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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
Sponsor:
Collaborator:
National Institute on Disability, Independent Living, and Rehabilitation Research
Information provided by (Responsible Party):
Tessa Hart, Albert Einstein Healthcare Network

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Behavioral: Motivation Behavioral: Intention Behavioral: BA-Tech Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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);
  • Concurrent involvement in one-to-one counseling or psychotherapy for emotional issues.

Information from the National Library of Medicine

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


Contacts
Contact: Julianne Wilson 215-663-6415 wilson10@einstein.edu

Locations
United States, Pennsylvania
Moss Rehabilitation Research Institue Recruiting
Elkins Park, Pennsylvania, United States, 19027
Principal Investigator: Tessa Hart, PhD         
Sponsors and Collaborators
Albert Einstein Healthcare Network
National Institute on Disability, Independent Living, and Rehabilitation Research
Investigators
Principal Investigator: Tessa Hart, PhD Moss Rehabilitation Research Institute

Responsible Party: Tessa Hart, Institute Scientist, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT02061553     History of Changes
Other Study ID Numbers: TBIMS HN4473
H133A120037 ( Other Grant/Funding Number: NIDRR/U.S. Dept. of Education )
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tessa Hart, Albert Einstein Healthcare Network:
traumatic brain injury
TBI
head injury
brain injury
depression
anxiety

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System