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Trial record 4 of 598 for:    Recruiting, Not yet recruiting, Available Studies | "Substance-Related Disorders"

Phone App for Grounding

This study is not yet open for participant recruitment.
Verified August 2017 by Treatment Innovations
Sponsor:
ClinicalTrials.gov Identifier:
NCT03258905
First Posted: August 23, 2017
Last Update Posted: August 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Treatment Innovations
  Purpose
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).

Condition Intervention Phase
Substance-Related Disorders Behavioral: Grounding enhanced app Behavioral: Grounding text-only app Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Phone App for Grounding (De-escalation) of Substance-abusing Transition-age Youth

Resource links provided by NLM:


Further study details as provided by Treatment Innovations:

Primary Outcome Measures:
  • Grounding Knowledge Test [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Total time spent on the app [ Time Frame: 6 weeks ]
  • BASIS-32 Impulsive and Addictive Behavior subscale [ Time Frame: 6 weeks ]
  • Difficulties in Emotion Regulation Scale [ Time Frame: 6 weeks ]

Other Outcome Measures:
  • Brief Addiction Monitor [ Time Frame: 6 weeks ]
  • Coping Self-Efficacy Scale [ Time Frame: 6 weeks ]
  • BASIS-32 total score [ Time Frame: 6 weeks ]
  • Perceived Stress Scale [ Time Frame: 6 weeks ]

Estimated Enrollment: 68
Anticipated Study Start Date: May 30, 2018
Estimated Study Completion Date: August 30, 2019
Estimated Primary Completion Date: August 30, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
A mobile app that uses the Seeking Safety grounding chapter content, enhanced with features designed to create strong engagement and interactivity
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
A mobile app that uses the Seeking Safety grounding chapter content in text format only

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258905


Contacts
Contact: Lisa Najavits, PhD 6172991620 director@treatment-innovations.org

Sponsors and Collaborators
Treatment Innovations
National Institutes of Health (NIH)
Investigators
Principal Investigator: Lisa Najavits, PhD Treatment Innovations
  More Information

Responsible Party: Treatment Innovations
ClinicalTrials.gov Identifier: NCT03258905     History of Changes
Other Study ID Numbers: R44AA026746-02A1 ( U.S. NIH Grant/Contract )
R44AA026746 ( U.S. NIH Grant/Contract )
First Submitted: August 16, 2017
First Posted: August 23, 2017
Last Update Posted: August 23, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Treatment Innovations:
transition-age youth
mobile app
grounding
Seeking Safety

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders