Collaborative Care for Anxiety and Depression in Epilepsy

Wake Forest University (WFU)

Status: Enrolling

Conditions: Epilepsy; Depression; Anxiety

Treatments: Behavioral: usual neurology care; Behavioral: collaborative care

Study type: Interventional

Funder types: Other

Identifiers

NCT05559749

IRB00088764

Details and patient eligibility

About

This is a randomized effectiveness/implementation trial comparing a 24-week neurology-based collaborative care intervention to usual neurology care among 60 adults with epilepsy.

Full description

The intervention is a 24-week, evidence-based collaborative care model initiated around the time of a neurology visit. The collaborative care team roles include the care manager/social worker and psychiatrist who interact with the patient participant and the patient's neurologist/neurology provider.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of signed and dated Informed Consent Form
• Stated willingness to comply with all study procedures
• Males and Females; Age >= 18 years
• * Diagnosis of epilepsy: Epilepsy diagnosis based on neurology clinician impression or EEG findings
• Anxiety or Depression symptoms
• Receiving clinical neurological care at Atrium Health

Exclusion criteria

• Current participation in another treatment of intervention study
• Cognitive limitations precluding completion of Anxiety and Depression self-report instruments on paper, electronically, or by interview
• Comorbid medical condition with life expectancy less than 6 months
• Not a good candidate for collaborative care due to:
• Active ongoing treatment by a psychiatrist
• Active suicidal ideation
• History of past suicide attempt and:
• receiving ongoing psychotherapy OR
• has seen a psychiatrist in the past year
• History of suicide attempt in the past year and:
• currently prescribed 2 or more psychotropic medications for psychiatric indication (not merely as a hypnotic) AND not felt to be a good candidate for collaborative care based on the judgement of the investigators
• Unstable drug or alcohol abuse

For the third Aim (sustainability supplement: intervention only care delivery exploratory study supplement) - the Participants meeting the following criteria may participate

• individuals who meet the above INC-EXC criteria and have completed the Control Arm of a collaborative care research study - NCT05559749 - NCT05353452 or
• individuals who meet the above INC-EXC criteria except rather than having a diagnosis of Epilepsy; they have a diagnosis of functional neurological disorder with seizures

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

collaborative care

Experimental group

Description:

The collaborative care team roles include the care manager/social worker and psychiatrist who interact with the patient participant and the patient's neurologist/neurology provider.

Treatment:

Behavioral: collaborative care

usual neurology care

Active Comparator group

Description:

Ongoing usual neurology care, without the addition of the collaborative care program - current standard care and is thus an ethically appropriate control condition for effectiveness and implementation trials.

Treatment:

Behavioral: usual neurology care