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Found 5 Actively Recruiting clinical trials

A

Actively Recruiting

Researchers are evaluating a brief, values-based behavioral intervention designed to help Veterans with opioid use disorder improve their interpersonal functioning, community integration, and quality of life during early medication treatment with buprenorphine, methadone, or naltrexone. The study addresses the challenges Veterans face in early recovery beyond medication effects, focusing on psychological and social support. This research follows the NIH Stage Model for Behavioral Intervention Development and includes three phases: treatment development, pilot testing, and a pilot randomized controlled trial (RCT). The intervention consists of four weekly 50-minute sessions that cover values clarification, understanding the role of values in treatment engagement, overcoming barriers and goal setting, and planning for recovery. Phase 1 involves manual development and stakeholder interviews with Veterans and VA providers. Phase 2 is an open pilot trial with 10 Veterans to refine the intervention and develop therapist adherence measures. Phase 3 is a pilot RCT with 40 Veterans randomized to either the intervention or treatment as usual, which includes case management and group therapy alongside medication. Treatment sessions are delivered mainly in-person, with remote options if necessary. Participants will attend assessments at baseline, post-treatment, and follow-ups at 3 and 6 months, conducted by independent evaluators. Researchers will measure treatment feasibility, acceptability, interpersonal functioning, community reintegration, quality of life, substance use, and treatment adherence. Therapist adherence and competence are monitored throughout. The study aims to inform a future fully powered randomized controlled trial by evaluating the intervention's preliminary effects and refining procedures. Participation duration spans up to three years, including all study phases and follow-ups.

Age: 18Years +All GendersPhase Not Applicable
1 location
A

Actively Recruiting

Healthy Volunteer

This research aims to evaluate the effects of the AgeWISE-Action Plan (AgeWISE-AP), a 20-week program designed to educate older Veterans about brain aging and to help them create personalized plans to improve brain health. The study focuses on enhancing engagement in brain-healthy lifestyle activities, improving psychological wellness, and boosting cognitive function. It also explores whether the program can influence brain health biomarkers through advanced imaging techniques over a one-year follow-up. The AgeWISE-AP program provides education about normal versus diseased brain aging and lifestyle factors that promote brain health. Participants receive collaborative, individualized action plans to increase their participation in brain-healthy activities such as diet, exercise, sleep, and cognitive stimulation. The program includes sessions teaching cognitive strategies and stress reduction techniques, and homework to help apply these strategies in daily life. Participants will complete various assessments at baseline, 4, 8, and 12 months to measure lifestyle engagement, psychological wellness, cognitive function, and brain health. These assessments include questionnaires on activities, mood, anxiety, sleep, social roles, cognition, and quality of life. Researchers will monitor changes in these measures and brain imaging results to evaluate the program's impact. The total participation duration extends over one year with multiple follow-up assessments.

Age: 60Years +All GendersPhase Not Applicable
1 location
A

Actively Recruiting

Chronic pain is a common and serious issue among Veterans, affecting their daily functioning, social interactions, sleep, and appetite. Veterans experience higher rates of chronic pain and severe pain compared to the general public, leading to increased health problems and reduced quality of life. Traditional medication treatments have limited success and potential risks, creating a need for innovative, accessible, non-medical pain self-management options. This research compares an online Acceptance and Commitment Therapy for Chronic Pain designed specifically for Veterans (VACT-CP) with an active online control program called Online Pain School to see how each supports pain management and improves functioning and quality of life. Participants will take part in one of two digital pain management programs. The VACT-CP group completes seven weekly online modules guided by an interactive virtual coach named Coach Anne, featuring personalized text-based conversations, videos, and goal-setting activities. The Online Pain School group also completes seven modules each lasting 15 to 20 minutes, providing educational videos, behavioral exercises, and wellness strategies to support pain self-management. Both programs are designed for at-home use to overcome barriers such as transportation and time constraints. During the study, researchers will assess changes in pain intensity, functioning, and quality of life at Week 7, and again at 3- and 6-month follow-ups using standardized measures including the Brief Pain Inventory and the Veteran's RAND 36 Item Health Survey. Participants' interactions with the programs and their feedback will be monitored to evaluate usability and impact. The total study duration includes these follow-up assessments to understand both short- and longer-term effects of the interventions.

Age: 18Years +All GendersPhase Not Applicable
3 locations
B

Actively Recruiting

Researchers are evaluating a telehealth-delivered behavioral activation program called ACTIVaTE to support physical, cognitive, and social functioning in older Veterans at risk for functional decline. The study aims to develop, adapt, and test this intervention to help maintain independence in daily activities. It includes three main phases: adapting the program with feedback, refining it in a small group, and conducting a randomized controlled trial comparing ACTIVaTE to usual care in 48 Veterans. The ACTIVaTE program consists of six sessions delivered by a psychology trainee via video telehealth. It is based on an existing behavioral activation model and tailored specifically for older Veterans, focusing on maintaining functional independence. Key elements include education, activity monitoring, values exploration, and activity planning. The usual care group receives educational materials about staying active and community resources. The study progresses from initial adaptation and feedback to a pilot trial testing feasibility and acceptability. Participants will be assessed at baseline, 8 weeks, and 12 weeks using measures of physical, cognitive, and social functioning, satisfaction, adherence, and qualitative interviews. Researchers will monitor enrollment, retention, and participant satisfaction to determine feasibility and acceptability. The total study duration for each participant includes up to 12 weeks of follow-up, with ongoing evaluations of intervention impact and participant experiences.

Age: 65Years +All GendersPhase Not Applicable
1 location
U

Actively Recruiting

This research investigates the use of Battlefield Acupuncture (BFA) to treat chronic pain in veterans who have a history of substance use disorder. The study aims to assess how effective BFA is in reducing chronic pain and to explore its effects on stress, mood, and sleep patterns over an eight-week period. Participants will also complete behavioral assessments measuring depression, anxiety, and substance use at three different times during the study. Participants will be randomly assigned to either an active treatment group receiving BFA or a waitlist control group for eight weeks. The BFA treatment involves placing up to five acupuncture tacks in each ear during weekly 15 to 20-minute appointments. Pain levels are recorded before treatment, after placing three needles in each ear, and again after adding the final two needles. Post-treatment instructions and questions are addressed at each visit. Throughout the study, participants will complete questionnaires on pain, stress, mood, activity levels, sleep, anxiety, depression, and substance use. Data will be securely stored and analyzed later to evaluate outcomes. The total participation time is 16 weeks, including an 8-week treatment or waitlist period followed by an 8-week post-treatment follow-up. Safety monitoring includes reviewing treatment responses and maintaining confidential records.

Age: 18Years +All GendersPhase Not Applicable
1 location
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