Clinical trial NCT03523637: Interoceptive Exposure as a Treatment Option for Disabling Fear of Pain
Official title: Interoceptive Exposure as a Treatment Option for Disabling Fear of Pain: a Single Case Series
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Lead sponsor: University of Leeds
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Replicated experimental case series, also called replicated single-subject design or replicated single-case research design.
Primary purpose: TREATMENT

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.

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.

Eligibility 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).

Primary outcomes:
measure: Change in Daily Diary
timeFrame: Assessed daily, throughout the duration of the study. Depending on the length of the baseline this will be between 42 and 56 days.
measure: Change in Activity levels, i.e. number of steps taken
timeFrame: 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:
measure: Pain Catastrophising Scale (PCS: Sullivan, Bishop & Pivik, 1995)
timeFrame: 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).
measure: Pain Anxiety Symptoms Scale Short Scale (PASS-20: McCracken & Dhingra, 2002)
timeFrame: 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).
measure: Pain Disability Index (PDI: Pollard, 1984)
timeFrame: 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).
measure: Hospital Anxiety and Depression Scale (HADS: Zigmond & Snaith, 1983)
timeFrame: 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).
measure: Chronic Pain Acceptance Questionnaire (CPAQ: McCracken, Vowles & Eccleston, 2004)
timeFrame: 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).
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Pain Clinic, Fielding House at St James's Hospital
state: West Yorkshire
Study officials:
References: