Interoceptive Exposure as a Treatment Option for Disabling Fear of Pain

NCT03523637 | Unknown

• 2 other identifiers: PY18/100386IRAS Project ID: 226054
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Change in Daily Diary

  The Daily Diary is a 9 item questionnaire used for recording daily ratings of pain distress, pain interference and the fear of pain. Items 1-4 use visual analogue scales (VAS) to measure pain distress and interference. Each VAS has two anchors: "not at all distressing" and "extremely distressing" for pain distress questions (Items 1-3) and "does not interfere" and "interferes completely" for pain interference (Item 4), providing a range of scores between 0 and 100. Higher scores indicate greater pain distress and interference. Additionally, there are 5 statements assessing the fear of pain, which participants rate on a 5 point Likert Scale, where the score of 0 equals "not at all" and score of 4 equals "all the time". An example question: "Pain Sensations are terrifying". Total Fear of Pain Score is calculated by adding up scores on items 5 to 9. Higher Scores indicate higher fear of pain, min = 0, max = 20.

  Assessed daily, throughout the duration of the study. Depending on the length of the baseline this will be between 42 and 56 days.

• Change in Activity levels, i.e. number of steps taken

  This will be measured with an activity monitor NOKIA GO worn by participants on their wrists or attached to their belt.

  Assessed daily, throughout the duration of the study. Depending on the length of the baseline this will be between 42 and 56 days.

Secondary Outcomes (5)

• Pain Catastrophising Scale (PCS: Sullivan, Bishop & Pivik, 1995)

  at three time points: assessment (day one), pre-intervention (depending on the length of the baseline 2 weeks, 3 weeks or 4 weeks later) and post-intervention (6, 7 or 8 weeks from the start of the intervention).

• Pain Anxiety Symptoms Scale Short Scale (PASS-20: McCracken & Dhingra, 2002)

  at three time points: assessment (day one), pre-intervention (depending on the length of the baseline 2 weeks, 3 weeks or 4 weeks later) and post-intervention (6, 7 or 8 weeks from the start of the intervention).

• Pain Disability Index (PDI: Pollard, 1984)

  at three time points: assessment (day one), pre-intervention (depending on the length of the baseline 2 weeks, 3 weeks or 4 weeks later) and post-intervention (6, 7 or 8 weeks from the start of the intervention).

• Hospital Anxiety and Depression Scale (HADS: Zigmond & Snaith, 1983)

  at three time points: assessment (day one), pre-intervention (depending on the length of the baseline 2 weeks, 3 weeks or 4 weeks later) and post-intervention (6, 7 or 8 weeks from the start of the intervention).

• Chronic Pain Acceptance Questionnaire (CPAQ: McCracken, Vowles & Eccleston, 2004)

  at three time points: assessment (day one), pre-intervention (depending on the length of the baseline 2 weeks, 3 weeks or 4 weeks later) and post-intervention (6, 7 or 8 weeks from the start of the intervention).

Study Arms (1)

Pain Education/Interoceptive Exposure

EXPERIMENTAL

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.

Behavioral: Interoceptive Exposure

Interventions

Interoceptive Exposure 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.

Pain Education/Interoceptive Exposure

Eligibility Criteria

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

You may qualify if:

• Presence of chronic pain (i.e. pain present for minimum of 3 months following tissue damage)
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Leeds: lead

Study Sites (1)

Pain Clinic, Fielding House at St James's Hospital

Leeds, West Yorkshire, LS9 7TF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Aleksandra Puchala

CONTACT

07925549965; umapu@leeds.ac.uk

Ciara Masterson, Dr

CONTACT

0113 343 8343; C.Masterson@leeds.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Replicated experimental case series, also called replicated single-subject design or replicated single-case research design.

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: May 14, 2018
• Study Start: March 5, 2018
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: May 14, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)