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Behavioural Intervention

Smartphone App for Opioid Use Disorder

N/A

Waitlist Available

Led By Noah R Wolkowicz, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

Competency to provide written informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of month 60 (final month of project, upon which completion of phase 3 (stage 1b rct) recruitment and follow-up is anticipated to complete)

Summary

This trial aims to develop a smartphone app called "ACT to RECOVER" to help Veterans with Opioid Use Disorder (OUD) improve their quality of life and functioning. The study will involve

Who is the study for?

This trial is for Veterans with Opioid Use Disorder (OUD) who are currently receiving medication treatment. It aims to improve their quality of life and psychosocial functioning through a new smartphone app, 'ACT to RECOVER'.

What is being tested?

The study tests 'ACT to RECOVER', an app based on Acceptance and Commitment Therapy, against standard symptom-monitoring via smartphone. The trial includes developing the app with Veteran feedback, refining it through usability testing, and then comparing outcomes in a pilot randomized controlled trial.

What are the potential side effects?

As this intervention involves a smartphone application designed for psychological support rather than a drug or medical procedure, traditional physical side effects are not expected. However, participants may experience emotional discomfort while engaging with therapeutic content.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I understand and can sign the consent form.

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I am currently on medication for opioid use disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of month 60 (final month of project, upon which completion of phase 3 (stage 1b rct) recruitment and follow-up is anticipated to complete)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of month 60 (final month of project, upon which completion of phase 3 (stage 1b rct) recruitment and follow-up is anticipated to complete)

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of month 60 (final month of project, upon which completion of phase 3 (stage 1b rct) recruitment and follow-up is anticipated to complete) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

App usage: Completion

App usage: Duration

App usage: Openings

+4 more

Secondary study objectives

Multidimensional Experiential Avoidance Questionnaire (MEAQ

Multidimensional Experiential Avoidance Questionnaire (MEAQ)

Short Inventory of Problems - Revised (SIP-R)

+12 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TreatmentExperimental Treatment1 Intervention

This Phase 3 (Stage 1b RCT) Arm will consist of n = 20 Veterans (anticipated enrollment) who will receive the prototype ACT to RECOVER smartphone intervention for 4 weeks.

Group II: ControlPlacebo Group1 Intervention

This Phase 3 (Stage 1b RCT) Arm will consist of n = 20 Veterans (anticipated enrollment) who will be assigned to receive a smartphone-based symptom-monitoring program for 4 weeks.

0 / 3Eligibility criteria met