = 0.010, d=0.62) and increased time to any mood relapse during up to 15 months follow-up (χ2 = 7.64, P<0.006, estimated hazard ratio (HR) = 0.38, 95% CI 0.18–0.78). Groups did not differ with respect to medication adherence.ConclusionsRecovery-focused CBT seems promising with respect to feasibility and potential clinical effectiveness. Clinical- and cost-effectiveness now need to be reliably estimated in a definitive trial.

scholarly journals Feasibility and acceptability of an enhanced cognitive behavioural therapy programme for parent–child dyads with anxiety disorders: a mixed-methods pilot trial protocol

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Samantha Galea ◽  
Chloe A. Salvaris ◽  
Marie B. H. Yap ◽  
Peter J. Norton ◽  
Katherine A. Lawrence
Keyword(s):  
Mixed Methods ◽  
Anxiety Disorders ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Behavioural Therapy ◽  
Self Report ◽  
Trial Registration ◽  
Cognitive Behavioural ◽  
Parent Child

Abstract Background Cognitive behavioural therapy (CBT) is the most widely recognised and efficacious psychological therapy for the treatment of anxiety disorders in children and adults. However, suboptimal remission rates indicate room for improvement in treatments, particularly when both children and their parents have anxiety disorders. Bidirectional transmission and maintenance of anxiety within parent–child dyads could be better targeted by CBT, to improve treatment outcomes for children and parents with anxiety disorders. This study aimed to develop and evaluate the feasibility and acceptability of a concurrent parent–child enhanced CBT intervention that targets the individual’s anxiety disorder(s), as well as the bidirectional factors that influence and maintain anxiety in the dyad. Methods Feasibility and acceptability of the proposed CBT protocol will be evaluated in an open-label pilot trial of the intervention utilising qualitative and quantitative data collection. Ten parent–child dyad participants (n = 20) with anxiety disorders will be recruited for the proposed intervention. The intervention is based on an empirically supported 10-week CBT programme for anxiety disorders in adults, adapted to be delivered to parent–child dyads concurrently, and to target anxious modelling and overprotective behaviours through joint observational exposures. Intervention feasibility will be explored by pre-post symptom change on a range of clinician- and self-report measures to determine preliminary indications of participants’ intervention response and effect size calculations to estimate sample size for a future definitive randomised controlled trial (RCT). Additional feasibility measures will include recruitment rates, completion rates, and adherence to programme requirements. To explore participant acceptability of the intervention, qualitative interviews will be conducted with five parent–child dyads who complete the intervention (n = 10), along with five parent–child dyads with anxiety symptoms who express interest in the intervention (n = 10). Acceptability measures will include prospective and retrospective quantitative self-report and qualitative interview data. Discussion This pilot trial will utilise a mixed-methods design to determine the feasibility and acceptability of delivering an enhanced CBT intervention for the concurrent treatment of parent–child dyads with anxiety disorders. The results of this trial will inform the development and implementation of a future definitive randomised clinical trial to evaluate intervention efficacy. Trial registration Australian and New Zealand Clinical Trials Registry, ANZCTR1261900033410. Prospectively registered: pre-results. Registered 04 March 2019.

scholarly journals Melodic intonation therapy in post-stroke nonfluent aphasia: a randomized pilot trial

2018 ◽  
Vol 33 (1) ◽  
pp. 44-53 ◽  
Author(s):  
Ana M Haro-Martínez ◽  
Genny Lubrini ◽  
Rosario Madero-Jarabo ◽  
Exuperio Díez-Tejedor ◽  
Blanca Fuentes
Keyword(s):  
Controlled Trial ◽  
Pilot Trial ◽  
Treated Group ◽  
Stroke Survivors ◽  
Nonfluent Aphasia ◽  
Post Stroke ◽  
Melodic Intonation Therapy ◽  
Intention To Treat ◽  
Group 2 ◽  
Group 1

Objective: To collect data to estimate the sample size of a definitive randomized controlled trial to evaluate the effects of Melodic Intonation Therapy in post-stroke nonfluent aphasia. Design: A randomized, crossover, interventional pilot trial. Setting: Departments of Neurology and Rehabilitation from a university general hospital. Participants: Stroke survivors with post-stroke nonfluent aphasia. Interventions: Patients randomized to group 1 had treatment with Melodic Intonation Therapy first (12 sessions over six weeks) followed by no treatment; the patients in group 2 started active treatment between three and six months after their inclusion in the study, serving as waiting list controls for the first phase. Main measures: The Communicative Activity Log (CAL) questionnaire and the Boston Diagnostic Aphasia Examination (BDAE) were evaluated at baseline, and at six and 12 weeks. Results: Twenty patients were included. Four of the patients allocated to group 2 crossed over to group 1, receiving the treatment at first. Intention-to-treat analysis: after adjustment for baseline scores, the mean difference in the CAL evaluation from baseline in the treated group was 8.5 points (95% confidence interval (CI), 0.11–17.0; P = .043), with no significant change in any of the BDAE sections. Per-protocol analysis showed similar results with a clear treatment effect ( P = .043) on the CAL. Conclusion: Melodic Intonation Therapy might have a positive effect on the communication skills of stroke survivors with nonfluent aphasia as measured by the CAL questionnaire. A full-scale trial with at least 27 patients per group is necessary to confirm these results.

scholarly journals Participant views on involvement in a trial of social recovery cognitive–behavioural therapy

2015 ◽  
Vol 206 (2) ◽  
pp. 122-127 ◽  
Author(s):  
Caitlin Notley ◽  
Rose Christopher ◽  
Joanne Hodgekins ◽  
Rory Byrne ◽  
Paul French ◽  
...  
Keyword(s):  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Behavioural Therapy ◽  
Future Research ◽  
Structured Interviews ◽  
Client Group ◽  
Cognitive Behavioural ◽  
Randomised Controlled ◽  
Social Recovery

BackgroundThe PRODIGY trial (Prevention of long term social disability amongst young people with emerging psychological difficulties, ISRCTN47998710) is a pilot trial of social recovery cognitive–behavioural therapy (SRCBT).AimsThe PRODIGY qualitative substudy aimed to (a) explore individual experiences of participating in the pilot randomised, controlled trial (recruitment, randomisation, assessment) and initial views of therapy, and (b) to explore perceived benefits of taking part in research v. ethical concerns and potential risks.MethodQualitative investigation using semi-structured interviews with thematic analysis.ResultsAnalysis revealed participant experiences around the key themes of acceptability, disclosure, practicalities, altruism and engagement.ConclusionsParticipants in both trial arms perceived themselves as gaining benefits from being involved in the study, above and beyond the intervention. This has implications for the design of future research and services for this client group, highlighting the importance of being flexible and an individualised approach as key engagement tools.

scholarly journals Exercise versus usual care after non-reconstructive breast cancer surgery (UK PROSPER): multicentre randomised controlled trial and economic evaluation

BMJ ◽  
2021 ◽  
pp. e066542
Author(s):  
Julie Bruce ◽  
Bruno Mazuquin ◽  
Alastair Canaway ◽  
Anower Hossain ◽  
Esther Williamson ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Usual Care ◽  
Upper Limb ◽  
Controlled Trial ◽  
Cost Effective ◽  
Exercise Programme ◽  
Cancer Surgery ◽  
Mean Difference ◽  
Breast Cancer Surgery ◽  
Intention To Treat

Abstract Objective To evaluate whether a structured exercise programme improved functional and health related quality of life outcomes compared with usual care for women at high risk of upper limb disability after breast cancer surgery. Design Multicentre, pragmatic, superiority, randomised controlled trial with economic evaluation. Setting 17 UK National Health Service cancer centres. Participants 392 women undergoing breast cancer surgery, at risk of postoperative upper limb morbidity, randomised (1:1) to usual care with structured exercise (n=196) or usual care alone (n=196). Interventions Usual care (information leaflets) only or usual care plus a physiotherapy led exercise programme, incorporating stretching, strengthening, physical activity, and behavioural change techniques to support adherence to exercise, introduced at 7-10 days postoperatively, with two further appointments at one and three months. Main outcome measures Disability of Arm, Hand and Shoulder (DASH) questionnaire at 12 months, analysed by intention to treat. Secondary outcomes included DASH subscales, pain, complications, health related quality of life, and resource use, from a health and personal social services perspective. Results Between 26 January 2016 and 31 July 2017, 951 patients were screened and 392 (mean age 58.1 years) were randomly allocated, with 382 (97%) eligible for intention to treat analysis. 181 (95%) of 191 participants allocated to exercise attended at least one appointment. Upper limb function improved after exercise compared with usual care (mean DASH 16.3 (SD 17.6) for exercise (n=132); 23.7 (22.9) usual care (n=138); adjusted mean difference 7.81, 95% confidence interval 3.17 to 12.44; P=0.001). Secondary outcomes favoured exercise over usual care, with lower pain intensity at 12 months (adjusted mean difference on numerical rating scale −0.68, −1.23 to −0.12; P=0.02) and fewer arm disability symptoms at 12 months (adjusted mean difference on Functional Assessment of Cancer Therapy-Breast+4 (FACT-B+4) −2.02, −3.11 to −0.93; P=0.001). No increase in complications, lymphoedema, or adverse events was noted in participants allocated to exercise. Exercise accrued lower costs per patient (on average −£387 (€457; $533) (95% confidence interval −£2491 to £1718; 2015 pricing) and was cost effective compared with usual care. Conclusions The PROSPER exercise programme was clinically effective and cost effective and reduced upper limb disability one year after breast cancer treatment in patients at risk of treatment related postoperative complications. Trial registration ISRCTN Registry ISRCTN35358984 .

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