Treatment retention, drug use and social functioning outcomes in those receiving 3 months versus 1 month of supervised opioid maintenance treatment. Results from the Super C randomized controlled trial

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

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Narrative enhancement and cognitive therapy (NECT) to improve social functioning in people with serious mental illness: study protocol for a stepped-wedge cluster randomized controlled trial

Trials ◽

10.1186/s13063-021-05067-1 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

J. Dubreucq ◽

M. Faraldo ◽

M. Abbes ◽

B. Ycart ◽

H. Richard-Lepouriel ◽

...

Keyword(s):

Mental Illness ◽

Randomized Controlled Trial ◽

Cognitive Therapy ◽

Social Functioning ◽

Serious Mental Illness ◽

Controlled Trial ◽

Control Group ◽

Stepped Wedge ◽

Randomized Controlled ◽

Cluster Randomized

Abstract Background Self-stigma is highly prevalent in serious mental illness (SMI) and is associated with poorer clinical and functional outcomes. Narrative enhancement and cognitive therapy (NECT) is a group-based intervention combining psychoeducation, cognitive restructuring and story-telling exercises to reduce self-stigma and its impact on recovery-related outcomes. Despite evidence of its effectiveness on self-stigma in schizophrenia-related disorders, it is unclear whether NECT can impact social functioning. Methods This is a 12-centre stepped-wedge cluster randomized controlled trial of NECT effectiveness on social functioning in SMI, compared to treatment as usual. One hundred and twenty participants diagnosed with schizophrenia, bipolar disorder or borderline personality disorder will be recruited across the 12 sites. The 12 centres participating to the study will be randomized into two groups: one group (group 1) receiving the intervention at the beginning of the study (T0) and one group (group 2) being a control group for the first 6 months and receiving the intervention after (T1). Outcomes will be compared in both groups at T0 and T1, and 6-month and 12-month outcomes for groups 1 and 2 will be measured without a control group at T2 (to evaluate the stability of the effects over time). Evaluations will be conducted by assessors blind to treatment allocation. The primary outcome is personal and social performance compared across randomization groups. Secondary outcomes include self-stigma, self-esteem, wellbeing, quality of life, illness severity, depressive symptoms and personal recovery. Discussion NECT is a promising intervention for reducing self-stigma and improving recovery-related outcomes in SMI. If shown to be effective in this trial, it is likely that NECT will be implemented in psychiatric rehabilitation services with subsequent implications for routine clinical practice. Trial registration ClinicalTrials.gov NCT03972735. Trial registration date 31 May 2019.

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