A structured, telephone-delivered intervention to reduce methamphetamine use: study protocol for a parallel-group randomised controlled trial
Abstract Background Australia has one of the highest rates of methamphetamine (MA) use in the world; however, uptake of in-person psychological treatment remains extremely low due to numerous individual (e.g. stigma, shame) and structural (e.g. service accessibility, geographical location) barriers...
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| Format: | Article |
| Language: | English |
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BMC
2023-03-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07172-9 |
| _version_ | 1797853599250776064 |
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| author | Dan I. Lubman Victoria Manning Shalini Arunogiri Kate Hall John Reynolds Peta Stragalinos Rachel Petukhova Robyn Gerhard Jonathan Tyler Anna Bough Anthony Harris Jasmin Grigg |
| author_facet | Dan I. Lubman Victoria Manning Shalini Arunogiri Kate Hall John Reynolds Peta Stragalinos Rachel Petukhova Robyn Gerhard Jonathan Tyler Anna Bough Anthony Harris Jasmin Grigg |
| author_sort | Dan I. Lubman |
| collection | DOAJ |
| description | Abstract Background Australia has one of the highest rates of methamphetamine (MA) use in the world; however, uptake of in-person psychological treatment remains extremely low due to numerous individual (e.g. stigma, shame) and structural (e.g. service accessibility, geographical location) barriers to accessing care. Telephone-delivered interventions are ideally placed to overcome many of the known barriers to treatment access and delivery. This randomised controlled trial (RCT) will examine the efficacy of a standalone, structured telephone-delivered intervention to reduce MA problem severity and related harms. Methods This study is a double-blind, parallel-group RCT. We will recruit 196 ± 8 individuals with mild to moderate MA use disorder from across Australia. After eligibility and baseline assessments, participants will be randomly allocated to receive either the Ready2Change-Methamphetamine (R2C-M) intervention (n = 98 ± 4; four to six telephone-delivered intervention sessions, R2C-M workbooks and MA information booklet) or control (n = 98 ± 4; four to six ≤5-min telephone check-ins and MA information booklet including information on accessing further support). Telephone follow-up assessments will occur at 6 weeks and 3, 6 and 12 months post-randomisation. The primary outcome is change in MA problem severity (Drug Use Disorders Identification Test, DUDIT) at 3 months post-randomisation. Secondary outcomes are as follows: MA problem severity (DUDIT) at 6 and 12 months post-randomisation, amount of methamphetamine used, methamphetamine use days, methamphetamine use disorder criteria met, cravings, psychological functioning, psychotic-like experiences, quality of life and other drug use days (at some or all timepoints of 6 weeks and 3, 6 and 12 months post-randomisation). Mixed-methods program evaluation will be performed and cost-effectiveness will be examined. Discussion This study will be the first RCT internationally to assess the efficacy of a telephone-delivered intervention for MA use disorder and related harms. The proposed intervention is expected to provide an effective, low-cost, scalable treatment for individuals otherwise unlikely to seek care, preventing future harms and reducing health service and community costs. Trial registration ClinicalTrials.gov NCT04713124 . Pre-registered on 19 January 2021. |
| first_indexed | 2024-04-09T19:53:21Z |
| format | Article |
| id | doaj.art-a11c511c0f9543039c7a330e92e186e8 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-09T19:53:21Z |
| publishDate | 2023-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-a11c511c0f9543039c7a330e92e186e82023-04-03T05:39:45ZengBMCTrials1745-62152023-03-0124111610.1186/s13063-023-07172-9A structured, telephone-delivered intervention to reduce methamphetamine use: study protocol for a parallel-group randomised controlled trialDan I. Lubman0Victoria Manning1Shalini Arunogiri2Kate Hall3John Reynolds4Peta Stragalinos5Rachel Petukhova6Robyn Gerhard7Jonathan Tyler8Anna Bough9Anthony Harris10Jasmin Grigg11Turning Point, Eastern HealthTurning Point, Eastern HealthTurning Point, Eastern HealthSchool of Psychology, Deakin UniversityFaculty of Medicine, Nursing and Health Sciences, Monash UniversityTurning Point, Eastern HealthTurning Point, Eastern HealthTurning Point, Eastern HealthTurning Point, Eastern HealthTurning Point, Eastern HealthCentre for Health Economics, Monash UniversityTurning Point, Eastern HealthAbstract Background Australia has one of the highest rates of methamphetamine (MA) use in the world; however, uptake of in-person psychological treatment remains extremely low due to numerous individual (e.g. stigma, shame) and structural (e.g. service accessibility, geographical location) barriers to accessing care. Telephone-delivered interventions are ideally placed to overcome many of the known barriers to treatment access and delivery. This randomised controlled trial (RCT) will examine the efficacy of a standalone, structured telephone-delivered intervention to reduce MA problem severity and related harms. Methods This study is a double-blind, parallel-group RCT. We will recruit 196 ± 8 individuals with mild to moderate MA use disorder from across Australia. After eligibility and baseline assessments, participants will be randomly allocated to receive either the Ready2Change-Methamphetamine (R2C-M) intervention (n = 98 ± 4; four to six telephone-delivered intervention sessions, R2C-M workbooks and MA information booklet) or control (n = 98 ± 4; four to six ≤5-min telephone check-ins and MA information booklet including information on accessing further support). Telephone follow-up assessments will occur at 6 weeks and 3, 6 and 12 months post-randomisation. The primary outcome is change in MA problem severity (Drug Use Disorders Identification Test, DUDIT) at 3 months post-randomisation. Secondary outcomes are as follows: MA problem severity (DUDIT) at 6 and 12 months post-randomisation, amount of methamphetamine used, methamphetamine use days, methamphetamine use disorder criteria met, cravings, psychological functioning, psychotic-like experiences, quality of life and other drug use days (at some or all timepoints of 6 weeks and 3, 6 and 12 months post-randomisation). Mixed-methods program evaluation will be performed and cost-effectiveness will be examined. Discussion This study will be the first RCT internationally to assess the efficacy of a telephone-delivered intervention for MA use disorder and related harms. The proposed intervention is expected to provide an effective, low-cost, scalable treatment for individuals otherwise unlikely to seek care, preventing future harms and reducing health service and community costs. Trial registration ClinicalTrials.gov NCT04713124 . Pre-registered on 19 January 2021.https://doi.org/10.1186/s13063-023-07172-9MethamphetamineSubstance use disorderTreatmentPsychological interventionTelehealthRandomised controlled trial |
| spellingShingle | Dan I. Lubman Victoria Manning Shalini Arunogiri Kate Hall John Reynolds Peta Stragalinos Rachel Petukhova Robyn Gerhard Jonathan Tyler Anna Bough Anthony Harris Jasmin Grigg A structured, telephone-delivered intervention to reduce methamphetamine use: study protocol for a parallel-group randomised controlled trial Trials Methamphetamine Substance use disorder Treatment Psychological intervention Telehealth Randomised controlled trial |
| title | A structured, telephone-delivered intervention to reduce methamphetamine use: study protocol for a parallel-group randomised controlled trial |
| title_full | A structured, telephone-delivered intervention to reduce methamphetamine use: study protocol for a parallel-group randomised controlled trial |
| title_fullStr | A structured, telephone-delivered intervention to reduce methamphetamine use: study protocol for a parallel-group randomised controlled trial |
| title_full_unstemmed | A structured, telephone-delivered intervention to reduce methamphetamine use: study protocol for a parallel-group randomised controlled trial |
| title_short | A structured, telephone-delivered intervention to reduce methamphetamine use: study protocol for a parallel-group randomised controlled trial |
| title_sort | structured telephone delivered intervention to reduce methamphetamine use study protocol for a parallel group randomised controlled trial |
| topic | Methamphetamine Substance use disorder Treatment Psychological intervention Telehealth Randomised controlled trial |
| url | https://doi.org/10.1186/s13063-023-07172-9 |
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