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Interoceptive Exposure as a Treatment Option for Disabling Fear of Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03523637
Recruitment Status : Unknown
Verified May 2018 by Aleksandra Puchala, University of Leeds.
Recruitment status was:  Recruiting
First Posted : May 14, 2018
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Aleksandra Puchala, University of Leeds

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: Interoceptive Exposure Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Replicated experimental case series, also called replicated single-subject design or replicated single-case research design.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interoceptive Exposure as a Treatment Option for Disabling Fear of Pain: a Single Case Series
Actual Study Start Date : March 5, 2018
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.




Primary Outcome Measures :
  1. Change in Daily Diary [ Time Frame: Assessed daily, throughout the duration of the study. Depending on the length of the baseline this will be between 42 and 56 days. ]
    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.

  2. Change in Activity levels, i.e. number of steps taken [ Time Frame: Assessed daily, throughout the duration of the study. Depending on the length of the baseline this will be between 42 and 56 days. ]
    This will be measured with an activity monitor NOKIA GO worn by participants on their wrists or attached to their belt.


Secondary Outcome Measures :
  1. Pain Catastrophising Scale (PCS: Sullivan, Bishop & Pivik, 1995) [ Time Frame: 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). ]
    Standardised measure of pain catastrophising. The PCS is a 13 item scale, with each item rated on a 5-point Likert type scale: 0 (Not at all) to 4 (all the time). Sample item: "I worry all the time about whether the pain will end". The PCS is broken into three sub-scales: magnification, rumination, and helplessness. Scores are added up for each sub-scale, a Total Score is achieved by adding up all 13 items. The higher the score, the more catastrophizing thoughts are present. Previous studies have shown a cutoff of more than 30 points to be associated with clinical relevance.

  2. Pain Anxiety Symptoms Scale Short Scale (PASS-20: McCracken & Dhingra, 2002) [ Time Frame: 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). ]
    The PASS-20 assesses pain specific anxiety symptoms using four components of pain-related anxiety: cognitive, fear, escape avoidance, and physiological. Each of the four sub-scales has five items. All items are rated from 0 (never) to 5 (always). Sample item: "I worry when I am in pain". Scores are added up for each sub-scale, a Total Score is achieved by adding up all 20 items. The higher the score, the more pain anxiety symptoms. Maximum Total Score: 100, Minimum Total Score: 0.

  3. Pain Disability Index (PDI: Pollard, 1984) [ Time Frame: 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). ]
    This is a brief self-report measure of disability and is designed to measure the extent to which chronic pain interferes with an individual's ability to engage in activities (Pollard, 1981). Respondents rate the degree to which pain interferes with functioning in seven broad areas: family/home responsibilities, recreation, social activity, occupation, sexual behaviour, self-care, and life-support activity on a ten-point scale of 0 (no disability) to 10 (total disability). Sample Item: "Recreation: This disability includes hobbies, sports, and other similar leisure time activities". An overall score (with a possible total of 70) is computed by summing the seven sub-scales, higher scores indicate greater level of pain related disability. Validity and reliability have been established for this measure (Tait, Chibnall and Krause, 1990).

  4. Hospital Anxiety and Depression Scale (HADS: Zigmond & Snaith, 1983) [ Time Frame: 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). ]
    Standardised questionnaire used in assessing generalised anxiety and depression. The questionnaire comprises seven questions for anxiety and seven questions for depression (total number of items = 14). Each item on the questionnaire is scored from 0 - 3 and this means that a person can score between 0 and 21 for either anxiety or depression. Sample Item: "I feel tense or 'wound up'", response options: "Most of the time" (scored 3 points), "A lot of the time" (Scored 2 points), "From time to time" (Scored 1 point), "Not at all" (Scored 0 points). Although the anxiety and depression questions are interspersed within the questionnaire, they can be added up together (Total Score) or added up within each sub-scale (Depression Total Score and Anxiety Total Score). Higher scores are indicative of more symptoms of Generalised Anxiety and Depression.

  5. Chronic Pain Acceptance Questionnaire (CPAQ: McCracken, Vowles & Eccleston, 2004) [ Time Frame: 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). ]
    Standardised questionnaire used in assessing the acceptance of pain in chronic pain sufferers. The CPAQ assesses acceptance of pain using two factors: Activity Engagement (participation in daily activities while acknowledging the presence of pain, 11 items) and Pain Willingness (the degree to which pain is allowed in experience without efforts to avoid or control it; 9 items). Sample Item: "My life is going well, even though I have chronic pain". The items on the CPAQ are rated on a 7-point scale from 0 (never true) to 6 (always true). Scoring is done by adding the items for Activity engagement and Pain willingness to obtain a Total Score for each factor. Additionally, a total score of Pain Acceptance is calculated by adding the scores for each factor together. Higher scores indicate higher levels of acceptance. Maximum Total Acceptance Score is 120, Minimum Total Acceptance Score is 0.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523637


Contacts
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Contact: Aleksandra Puchala 07925549965 umapu@leeds.ac.uk
Contact: Ciara Masterson, Dr 0113 343 8343 C.Masterson@leeds.ac.uk

Locations
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United Kingdom
Pain Clinic, Fielding House at St James's Hospital Recruiting
Leeds, West Yorkshire, United Kingdom, LS9 7TF
Contact: Vivienne Laidler, Dr    0113 206 5897    vivienne.laidler@nhs.net   
Principal Investigator: Aleksandra Puchala         
Sponsors and Collaborators
University of Leeds
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Responsible Party: Aleksandra Puchala, Principal Investigator, University of Leeds
ClinicalTrials.gov Identifier: NCT03523637    
Other Study ID Numbers: PY18/100386
IRAS Project ID: 226054 ( Other Identifier: Integrated Research Application System )
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms