CClinicalTrials.gg
CompletedNCT03258905Updated Dec 14, 2021

Phone App for Grounding

A Phase 2 interventional study of Grounding enhanced app and Grounding text-only app in Substance-Related Disorders, sponsored by Treatment Innovations. Completed at 1 site in United States. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2021-12-14.

Sponsored by Treatment Innovations · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Substance-Related Disorders

Keywords

  • transition-age youth
  • mobile app
  • grounding
  • Seeking Safety
03

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    Grounding enhanced app

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

    Behavioral: Grounding enhanced app

  • Active comparator
    Grounding text-only app

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

    Behavioral: Grounding text-only app

Interventions

  • BehavioralGrounding enhanced app

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

  • BehavioralGrounding text-only app

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

05

What researchers measure

Primary outcomes

  1. Grounding Knowledge Test

    Time frame: 6 weeks

Secondary outcomes

  1. Total time spent on the app

    Time frame: 6 weeks

  2. BASIS-32 Impulsive and Addictive Behavior subscale

    Time frame: 6 weeks

  3. Difficulties in Emotion Regulation Scale

    Time frame: 6 weeks

Other outcomes

  1. Brief Addiction Monitor

    Time frame: 6 weeks

  2. Coping Self-Efficacy Scale

    Time frame: 6 weeks

  3. BASIS-32 total score

    Time frame: 6 weeks

  4. Perceived Stress Scale

    Time frame: 6 weeks

06

Study locations

1 site
  • Treatment Innovations
    Newton, Massachusetts 02459, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03258905
Lead sponsor
Treatment Innovations
Collaborators
National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party
Sponsor
First posted
Aug 23, 2017
Start date
Nov 1, 2019
Primary completion
Sep 3, 2020
Completion
Sep 3, 2020
Last update
Dec 14, 2021

Study contacts

Lisa Najavits, PhD
principal investigator · Treatment Innovations

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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