SMS Messaging to Reduce Depression and Anxiety Following TBI

SMS Messaging to Reduce Depression and Anxiety Following TBI

 

Detailed Description:

This study employs a 2-group randomized controlled design to examine the efficacy of a treatment based on BA using SMS message reminders (ie text messages) containing self-statements in the form of implementation intentions. These implementation intentions are created collaboratively by participants and therapists in a single 2-hour session that uses principles of brief BA, which incorporates the translation of important life values into the planning of rewarding activities that support those values.

Participants will be randomized 2:1 to a condition using BA-based implementation intentions delivered daily x 8 weeks (Intention group) or to 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). This condition will control for non-specific motivating effects of attention from a therapist and the novelty or "alerting" value of receiving SMS messages, without the hypothesized "active ingredient" provided by reminding of specific action plans (intentions). Participants in both groups will be contacted by phone at 4 weeks to offer modifications or replacements for their messages. We will compare groups on change over 8 weeks on: (1) perceived degree of environmental reward, (2) degree of behavioral activation, (3) emotional status, (4) societal participation, and (5) satisfaction with life.

 

 Eligibility
 

Ages Eligible for Study:  

18 Years and older   (Adult, Senior)

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.

 

Contacts and Locations

·         Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies. 

Please refer to this study by its ClinicalTrials.gov identifier: NCT02061553
 

Contacts

Contact: Kelly Bognar

215-663-6411

MacNamaK@einstein.edu

 

Locations

United States, Pennsylvania

Moss Rehabilitation Research Institue

Recruiting

Elkins Park, PennsylvaniaUnited States, 19027

Principal Investigator: Tessa Hart, PhD         

Sponsors and Collaborators

Albert Einstein Healthcare Network

U.S. Department of Education

Investigators

Principal Investigator:

Tessa Hart, PhD

Moss Rehabilitation Research Institute