Adaptation of the STAIR-NT for First Responders

NCT ID: NCT07212140

Last Updated: 2025-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-06-30

Study Completion Date

2027-06-30

Brief Summary

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This study is a randomized controlled pilot examining the implementation of an adapted intervention, Skills Training in Affective and Interpersonal Regulation-Narrative Therapy (STAIR-NT), among a first responder population with a history of TBI and PTSD.

Detailed Description

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The primary objective of the study is to implement and evaluate the effectiveness of an evidence-based intervention, STAIR-NT, which will be adapted with Goal Management Training (GMT). A small-scale randomized control pilot will be conducted using the adapted intervention to examine implementation (i.e., feasibility, acceptability) and improvements in short-term PTSD, as well as secondary mental health outcomes (e.g., anxiety, and depression symptoms, substance misuse) among a first responder population with a history of TBI and PTSD.

Conditions

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PTSD - Post Traumatic Stress Disorder TBI-Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pilot randomized control trial with an intervention arm and a treatment-as-usual arm.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Adapted STAIR-NT Intervention

Participants in this arm will receive the adapted version of Skills Training in Affective and Interpersonal Regulation-Narrative Therapy (STAIR-NT).

Group Type EXPERIMENTAL

Adapted STAIR-NT

Intervention Type BEHAVIORAL

An adapted version of STAIR-NT that utilizes components from GMT in order to treat PTSD and TBI.

Treatment as usual (TAU)

Participants in this arm will receive treatment as usual.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Adapted STAIR-NT

An adapted version of STAIR-NT that utilizes components from GMT in order to treat PTSD and TBI.

Intervention Type BEHAVIORAL

Other Intervention Names

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Skills Training in Affective and Interpersonal Regulation with Narrative Therapy

Eligibility Criteria

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Inclusion Criteria

* 18 years or older
* be a first responder within the state of Minnesota
* have a history of a TBI
* screen for PTSD.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Invisible Wounds Project

UNKNOWN

Sponsor Role collaborator

United States Department of Defense

FED

Sponsor Role collaborator

Florida State University

OTHER

Sponsor Role lead

Responsible Party

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Joseph Schwartz

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph Schwartz, PhD

Role: PRINCIPAL_INVESTIGATOR

Florida State University

Locations

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Invisible Wounds Project

Forest Lake, Minnesota, United States

Site Status

Countries

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United States

Central Contacts

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Joseph Schwartz, PhD

Role: CONTACT

850-644-7949

Tanya Renn, PhD

Role: CONTACT

850-645-0903

Facility Contacts

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Russ Hanes

Role: primary

(763) 486-3079

Other Identifiers

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HT9425-24-1-0782

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY00005143

Identifier Type: -

Identifier Source: org_study_id

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