SMS Messaging to Reduce Depression and Anxiety Following TBI

NCT02061553 | Completed

• 2 other identifiers: TBIMS HN4473H133A120037
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury; TBI; head injury; brain injury; depression; anxiety

Outcome Measures

Primary Outcomes (1)

• Change from baseline on Brief Symptom Inventory-18 (BSI-18) Global Severity Index

  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.

  Baseline, 8 weeks (post-treatment)

Study Arms (3)

Motivation

SHAM COMPARATOR

1 in person session focused on importance of motivation followed by 8 wk SMS messages with self-selected motivational statements.

Behavioral: Motivation

Intention

ACTIVE COMPARATOR

1 session of Behavioral Activation followed by 8 wk SMS messages in the form of BA- based implementation intentions.

Behavioral: Intention

BA-Tech

EXPERIMENTAL

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

Interventions

Motivation BEHAVIORAL

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.

Motivation

Intention BEHAVIORAL

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.

Intention

BA-Tech BEHAVIORAL

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.

BA-Tech

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

Moss Rehabilitation Research Institue

Elkins Park, Pennsylvania, 19027, United States

Location

Related Publications (1)

• 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.

  PMID: 30870102 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Craniocerebral Trauma; Brain Injuries; Depression; Anxiety Disorders

Interventions

Information Motivation Behavioral Skills Model; Intention to Treat Analysis

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Models, Psychological; Models, Theoretical; Investigative Techniques; Randomized Controlled Trials as Topic; Controlled Clinical Trials as Topic; Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Amanda Rabinowitz, PhD

  Moss Rehabilitation Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Institute Scientist

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: February 13, 2014
• Study Start: October 22, 2013
• Primary Completion: May 9, 2023
• Study Completion: July 13, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)