N/A N=78 Randomized Double-blind Treatment

Neuromodulation Enhanced Cognitive Restructuring: A Proof of Concept Study

Anxiety · Depression · Personality Disorders · Trauma and Stress-related Disorders · Somatic Disorders

Bottom Line

View on ClinicalTrials.gov: NCT02573246 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2021

Primary outcome: Primary: Time to Return to Heart Rate Baseline During the Regulation Period During Training — 1.591; 1.828; 1.505; 1.534475 log (seconds) — p=0.019

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Cognitive Restructuring (Behavioral); rTMS (Device); Sham rTMS (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Feb 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Return to Heart Rate Baseline During the Regulation Period During Training	1.591; 1.828; 1.505; 1.534475; 1.946232	0.019 sig
PRIMARY Time to Return to Heart Rate Baseline During the Regulation Period at Follow up	1.448; 1.286; 1.1474; 1.5535; 1.4055	.51
PRIMARY Physiological Emotion Regulation	1.919; 1.763; 1.869; 1.722; 1.549	.022 sig
PRIMARY Changes in Activation in the Neural Emotion Regulation Network	0.573; .462; 0.965; 0.606; 2.597; 2.376	.236
SECONDARY Acceptability, as Measured by Qualitative Exit Interview	7.11; 7.48; 7.20; 6.99; 7.65	0.69
SECONDARY Feasibility, as Measured by Qualitative Exit Interview	6.4545; 6.7500; 6.7481; 6.3651; 6.4646	0.551
SECONDARY Change in General Psychological Distress, as Measured by the Outcome Questionaire -45	59.996; 53.955; 53.049; 74.41; 63.95	0.61
SECONDARY Change in Daily General Emotional Distress	1.388; 1.941; 1.791; 2.026; 1.395	.034 sig
SECONDARY Change in Emotion Dysregulation and Functional Impairment	88.413631; 89.341540; 79.212163; 99.447060; 4.289242; 4.493290	0.629061

Summary

Psychological treatments are effective, but take a long time and can be burdensome. Therefore, avenues to optimize behavioral treatments are needed. Despite important advancements, neuroscience has had a limited effect on psychotherapy development. Therefore, one paradigm shift would be to develop neuroscience informed behavioral treatments. The investigators identified from the literature a problem that affects several mental disorders (emotion dysregulation) and a neural circuit that underlies this important concern. They found that this circuit is dysfunctional in those with psychopathology but can be changed with treatment. The goal is in one session to train this brain network to operate more efficiently and to test the short and long term effects of this intervention. The investigators plan to engage this brain network using a traditional psychotherapy strategy (cognitive restructuring) and to enhance learning using repetitive transcranial magnetic stimulation (rTMS), a neuromodulation technique through which magnetic stimulation enhances the electrical activity in brain areas close to the scalp. The study team proposed two studies to examine this novel approach, In one of the studies 83 participants were enrolled and 47 eligible participants were divided into 3 groups. All participants were trained in emotion regulation by first being asked to remember an event where they experienced a negative emotion and then being instructed either to think differently about the event, or to wait. Participants simultaneously underwent either active (left or right side of brain) or sham rTMS. In a second study 65 participants were enrolled, and 31 were assigned to either active left or sham rTMS guided using neuroimaging results. Across both studies, the investigators measured regulation in the lab and during a-week long naturalistic assessment. Participants in the second study returned for a follow up neuroimaging visit at the end of this week. Participants returned for a one moth follow up assessment and to rate feasibility, acceptability, and provide feedback. This proof of concept set of studies demonstrated feasibility and preliminary efficacy for this approach, which opens new frontiers for neuroscience informed treatment development.

Eligibility Criteria

Inclusion Criteria

Has difficulty thinking differently in emotional situations
Meets diagnostic criteria for a current DSM-5 depressive, anxiety, obsessive-compulsive, somatic, personality, eating, or trauma and stress-related disorders (including in partial remission): major depressive disorder, persistent depressive disorder, panic disorder, agoraphobia, social anxiety disorder, specific phobia, generalized anxiety disorder, obsessive-compulsive disorder, trichotillomania, excoriation disorder, hoarding disorder, body dysmorphic disorder, other specified, or unspecified obsessive-compulsive disorder, posttraumatic stress disorder, acute stress disorder, adjustment disorders, somatic symptom disorder, conversion disorder, anorexia nervosa, bulimia nervosa, binge-eating disorder, borderline personality disorder, narcissistic personality disorder, histrionic personality disorder, antisocial personality disorder, paranoid personality disorder, schizoid personality disorder, schizotypal personality disorder, avoidant personality disorder, dependent personality disorder, obsessive-compulsive personality disorder, personality disorder unspecified, depressive disorder unspecified, anxiety disorder unspecified.
Willing and able to participate in the intervention and all required study visits, stay on the same dose of psychiatric medication (if any) throughout the study, not participate in cognitive-behavioral therapy throughout their participation in the study.
Has cellphone that can be used during the ambulatory assessment portion of the study.

Exclusion Criteria

Current or recent (within the past 6 months) substance dependence disorder(excluding nicotine and caffeine)
Current serious medical illness, including migraine headaches. '
Currently on psychotropic medications with dosage unchanged for less than four weeks prior to study entry OR plan to make changes in medication within 2 months after starting the study
History of seizure except those therapeutically induced by electroconvulsive therapy (ECT), history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, cranial metal implants, known structural brain lesion, devices that may be affected by TMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator).
Diagnosed with the following conditions: psychotic disorder, any DSM disorder secondary to a general medical condition, or substance-induced, Bipolar I disorder (current or lifetime), life-threatening anorexia or any other disorder requiring immediate hospitalization, high-risk for suicidal behavior, including current suicidal ideation with a method and plan or hospitalization for suicidal behavior within 1yr before the study.
Currently engaged or planning to engage in other treatment during the course of the study (including behavior therapy, or other types of individual, family, or group psychotherapy/counseling).
Is diagnosed with a clinically defined neurological disorder including, but not limited to: any condition likely to be associated with increased intracranial pressure; space occupying brain lesion; history of stroke, transient ischemic attack within two years; cerebral aneurysm; dementia; Parkinson's disease; Huntington's disease; Multiple sclerosis.
Has increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication that lowers the seizure threshold (e.g Wellbutrin, Adderall, Clozaril).
Has any of the following treatment histories: TMS treatment at any point in their lifetime; use of any investigational drug or device within 4 weeks of the screening.
Subjects with cochlear implants
Women who are pregnant or breast feeding
Chronic absence of shelter or impending jail that would make consistent participation in the study difficult
Cannot easily come to Duke several times for the study procedures

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Data sourced from ClinicalTrials.gov (NCT02573246). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.