Clinical Trial Comparing the Efficacy of Two Teletherapy Programs at Improving Psychological Health in People With Brain Injury

BEHAVIORAL

Program 1

Program 1 will teach participants how to recognize, label, and differentiate their emotions. The program will cover ways to reduce feeling "confused" or numb, and decrease the feelings of anger, stress and being overwhelmed.

BEHAVIORAL

Program 2

Program 2 will teach participants strategies to improve their overall brain health and functioning. It will also teach participants how to develop and work towards individualized short-term and long-term goals aimed at improving their quality of life.

Toronto Alexithymia Scale-20

Time frame: 1) baseline 2) immediate post-treatment, 3) 3 months post-treatment; 4) 6- months post-treatment.

his widely used alexithymia assessment (including the TBI population), is comprised of 3 factors: 1) ability to identify emotions); 2) ability to describe emotions; and 3) externally-oriented thinking. In addition to being a co-primary outcome measure, the TAS-20 scores will be used to determine eligibility (\>.5 SD above published means). It is a CDE and a PhenX toolkit measure has good psychometric properties, including good test-retest reliability. Range: Min/ Max = 20 to 100 Lower scores indicate less alexithymia (good); higher scores indicate greater alexithymia (bad)

Difficulty with Emotion Regulation Scale (DERS; Co-Primary outcome)

Time frame: 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months

This commonly used measure of emotion dysregulation, uses a 5-point Likert scale, participants rate the frequency they utilize self-regulation behaviors in response to general emotional distress. Items are summed to provide a Total Emotion Dysregulation score. The DERS has high internal consistency, test-retest reliability, and good construct validity.56 Will be used to evaluate emotion dysregulation and to determine eligibility (\>.5 SD above published means). Range: Min/ Max = 36 to 180. Lower scores indicate less dysregulation (good); higher scores indicate more dysregulation (bad)

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.