SEARCH · PubMed Health

Results for “Randomised Controlled Trial”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 1,549 records · Page 86Linked to original sources

PubMed2004

Acupuncture as a complementary therapy to the pharmacological treatment of osteoarthritis of the knee: randomised controlled trial.

OBJECTIVES: To analyse the efficacy of acupuncture as a complementary therapy to the pharmacological treatment of osteoarthritis of the knee, with respect to pain relief, reduction of stiffness, and increased physical function during treatment; modifications in the consumption of diclofenac during treatment; and changes in the patient's quality of life. DESIGN: Randomised, controlled, single blind trial, with blinded evaluation and statistical analysis of results. SETTING: Pain management unit in a public primary care centre in southern Spain, over a period of two years. PARTICIPANTS: 97 outpatients presenting with osteoarthritis of the knee. INTERVENTIONS: Patients were randomly separated into two groups, one receiving acupuncture plus diclofenac (n = 48) and the other placebo acupuncture plus diclofenac (n = 49). MAIN OUTCOME MEASURES: The clinical variables examined included intensity of pain as measured by a visual analogue scale; pain, stiffness, and physical function subscales of the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index; dosage of diclofenac taken during treatment; and the profile of quality of life in the chronically ill (PQLC) instrument, evaluated before and after the treatment programme. RESULTS: 88 patients completed the trial. In the intention to treat analysis, the WOMAC index presented a greater reduction in the intervention group than in the control group (mean difference 23.9, 95% confidence interval 15.0 to 32.8) The reduction was greater in the subscale of functional activity. The same result was observed in the pain visual analogue scale, with a reduction of 26.6 (18.5 to 34.8). The PQLC results indicate that acupuncture treatment produces significant changes in physical capability (P = 0.021) and psychological functioning (P = 0.046). Three patients reported bruising after the acupuncture sessions. CONCLUSIONS: Acupuncture plus diclofenac is more effective than placebo acupuncture plus diclofenac for the symptomatic treatment of osteoarthritis of the knee.

Acupuncture Therapy↗

PubMed1999

Topical antiseptic agent after large loop excision of the transformation zone: results of a randomised controlled trial.

One hundred patients undergoing large loop excision of the transformation zone (LLETZ) were randomised to receive postoperative local treatment with sultrin (sulphathiazole 3.42%, sulphacetamide 2.86%, sulphabenzamide 3.7%) pessaries: one pessary twice daily for 5 days, or no treatment. Outcome measures included duration and severity of vaginal bleeding, discharge, pelvic pain, need for oral antibiotic therapy and unplanned hospital admission. There was no significant difference in the severity of symptoms in the treatment and control groups for bleeding, discharge or pain, averaged over the study period. Postoperative morbidity following LLETZ was frequent but mild. Use of prophylactic antiseptic agents is not recommended.

Clinical Trial↗

PubMed1998

Tamoxifen in treatment of hepatocellular carcinoma: a randomised controlled trial. CLIP Group (Cancer of the Liver Italian Programme)

BACKGROUND: Results from small randomised trials on tamoxifen in the treatment of hepatocellular carcinoma (HCC) are conflicting. We studied whether the addition of tamoxifen to best supportive care prolongs survival of patients with HCC. METHODS: Patients with any stage of HCC were eligible, irrespective of locoregional treatment. Randomisation was centralised, with a minimisation procedure accounting for centre, evidence of disease, and time from diagnosis. Patients were randomly allocated best supportive care alone or in addition to tamoxifen. Tamoxifen was given orally, 40 mg per day, from randomisation until death. RESULTS: 496 patients from 30 institutions were randomly allocated treatment from January, 1995, to January, 1997. Information was available for 477 patients. By Sept 15, 1997, 119 (50%) of 240 and 130 (55%) of 237 patients had died in the control and tamoxifen arms, respectively. Median survival was 16 months and 15 months (p=0.54), respectively. No differences were found within subgroups defined by prognostic variables. Relative hazard of death for patients receiving tamoxifen was 1.07 (95% CI 0.83-1.39). INTERPRETATION: Our findings show that tamoxifen is not effective in prolonging survival of patients with HCC.

Adult↗

PubMed2005

Randomised controlled trial of sub-Tenon's block versus topical anaesthesia for cataract surgery: a comparison of patient satisfaction.

BACKGROUND/AIM: Sub-Tenon's block (STB) or topical anaesthesia alone (TOP) are popular techniques employed during cataract surgery. TOP is often preferred by healthcare providers because of financial or staffing reasons, despite existing evidence that pain during surgery is better controlled with STB. Pain is not the only consideration that determines patient preference for the anaesthesia technique. The authors decided to investigate the issue of patient satisfaction using the recently developed Iowa Satisfaction with Anesthesia Scale (ISAS). METHOD: In a randomised controlled pilot trial, 28 patients were enrolled to receive either STB with 3 ml of 2% lidocaine and hyaluronidase, or TOP with proxymetacaine 0.5% and amethocaine 1% (Tetracaine) eye drops. Postoperatively patients rated their satisfaction with anaesthesia care by filling in the self administered written questionnaire, the ISAS. RESULTS: One patient in the TOP group dropped out of the study because of intolerable pain. Analysis of the questionnaire results with a two sample Wilcoxon rank sum test showed a significant difference in patient satisfaction (p<0.0085). The median satisfaction score was higher in the STB group 2.77 (interquartile range IQR 2.45 to 3), than in the TOP group 2.04 (IQR 1.54 to 2.5). CONCLUSION: In the setting of day case cataract surgery, patients report significantly higher satisfaction scores with STB than with TOP alone.

Administration, Topical↗

PubMed2003

Efficacy and cost-effectiveness of drug and psychological treatments for common mental disorders in general health care in Goa, India: a randomised, controlled trial.

BACKGROUND: Common mental disorders are associated with substantial morbidity and disability in developing countries, but there are no data for efficacy of treatment. We aimed to assess the efficacy and cost-effectiveness of antidepressant and psychological treatment for common mental disorders in general health-care settings. METHOD: We did a randomised, placebo-controlled trial (double-blind for the antidepressant group) in general outpatient clinics in two district hospitals in Goa, India. Consecutive eligible adults who scored more than 15 on the Revised Clinical Interview Schedule (n=450) were randomly assigned to antidepressant (fluoxetine), placebo, or psychological treatment. Antidepressant or placebo was provided for up to 6 months. Up to six sessions of psychological treatment were provided by trained therapists. The primary outcome was psychiatric morbidity; secondary outcomes were disability and costs. Outcome measurements were done at 2, 6, and 12 months. Intention-to-treat analyses were done with linear regression. FINDINGS: 80% of patients were reviewed; the number of drop-outs was similar in all three groups. Psychiatric outcome was significantly better with antidepressant than with placebo at 2 months (p=0.02; standardised effect size 0.3), but not over the 2-12 month period (p=0.10); antidepressants were significantly more cost effective than placebo in the short term and long term (p<0.05). Psychological treatment was not more effective than placebo for any outcome during either period. INTERPRETATION: Affordable antidepressants such as fluoxetine should be the treatment of choice for common mental disorders in general health-care settings in India, since they are associated with improved clinical and economic outcomes, especially in the short term.

Antidepressive Agents, Second-Generation↗

PubMed2002

Use of evidence based leaflets to promote informed choice in maternity care: randomised controlled trial in everyday practice.

OBJECTIVE: To assess the effect of leaflets on promoting informed choice in women using maternity services. DESIGN: Cluster trial, with maternity units randomised to use leaflets (intervention units) or offer usual care (control units). Data collected through postal questionnaires. SETTING: 13 maternity units in Wales. PARTICIPANTS: Four separate samples of women using maternity services. Antenatal samples: women reaching 28 weeks' gestation before (n=1386) and after (n=1778) the intervention. Postnatal samples: women at eight weeks after delivery before (n=1741) and after (n=1547) the intervention. INTERVENTION: Provision of 10 pairs of Informed Choice leaflets for service users and midwives and a training session for staff in their use. MAIN OUTCOME MEASURES: Change in the proportion of women who reported exercising informed choice. SECONDARY OUTCOMES: changes in women's knowledge; satisfaction with information, choice, and discussion; and possible consequences of informed choice. RESULTS: There was no change in the proportion of women who reported that they exercised informed choice in the intervention units compared with the control units for either antenatal or postnatal women. There was a small increase in satisfaction with information in the antenatal samples in the intervention units compared with the control units (odds ratio 1.40, 95% confidence interval 1.05 to 1.88). Only three quarters of women in the intervention units reported being given at least one of the leaflets, indicating problems with the implementation of the intervention. CONCLUSION: In everyday practice, evidence based leaflets were not effective in promoting informed choice in women using maternity services.

Attitude to Health↗

PubMed2005

Randomised controlled trial of home based motivational interviewing by midwives to help pregnant smokers quit or cut down.

OBJECTIVE: To determine whether motivational interviewing--a behavioural therapy for addictions-provided at home by specially trained midwives helps pregnant smokers to quit. DESIGN: Randomised controlled non-blinded trial analysed by intention to treat. SETTING: Clinics attached to two maternity hospitals in Glasgow. PARTICIPANTS: 762/1684 pregnant women who were regular smokers at antenatal booking: 351 in intervention group and 411 in control group. INTERVENTIONS: All women received standard health promotion information. Women in the intervention group were offered motivational interviewing at home. All interviews were recorded. MAIN OUTCOME MEASURES: Self reported smoking cessation verified by plasma or salivary cotinine concentration. RESULTS: 17/351 (4.8%) women in the intervention group stopped smoking (according to self report and serum cotinine concentration < 13.7 ng/ml) compared with 19/411(4.6%) in the control group. Fifteen (4.2%) women in the intervention group cut down (self report and cotinine concentration less than half that at booking) compared with 26 (6.3%) in the control group. Fewer women in the intervention group reported smoking more (18 (5.1%) v 44 (10.7%); relative risk 0.48, 95% confidence interval 0.28 to 0.81). Birth weight did not differ significantly (mean 3078 g v 3048 g). CONCLUSION: Good quality motivational interviewing did not significantly increase smoking cessation among pregnant women.

Adult↗

PubMed2003

Intravenous bolus somatostatin after diagnostic cholangiopancreatography reduces the incidence of pancreatitis associated with therapeutic endoscopic retrograde cholangiopancreatography procedures: a randomised controlled trial.

BACKGROUND: Previous studies suggested that somatostatin given before endoscopic retrograde cholangiopancreatography (ERCP) may reduce the incidence of post-ERCP pancreatitis. However, the routine use of somatostatin in all patients undergoing ERCP is not likely to be cost effective. This study evaluated whether intravenous bolus somatostatin given after diagnostic cholangiopancreatography could reduce the incidence of pancreatitis in a group of patients undergoing therapeutic ERCP procedures. METHODS: In a randomised, double blind, controlled trial, the effect of intravenous bolus somatostatin 250 microg given immediately after diagnostic cholangiopancreatography was compared with that of placebo in patients who required endoscopic sphincterotomy or other therapeutic procedures. The primary end point was the incidence of post-ERCP clinical pancreatitis, and a secondary end point was the incidence of hyperamylasemia. RESULTS: A total of 270 patients were randomised. The somatostatin group (n=135) and the placebo group (n=135) were comparable in age, sex, indications for treatment, and types of procedure. The frequencies of clinical pancreatitis (4.4% v 13.3%; p=0.010) and hyperamylasemia (26.0% v 38.5%; p=0.036) were both significantly lower in the somatostatin group compared with the placebo group. CONCLUSIONS: A single dose of intravenous bolus somatostatin, given immediately after diagnostic cholangiopancreatography, is effective in reducing the incidence of pancreatitis after therapeutic ERCP. This novel approach of administering prophylactic somatostatin may offer a cost effective prophylaxis for post-ERCP pancreatitis.

Acute Disease↗

PubMed2001

A randomised controlled trial of high versus low long chain triglyceride whole protein feed in active Crohn's disease.

BACKGROUND: Polymeric feeds have shown variable efficacy in active Crohn's disease (CD) with remission rates from 36% to 82%. Meta-analyses of elemental, peptide, and whole protein feeds have shown a strong negative correlation between remission rate in CD and the long chain triglyceride (LCT) content of the feed. We performed a randomised controlled double blind trial in patients with active CD comparing two single whole protein feeds with LCT supplying 5% or 30% of the total energy. METHODS: Fifty four patients with active CD (Crohn's disease activity index (CDAI) >200, serum C reactive protein (CRP) 10 mg/l) were randomised to a high or low LCT feed for three weeks. The total amount of energy supplied by fat was identical in the two feeds. Remission was defined as a CDAI < or =150 and response as a fall in CDAI of > or =70 or a CRP <10 mg/l. RESULTS: Overall remission rate by intention to treat was 26% for the low LCT feed and 33% for the high LCT feed (p=0.38). Response was achieved in 33% with the low LCT and in 52% with the high LCT feed (p=0.27). CRP <10 mg/l was achieved in 30% in the low LCT and 33% in the high LCT group (p=0.99). Thirty nine per cent (21/54) of patients withdrew before three weeks because of inability to tolerate the diet. Excluding patients unable to tolerate the diet, remission rates were 46% for low LCT and 45% for high LCT (p=0.99). DISCUSSION: This trial has shown no difference in the effect of low and high LCT whole protein feeds in active CD. The previously reported correlation between LCT content of diet and response in active CD is unlikely to be due to LCT itself and may be due to some other component of high LCT feeds.

Acute Disease↗

PubMed2002

Naltrexone in alcohol dependence: a randomised controlled trial of effectiveness in a standard clinical setting.

OBJECTIVES: To determine whether naltrexone is beneficial in the treatment of alcohol dependence in the absence of obligatory psychosocial intervention. DESIGN: Multicentre, randomised, double-blind, placebo-controlled trial. SETTING: Hospital-based drug and alcohol clinics, 18 March 1998 - 22 October 1999. PATIENTS: 107 patients (mean age, 45 years) fulfilling Diagnostic and statistical manual of mental disorders (4th edition) criteria for alcohol dependence. INTERVENTIONS: Patients with alcohol dependence were randomly allocated to naltrexone (50 mg/day) or placebo for 12 weeks. They were medically assessed, reviewed and advised by one physician, and encouraged to strive for abstinence and attend counselling and/or Alcoholics Anonymous, but this was not obligatory. MAIN OUTCOME MEASURES: Relapse rate; time to first relapse; side effects. RESULTS: On an intention-to-treat basis, the Kaplan-Meier survival curve showed a clear advantage in relapse rates for naltrexone over placebo (log-rank test, chi(2)(1) = 4.15; P = 0.042). This treatment effect was most marked in the first 6 weeks of the trial. The median time to relapse was 90 days for naltrexone, compared with 42 days for placebo. In absolute numbers, 19 of 56 patients (33.9%) taking naltrexone relapsed, compared with 27 of 51 patients (52.9%) taking placebo (P = 0.047). Naltrexone was well tolerated. CONCLUSIONS: Unlike previous studies, we have shown that naltrexone with adjunctive medical advice is effective in the treatment of alcohol dependence irrespective of whether it is accompanied by psychosocial interventions.

Adolescent↗

PubMed2004

A randomised controlled trial of occupational therapy for people with early rheumatoid arthritis.

BACKGROUND: Occupational therapy (OT) aims at improving performance of daily living tasks, facilitating successful adjustments in lifestyle, and preventing losses of function. OBJECTIVE: To evaluate the effects of a pragmatic, comprehensive OT programme on self management and health status of people with early rheumatoid arthritis (RA) (<2.5 years). METHODS: A randomised, controlled "assessor blinded" trial was conducted with assessments made at entry, 6, 12, and 24 months. Main outcomes were AIMS2: physical function (PF), pain visual analogue scale (VAS), and Arthritis Self-Efficacy Scale (ASES). RESULTS: Groups had similar disease duration (9 months OT (n = 162) v 10 months control (n = 164)). The OT group received 7.57 (SD 3.04) hours of therapy. Self management significantly increased in the OT group. Otherwise, there were no significant differences in any outcome measures, or between groups, by ACR functional class: AIMS2: PF (F = 0.04; p = 0.96); pain VAS (F = 0.29; p = 0.74); total ASES score (F = 0.93; p = 0.39). CONCLUSIONS: OT improved self management but not health status in early RA. Functional ability remains reasonably good for many in the first five years, so preventive benefits of self management may not yet be apparent and longer follow up is needed. Although many considered the education and therapy useful, insufficient numbers in the OT group used self management sufficiently to make a difference. Behavioural approaches can improve adherence and, potentially, the long term benefits. Future research should evaluate OT as a complex intervention and develop programmes from a theoretical and evidence base.

Adult↗

PubMed2005

Effects of probiotics on atopic dermatitis: a randomised controlled trial.

BACKGROUND: The aim of the study was to investigate the effects of probiotics on moderate or severe atopic dermatitis (AD) in young children. METHODS: Fifty six children aged 6-18 months with moderate or severe AD were recruited into a randomised double blind placebo controlled trial in Perth, Western Australia; 53 children completed the study. The children were given a probiotic (1x10(9)Lactobacillus fermentum VRI-033 PCC; Probiomics) or an equivalent volume of placebo, twice daily for 8 weeks. A final assessment at 16 weeks was performed. RESULTS: The main outcome measures were severity and extent of AD at the end of the study, as measured by the Severity Scoring of Atopic Dermatitis (SCORAD) index. The reduction in the SCORAD index over time was significant in the probiotic group (p = 0.03) but not the placebo group. Significantly more children receiving probiotics (n = 24, 92%) had a SCORAD index that was better than baseline at week 16 compared with the placebo group (n = 17, 63%) (p = 0.01). At the completion of the study more children in the probiotic group had mild AD (n = 14, 54%) compared to the placebo group (n = 8, 30%). CONCLUSION: Supplementation with probiotic L fermentum VRI-003 PCC is beneficial in improving the extent and severity of AD in young children with moderate or severe disease.

Anti-Allergic Agents↗

PubMed2002

A randomised controlled trial of outpatient versus inpatient cervical cerclage.

Fifty patients with cervical incompetence were randomised to have cervical cerclage either as inpatients, spending 3 days in hospital post-procedure on supervised bed rest or as outpatients spending the time at home on bed rest. Both groups had a clinical diagnosis of cervical incompetence and both had either McDonald or Shirodkar cerclage with mersilene tape. Both groups were given salbutamol tablets for tocolysis, postoperatively. There were no significant difference in the demographic variables between the groups such as previous cerclage, gestational age at insertion, parity and gestational age at delivery. There were also no significant differences in early complications such as bleeding. Most late complications were also not different, including the spontaneous abortion rate, premature rupture of membranes, cervical dystocia and preterm delivery. However, more patients in the outpatient group had premature contractions (26.1% vs. 4.3% P=0.0479). More patients in the inpatient group had a delivery of a live neonate, 86.9% vs. 78.3%, but the difference was not statistically significant. In conclusion, out patient cerclage appears to be a valid option, the higher rate of premature contraction in this group is not a cause for concern in view of the similar mean gestational age at delivery.

Adult↗

PubMed2001

Intrapleural urokinase in the management of parapneumonic empyema: a randomised controlled trial.

We compared the effectiveness of intrapleural urokinase versus normal saline via a thoracostomy tube in the treatment of parapneumonic empyema in a randomised controlled study. Forty-nine patients with parapneumonic empyema were randomly assigned to receive either intrapleural urokinase or normal saline treatment. The daily volume instilled through a chest tube was 100 ml in both groups. Urokinase (100,000 IU/day) was diluted in normal saline before instillation. The mean duration for defervescence was shorter (7 +/- 3 vs 13 +/- 5 days, p<0.01) and the mean volume of drained fluid during the five-day treatment period was significantly greater in the urokinase group (1.8 +/- 1.5 vs 0.8 +/- 0.8 litres, p<0.001) than in the control group. The subsequent decortication rate was 60% and 29.1%, respectively (p<0.001). The duration of hospitalisation was also shorter in the urokinase group (14 +/- 4 vs 21 +/- 4 days, p<0.001) than in the saline group. We conclude that intrapleural instillation of urokinase in the management of parapneumonic empyema provides a better outcome and reduces the need for decortication.

Adolescent↗

PubMed2006

Magnesium sulphate for treatment of severe tetanus: a randomised controlled trial.

BACKGROUND: The most common cause of death in individuals with severe tetanus in the absence of mechanical ventilation is spasm-related respiratory failure, whereas in ventilated patients it is tetanus-associated autonomic dysfunction. Our aim was to determine whether continuous magnesium sulphate infusion reduces the need for mechanical ventilation and improves control of muscle spasms and autonomic instability. METHODS: We did a randomised, double blind, placebo controlled trial in 256 Vietnamese patients over age 15 years with severe tetanus admitted to the Hospital for Tropical Medicine, Ho Chi Minh City, Vietnam. Participants were randomly assigned magnesium sulphate (n=97) or placebo solution (n=98) intravenously for 7 days. The primary outcomes were requirement of assisted ventilation and of drugs to control muscle spasms and cardiovascular instability within the 7-day study period. Analyses were done by intention to treat. This trial is registered as an International Standard Randomised Clinical Trial, number ISRCTN74651862. FINDINGS: No patients were lost to follow-up. There was no difference in requirement for mechanical ventilation between individuals treated with magnesium and those receiving placebo (odds ratio 0.71, 95% CI 0.36-1.40; p=0.324); survival was also much the same in the two groups. However, compared with the placebo group, patients receiving magnesium required significantly less midazolam (7.1 mg/kg per day [0.1-47.9] vs 1.4 mg/kg per day [0.0-17.3]; p=0.026) and pipecuronium (2.3 mg/kg per day [0.0-33.0] vs 0.0 mg/kg per day [0.0-14.8]; p=0.005) to control muscle spasms and associated tachycardia. Individuals receiving magnesium were 4.7 (1.4-15.9) times less likely to require verapamil to treat cardiovascular instability than those in the placebo group. The incidence of adverse events was not different between the groups. INTERPRETATION: Magnesium infusion does not reduce the need for mechanical ventilation in adults with severe tetanus but does reduce the requirement for other drugs to control muscle spasms and cardiovascular instability.

Adult↗

PubMed1997

Preoperative local infiltration with ropivacaine for postoperative pain relief after inguinal hernia repair. A randomised controlled trial.

OBJECTIVE: To assess the effect of preoperative local anaesthesia with ropivacaine and find out if there was a dose-response relationship with postoperative pain after inguinal hernia repair. DESIGN: Randomised, double-blind, placebo-controlled trial. SETTING: Two Swedish and two Norwegian hospitals. SUBJECTS: 131 Male patients undergoing elective inguinal hernia repair. INTERVENTION: Infiltration of the inguinal field before operation with 0.5% ropivacaine 40 ml (200 mg), 0.25% ropivacaine 40 ml (100 mg) or saline 40 ml. MAIN OUTCOME MEASURES: Wound pain at rest and during mobilisation, pressure exerted to reach pain threshold and maximum pain tolerance after 3, 6, 10, and 24 hours, and after 7 days; consumption of analgesics; and Quality of Life assessed by two independent questionnaires before and after operation. RESULTS: Pain scores after 3 hours were significantly lower in the ropivacaine groups compared with the saline group for all variables (p < 0.05). At 6 hours pain scores were significantly lower for ropivacaine 0.5% compared with saline for wound pain during mobilisation and pressure exerted to reach maximum pain tolerance. Patients given saline made their first request for analgesics significantly sooner than in the other two groups (p < 0.05), and a significantly larger percentage of them requested analgesics during the first 24 hours (p < 0.05). Evaluation of the Quality of Life questionnaires showed no significant differences between the groups. CONCLUSION: Ropivacaine has a significant, dose-related pain-reducing effect in the immediate postoperative period but we could find no support for the theory that preoperative infiltration analgesia reduces long term pain.

Adolescent↗

PubMed1998

Randomised controlled trial of aminophylline for severe acute asthma.

OBJECTIVES: To determine whether children with severe acute asthma treated with large doses of inhaled salbutamol, inhaled ipratropium, and intravenous steroids are conferred any further benefits by the addition of aminophylline given intravenously. STUDY DESIGN: Randomised, double blind, placebo controlled trial of 163 children admitted to hospital with asthma who were unresponsive to nebulised salbutamol. RESULTS: The placebo and treatment groups of children were similar at baseline. The 48 children in the aminophylline group had a greater improvement in spirometry at six hours and a higher oxygen saturation in the first 30 hours. Five subjects in the placebo group were intubated and ventilated after enrollment compared with none in the aminophylline group. CONCLUSIONS: Aminophylline continues to have a place in the management of severe acute asthma in children unresponsive to initial treatment.

Acute Disease↗

PubMed2026

Five-year outcomes in a randomised controlled trial of prolonged exposure therapy and supportive counselling for post-traumatic stress disorder in adolescents: a task-shifted intervention.

BACKGROUND: Cognitive-behavioural therapies with a trauma focus are effective in reducing posttraumatic stress disorder and other psychological distress in adolescents. Long-term follow-up data on adolescents treated for PTSD remain scarce, with few studies extending beyond 12 months after treatment completion. OBJECTIVE: To evaluate the maintenance of treatment gains in a comparative study of effectiveness of PE-A and SC up to 60 months post-treatment. METHOD: Sixty-three adolescents diagnosed with PTSD were randomly assigned to either treatment, provided by newly trained and supervised non-specialist health workers. The primary outcome measure was PTSD symptom severity, as independently assessed on the Child PTSD Symptom Scale (CPSS). We report on the 60-month post-treatment follow-up, building on post-treatment, 3-month, 6-month, 12-month and 24-month post-treatment data that have been published previously. RESULTS: Participants in both treatment groups maintained a significant reduction in PTSD symptoms up to 60-months post-treatment (F (7, 343) = 2.86, p < .01). Participants receiving prolonged exposure experienced greater improvement on the CPSS at all follow-up assessment timepoints, except for the 60-month FU (p = .28; g = 0.33). CONCLUSION: Adolescents with PTSD continued to maintain treatment gains up to 60-months post-treatment. These data, along with findings from the original RCT, indicate that a brief treatment protocol (averaging 9 sessions of PE-A or SC) in a LMIC, task-shifted to be delivered by nurses without prior psychotherapy experience, led to lasting improvements in PTSD and comorbid symptoms for up to five years. The sustained benefits and improved functioning over the first few years post-treatment support expanding both treatments, especially PE-A, in community settings.

Humans↗