Friendship Bench for Women Who Use Methamphetamine in Vietnam

NCT06789523 | Recruiting

• 1 other identifier: K43TW012620-01A1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Methamphetamine Use; Common Mental Disorders (CMD)

Keywords

methamphetamine; women who use drugs; common mental disorders; Friendship Bench; lay worker-delivered intervention

Outcome Measures

Primary Outcomes (5)

• Feasibility: the ability to enroll women who use meth with common mental disorders in the pilot

  The ability to enroll WWUM is assessed through the recruitment rate (number of WWUM approached to accrue the final sample) and reasons for non-participation.

  From enrollment to the end of intervention at 6 weeks

• Feasibility: the ability to retain WWUM with common mental disorders in the pilot

  Based on data from previous studies in Vietnam, the study team defines feasible retention as 80% retention at 6-weeks.

  From enrollment to the end of intervention at 6 weeks

• Feasibility: adequate completion of Friendship Bench sessions

  As peer outreach workers will conduct home visits or visits to workplace, the study team considers 70% participants attending all 6 individual sessions to be feasible. The reasons for session non-attendance, and counselor time per session and per patient including preparation, documentation, and supervision will also be assessed to explain the Friendship Bench completion rate.

  From enrollment to the end of intervention at 6 weeks

• Acceptability

  Acceptability is defined as the perception among implementation stakeholders that the intervention is agreeable or satisfactory. The study team will assess acceptability through the 6-week follow-up interview with all participants (n=100) and peer workers (n=10). Acceptability will also be assessed qualitatively using the post-intervention in-depth interviews with peer workers (n=10), participants (n=20) and brief exit interviews with supervisors (n=2). The interviews will assess how easy the intervention is to participate and to deliver, the perceived usefulness of the intervention and suggestions for improvement. Intervention acceptability is defined as 80% participants rating the intervention as acceptable and by a common theme of positive perceptions of Friendship Bench in qualitative data.

  At Week 6

• Fidelity

  Fidelity is defined as delivery of the intervention as intended. Master trainers will use a checklist to assess fidelity to session content either during direct monitoring or using audio recording of 1 randomly chosen session per patient or up to 8 sessions per counselor. Covering at least 75% of checklist items during each session is considered fidelity to the intervention protocol.

  From enrollment to the end of intervention at 6 weeks

Secondary Outcomes (3)

• Mental health: changes in CMD symptom response

  From enrollment to the end of intervention at 6 weeks

• Meth use: self-reported changes in meth use behaviors

  From enrollment to the end of intervention at 6 weeks

• Meth use: changes in urinalysis

  From enrollment to the end of intervention at 6 weeks

Study Arms (2)

Friendship Bench

EXPERIMENTAL

Participants randomized to the intervention condition will receive the adapted Friendship Bench intervention.

Behavioral: Friendship Bench

Usual psychiatric care

ACTIVE COMPARATOR

Participants in the control group will receive usual care for their common mental disorders.

Behavioral: Usual psychiatric care

Interventions

Friendship Bench BEHAVIORAL

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-focused content on pregnancy and postpartum depression that we plan to include.

Friendship Bench

Usual psychiatric care BEHAVIORAL

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.

Usual psychiatric care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study focuses on women who use methamphetamine.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Hanoi Medical University: lead
• Fogarty International Center of the National Institute of Health: collaborator
• University of North Carolina, Chapel Hill: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Friendship Bench & Lighthouse

Haiphong, Hai Phong, 100000, Vietnam

RECRUITING

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 28800503 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 22257753 BACKGROUND

• 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.

  PMID: 25277726 BACKGROUND

Central Study Contacts

Trang Thu Nguyen, PhD

CONTACT

+84 988 424 871; trangthu@hmu.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: January 23, 2025
• Study Start: June 11, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): August 31, 2029
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

VN (1)