FDA-Approved & Evidence-Based Non-Medication Treatments for Anxiety, Depression & PTSD

Jan 7

4 min read

Updated: Aug 20

Modern mental health care extends far beyond medication. While medications remain valuable—and sometimes essential—many people are seeking options that support healing from different angles. Today, patients have access to a growing number of FDA-approved digital tools, brain-based treatments, and a wide range of research-backed psychotherapies provided by licensed clinicians.

Below is a guide for FDA-approved/cleared digital therapeutics, prescription software apps, and home medical devices across psychiatry and behavioral health.

Medical Devices & Neurostimulation Wearables

Alpha-Stim (AID / M)
- For: Anxiety, Insomnia, Depression, and Acute/Chronic Pain
- Mechanism: A handheld Cranial Electrotherapy Stimulation (CES) device using earclip electrodes to deliver patented micro-current waveforms that modulate neuronal activity.
- Website: alpha-stim.com
Fisher Wallace Stimulator (KTS / Circadia)
- For: Depression, Anxiety, and Insomnia
- Mechanism: A wearable CES neurostimulation headband delivering gentle electrical currents to stimulate brainwave patterns and key neurotransmitters (serotonin, endorphins) at home.
- Website: fisherwallace.com
Flow FL-100 Headset
- For: Major Depressive Disorder (MDD)
- Mechanism: An at-home tDCS (Transcranial Direct Current Stimulation) device targeting the dorsolateral prefrontal cortex (DLPFC), paired with a behavioral activation app.
- Website: flowneuroscience.com
Freespira
- For: Panic Disorder & PTSD-Related Panic
- Mechanism: A home-based capnometry system that measures breathing rate and exhaled CO2 levels to train and regulate breathing patterns that trigger panic attacks.
- Website: freespira.com
NightWare
- For: PTSD-Related Nightmares
- Mechanism: An Apple Watch-based software system that tracks heart rate and motion during sleep to detect nightmare distress and delivers gentle haptic vibrations to interrupt the nightmare without waking the user.
  NightWare
- Website: nightware.com
Prism for PTSD
- For: Post-Traumatic Stress Disorder (PTSD) & Depression
- Mechanism: An FDA-cleared EEG neurofeedback platform using digital fMRI-informed biomarkers to help patients regulate amygdala-driven stress responses. (Note: Often administered in clinic or clinician-guided settings).
- Website: graymatters-health.com
ProlivRx (by Neurolief)
- For: Major Depressive Disorder (MDD)
- Mechanism: An at-home, non-invasive headband delivering targeted multi-channel electrical stimulation to neural pathways involved in mood regulation.
- Website: prolivrx.com

Prescription Digital Therapeutics (Software & Apps)

DaylightRx (by Big Health)
- For: Generalized Anxiety Disorder (GAD)
- Mechanism: Delivers digital Cognitive Behavioral Therapy (CBT) modules—including imaginal exposure, cognitive restructuring, and applied relaxation—via interactive app sessions.
- Website: bighealth.com/daylight-rx
EndeavorRx (by Akili Interactive)
- For: Pediatric ADHD (Ages 8–17)
- Mechanism: A prescription action-video game designed to target and stimulate specific sensory and motor cortex pathways involved in attention and executive functioning.
- Website: endeavorrx.com
gameChange (by RealizedCare)
- For: Agoraphobic Avoidance, Severe Anxiety & Psychosis
- Mechanism: A prescription Virtual Reality (VR) therapeutic delivering automated, virtual-coach-guided exposure therapy to reduce avoidance in everyday social settings.
- Website: realizedcare.com
Lumosity Rx (by Lumos Labs)
- For: Adult ADHD (Ages 22–55)
- Mechanism: An FDA-cleared digital exercise program providing targeted cognitive training to enhance working memory, processing speed, and attention
- Website: lumosity.com/rx
MamaLift Plus (by Curio Digital Therapeutics)
- For: Postpartum Depression (PPD)
- Mechanism: A digital behavioral health program providing tailored cognitive behavioral strategies, tracking, and skill building for maternal mood changes.
- Website: mymamalift.com
reSET & reSET-O (by Pear Therapeutics / Nox Health)
- For: Substance Use Disorder (SUD) & Opioid Use Disorder (OUD)
- Mechanism: Mobile apps that deliver structured CBT lessons, contingency management incentives, and craving tracking to support recovery and relapse prevention.
- Website: resetforrecovery.com
Rejoyn (by Otsuka America)
- For: Major Depressive Disorder (MDD)
- Mechanism: A prescription smartphone app combining cognitive-emotional training exercises and CBT lessons to serve as an adjunct to antidepressant medication.
- Website: rejoyn.com
SleepioRx (by Big Health)
- For: Chronic Insomnia
- Mechanism: An FDA-cleared, personalized digital CBT for Insomnia (CBT-I) platform that uses automated sleep coaching to retrain sleep habits.
- Website: bighealth.com/sleepio-rx
Somryst (by Pear Therapeutics / Nox Health)
- For: Chronic Insomnia
- Mechanism: A prescription app delivering structured CBT-I modules—including sleep restriction, stimulus control, and cognitive restructuring—to address nighttime thinking and sleep maintenance.
- Website: somryst.com

Evidence-Based Psychotherapies Delivered by Licensed Clinicians

In addition to digital therapeutics, therapy with a trained professional remains one of the most effective non-medication treatments for depression, anxiety, trauma, and emotional dysregulation.

Here are leading therapies supported by research:

Cognitive Behavioral Therapy (CBT)

For: Depression, anxiety, panic & more.

CBT focuses on learning about the association and interplay of thoughts, feelings, behaviors and physical sensations. Developing this insight into ourselves helps us coming up with coping skills when symptoms arise.

Interpersonal Therapy (IPT)

For: Depression.

Addresses how relationship patterns, role transitions, grief, and communication influence mood.

Acceptance and Commitment Therapy (ACT)

For: Anxiety, depression, trauma, and chronic stress.

Helps individuals develop psychological flexibility by learning to allow difficult thoughts and emotions to be present without driving behaviors which allows for allowing other behaviors that are in line with personal values.

Dialectical Behavior Therapy (DBT)

For: Initially developed to treat Borderline Personality Disorder, but found to be helpful for emotional dysregulation, self-harm behaviors, and chronic stress.

Integrates mindfulness, distress tolerance, emotion regulation, and interpersonal effectiveness to build stability and resilience.

Psychodynamic Psychotherapy

For: Mood, anxiety, trauma, and relational patterns.

Explores how past experiences, unconscious feelings, and internal conflicts influence current behaviors, relationships, and emotions—supporting deeper insight and lasting change.

PTSD and Trauma-Focused Therapies

Prolonged Exposure (PE) Helps reduce avoidance and emotional reactivity by gently discussing and reprocessing traumatic memories.
Cognitive Processing Therapy (CPT) Challenges trauma-related beliefs about safety, trust, guilt, and identity. Can be done with trauma reprocessing or independently working on distorted thoughts without delving into trauma.
Eye Movement Desensitization & Reprocessing (EMDR) Uses structured recall paired with bilateral stimulation to resolve traumatic memories stored in the nervous system.

Expanding the Landscape of Care

These approaches—whether structured psychotherapies, digital programs, or device-based treatments—offer individuals multiple paths to healing.

The benefits include:

Options beyond or alongside medication
Skills-building that lasts after treatment
Trauma-informed strategies
Care tailored to personal values and lived experiences

Medication can remain part of the picture, but people deserve personalized, multimodal treatment that matches their goals and needs.