Clinical trial NCT06789523: Friendship Bench for Women Who Use Methamphetamine in Vietnam
Official title: Friendship Bench for Women Who Use Methamphetamine in Vietnam
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Methamphetamine Use
Common Mental Disorders (CMD)
Keywords: methamphetamine
women who use drugs
common mental disorders
Friendship Bench
lay worker-delivered intervention
Lead sponsor: Hanoi Medical University
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
name: University of North Carolina, Chapel Hill
name: National Institute on Drug Abuse (NIDA)
First posted: 2025-01-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Feasibility: the ability to enroll women who use meth with common mental disorders in the pilot
timeFrame: From enrollment to the end of intervention at 6 weeks
measure: Feasibility: the ability to retain WWUM with common mental disorders in the pilot
timeFrame: From enrollment to the end of intervention at 6 weeks
measure: Feasibility: adequate completion of Friendship Bench sessions
timeFrame: From enrollment to the end of intervention at 6 weeks
measure: Acceptability
timeFrame: At Week 6
measure: Fidelity
timeFrame: From enrollment to the end of intervention at 6 weeks
Secondary outcomes:
measure: Mental health: changes in CMD symptom response
timeFrame: From enrollment to the end of intervention at 6 weeks
measure: Meth use: self-reported changes in meth use behaviors
timeFrame: From enrollment to the end of intervention at 6 weeks
measure: Meth use: changes in urinalysis
timeFrame: From enrollment to the end of intervention at 6 weeks
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Center for Training and Research on Substance Use & HIV
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.2017.07.004. Epub 2017 Aug 2.
citation: 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.
citation: 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.
citation: Des Jarlais DC, Feelemyer JP, Modi SN, Arasteh K, Hagan H. Are females who inject drugs at higher risk for HIV infection than males who inject drugs: an international systematic review of high seroprevalence areas. Drug Alcohol Depend. 2012 Jul 1;124(1-2):95-107. doi: 10.1016/j.drugalcdep.2011.12.020. Epub 2012 Jan 17.
citation: Azim T, Bontell I, Strathdee SA. Women, drugs and HIV. Int J Drug Policy. 2015 Feb;26 Suppl 1(0 1):S16-21. doi: 10.1016/j.drugpo.2014.09.003. Epub 2014 Sep 17.