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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 : December 14, 2018
Sponsor:
Collaborator:
National Institute on Disability, Independent Living, and Rehabilitation Research
Information provided by (Responsible Party):
Amanda Rabinowitz, Albert Einstein Healthcare Network

Tracking Information
First Submitted Date  ICMJE February 11, 2014
First Posted Date  ICMJE February 13, 2014
Last Update Posted Date December 14, 2018
Actual Study Start Date  ICMJE October 22, 2013
Estimated Primary Completion Date May 16, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 11, 2014)
Change from baseline on Environmental Reward Observation Scale (EROS) [ Time Frame: Baseline, 8 weeks (post-treatment) ]
EROS is a recently developed tool with good psychometric properties that provides a direct measure of exposure to environmental reward, an increase of which is the proposed mechanism of changes in mood state with BA treatment. Scores have been shown to account for incremental variance in time spent in high- and low-reward behaviors, over and above the variance attributable to depressive symptoms.
Change History Complete list of historical versions of study NCT02061553 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2014)
  • Change from baseline on Behavioral Activation for Depression Scale (BADS) [ Time Frame: Baseline, 8 weeks (post-treatment) ]
    Measure of the frequency of activation, escape, and avoidance behaviors that are predicted to change with BA-style treatment.
  • Change from baseline on Brief Symptom Inventory-18 (BSI-18) [ Time Frame: Baseline, 8 weeks (post-treatment) ]
    Measure of mood and emotional distress. Depression, Anxiety and Global Distress sub-scale T-scores to be examined.
  • Change from Baseline on Frontal Systems Behavior Scale (FrSB) [ Time Frame: Baseline, 8 weeks (post-treatment) ]
    Measure of behavioral function with separate examination of its 3 sub-scales and separate examination of self- and proxy-report;
  • Change from baseline on Participation Assessment with Recombined Tools- Objective (PART-O) [ Time Frame: Baseline, 8 weeks (post-treatment) ]
    Measure of social/ community participation, with separate examination of the 3 sub-scales and separate examination of self- and proxy-report.
  • Change from baseline on Diener Satisfaction With Life Scale (SWLS) [ Time Frame: Baseline, 8 weeks (post-treatment) ]
    This survey is a subjective, 5-item scale of self-rating of global life satisfaction
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SMS Messaging to Reduce Depression and Anxiety Following TBI
Official Title  ICMJE Use of SMS Messaging to Promote Emotional Health for People With Traumatic Brain Injury: A Randomized Controlled Trial
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Traumatic Brain Injury
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Sham Comparator: Motivation
    1 in person session focused on importance of motivation followed by 8 wk SMS messages with self-selected motivational statements.
    Intervention: Behavioral: Motivation
  • Active Comparator: Intention
    1 session of Behavioral Activation followed by 8 wk SMS messages in the form of BA- based implementation intentions.
    Intervention: Behavioral: Intention
  • 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.
    Intervention: Behavioral: BA-Tech
Publications * Hart T, Vaccaro M, Collier G, Chervoneva I, Fann JR. Promoting mental health in traumatic brain injury using single-session Behavioural Activation and SMS messaging: A randomized controlled trial. Neuropsychol Rehabil. 2019 Mar 14:1-20. doi: 10.1080/09602011.2019.1592761. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 30, 2018)
119
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2014)
60
Estimated Study Completion Date  ICMJE September 16, 2022
Estimated Primary Completion Date May 16, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Julianne Wilson 215-663-6415 wilson10@einstein.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02061553
Other Study ID Numbers  ICMJE TBIMS HN4473
H133A120037 ( Other Grant/Funding Number: NIDRR/U.S. Dept. of Education )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Amanda Rabinowitz, Albert Einstein Healthcare Network
Study Sponsor  ICMJE Albert Einstein Healthcare Network
Collaborators  ICMJE National Institute on Disability, Independent Living, and Rehabilitation Research
Investigators  ICMJE
Principal Investigator: Amanda Rabinowitz, PhD Moss Rehabilitation Research Institute
PRS Account Albert Einstein Healthcare Network
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP