scholarly journals Evaluation of the Intensive Treatment and Rehabilitation Program for Residential Treatment and Rehabilitation Centers (INTREPRET) in the Philippines: a study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Takayuki Harada ◽  
Toshiaki Baba ◽  
Tomohiro Shirasaka ◽  
Shogo Kanamori
Keyword(s):  
Randomized Controlled Trial ◽  
Drug Use ◽  
Treatment Program ◽  
Drug Users ◽  
Controlled Trial ◽  
Well Being ◽  
The Philippines ◽  
Consent Form ◽  
Comprehensive Treatment ◽  
Randomized Controlled

Abstract Background The Philippines has been severely affected by the methamphetamine crisis. The government has launched a policy war against drug use, although the severe sanctions imposed on drug users have been criticized internationally. To help implement a more effective and humane approach to drug use, this study aimed to introduce a comprehensive treatment program for methamphetamine users based on cognitive-behavioral therapy (CBT) whose effectiveness will be evaluated through a randomized controlled trial. Methods Methamphetamine users admitted into government-run rehabilitation facilities are recruited and randomly assigned to either a CBT-based treatment program or existing therapeutic community (TC)-based treatment. The CBT treatment program was developed based on the Matrix Model that considers cultural and social factors in the Philippines. After 6 months of treatment, there will be a three-month follow-up, when the participants’ drug use (tested through urine testing) and other psychological variables, including craving, coping skills, and well-being, will be compared. Potential participants are given a summary of the study and a consent form. The consent form is signed and dated by participants prior to their study participation. Ethical approval was obtained prior to the commencement of the study. Discussion This is the first randomized controlled trial to compare the residential CBT program and the TC model for methamphetamine users in the Philippines. The study aims to fill the current knowledge and capacity gaps by introducing a CBT-based treatment program to improve the psychosocial well-being of drug users in the Philippines. Moreover, if the effectiveness of the treatment program is demonstrated, anti-drug campaigns and severe sanctions against drug users may be reconsidered. Trial registration UMIN Clinical Trials Registry JPRN-UMIN000038597. Registered on 15 November 2019. Protocol version October 17, 2021 ver.2

Evaluation of the Intensive Treatment and Rehabilitation Program for Residential Treatment and Rehabilitation Centers (INTREPRET) in the Philippines: A Study Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
Takayuki Harada ◽  
Toshiaki Baba ◽  
Tomohiro Shirasaka ◽  
Shogo Kanamori
Keyword(s):  
Research Ethics ◽  
Treatment Program ◽  
Controlled Trial ◽  
Well Being ◽  
The Philippines ◽  
Consent Form ◽  
Comprehensive Treatment ◽  
Study Participation ◽  
Joint Research ◽  
Urine Testing

Abstract Background: The Philippines is one of the most severely affected countries by the methamphetamine epidemic in the world. The government launched a war on drugs policy to counter the situation in the country. However, brutality against drug users was criticized internationally. Thus, we have developed a comprehensive treatment program for methamphetamine users based on cognitive-behavioral therapy (CBT) and are going to evaluate its effectiveness. If its effectiveness is demonstrated, it will be helpful to implement much more effective and humane approaches to drug issues in the Philippines.Methods: Methamphetamine users who are admitted to government-run rehabilitation facilities are recruited and are randomly assigned either to the CBT-based treatment program or existing therapeutic community (TC)-based treatment. The CBT treatment program was developed based on the Matrix model considering the cultural and social factors in the Philippines. After 6-months treatment, participants will be followed up for 3 months and drug use (urine testing) and other psychological variables including craving, coping skills, and well-being will be compared.Ethics and dissemination Informed consent will be obtained from study participants prior to study participation. Ethical approval was obtained from research ethics review boards in both countries. This study was approved by Single Joint Research Ethics Board of the Department of Health, Republic of the Philippines (SJREB-2019-27) and the University of Tsukuba Faculty of Human Sciences Ethics Committee (T2019-70). 1). Potential participants will be given a summary of the study and a consent form. The consent form is signed and dated by participants prior to their study participation. Findings of this study will be submitted for publication in international scientific peer-reviewed journals and be presented at academic conferences.Trial registration number: UMIN Clinical Trials Registry JPRN-UMIN000038597. Registered on 15 November 2019. Protocol version February 13, 2020 ver.1

A Community-based Addiction Rehabilitation Electronic System to Improve Recovery Outcomes in Patients with Drug Use Disorder: Protocol for a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Zhe WANG ◽  
Shujuan CHEN ◽  
Junning CHEN ◽  
Chunfeng XU ◽  
Zhikang CHEN ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Drug Use ◽  
Illicit Drug ◽  
Service Providers ◽  
Controlled Trial ◽  
Electronic System ◽  
Community Based ◽  
Randomized Controlled ◽  
Community Rehabilitation ◽  
Drug Use Disorder

BACKGROUND Relapse is very common in patients with illicit drug use disorder and contributes to a series of bad consequences that substantially impact their physical and social functions. Due to the limited existence of effective addiction treatment, the majority of patients with drug use disorder could not access help when needing. Mobile health (mHealth) offers a potential solution to improving recovery outcome for patients in community. OBJECTIVE This paper is a protocol for a randomized controlled trial (RCT) of a smart phone application called community-based addiction rehabilitation electronic system (CAREs). This interactive system consists of an APP for clients and a webpage for service providers, with the aim of teaching clients craving and emergency coping skills and helping service providers to improve their work efficiency and effectiveness in community. METHODS A randomized controlled trial (RCT) will be conducted. Sixty drug illicit users who are newly ordered to undergo community rehabilitation will be recruited from the community in Shanghai. Participants will be 1:1 randomly assigned to receive integrated community rehabilitation by using CAREs or only receiving routine community rehabilitation for 6 months. Corresponding anti-drug social workers will provide service and monitor their drug use behavior in accordance with the routine work-flow. Outcomes will be assessed at baseline and in the 6th month. The primary study outcome is the performance on illicit drug urine test which will be carried on regularly twice per week during the study period. Secondary study outcomes include longest duration of sustained abstinence, days that participants interact with anti-drug social workers, and the decrease rate of addiction-related issues severity index. RESULTS Recruitment is currently underway with the aim of recruiting 60 subjects with drug use disorder. Recruitment will continue until the end of 2018. CONCLUSIONS This is the first known trial of a smartphone-based psychotherapy program for improving recovery outcomes in illicit drug users in community. The study provides evidence for the feasibility and effectiveness of the "CAREs" system through comparing the results of the intervention group with the control group. This paper describes the design and methodology of the study. CLINICALTRIAL ClinicalTrials.gov NCT03451344, https://clinicaltrials.gov/ct2/show/NCT03451344

Efficacy of the Fun For Wellness Online Intervention to Promote Multidimensional Well-Being: a Randomized Controlled Trial

2017 ◽  
Vol 18 (8) ◽  
pp. 984-994 ◽  
Author(s):  
Nicholas D. Myers ◽  
Isaac Prilleltensky ◽  
Ora Prilleltensky ◽  
Adam McMahon ◽  
Samantha Dietz ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Online Intervention ◽  
Well Being ◽  
Randomized Controlled

scholarly journals The Influence of Connectedness to Nature on Psychological Well-Being: Evidence from the Randomized Controlled Trial Play&Grow

Challenges ◽  
2021 ◽  
Vol 12 (1) ◽  
pp. 12
Author(s):  
Tanja Sobko ◽  
Gavin T. L. Brown
Keyword(s):  
Randomized Controlled Trial ◽  
Young Children ◽  
Psychological Health ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Well Being ◽  
Path Model ◽  
Psychological Well Being ◽  
Connectedness To Nature ◽  
Randomized Controlled

Urbanized children today have fewer opportunities to interact with nature which may lead to a greater risk of mental health problems. The objective of this randomized controlled trial was to investigate which particular changes in connectedness to nature (CN) would improve psychological well-being (PW) in young children. Six hundred and thirty-nine preschoolers (52.0% boys, age 34.9 ± 9.5 months) participated in Play&Grow, an early environmental education intervention. Children’s CN and PW were evaluated by parents before and after the program with validated measures; the CNI-PPC (four factors) and the SDQ, Strength and Difficulties questionnaire (five factors), respectively. The effectiveness of the intervention on the primary outcomes (CN, PW) as well as the relationship between them was analyzed in a repeated measures path model with intervention status as a causal predictor. Specific CN factors consistently increased ProSocial behavior and reduced Hyperactivity and Emotional problems. In summary, this study showed that the previously reported impact shifted from the total CN score to the specific CN factors. The Play&Grow intervention positively increased children’s CN and improved some aspects of psychological well-being in children which is a preliminary evidence of developmental benefits of connecting young children with nature. Our results indicate promising direction of action for the improvement of families’ psychological health.

scholarly journals Can SMS Technology Improve Low Take-up of Social Benefits?

2014 ◽  
Vol 20 (1) ◽  
pp. 61-81 ◽  
Author(s):  
Mariana Blanco ◽  
Juan F. Vargas
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Social Benefits ◽  
Limited Evidence ◽  
Randomized Controlled ◽  
Potential Channels ◽  
Informational Barriers ◽  
Government Benefits

AbstractLow take-up of stigma-free social benefits is often blamed on information asymmetries or administrative barriers. There is limited evidence on which of these potential channels is more salient in which contexts. We designed and implemented a randomized controlled trial to assess the extent to which informational barriers are responsible for the prevalent low take-up of government benefits among Colombian conflict-driven internal refugees. We provide timely information on benefits eligibility via SMS to a random half of the displaced household that migrated to Bogotá over a 6-month period. We show that improving information increases benefits’ take-up. However, the effect is small and only true for certain type of benefits. Hence, consistent with previous experimental literature, the availability of timely information explains only part of the low take-up rates and the role of administrative barriers and bureaucratic processes should be tackled to increase the well-being of internal refugees in Colombia.

Acupuncture Versus Venlafaxine for the Management of Vasomotor Symptoms in Patients With Hormone Receptor–Positive Breast Cancer: A Randomized Controlled Trial

2010 ◽  
Vol 28 (4) ◽  
pp. 634-640 ◽  
Author(s):  
Eleanor M. Walker ◽  
Alba I. Rodriguez ◽  
Beth Kohn ◽  
Ronald M. Ball ◽  
Jan Pegg ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Adverse Effects ◽  
Controlled Trial ◽  
Hot Flashes ◽  
Well Being ◽  
Post Treatment ◽  
Acupuncture Group ◽  
Vasomotor Symptoms ◽  
Randomized Controlled

Purpose Vasomotor symptoms are common adverse effects of antiestrogen hormone treatment in conventional breast cancer care. Hormone replacement therapy is contraindicated in patients with breast cancer. Venlafaxine (Effexor), the therapy of choice for these symptoms, has numerous adverse effects. Recent studies suggest acupuncture may be effective in reducing vasomotor symptoms in menopausal women. This randomized controlled trial tested whether acupuncture reduces vasomotor symptoms and produces fewer adverse effects than venlafaxine. Patients and Methods Fifty patients were randomly assigned to receive 12 weeks of acupuncture (n = 25) or venlafaxine (n = 25) treatment. Health outcomes were measured for up to 1 year post-treatment. Results Both groups exhibited significant decreases in hot flashes, depressive symptoms, and other quality-of-life symptoms, including significant improvements in mental health from pre- to post-treatment. These changes were similar in both groups, indicating that acupuncture was as effective as venlafaxine. By 2 weeks post-treatment, the venlafaxine group experienced significant increases in hot flashes, whereas hot flashes in the acupuncture group remained at low levels. The venlafaxine group experienced 18 incidences of adverse effects (eg, nausea, dry mouth, dizziness, anxiety), whereas the acupuncture group experienced no negative adverse effects. Acupuncture had the additional benefit of increased sex drive in some women, and most reported an improvement in their energy, clarity of thought, and sense of well-being. Conclusion Acupuncture appears to be equivalent to drug therapy in these patients. It is a safe, effective and durable treatment for vasomotor symptoms secondary to long-term antiestrogen hormone use in patients with breast cancer.

scholarly journals The STress-And-coping suppoRT Intervention (START) for Chinese Women Undergoing Abortion: a Randomized Controlled Trial Protocol

2022 ◽  
Author(s):  
Na Wang ◽  
Jenny Gamble ◽  
Qiuxiang Zhang ◽  
Elizabeth Elder ◽  
Jyai Allen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Chinese Women ◽  
Research Training ◽  
Controlled Trial ◽  
Ethics Committees ◽  
Well Being ◽  
Depression Symptoms ◽  
Randomized Controlled ◽  
Abortion Care ◽  
Research Training Program

Abstract Background:Undergoing an abortion is stressful. This protocol aims to assess the feasibility, acceptability, and primary effects of a complex intervention to promote positive coping behaviors and alleviating depression symptoms among Chinese women undergo abortion.Methods:A two-arm randomized controlled trial design will be used. Participants will be recruited at their first appointment with the abortion clinic, those who consent to participate will be randomly allocated to receive either the START intervention (in addition to standard abortion care) or standard care only. All participants will receive survey follow-up until six weeks post-abortion. Ethical has been granted by local and university ethics committees. This research was supported by an Australian Government Research Training Program (RTP) Scholarship Discussion:Results will assist refinement and further evaluations of the START intervention, contribute to improved abortion care practices in China, and enrich the literature evidence on improving women’s psychological well-being following abortion in ChinaTrial registration: Registered at the Chinese Clinical Trials.gov: ChiCTR2100046101. Date of registration: May 4, 2021

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