Alliance for Public Health
Kyiv, Ukraine
NCT Number: NCT07672457
This study is a randomized controlled trial among 144 internally displaced people to determine the feasibility, acceptability, and preliminary effectiveness of a single-session Acceptance of Commitment Therapy (ACT) group therapy on preventing or reducing substance use behaviors.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Kyiv, Ukraine
The war in Ukraine has provoked the world's current largest humanitarian displacement: since February 2022, over 13 million people, i.e., one-third of Ukrainians, have been forced to leave their homes, resulting in nearly 6 million internally displaced persons (IDPs). War and humanitarian emergencies may exacerbate substance use, but the incidence and prevalence of unhealthy substance use in humanitarian settings, including Ukraine, are currently largely unknown. This lack of data limits the ability to tailor targeted, effective preventive substance use interventions for these mobile populations. Addressing this knowledge gap is an immense priority for Ukraine, where rates of substance use were high even prior to the Russian invasion in February 2022, and in other settings hosting large populations of IDPs, including the United States.
To determine the feasibility, acceptability, and preliminary effectiveness of the intervention among IDPs, a RCT to evaluate implementation and substance use outcomes associated with the intervention at 1 and 6 months.
The investigators hypothesize that an ACT-based intervention delivered in a humanitarian context will help displaced persons in Ukraine build skills to manage stress and prevent or reduce substance use behaviors, ultimately mitigating the onset of substance use disorders.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The ACT group intervention will involve a mixture of didactic instruction, discussion, and experiential activities. ACT will help internally displaced persons to manage stress and prevent or reduce substance use behaviors, ultimately mitigating the onset of substance use disorders.
Usual care will be minimally enhanced by providing participants with an educational information session that provides information on health promotion.
Time frame: 1 month and 6 months
Feasibility will be assessed using the 14-item feasibility subscales of the Applied Mental Health Research Group Implementation Measure (AMHR-IM). Each item is rated on a 4-point scale where "0" means "not at all" and "3" means "a lot". The overall Feasibility score is calculated as the mean (average) across all 14 completed items, where higher scores (closer to 3) reflect a higher level of perceived feasibility of the intervention.
Time frame: 1 month and 6 months
Acceptability will be assessed using the 17-item acceptability subscales of the Applied Mental Health Research Group Implementation Measure (AMHR-IM). Each item is rated on a 4-point Likert scale where "0" means "not at all" and "3" means "a lot". The overall Acceptability score is calculated as the mean (average) across all 17 completed items, where higher scores (closer to 3) reflect a higher level of perceived acceptability of the intervention.
Contact information is provided by the study sponsor or research team.
Karsten Lunze, MD DrPH MPH
CONTACT
Kimberly Hook, PhD MA
CONTACT
Boston Medical Center
Other
Acronym: SUPRA RCT R33
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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