SMS Messaging to Reduce Depression and Anxiety Following TBI

October 19, 2023 updated by: Amanda Rabinowitz, Albert Einstein Healthcare Network

Use of SMS Messaging to Promote Emotional Health for People With Traumatic Brain Injury: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Elkins Park, Pennsylvania, United States, 19027
        • Moss Rehabilitation Research Institue

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Motivation
1 in person session focused on importance of motivation followed by 8 wk SMS messages with self-selected motivational statements.
Behavioral: Motivation
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.
Active Comparator: Intention
1 session of Behavioral Activation followed by 8 wk SMS messages in the form of BA- based implementation intentions.
Behavioral: Intention
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.
Experimental: BA-Tech
6 in person and 2 phone sessions of Behavioral Activation with EMA-based activity monitoring and SMS-assisted scheduling of value-based activities.
Behavioral: BA-Tech
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline on Brief Symptom Inventory-18 (BSI-18) Global Severity Index
Time Frame: Baseline, 8 weeks (post-treatment)
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.
Baseline, 8 weeks (post-treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Einstein Healthcare Network

Collaborators

National Institute on Disability, Independent Living, and Rehabilitation Research

Investigators

  • Principal Investigator: Amanda Rabinowitz, PhD, Moss Rehabilitation Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2013

Primary Completion (Actual)

May 9, 2023

Study Completion (Actual)

July 13, 2023

Study Registration Dates

First Submitted

February 11, 2014

First Submitted That Met QC Criteria

February 11, 2014

First Posted (Estimated)

February 13, 2014

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBIMS HN4473
  • H133A120037 (Other Grant/Funding Number: NIDRR/U.S. Dept. of Education)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Traumatic Brain Injury

Clinical Trials on Motivation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe