Application of Vagal Stimulation in Exposure and Response Prevention for Obsessive Compulsive Disorder

NCT02196090 | Unknown

• 1 other identifier: SLAM-RD-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Obsessive Compulsive Disorder (OCD) is a condition associated with recurrent intrusive distressing thoughts, images and urges compelling the person to perform neutralizing acts or thoughts to the extent of significantly interfering with their daily activities. The symptoms of OCD are associated with both subjective and objective signs of distress. Treatment for Obsessive Compulsive Disorder is often associated with significant subjective distress with high dropout rates and often only limited improvement. Attempts to reduce distress in anxiety often focus on re-establishing the sympathovagal balance by enhancing the vagal or parasympathetic tone and it has been suggested that this can reduce the mobilization behaviours of fight or flight response and improve emotion regulation. This study will investigate the effect of a procedure potentially reducing distress and improving outcome of treatment in inpatients admitted for treatment for OCD to the Anxiety Disorders Residential Unit. The procedure will be based on increasing vagal tone by application of cold face mask on 3 consecutive days in addition to the standard Exposure and Response Prevention therapy (ERP).

Conditions

Obsessive Compulsive Disorder

Keywords

OCD, Exposure and Response Prevention, Vagal Stimulation

Outcome Measures

Primary Outcomes (5)

• Visual analogue scales at baseline

  Rates of Anxiety, Disgust, Strength of belief in obsession, Strength of urge to carry out the compulsion, Strength of belief in theory A/B, Strength of belief in Theory A/B, Feeling of being supported, Readiness to face the fear obtained from visual analogue scales.

  This measure will be assessed with every exposure on each day of the study at baseline - 5 minutes prior to exposure.

• Visual analogue scales at exposure

  Rates of Anxiety, Disgust, Strength of belief in obsession, Strength of urge to carry out the compulsion, Strength of belief in theory A/B, Strength of belief in Theory A/B, Feeling of being supported, Readiness to face the fear obtained from visual analogue scales.

  This measure will be assessed with every exposure on each day of the study immediately after finishing the exposure

• Visual analogue scales 5 minutes post exposure

  Rates of Anxiety, Disgust, Strength of belief in obsession, Strength of urge to carry out the compulsion, Strength of belief in theory A/B, Strength of belief in Theory A/B, Feeling of being supported, Readiness to face the fear obtained from visual analogue scales.

  This measure will be assessed with every exposure on each day of the study at 5 minutes after the exposure.

• Visual analogue scales 10 minutes post exposure

  Rates of Anxiety, Disgust, Strength of belief in obsession, Strength of urge to carry out the compulsion, Strength of belief in theory A/B, Strength of belief in Theory A/B, Feeling of being supported, Readiness to face the fear obtained from visual analogue scales.

  This measure will be assessed with every exposure on each day of the study at 10 minutes after the exposure.

• Visual analogue scales 15 minutes post exposure

  Rates of Anxiety, Disgust, Strength of belief in obsession, Strength of urge to carry out the compulsion, Strength of belief in theory A/B, Strength of belief in Theory A/B, Feeling of being supported, Readiness to face the fear obtained from visual analogue scales.

  This measure will be assessed with every exposure on each day of the study at 15 minutes after the exposure.

Secondary Outcomes (1)

• Heart rate variability measures

  Heart rate variability measures will be analyzed for specific timeintervals at baseline, during exposure and at three time points after the exposure, at 5, 10 and 15 minutes after exposure.

Other Outcomes (2)

• Symptom severity measures

  These measures will be assessed within 1 week prior to the beginning of study and within 1 week after the last ERP session.

• Client Satisfaction Questionnaire

  This measure will be assessed within 1 week of completing the study.

Study Arms (1)

Single arm

EXPERIMENTAL

Study uses the single case series design with only one arm. All participants in the one arm will have procedures with treatment as usual (Exposure and Response Prevention) alternating with procedures including the vagal maneuver (Cold Face Gel Mask).

Behavioral: Exposure and Response Prevention; Device: Cold face gel mask

Interventions

Exposure and Response Prevention BEHAVIORAL

A procedure where patients with OCD test out their fears without responding by compulsive act.

Also known as: ERP

Single arm

Cold face gel mask DEVICE

Temporary application of cold eye mask on the face is commonly used for relaxation purpose.

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age over 18 years
• signed informed consent
• established diagnosis of OCD

You may not qualify if:

• patients who do not understand English sufficiently to complete the questionnaires
• patients who do not have mental capacity to provide informed consent

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

Anxiety Disorders Residential Unit, Bethlem Royal Hospital

Beckenham, Kent, BR3 3BX, United Kingdom

RECRUITING

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MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Roman Duncko, PhD MRCPsych

  South London and Mausdley NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roman Duncko, PhD MRCPsych

CONTACT

+44(0)2032284545; roman.duncko@slam.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: July 21, 2014
• Study Start: July 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 29, 2016

Record last verified: 2016-02

Locations

GB (1)