Clinical trial NCT02061553: SMS Messaging to Reduce Depression and Anxiety Following TBI
Official title: Use of SMS Messaging to Promote Emotional Health for People With Traumatic Brain Injury: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: traumatic brain injury
TBI
head injury
brain injury
depression
anxiety
Lead sponsor: Albert Einstein Healthcare Network
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2014-02-13
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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);
* Inability to use phone texting function due to sensory or motor limitations;
* Concurrent involvement in one-to-one counseling or psychotherapy for emotional issues.

Primary outcomes:
measure: Change from baseline on Brief Symptom Inventory-18 (BSI-18) Global Severity Index
timeFrame: Baseline, 8 weeks (post-treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Elkins Park
country: United States
facility: Moss Rehabilitation Research Institue
state: Pennsylvania
Study officials:
affiliation: Moss Rehabilitation Research Institute
name: Amanda Rabinowitz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. 2020 Sep;30(8):1523-1542. doi: 10.1080/09602011.2019.1592761. Epub 2019 Mar 14.