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Recruiting NCT06789523

Friendship Bench for Women Who Use Methamphetamine in Vietnam

No phase Interventional Methamphetamine Use Common Mental Disorders (CMD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Friendship Bench, Usual psychiatric care.
Who it may be relevant to
Registry conditions: Methamphetamine Use, Common Mental Disorders (CMD). Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Vietnam
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The high comorbidity of mental health issues and meth use in women worsens both their mental health and meth use outcomes. The study team proposes to evaluate the potential of Friendship Bench to be used as a low-threshold, task-shifting mental health intervention among women who use methamphetamine in Vietnam - a lower-middle-income country. The study will provide preliminary data for a R01 trial testing the effectiveness Friendship Bench to improve mental health and methamphetamine use outcomes among women who use methamphetamine in Vietnam.

Detailed description

The specific aims of this research proposal are to: (1) assess the mental health needs of WWUM in Haiphong, (2) adapt Friendship Bench to the specific needs of Vietnamese WWUM and (3) assess the feasibility, fidelity, and acceptability of the adapted Friendship Bench for common mental disorders among WWUM and preliminary indicators of its impact in improving their mental health and methamphetamine use in a two-arm randomized trial, comparing Friendship Bench with usual psychiatric care.

Interventions

  • Behavioral Friendship Bench
    The Friendship Bench model comprises 6 weekly, individual sessions with trained peer workers in addition to the usual care. Peer workers will help participants identify problems, outline potential solutions, and implement selected solutions. The adaptation of Friendship Bench for Vietnamese methadone patients made revisions, such as removing the 'Belief in supernatural powers' section, replacing the Shona Symptom Questionnaire with DASS-21, and adding meth use. But this adaptation removed women
  • Behavioral Usual psychiatric care
    Usual care includes monthly check-ups by peer workers, referral to hospital-based psychiatric services or other available mental health services if needed. This usual care might surpass standard psychiatric care in other provinces given that peer workers in Haiphong have been well trained on case management skills.

Primary outcome measures

  • Feasibility: the ability to enroll women who use meth with common mental disorders in the pilot [Time frame: From enrollment to the end of intervention at 6 weeks]
  • Feasibility: the ability to retain WWUM with common mental disorders in the pilot [Time frame: From enrollment to the end of intervention at 6 weeks]
  • Feasibility: adequate completion of Friendship Bench sessions [Time frame: From enrollment to the end of intervention at 6 weeks]
  • Acceptability [Time frame: At Week 6]
  • Fidelity [Time frame: From enrollment to the end of intervention at 6 weeks]
Secondary outcome measures (3)
  • Mental health: changes in CMD symptom response [Time frame: From enrollment to the end of intervention at 6 weeks]
  • Meth use: self-reported changes in meth use behaviors [Time frame: From enrollment to the end of intervention at 6 weeks]
  • Meth use: changes in urinalysis [Time frame: From enrollment to the end of intervention at 6 weeks]

Eligibility criteria

Inclusion criteria

  • Adult women (>=18 years old)
  • Moderate or greater risk for meth use (ASSIST ≥ 4)
  • Moderate or greater CMD symptom severity (Depression ≥ 10, Anxiety ≥ 8, and/or Stress ≥ 15 on DASS-21)

Exclusion criteria

  • Severe psychotic disorders or other interfering problems that require specialty care;
  • Inability to understand study procedures by the research team's judgment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Vietnam · 1 center
  • Friendship Bench & Lighthouse — Haiphong

Publications

  • Tran HV, Nong HTT, Tran TTT, Filipowicz TR, Landrum KR, Pence BW, Le GM, Nguyen MX, Chibanda D, Verhey R, Go VF, Ho HT, Gaynes BN. Adaptation of a Problem-solving Program (Friendship Bench) to Treat Common Mental Disorders Among People Living With HIV and AIDS and on Methadone Maintenance Treatment in Vietnam: Formative Study. JMIR Form Res. 2022 Jul 8;6(7):e37211. doi: 10.2196/37211. PMID 35802402
  • Chibanda D, Weiss HA, Verhey R, Simms V, Munjoma R, Rusakaniko S, Chingono A, Munetsi E, Bere T, Manda E, Abas M, Araya R. Effect of a Primary Care-Based Psychological Intervention on Symptoms of Common Mental Disorders in Zimbabwe: A Randomized Clinical Trial. JAMA. 2016 Dec 27;316(24):2618-2626. doi: 10.1001/jama.2016.19102. PMID 28027368
  • Chibanda D. Reducing the treatment gap for mental, neurological and substance use disorders in Africa: lessons from the Friendship Bench in Zimbabwe. Epidemiol Psychiatr Sci. 2017 Aug;26(4):342-347. doi: 10.1017/S2045796016001128. Epub 2017 Apr 12. PMID 28399952
  • Chibanda D, Mesu P, Kajawu L, Cowan F, Araya R, Abas MA. Problem-solving therapy for depression and common mental disorders in Zimbabwe: piloting a task-shifting primary mental health care intervention in a population with a high prevalence of people living with HIV. BMC Public Health. 2011 Oct 26;11:828. doi: 10.1186/1471-2458-11-828. PMID 22029430
  • Giang HT, Duc NQ, Khue PM, Quillet C, Oanh KTH, Thanh NTT, Vallo R, Feelemyer J, Vinh VH, Rapoud D, Michel L, Laureillard D, Moles JP, Jarlais DD, Nagot N, Huong DT. Gender Differences in HIV, HCV risk and Prevention Needs Among People who Inject drug in Vietnam. AIDS Behav. 2023 Jun;27(6):1989-1997. doi: 10.1007/s10461-022-03932-x. Epub 2022 Nov 28. PMID 36441408
  • Michel L, Des Jarlais DC, Duong Thi H, Khuat Thi Hai O, Pham Minh K, Peries M, Vallo R, Nham Thi Tuyet T, Hoang Thi G, Le Sao M, Feelemyer J, Vu Hai V, Moles JP, Laureillard D, Nagot N; DRIVE Study Team. Intravenous heroin use in Haiphong, Vietnam: Need for comprehensive care including methamphetamine use-related interventions. Drug Alcohol Depend. 2017 Oct 1;179:198-204. doi: 10.1016/j.drugalcdep PMID 28800503
  • Kittirattanapaiboon P, Srikosai S, Wittayanookulluk A. Methamphetamine use and dependence in vulnerable female populations. Curr Opin Psychiatry. 2017 Jul;30(4):247-252. doi: 10.1097/YCO.0000000000000335. PMID 28426546
  • Tracy D, Hahn JA, Fuller Lewis C, Evans J, Briceno A, Morris MD, Lum PJ, Page K. Higher risk of incident hepatitis C virus among young women who inject drugs compared with young men in association with sexual relationships: a prospective analysis from the UFO Study cohort. BMJ Open. 2014 May 29;4(5):e004988. doi: 10.1136/bmjopen-2014-004988. PMID 24875490

Identifiers

NCT: NCT06789523 · K43TW012620-01A1 · K43TW012620-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗