Interoceptive Exposure as a Treatment Option for Disabling Fear of Pain

NCT ID: NCT03523637

Last Updated: 2018-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-05

Study Completion Date

2018-09-30

Brief Summary

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The aim of this study is to investigate the use of Interoceptive Exposure (IE) in treatment of disabling fear of pain using a single-case series design.

Detailed Description

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The intervention Interoceptive Exposure (IE) is an exposure to bodily sensations used in treatment of variety of problems where body sensations are experienced as threatening. The application of IE is expected to reduce the threat value of pain and subsequently promote recovery. This study will evaluate the effects of IE and will briefly comprises of: education session explaining the rationale behind IE practice, teaching of the technique, supervised IE practice and self-monitored home practice twice daily for the period of two weeks. Depending on the length of baseline (i.e. observation period before the start of intervention) the study will last between 6 and 8 weeks. Daily Diary, a short nine item instrument was designed to measure the pain experience (intensity and interference) and fear of pain on a daily basis. Other, standard outcome measures include: pain related anxiety, pain catastrophising, pain related disability, knowledge about pain and general anxiety and depression. Study participants will be recruited during routine psychology screening assessment at the Pain Clinic at St James' Hospital. This study will recruit from clinical psychology waiting list patients.

Conditions

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Chronic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Replicated experimental case series, also called replicated single-subject design or replicated single-case research design.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pain Education/Interoceptive Exposure

This study will evaluate the effects of IE and will briefly comprises of: education session explaining the rationale behind IE practice, teaching of the technique, supervised IE practice and self-monitored home practice twice daily for the period of two weeks.

Group Type EXPERIMENTAL

Interoceptive Exposure

Intervention Type BEHAVIORAL

The intervention Interoceptive Exposure (IE) is an exposure to bodily sensations used in treatment of variety of problems where body sensations are experienced as threatening. This psychological technique is about focusing attention on pain, 'staying with the pain' without trying to escape it.

Interventions

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Interoceptive Exposure

The intervention Interoceptive Exposure (IE) is an exposure to bodily sensations used in treatment of variety of problems where body sensations are experienced as threatening. This psychological technique is about focusing attention on pain, 'staying with the pain' without trying to escape it.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Presence of chronic pain (i.e. pain present for minimum of 3 months following tissue damage)
* 18 years or older
* Capacity to give informed consent
* Appropriate diagnostic investigations in other specialties as appropriate have been exhausted and first line interventions, like analgesia, have been tried.
* Participant has appropriate expectations regarding psychological treatment, i.e. does not expect injections etc.

Exclusion Criteria

* Insufficient understanding of English or additional needs which mean the potential participant is unable to complete questionnaires independently. This is because the research project does not have the resources to make significant adaptations to the materials i.e. translation into another language or into Braille.
* Unable to meet the demands of the study (i.e. daily recording of data, daily practice of IE, coming for sessions to St James' Hospital).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Leeds

OTHER

Sponsor Role lead

Responsible Party

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Aleksandra Puchala

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pain Clinic, Fielding House at St James's Hospital

Leeds, West Yorkshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Aleksandra Puchala

Role: CONTACT

07925549965

Ciara Masterson, Dr

Role: CONTACT

0113 343 8343

Facility Contacts

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Vivienne Laidler, Dr

Role: primary

0113 206 5897

Other Identifiers

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IRAS Project ID: 226054

Identifier Type: OTHER

Identifier Source: secondary_id

PY18/100386

Identifier Type: -

Identifier Source: org_study_id

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