Mobile Messaging Assisted Treatment (MMAT) for Patients with Methamphetamine Use Disorder: A Preliminary Randomized Controlled Trial (Preprint)

BACKGROUND Methamphetamine (MA) use disorder can cause various physical and psychological harms. Despite current evidence demonstrating the therapeutic effects of psychosocial interventions, finding an approach to increase patient adherence to treatment remains a real-world challenge. The rapid development of new technologies, such as mobile health (mHealth) systems, suggests the potential to provide real-time personalized care at any time and from any location, minimize barriers to treatment, maximize use, and promote the dissemination of accessible therapeutic tools in at-risk populations. OBJECTIVE Objectives of our study investigated the feasibility and effectiveness of implementing mHealth technology in the treatment of MA use disorder. METHODS The inclusion criteria were (a) a diagnosis of MA abuse or dependence as defined by the DSM-IV-TR (b) age between 18 and 65 years, (c) no initial diagnosis of severe physical or mental illness, such as schizophrenia or bipolar I disorder, at baseline of the survey, and (d) willingness to participate in standard outpatient treatment for 1 year. Participants were randomly allocated to either a mobile messaging–assisted treatment (MMAT) group which delivered relapse prevention and recovery skills or a control group following simple randomization procedures (computerized random numbers) without blinding. All participants were followed for 6 months. Treatment retention and results of monthly urine tests were analysed as outcome measures. Feasibility and participant satisfaction were also assessed based on patients’ experiences with MMAT. RESULTS 50 participants were allocated to MMAT group and 49 to control. The average retention was 142.42 ± 60.54 days for the MMAT group and 118.12 ± 73.41 days for the control group, with no significant differences between the two treatment groups (df = 1, p = .099). Compared with the control group, the MMAT group had fewer MA-positive urine samples (19.5% vs 29.6%, F = 9.116, p = .003). Moreover, the proportion of MA-positive urine samples was positively correlated with the frequency of MA use (r = .323, p = .001), severity of MA use disorder (r = 0.364, p < .001), and polysubstance use (r = .212, p = .035) and negatively correlated with readiness to change (r = -.330, p = .001). At 6-month follow-up, 55 participants who completed the study reported high satisfaction with receiving MMAT. There was no significant adverse effects reported. CONCLUSIONS Participants in this study diagnosed as having MA use had high adherence to MMAT, generally positive treatment outcomes, and favorable acceptance, which indicates that this type of intervention is feasible for individuals with MA use disorder. Therefore, this study supports the efficacy and feasibility of using mobile phones for treating people who use MA. Future studies should investigate MMAT’s ability to (a) engage patients in the assessment of their own symptoms and daily functioning, (b) increase patients’ self-awareness and self-management of symptoms, (c) improve patients’ ability to identify triggers and track their own disease progression, and (d) increase patients’ willingness to seek care when necessary. CLINICALTRIAL Study Registry: ISRCTN16586487 (https://doi.org/10.1186/ISRCTN16586487)

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Efficacy of electroacupuncture plus warm needling therapy for plantar heel pain: a randomised waitlist-controlled trial

Acupuncture in Medicine ◽

10.1177/0964528420946048 ◽

2020 ◽

pp. 096452842094604

Author(s):

Lai Fun Ho ◽

Yuanqi Guo ◽

Jessica Yuet-Ling Ching ◽

Kam Leung Chan ◽

Ping Him Tsang ◽

...

Keyword(s):

Treatment Group ◽

Controlled Trial ◽

Heel Pain ◽

Community Dwelling ◽

Control Group ◽

Therapeutic Effects ◽

Global Rating ◽

Plantar Heel Pain ◽

Foot Function ◽

Warm Needling

Objective: To investigate the therapeutic effects of electroacupuncture plus warm needling (EAWN) therapy on pain and foot function in adults with plantar heel pain (PHP). Methods: This prospective, randomised, parallel-group, waitlist-controlled trial was conducted at a Chinese medicine centre in Hong Kong between May 2018 and February 2019. Eighty eligible community-dwelling subjects with PHP (mean age 59.7 years; 85% female) were equally randomised to receive EAWN therapy or remain on a waitlist. The treatment group received six 30-min sessions of standardised EAWN therapy over 4 weeks; the control group received no treatment. The outcome measures were the visual analogue scale (VAS) score for first-step pain, foot function index (FFI) scores and global rating of change (GRC) scale scores. Assessments were made at baseline, week 2 and week 4 (primary endpoint). The treatment group underwent additional assessments at week 8. Outcomes were evaluated by intention-to-treat analysis. Results: Patients who received EAWN therapy exhibited greater improvements in the mean first-step pain VAS and all FFI scores than did those in the control group at weeks 2 and 4, with significant between-group differences (all P < 0.001). Compared with baseline, there were significant decreases in mean first-step pain VAS scores at weeks 2 and 4, and FFI scores at week 4, in the treatment group but not in the control group. The improvements in the treatment group continued until week 8. GRC scores at week 4 indicated improvement in all treated patients and only 22.5% of the control group patients ( P < 0.001). There were no study-related adverse events. Conclusion: EAWN therapy could be an effective treatment for PHP in middle-aged and older adults. Trial registration number: ChiCTR1800014906 (Chinese Clinical Trials Registry)

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Abstinence-contingent wage supplements to promote drug abstinence and employment: a randomised controlled trial

Journal of Epidemiology & Community Health ◽

10.1136/jech-2020-213761 ◽

2020 ◽

Vol 74 (5) ◽

pp. 445-452 ◽

Cited By ~ 2

Author(s):

August F Holtyn ◽

Forrest Toegel ◽

Shrinidhi Subramaniam ◽

Brantley P Jarvis ◽

Jeannie-Marie Leoutsakos ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Urine Samples ◽

Control Group ◽

Opioid Use ◽

Employment Services ◽

Employment Specialist ◽

Drug Abstinence ◽

Randomised Controlled

BackgroundPoverty, unemployment and substance abuse are inter-related problems. This study evaluated the effectiveness of abstinence-contingent wage supplements in promoting drug abstinence and employment in unemployed adults in outpatient treatment for opioid use disorder.MethodsA randomised controlled trial was conducted in Baltimore, MD, from 2014 to 2019. After a 3-month abstinence initiation and training period, participants (n=91) were randomly assigned to a usual care control group that received employment services or to an abstinence-contingent wage supplement group that received employment services plus abstinence-contingent wage supplements. All participants were invited to work with an employment specialist to seek employment in a community job for 12 months. Abstinence-contingent wage supplement participants could earn training stipends for working with the employment specialist and wage supplements for working in a community job, but had to provide opiate and cocaine-negative urine samples to maximise pay.ResultsAbstinence-contingent wage supplement participants provided significantly more opiate and cocaine-negative urine samples than usual care control participants (65% vs 45%; OR=2.29, 95% CI 1.22 to 4.30, p=0.01) during the 12-month intervention. Abstinence-contingent wage supplement participants were significantly more likely to have obtained employment (59% vs 28%; OR=3.88, 95% CI 1.60 to 9.41, p=0.004) and lived out of poverty (61% vs 30%; OR=3.77, 95% CI 1.57 to 9.04, p=0.004) by the end of the 12-month intervention than usual care control participants.ConclusionAbstinence-contingent wage supplements can promote drug abstinence and employment.Trial registration numberClinicalTrials.gov NCT02487745.

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Transtheoretical model for change in obese adolescents: MERC randomized clinical trial

Journal of Health Psychology ◽

10.1177/1359105318793189 ◽

2018 ◽

Vol 25 (13-14) ◽

pp. 2272-2285 ◽

Cited By ~ 2

Author(s):

Raquel de Melo Boff ◽

Marina Alves Dornelles ◽

Ana Maria Pandolfo Feoli ◽

Andreia da Silva Gustavo ◽

Margareth da Silva Oliveira

Keyword(s):

Transtheoretical Model ◽

Readiness To Change ◽

Controlled Trial ◽

Intervention Group ◽

Transtheoretical Model Of Change ◽

Control Group ◽

Obese Adolescents ◽

Randomized Controlled ◽

Significant Difference ◽

And Control

The randomized controlled trial evaluated the effectiveness of an intervention based on the Transtheoretical Model of Change on anthropometric, metabolic and motivational outcomes in obese adolescents. A total of 135 male and female adolescents were randomized to two groups: intervention group ( n = 65) and control group ( n = 70). The adolescents were evaluated 1 week before the interventions began and at the end of 12 weeks. There was no statistically significant difference between groups in the outcome variables. Intervention group reported magnitude of effect more expressive on body mass index percentile, waist circumference, waist-to-hip ratio, readiness to change diet and readiness to start exercise.

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159 Reactive Balance Training for Preventing Falls in Older People

Age and Ageing ◽

10.1093/ageing/afz164.159 ◽

2019 ◽

Vol 48 (Supplement_4) ◽

pp. iv34-iv39

Author(s):

Daina Sturnieks ◽

Yoshiro Okubo ◽

Matthew Brodie ◽

Stephen Lord

Keyword(s):

Older People ◽

Fall Prevention ◽

Controlled Trial ◽

Intervention Group ◽

Balance Training ◽

Good Evidence ◽

Current Evidence ◽

Control Group ◽

Prevention Interventions ◽

Reactive Balance

Abstract Appropriately timed and directed balance responses are crucial for avoiding a fall. These responses, including feet-in-place adjustments of the centre of mass, stepping and gait adaptations, may be initiated voluntarily to proactively avoid falling or induced reactively in response to sudden external perturbations to balance. Despite good evidence that poor reactive balance responses contribute to falls and injuries, traditional fall prevention interventions have ignored this skill. Reactive balance (or perturbation) training intervention methods are emerging and show promise for preventing falls in older people, some evidence suggesting a 50% reduction in falls. We recruited 44 older adults into a parallel, blinded randomized controlled trial, comparing 3 sessions of reactive balance training (exposure to trips and slips) to one session of sham training. The primary outcome was falls following laboratory-induced trips and slips (>30% body weight in harness). Relative to the control group, the intervention group experienced fewer total falls (rate ratio [RR]=0.40, 95% confidence interval [CI]=0.22-0.76), slip falls (RR=0.33, 95% CI=0.12-0.90) and trip falls (RR=0.49, 95% CI=0.21-1.12). These results will be discussed in the context of other current evidence for reactive balance training and suggestions made for how such interventions might influence the future of fall prevention.

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En_Línea. An online treatment to change lifestyle in overweight and obesity: study protocol for a randomized controlled trial

BMC Public Health ◽

10.1186/s12889-019-7928-1 ◽

2019 ◽

Vol 19 (1) ◽

Cited By ~ 1

Author(s):

Carmen Varela ◽

Carmina Saldaña

Keyword(s):

Randomized Controlled Trial ◽

Group Therapy ◽

Weight Control ◽

New Technologies ◽

Controlled Trial ◽

Post Treatment ◽

Control Group ◽

Standard Group ◽

Control Programs ◽

Randomized Controlled

Abstract Background Obesity has become a major public health problem. Innovative treatments are necessary. Internet and new technologies have been reported effective results in weight control programs, especially those with personalized feedback. This paper presents the protocol for a randomized controlled trial to test the effectiveness of an online weight control program, called en_línea, comparing with a standard group therapy and a control group. Methods This is a randomized controlled trial with three intervention arms: en_línea, standard group therapy and control group. To perform this study, 305 adults (18–65 years) with overweight type II (27–29.9 kg/m2) or obesity type I (30–34.9 kg/m2) will be invited to participate. Interventions will last 17 weeks with follow-ups 1, 3, 6 and 12 months after the post-treatment appointment. The primary outcome will be post-treatment weight loss and the maintenance during the follow-ups. Secondary outcomes will be adherence rates, drop outs and quality of life. Participants will be assessed before randomization and they will be sign an inform consent. Discussion The future challenge is to design innovative obesity treatments. Internet could be a useful tool to improve traditional weight control programs. This new intervention format is appropriate for patients who prefer not to share their intimate problems with a group, and for the new generations who feel comfortable using new technologies. Besides, Internet allows reaching a large amount of people at the same time, even if they live far away. Trial registration ClinicalTrials.gov NCT04127201. Retrospectively registered 15th October 2019.

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A Randomized Controlled Trial on the Effectiveness of Epidermal Growth Factor-Containing Ointment on the Treatment of Solar Lentigines as Adjuvant Therapy

Medicina ◽

10.3390/medicina57020166 ◽

2021 ◽

Vol 57 (2) ◽

pp. 166

Author(s):

Hye One Kim ◽

Hye Ran Kim ◽

Jin Cheol Kim ◽

Seok Young Kang ◽

Min Je Jung ◽

...

Keyword(s):

Growth Factor ◽

Epidermal Growth Factor ◽

Nd:Yag Laser ◽

Controlled Trial ◽

Control Group ◽

Therapeutic Effects ◽

Study Group ◽

Patient’S Satisfaction ◽

Epidermal Growth ◽

532 Nm

Background and Objective: Little is known about the anti-pigmentation effects of whitening agents on solar lentigines. Epidermal growth factor (EGF) has been used as a booster for wound healing in the skin, and it has been suggested to have anti-pigmentation effects. This study aimed to evaluate the effect and safety of EGF-containing ointment for treating solar lentigines with a Q-switched (QS) 532 nm neodymium-doped yttrium aluminum garnet (Nd:YAG) laser (Bluecore company, Seoul, Republic of Korea). Materials and Methods: Subjects who underwent QS 532 nm Nd:YAG laser treatment of solar lentigines were randomly assigned to treatment with an EGF ointment or petrolatum. After the laser procedure, the subjects were administered the test ointment twice a day for 4 weeks. The physician’s assessment of the degree of pigment clearance and patient’s satisfaction were assessed after 4 and 8 weeks. Additionally, the melanin index (MI), erythema index (EI), transepidermal water loss (TEWL), and post-inflammatory hyperpigmentation (PIH) were evaluated. This trial was registered with ClinicalTrials.gov (NCT04704245). Results: The blinded physician’s assessment using 5-grade percentage improvement scale and patient’s satisfaction were significantly higher in the study group than in the control group at the 4th and 8th weeks. The MI was significantly higher in the control group than in the study group at the 4th and 8th weeks. The EI and TEWL did not differ significantly between the two groups at either time point. The incidence of PIH was higher in the control group (37.5%) than in the EGF group (7.14%) at the 8th week. Conclusions: The application of EGF-containing ointment on facial solar lentigines with a QS 532 nm Nd:YAG laser showed efficient and safe therapeutic effects, with less PIH. Thus, EGF-containing ointment could be suggested as the promising adjuvant treatment strategy with a QS laser for solar lentigines.

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The Efficacy of Lactobacillus plantarum as Adjunctive Therapy of Bacterial Vaginosis: A Double-blind, Randomized, Placebo-controlled Trial

Berkala Ilmu Kesehatan Kulit dan Kelamin ◽

10.20473/bikk.v32.3.2020.214-220 ◽

2020 ◽

Vol 32 (3) ◽

pp. 214

Author(s):

Ridha Ramadina Widiatma ◽

Muhammad Yulianto Listiawan ◽

Dwi Murtiastutik ◽

Cita Rosita Sigit Prakoeswa ◽

Sawitri Sawitri ◽

...

Keyword(s):

Placebo Group ◽

Bacterial Vaginosis ◽

Lactobacillus Plantarum ◽

Adjunctive Therapy ◽

Controlled Trial ◽

Vaginal Flora ◽

Control Group ◽

Therapeutic Effects ◽

Cure Rate ◽

Double Blind

Background: Bacterial vaginosis (BV) is a clinical syndrome caused by the changing of Lactobacillus spp., a producer of hydrogen peroxide, in the normal vagina with a high concentration of anaerobic bacteria, Gardnerella vaginalis and Mycoplasma hominis. This study reports a resistance of BV therapy regimens, high recurrence rates, and side effects of an antibiotic. Therefore, adjunctive therapy for BV management is needed. Research has reported the therapeutic effects of probiotic in BV; however, the results are inconsistent. Purpose: To evaluate the efficacy of standard therapy using metronidazole and Lactobacillus plantarum for BV measured by the cure rate and vaginal flora balance. Methods: A randomized, double-blind, placebo-controlled trial, 30 subjects were randomized to take metronidazole 500 mg twice a day for seven days with weekly evaluation. The Lactobacillus plantarum or placebo group was evaluated every 4 weeks. The cure rate and vaginal flora balance were evaluated using the Amsel criteria and Nugent score before and after the intervention. Result: A total of 30 subjects returned for 28-day follow-up, of which 60% subjects of the antibiotic/probiotic group were cured compared to 40% in the antibiotic/placebo group (p>0.05). Conclusion: There was no difference in the increase of cure rate and vaginal flora balance between the treatment group and significant control group.

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The Methodology of Controlled Trials of Acupuncture

Acupuncture in Medicine ◽

10.1136/aim.6.1.9 ◽

1989 ◽

Vol 6 (1) ◽

pp. 9-13 ◽

Cited By ~ 19

Author(s):

C A Vincent

Keyword(s):

Controlled Trial ◽

Specific Effect ◽

Control Group ◽

Placebo Control ◽

Controlled Trials ◽

Control Procedure ◽

Therapeutic Effects ◽

Trial Methodology ◽

Double Blind ◽

Single Blind

The double-blind controlled trial methodology cannot be straightforwardly applied to trials of acupuncture. The double-blind condition, where the clinician is ignorant of the treatment allocation, cannot be sensibly maintained in trials of acupuncture or other physical treatments. The definition of an appropriate control group is also a difficult matter. The great majority of controlled trials of acupuncture so far conducted are seriously flawed by the use of a placebo control that itself has therapeutic effects. Recently more appropriate control groups have been developed, notably mock TENS, which is inert, and minimal acupuncture, which has only a very slight specific effect. As trials can only be single blind, if is especially important to monitor the adequacy of the control procedure, to ensure that it is perceived as being as effective as the true treatment. It is suggested that this can be achieved by assessing the: credibility of the two treatment procedures. Controlled trials of acupuncture should therefore be single blind, and employ a control condition that has no more than minimal specific effects, but is nevertheless seen as a credible, bona fide treatment by patients.

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A Randomized Controlled Trial Evaluating the Effects of Diosmin in the Treatment of Radicular Pain

BioMed Research International ◽

10.1155/2017/6875968 ◽

2017 ◽

Vol 2017 ◽

pp. 1-7

Author(s):

Yinhe Wang ◽

Xin Fang ◽

Lei Ye ◽

Yishan Li ◽

Hongfei Shi ◽

...

Keyword(s):

Controlled Trial ◽

Radicular Pain ◽

Psychological Status ◽

Control Group ◽

Therapeutic Effects ◽

Satisfaction Rate ◽

Total Satisfaction ◽

Significant Difference ◽

Anti Inflammatory ◽

Vascular Pain

Diosmin has been widely used to treat patients with vascular pain for its potent anti-inflammatory and analgesic effects. To evaluate the therapeutic effects of Diosmin in the treatment of radicular pain, we conducted an investigator-initiated, randomized, active-controlled noninferiority trial between January 1, 2009, and December 1, 2010. Diosmin (50 mg/kg/day) was orally administered to treat the radicular pain in 150 patients for one month. Another 150 patients with the same symptom were given 20% 250 ml mannitol (1 g/kg/day) for 7 days and dexamethasone (10 mg/day) for 3 days intravenously guttae. Short-term relief and long-term relief were measured. Secondary outcomes include improvement in functional and psychological status, return to work, and reduction in anti-inflammatory analgesic drugs intake. Patients treated with oral Diosmin achieved reduction in radicular pain. The total satisfaction rate of Diosmin group was 84.7% [95% confidence interval (CI): 77.9%, 90.0%], and the complete satisfaction rate was 50.7% (95% CI: 42.4%, 58.9%). No statistically significant difference was found between the Diosmin group and the active-control group regarding patient satisfaction. No adverse effects were found during the study period. Our study suggests that clinical application of Diosmin with a dose of 50 mg/kg/day might reduce the radicular pain. This trial is registered with ISRCTN97157037.

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Evaluation of the Quick Wee method of inducing faster clean catch urine collection in pre-continent infants: a randomized controlled trial

World Journal of Pediatrics ◽

10.1007/s12519-021-00483-4 ◽

2021 ◽

Author(s):

Aoife Branagan ◽

Niofa Canty ◽

Evanne O’Halloran ◽

Marian Madden ◽

Michael Brendan O’Neill

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Clinical Care ◽

Intervention Group ◽

Urine Samples ◽

Absolute Difference ◽

Control Group ◽

Randomized Controlled ◽

Irish Hospital ◽

To Receive

Abstract Introduction The acquisition of non-contaminated urine samples in pre-continent infants remains a challenge. The Quick Wee method uses bladder stimulation to induce voiding. A previous randomized trial showed a higher rate of voiding within 5 minutes using this method. We evaluated this method in an Irish hospital providing secondary care. Methods A non-blinded, randomized, controlled trial was carried out. Eligible infants were between 1 and 12 months of age, who required urine sampling as part of clinical care. Participants were randomly allocated to receive the intervention (Quick Wee Method—supra-pubic stimulation with cold saline) or the control (usual care—clean catch with no bladder stimulation) for 5 min. Primary outcome was voiding of urine within 5 min. Results A total of 140 infants were included in this study (73 in intervention group; 67 in control group). Baseline characteristics were similar. 25% in the intervention group passed urine in the 5-min trial period compared with 18% in the control group [P = 0.4, absolute difference 7% (95% confidence interval: − 7% to + 20%)]. Conclusion The Quick Wee method is a simple and inexpensive intervention that did not show a statistically significant increase in urine samples obtained in pre-continent infants.

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