NCT02061553

SMS Messaging to Reduce Depression and Anxiety Following TBI

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Albert Einstein Healthcare Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2013-10-22
• Primary completion: 2023-05-09
• Completion: 2023-07-13
• First posted: 2014-02-13
• Last updated: 2023-10-23

Locations

1 site across 1 country: United States