SMS Messaging to Reduce Depression and Anxiety Following TBI

Traumatic Brain Injury Clinical Trial

Official title:

Use of SMS Messaging to Promote Emotional Health for People With Traumatic Brain Injury: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02061553
• Other study ID #: TBIMS HN4473
• Secondary ID: H133A120037
• Status: Completed
• Phase: N/A
• Start date: October 22, 2013
• Est. completion date: July 13, 2023

Study information

• Verified date: August 2023
• Source: Albert Einstein Healthcare Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: July 13, 2023
• Est. primary completion date: May 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Moss Rehabilitation Research Institue	Elkins Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein Healthcare Network	National Institute on Disability, Independent Living, and Rehabilitation Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)