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SMS Messaging to Reduce Depression and Anxiety Following TBI

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivation
Intention
BA-Tech
Sponsored by
Albert Einstein Healthcare Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring traumatic brain injury, TBI, head injury, brain injury, depression, anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • TBI (open or closed), sustained at least 6 months prior, of at least complicated-mild injury severity as evidenced by loss or alteration of consciousness not due to intoxication/ sedation and/ or positive neuroimaging findings consistent with TBI;
  • At least mild depression and/ or anxiety as evidenced by a score of >5 on PHQ-9 and/ or GAD-7, but without endorsement of suicidal ideation
  • Independent in basic home activities and able to travel independently in the community
  • Fluent in English and able to communicate adequately for participation in the experimental protocol

Exclusion Criteria:

  • History of serious mental illness such as schizophrenia, schizo-affective disorder, or well-documented bipolar disorder;
  • Current psychiatric instability, including very severe depression/ anxiety as indicated by PHQ-9 or GAD-7 ≥20; current substance dependence; or active suicidal ideation
  • Significant cognitive disability for reasons other than TBI (e.g., developmental disability);
  • Inability to use phone texting function due to sensory or motor limitations;
  • Concurrent involvement in one-to-one counseling or psychotherapy for emotional issues.

Sites / Locations

  • Moss Rehabilitation Research Institue

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

Experimental

Arm Label

Motivation

Intention

BA-Tech

Arm Description

1 in person session focused on importance of motivation followed by 8 wk SMS messages with self-selected motivational statements.

1 session of Behavioral Activation followed by 8 wk SMS messages in the form of BA- based implementation intentions.

6 in person and 2 phone sessions of Behavioral Activation with EMA-based activity monitoring and SMS-assisted scheduling of value-based activities.

Outcomes

Primary Outcome Measures

Change from baseline on Brief Symptom Inventory-18 (BSI-18) Global Severity Index
The Brief Symptom Inventory (BSI) measure consists of 18 emotional distress items that are rated on a 5 point Likert scale and yield a Global Severity Index as well as Symptom Dimensions (Somatization, Depression, Anxiety.

Secondary Outcome Measures

Full Information

First Posted
February 11, 2014
Last Updated
October 19, 2023
Sponsor
Albert Einstein Healthcare Network
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research
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1. Study Identification

Unique Protocol Identification Number
NCT02061553
Brief Title
SMS Messaging to Reduce Depression and Anxiety Following TBI
Official Title
Use of SMS Messaging to Promote Emotional Health for People With Traumatic Brain Injury: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 22, 2013 (Actual)
Primary Completion Date
May 9, 2023 (Actual)
Study Completion Date
July 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein Healthcare Network
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research

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
This investigation addresses emotional health in community dwelling persons with traumatic brain injury (TBI). It is designed to test the efficacy of a novel behavioral treatment for depression and anxiety symptoms. This treatment incorporates principles of Behavioral Activation (BA), a promising treatment model for depression and anxiety after TBI, and implementation intentions, a theoretically motivated method to enhance enactment of goal-relevant behaviors via action planning. To maximize the impact of this intervention over time, we use the low-cost, widely available technology of SMS, or text messaging, to promote positive behavior change in accordance with planned values and intentions. Participants are randomized 1:2:2 to one of three conditions. Condition 1: a control condition in which participants receive SMS messages with self-selected motivational statements. Condition 2: a condition using BA-based implementation intentions. Condition 3: a condition using BA-based activity monitoring and scheduling based on personal values.
Detailed Description
This study employs a 3-group randomized controlled design to examine the efficacy of treatment based on BA using SMS (i.e., text messages) containing reminders to perform scheduled activities based on personal values. These activities are determined collaboratively by participants and therapists during therapy sessions using principles of BA, which incorporates the translation of important life values into the planning of rewarding activities that support those values. Participants will be randomized 1:2:2 to one of three conditions. The first is a control condition in which participants receive a 2-hour session with education on the importance of self-confidence and motivation, followed by 8 weeks of daily SMS messages with self-selected motivational statements (Motivation group). The second condition uses BA-based implementation intentions delivered daily x 8 weeks (Intention group). The third condition (BA-Tech) has a total of 8 therapy sessions, 6 in person and 2 by phone, and uses BA-based activity scheduling with SMS reminders, plus app-based ecological momentary assessment (EMA) for monitoring the relations among activities, contexts, and reward. The first condition will control for non-specific motivating effects of attention from a therapist and the novelty or "alerting" value of receiving SMS messages. The second condition introduces the idea of Behavioral Activation but does not contain activity monitoring or value-based activity scheduling. Participants in the Motivation and Intention groups will be contacted by phone at 4 weeks to offer modifications or replacements for their messages. Participants in the BA-Tech group will be able to modify their messages weekly once begun. We will compare groups on change over 8 weeks on: (1) emotional status, (2) perceived degree of environmental reward, (3) degree of behavioral activation, (4) societal participation, and (5) satisfaction with life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
traumatic brain injury, TBI, head injury, brain injury, depression, anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motivation
Arm Type
Sham Comparator
Arm Description
1 in person session focused on importance of motivation followed by 8 wk SMS messages with self-selected motivational statements.
Arm Title
Intention
Arm Type
Active Comparator
Arm Description
1 session of Behavioral Activation followed by 8 wk SMS messages in the form of BA- based implementation intentions.
Arm Title
BA-Tech
Arm Type
Experimental
Arm Description
6 in person and 2 phone sessions of Behavioral Activation with EMA-based activity monitoring and SMS-assisted scheduling of value-based activities.
Intervention Type
Behavioral
Intervention Name(s)
Motivation
Intervention Description
Control condition in which participants receive a single session with education on the importance of self-confidence and motivation, followed by 8 weeks of daily SMS messages with self-selected motivational statements.
Intervention Type
Behavioral
Intervention Name(s)
Intention
Intervention Description
Implementation intentions are created collaboratively by participants and therapists in a single 2-hour session that uses principles of brief BA (the planning of rewarding activities). BA-based implementation intentions will then be delivered daily by text for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
BA-Tech
Intervention Description
Participants undergo a total of 8 sessions with a therapist. During these sessions, participants learn about the principles of BA (the translation of important life values into the planning of rewarding activities that support those values). The participants' values are explored and an activity schedule is created collaboratively by participants and therapists based on those values. Reminders to complete the scheduled activities will then be delivered by text once the schedule is made. Participants in this arm will also be monitoring their daily activities (and rating them based on enjoyment and perceived achievement) using a cell phone application.
Primary Outcome Measure Information:
Title
Change from baseline on Brief Symptom Inventory-18 (BSI-18) Global Severity Index
Description
The Brief Symptom Inventory (BSI) measure consists of 18 emotional distress items that are rated on a 5 point Likert scale and yield a Global Severity Index as well as Symptom Dimensions (Somatization, Depression, Anxiety.
Time Frame
Baseline, 8 weeks (post-treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: TBI (open or closed), sustained at least 6 months prior, of at least complicated-mild injury severity as evidenced by loss or alteration of consciousness not due to intoxication/ sedation and/ or positive neuroimaging findings consistent with TBI; At least mild depression and/ or anxiety as evidenced by a score of >5 on PHQ-9 and/ or GAD-7, but without endorsement of suicidal ideation Independent in basic home activities and able to travel independently in the community Fluent in English and able to communicate adequately for participation in the experimental protocol Exclusion Criteria: History of serious mental illness such as schizophrenia, schizo-affective disorder, or well-documented bipolar disorder; Current psychiatric instability, including very severe depression/ anxiety as indicated by PHQ-9 or GAD-7 ≥20; current substance dependence; or active suicidal ideation Significant cognitive disability for reasons other than TBI (e.g., developmental disability); Inability to use phone texting function due to sensory or motor limitations; Concurrent involvement in one-to-one counseling or psychotherapy for emotional issues.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda Rabinowitz, PhD
Organizational Affiliation
Moss Rehabilitation Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moss Rehabilitation Research Institue
City
Elkins Park
State/Province
Pennsylvania
ZIP/Postal Code
19027
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30870102
Citation
Hart T, Vaccaro M, Collier G, Chervoneva I, Fann JR. Promoting mental health in traumatic brain injury using single-session Behavioural Activation and SMS messaging: A randomized controlled trial. Neuropsychol Rehabil. 2020 Sep;30(8):1523-1542. doi: 10.1080/09602011.2019.1592761. Epub 2019 Mar 14.
Results Reference
derived

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SMS Messaging to Reduce Depression and Anxiety Following TBI

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