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Phone App for Grounding

Primary Purpose

Substance-Related Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Grounding enhanced app
Grounding text-only app
Sponsored by
Treatment Innovations
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance-Related Disorders focused on measuring transition-age youth, mobile app, grounding, Seeking Safety

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • outpatient
  • meets criteria for substance use disorder per the treatment site
  • has a smartphone (either Android or iOS)
  • has not attended and is not currently attending Seeking Safety treatment

Exclusion Criteria:

  • current uncontrolled psychotic or bipolar disorder
  • currently criminal-justice involved such that we would need to report substance use or other possible criminal behavior (e.g., to a parole or probation officer)

Sites / Locations

  • Treatment Innovations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Grounding enhanced app

Grounding text-only app

Arm Description

A mobile app that uses the Seeking Safety grounding chapter content, enhanced with features designed to create strong engagement and interactivity

A mobile app that uses the Seeking Safety grounding chapter content in text format only

Outcomes

Primary Outcome Measures

Grounding Knowledge Test

Secondary Outcome Measures

Total time spent on the app
BASIS-32 Impulsive and Addictive Behavior subscale
Difficulties in Emotion Regulation Scale

Full Information

First Posted
August 16, 2017
Last Updated
December 12, 2021
Sponsor
Treatment Innovations
Collaborators
National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT03258905
Brief Title
Phone App for Grounding
Official Title
Phone App for Grounding (De-escalation) of Substance-abusing Transition-age Youth
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
September 3, 2020 (Actual)
Study Completion Date
September 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Treatment Innovations
Collaborators
National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this project is to continue to develop a smartphone application ("app") to help youth from ages 18-25 who have a substance abuse problem. The app will engage them in grounding, which is a sensory-based experience to help them feel calm by reducing intense negative feelings and impulses (such as the urge to use a substance or hurt themselves or others).
Detailed Description
Substance use disorder (SUD) is the second most common psychiatric diagnosis in the U.S. population. Transition-age youth (TAY) from ages 18-25 are especially vulnerable to substance use and SUD. This time period represents a distinct stage separate from adolescence and later adulthood. It includes tasks such as leaving home to enter college, the workforce, or the military; clarifying vocational goals; and attaining legal drinking age. This period is also prime for experimentation with substance use and associated risks such as driving under the influence, accidents, fighting and violence, HIV, and vulnerability to sexual assault. This project focused on a major strategy, grounding, to help TAY de-escalate (reduce) intense negative emotions and impulses. Grounding has long been used in psychiatric hospitals to provide a safe, quick, and powerful way to reduce any intense negative feeling such as impulses to hurt self or others, substance craving, anger, anxiety, etc. Described in detail in the book Seeking Safety (SS), grounding using three pathways to focus the mind (mental), body (physical), and heart (soothing). Grounding provides a way to regulate emotion, which is a major challenge for TAY, especially given their hormone changes and emotional intensity. Indeed substance use is often described as a short-term way to regulate emotion. Grounding is a key module of SS, a widely-implemented, evidence-based SUD treatment model. In phase 1 the investigator developed a beta version of a grounding app. The app promotes the use of grounding in any environment in which emotions and impulses need to be regulated. It capitalizes on TAYs' widespread use of mobile devices; and because grounding is a stand-alone skill and sensory-oriented, it lends itself wonderfully to an app approach. An iterative product development methodology was used based on end-user feedback and the impact of the app was studied in a pilot randomized controlled trial (RCT) with 24 TAY. Half received the app and the other half received grounding handouts. Results showed that the app was consistently more positively rated than the handouts and was associated with significantly more use of grounding and a higher score on a grounding knowledge test. All phase 1 benchmarks were met. In phase 2 the investigator proposes to scale up both the app and the evaluation of it. There are two specific aims: (1) To enhance the mobile grounding app by using exciting, innovative technology approaches as well as expanding the grounding content in amount and type. (2) To conduct an RCT with 68 TAY to evaluate the grounding app versus a control app. The control app would control for both the use of a mobile device and the grounding content. The primary outcome is based on power analysis from the phase 1 pilot; other outcomes and measures are also included. The RCT uses rigorous scientific methods in its design, measures, and statistics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders
Keywords
transition-age youth, mobile app, grounding, Seeking Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Grounding enhanced app
Arm Type
Experimental
Arm Description
A mobile app that uses the Seeking Safety grounding chapter content, enhanced with features designed to create strong engagement and interactivity
Arm Title
Grounding text-only app
Arm Type
Active Comparator
Arm Description
A mobile app that uses the Seeking Safety grounding chapter content in text format only
Intervention Type
Behavioral
Intervention Name(s)
Grounding enhanced app
Intervention Description
A mobile app that uses the Seeking Safety grounding chapter content, enhanced with features designed to create strong engagement and interactivity
Intervention Type
Behavioral
Intervention Name(s)
Grounding text-only app
Intervention Description
A mobile app that uses the Seeking Safety grounding chapter content in text format only
Primary Outcome Measure Information:
Title
Grounding Knowledge Test
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Total time spent on the app
Time Frame
6 weeks
Title
BASIS-32 Impulsive and Addictive Behavior subscale
Time Frame
6 weeks
Title
Difficulties in Emotion Regulation Scale
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Brief Addiction Monitor
Time Frame
6 weeks
Title
Coping Self-Efficacy Scale
Time Frame
6 weeks
Title
BASIS-32 total score
Time Frame
6 weeks
Title
Perceived Stress Scale
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: outpatient meets criteria for substance use disorder per the treatment site has a smartphone (either Android or iOS) has not attended and is not currently attending Seeking Safety treatment Exclusion Criteria: current uncontrolled psychotic or bipolar disorder currently criminal-justice involved such that we would need to report substance use or other possible criminal behavior (e.g., to a parole or probation officer)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Najavits, PhD
Organizational Affiliation
Treatment Innovations
Official's Role
Principal Investigator
Facility Information:
Facility Name
Treatment Innovations
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Phone App for Grounding

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