SMS Messaging to Reduce Depression and Anxiety Following TBI
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|ClinicalTrials.gov Identifier: NCT02061553|
Recruitment Status : Recruiting
First Posted : February 13, 2014
Last Update Posted : September 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Behavioral: Motivation Behavioral: Intention Behavioral: BA-Tech||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||119 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Use of SMS Messaging to Promote Emotional Health for People With Traumatic Brain Injury: A Randomized Controlled Trial|
|Actual Study Start Date :||October 22, 2013|
|Estimated Primary Completion Date :||May 16, 2022|
|Estimated Study Completion Date :||September 16, 2022|
Sham Comparator: Motivation
1 in person session focused on importance of motivation followed by 8 wk SMS messages with self-selected motivational statements.
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.
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.
6 in person and 2 phone sessions of Behavioral Activation with EMA-based activity monitoring and SMS-assisted scheduling of value-based activities.
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061553
|Contact: Julianne Wilsonfirstname.lastname@example.org|
|United States, Pennsylvania|
|Moss Rehabilitation Research Institue||Recruiting|
|Elkins Park, Pennsylvania, United States, 19027|
|Principal Investigator: Tessa Hart, PhD|
|Principal Investigator:||Tessa Hart, PhD||Moss Rehabilitation Research Institute|