A Trial of Cognitive Behavioral Therapy in Familial Dysautonomia

NYU Langone Health

Status: Completed

Conditions: Familial Dysautonomia; Autosomal Recessive Disease; Dysthymia; Paroxysmal Hypertension; Anxiety Disorders

Treatments: Behavioral: 8-week CBT Program

Study type: Interventional

Funder types: Other

Identifiers

NCT03013777

16-01823

Details and patient eligibility

About

To determine the effect of cognitive behavioral therapy (CBT) in the severity of anxiety and depression in adult patients with familial dysautonomia. Patients will be enrolled in an 8-week CBT program. All CBT sessions will be done either in person at the NYU Dysautonomia Center or over the phone to help accommodate disability and potential physical limitations of our patient population.

Full description

Cognitive behavioral therapy (CBT), defined as a program of interventions that utilize education to teach relaxation, healthy coping skills, stress management, assertiveness training in order to help the individual identify and correct maladaptive beliefs in combination with education to help practice symptom reduction and improve quality of life and function. Patients will participate in eight forty-five minute sessions of CBT with a mental health therapist in order to help treat generalized anxiety disorder, anxiety disorder due to another medical condition (familial dysautonomia), major depressive disorder, persistent depressive disorder (dysthymia), substance/medication- induced depressive disorder, depressive disorder due to another medical condition.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of FD (genetically confirmed)
• DSM-V criteria of major depressive disorder OR anxiety disorder
• STAI score ≥ 25 OR a PHQ-9 depression scale score ≥ 5 or greater
• Willing and able to complete 8 CBT sessions
• Maintain constant psychoactive medication through out study and no concurrent talk therapy from another therapist.

Exclusion criteria

• Currently suicidal or having current suicidal ideations
• Currently under psychiatric treatment for depression or anxiety
• Have started any psychoactive medication within 3 months prior to screening

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Cognitive behavioral therapy (CBT)

Experimental group

Description:

The patient would participate in eight forty-five minute sessions of CBT with a mental health therapist. Cognitive behavioral therapy (CBT), defined as a program of interventions that utilize education to teach relaxation, healthy coping skills, stress management, assertiveness training in order to help the individual identify and correct maladaptive beliefs in combination with education to help practice symptom reduction and improve quality of life and function.

Treatment:

Behavioral: 8-week CBT Program