SMS Messaging to Reduce Depression and Anxiety Following TBI



Status:Recruiting
Conditions:Hospital, Neurology
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - Any
Updated:12/16/2018
Start Date:October 22, 2013
End Date:September 16, 2022
Contact:Julianne Wilson
Email:wilson10@einstein.edu
Phone:215-663-6415

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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.

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.

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.
We found this trial at
1
site
Elkins Park, Pennsylvania 19027
Principal Investigator: Amanda Rabinowitz, PhD
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from
Elkins Park, PA
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