SMS Messaging to Reduce Depression and Anxiety Following TBI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-22

Study Completion Date

2023-07-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Brain Stimulation and Cognitive Training

NCT03338673

Bipolar Disorder Schizo Affective Disorder Schizophrenia

COMPLETED NA

Mobile Phone Text Message Program to Understand Symptoms and Improve Outcomes in Minor Head Injury Patients

NCT01668342

Head Injury, Minor

COMPLETED PHASE1

Cognitive Activation Therapy for MCI: A Randomized Control Study

NCT01641328

Mild Cognitive Impairment

UNKNOWN PHASE1

Pain Management Using Mobile Technology in Veterans With PTSD and TBI

NCT02237885

Chronic Pain Posttraumatic Stress Disorders Traumatic Brain Injury

COMPLETED NA

Efficacy of MindAhead's Digital Behavioral Activation Therapy in Adults with MCI or Mild Dementia

NCT06149013

Mild Cognitive Impairment Mild Dementia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Traumatic Brain Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Motivation

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

Group Type SHAM_COMPARATOR

Motivation

Intervention Type 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.

Intention

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

Group Type ACTIVE_COMPARATOR

Intention

Intervention Type 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.

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.

Group Type EXPERIMENTAL

BA-Tech

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No