Binge Drinking Clinical Trial
Official title:
My Pathway to Healing: Adaptation and Testing of a Common Elements Treatment Approach to Address Trauma, Suicide Ideation and Substance Abuse
The goal of this project is to test the effectiveness, feasibility and acceptability of a common elements intervention delivered by community mental health workers for adults with a history of adverse childhood experiences. "Common elements" interventions build cognitive, emotional, interpersonal, and behavioral skills to help address trauma-related distress and build resilience. This will be accomplished using a randomized control trial with Apache adults ages 25-65 with recent suicidal behaviors, self-injurious behaviors, and/or binge substance use.
This is a mixed-methods study with qualitative data informing adaptation and evaluation of a common elements intervention delivered by community mental health specialists, named "My Pathway to Healing." Apache partners selected a randomized control trial, as it is a rigorous study design for understanding whether an intervention works, to evaluate the effectiveness of the My Pathway to Healing intervention delivered by community mental health specialists (CMHS). This intervention integrates psychoeducation, relaxation techniques, problem solving and cognitive coping, and addresses safety (when identified as a problem area). The intervention used in the intervention arm of our study has been developed for the specific context and culture of White Mountain Apache. Those randomized into the My Pathway to Healing group will receive 4-8 hour-long sessions with a community mental health specialist, taking place over 8-12 weeks. The exact number of sessions will depend on presentation and symptom level using a stepped care approach where participants receive only what they need, but the provider can provide additional sessions if needed (i.e., increased element dosage; additional optional elements for specific issues). Those randomized into the control will continue to receive the standard case management via the Apache surveillance system. These control participants will be offered the My Pathway to Healing Program upon completion of the study. Participants will be asked to partake in 5 study assessments. For intervention participants these assessments will take place at: baseline, after their last intervention session (endline; approximately 8-12 weeks post-baseline) and 4, 8, and 12 weeks post-endline. For control participants, these assessments will take place at: baseline, 8-12 weeks post-baseline (the maximum time the intervention would last; will be referred to as an endline) and 4, 8 and 12 weeks post-endline. These assessment visits will be conducted by Research Program Assistants. Assessments will take approximately 45-90 minutes to complete. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04105725 -
Balanced Lifestyle for Undergraduate Excellence - Mobile (Project BLUEM)
|
N/A | |
Recruiting |
NCT05491551 -
Alcohol-ROC-Training
|
N/A | |
Completed |
NCT02064998 -
Two Consecutive Randomized Controlled Trials Using Mobile Phone Applications for Risky Alcohol Use
|
N/A | |
Completed |
NCT02336204 -
Alcohol Consumption Relation With Nutritional Knowledge and Body Weight
|
N/A | |
Not yet recruiting |
NCT06326099 -
Brief Binge Eating and Drinking Online Intervention
|
N/A | |
Recruiting |
NCT05565989 -
Alcohol Consumption, Intention Implementation and Mindfulness Meditation (ADUC-Volet 3 " Prevention ")
|
N/A | |
Completed |
NCT01125371 -
Computerized Brief Alcohol Intervention (BI) for Binge Drinking HIV At-Risk and Infected Women
|
N/A | |
Recruiting |
NCT06084832 -
Smartphone Application for University Students With Binge Drinking Behavior
|
N/A | |
Completed |
NCT04853628 -
An Animation- Versus Text-based Computer-tailored Game Intervention to Prevent Alcohol Consumption in Adolescents
|
N/A | |
Completed |
NCT03449095 -
Understanding Alcohol Reward in Social Context
|
N/A | |
Recruiting |
NCT05522075 -
Reducing Blood Pressure in Mid-life Adult Binge Drinkers
|
N/A | |
Completed |
NCT03652675 -
Understanding and Intervening With Heavy Drinking Among Patients With HIV and HCV
|
N/A | |
Completed |
NCT02842073 -
An Open Label Trial of Bupropion and Naltrexone for Binge Drinking
|
Phase 2 | |
Completed |
NCT03288896 -
Alerta Alcohol. Web-based Computer-tailored Intervention for Binge-drinking Prevention in Spanish Adolescents
|
N/A | |
Active, not recruiting |
NCT03567434 -
Alcohol and Neural Cardiovascular Control in Binge Drinkers
|
N/A | |
Recruiting |
NCT03224416 -
Individual and Contextual Factors That Influence Sexual Decisions
|
N/A | |
Active, not recruiting |
NCT05882214 -
Metabolic Changes Induced by NMN in Healthy Subjects With Acute Binge Drink
|
N/A | |
Completed |
NCT01546025 -
Brief Alcohol Intervention for School-to-Work Transitions
|
N/A | |
Completed |
NCT01503255 -
A Stage 2 Cognitive-behavioral Trial: Reduce Alcohol First in Kenya Intervention
|
Phase 1 | |
Recruiting |
NCT05369169 -
Afferent Neurocardiac Signals, Cue Reactivity, and Cognitive Control
|
N/A |