The Carolina Recovery From Depression Protocol (CARED) : A Novel Rapid Treatment Paradigm for Depression
University of North Carolina, Chapel Hill
Summary
The purpose of this study is to primarily assess the feasibility and secondarily assess the efficacy of a single session intervention (SSI) that combines non-invasive brain stimulation and psychotherapy for Major Depressive Disorder (MDD). investigators will recruit 30 people with MDD, with at least mild to moderate symptoms, who are resistant to typical treatments for Major Depressive Disorder. In this trial, participants will receive psychotherapy, Intermittent Theta Burst Stimulation Transcranial Magnetic Stimulation (iTBS), and either active or sham (placebo) Transcranial Alternating Current Stimulation (tACS).
Description
The purpose of this study is to primarily assess the feasibility and secondarily assess the efficacy of a single session intervention (SSI) that combines non-invasive brain stimulation and psychotherapy for Major Depressive Disorder (MDD). Investigators will recruit 30 people with MDD, with at least mild to moderate symptoms, who are resistant to typical interventions for Major Depressive Disorder. In this trial, participants will receive 3 interventions in a single session: psychotherapy, Intermittent Theta Burst Stimulation (iTBS), and participants will be randomized to receive either active…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Any gender, aged 18 - 70 * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * DSM-5 diagnosis of unipolar, non-psychotic MDD as evidenced by the Diagnostic Interview for Anxiety, Mood, and Obsessive-Compulsive and Related Neuropsychiatric Disorders (DIAMOND) * HDRS-17 score ≥14 * Low suicide risk (defined for this study as no active suicidal ideation in the past month and no suicide attempts, preparatory actions, or significant non-suicidal self-harm in the previous…
Interventions
- DeviceIntermittent Theta Burst Stimulation (iTBS)
The TMS stimulation will be delivered using the MagPro X100 system (MagVenture Inc., Alpharetta, Georgia, USA). Participants will receive theta-burst stimulation (iTBS) consisting of 1,800 biphasic pulses delivered in bursts of three pulses at 50 Hz, repeated at 5 Hz (2-s trains, 8-s inter-train interval, 30 trains total per block), at an intensity of 90 % of the resting motor threshold. TMS will be delivered before each tACS/therapy block (over the tACS electrodes), totaling 5 blocks of TMS throughout the single session intervention.
- DeviceTranscranial Alternating Current Stimulation (tACS)
The alpha and -theta tACS stimulation will be delivered using the neuroConn DC Stimulator MC.The interventional tACS stimulation will be 120 minutes of tACS total; 60 minutes will be delivered during the second block of therapy and 60 minutes will be delivered during the third block of therapy.F3 and F4 will be stimulated 'in-phase', with 1 mA applied at each location, and Cz will be stimulated 'anti-phase' with 2mA applied (zero to peak). tACS will be delivered with a 20 second ramp up and ramp down, at the beginning and end of stimulation. The stimulation amplitude delivered is standard for tACS studies conducted in the Frohlich Lab.
- BehavioralPsychotherapy
The three, 1-hour psychotherapy blocks were designed to incorporate effective components from multiple psychotherapies, with an emphasis on functional analysis to define the presenting concern, followed by Behavioral Activation (BA) and Acceptance and Commitment Therapy modules to target low mood and psychological flexibility, respectively. The SSI was designed to incorporate ACT principles throughout the modules, guided by the tenets of psychological flexibility, as described by Hayes. Be present, open up, do what matters. The manual was created by a team of several advanced clinical trainees and two licensed clinical psychologists. The last 10 minutes of each session will be spent briefly reviewing the day's activities, what stood out for participants (negative or positive), and whether they had feedback for the clinician.
Location
- Carolina Center for NeurostimulationChapel Hill, North Carolina