Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000758808
Ethics application status
Approved
Date submitted
11/04/2021
Date registered
16/06/2021
Date last updated
9/05/2024
Date data sharing statement initially provided
16/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exploration of the impact of Obsessive-Compulsive Disorder in Chronic Pain and associated rehabilitation through a mixed-method design.
Scientific title
Exploration of the impact of Obsessive-Compulsive Disorder in Chronic Pain and associated rehabilitation through a mixed-method design.
Secondary ID [1] 303699 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 321116 0
Obsessive-Compulsive Disorder 321117 0
Condition category
Condition code
Anaesthesiology 318910 318910 0 0
Pain management
Mental Health 318911 318911 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The aim of this study is to explore the prevalence and impact of Obsessive-Compulsive Disorder (OCD) amongst Chronic Pain sufferers attending a Community Pain Service in New Zealand.
Community Pain Services in New Zealand are specialist multidisciplinary services consisting of two stages, with individuals with Chronic Pain issues referred into the first stage. The second stage expands and builds upon services delivered in the first stage, and includes mandatory medical practitioner input and medication review. Progression into a second stage depends on individual needs, complexity of barriers to pain rehabilitation, and resource requirements. There are no specific timeframes for completion of a Community Pain Service Programme, although there are limitations in terms of resources and funding. As part of standard service practices, Electronic Persistent Pain Outcome Collaboration (ePPOC) data sets are administered at intake and on completion (either at stage one or two depending on the individual’s service progression) points of individual Pain Service programmes. These data sets contain 17 registration and demographic items; a total of 56 questions across five individual clinical assessment measures (i.e. Brief Pain Inventory [BPI], Body Map, Depression Anxiety Stress Scale-21 [DASS-21], Pain Self-Efficacy Questionnaire [PSEQ], and Pain Catastrophising Scale [PCS]); as well as supplementary questions relating to medication, health services utilization, and treatment provided. The estimated completion time for these data sets are 20 minutes, although this is subject to personal variability for factors such age, language, and level of disability.
A study flyer, including the primary researcher’s (CS) contact details, will be included with initial service documents sent to individuals starting at a Community Pain Service with a private rehabilitation-focused company, Habit Health. Pain Service Key Workers (clinicians performing the initial assessment and managing the overall programme) will also approach already enrolled, and eligible, service clients at any time during the course of their active programme (no set time frame), to inform them of the study and to attain verbal consent for their contact details to be passed on to the primary researcher. The primary researcher would then contact, or be contacted by, assenting individuals to discuss the study details and confirm eligibility. Eligible clients will be emailed a link via REDCap web-based survey to complete informed consent and baseline measure, the Obsessive Compulsive Inventory-Revised (OCI-R). Individuals unable to access the online survey will be provided with a physical study pack comprising the study information sheet, informed consent form, an OCI-R measure, and postage-paid return envelope. The OCI-R is anticipated to take 5 to 10 minutes to complete. The primary researcher will follow-up on surveys where there has been no response within 1 to 2 weeks of the survey initially being sent. This will occur via either email or telephone call.
Results from the OCI-R will be used to make comparisons of results from the ePPOC measure sets, at both participant intake and at completion of each Pain Service programme. This study anticipates recruiting 150 participants.
Additionally, through purposeful sampling, 3-6 individuals indicating OCD–Chronic Pain comorbidity, (either by clinical diagnosis or as supported by high OCI-R and ePPOC results) will be approached to participate in a one-on-one semi-structured interview. This interview will be conducted by the primary researcher, a registered clinical psychologist, following the completion of any active Community Pain Service, and will be focused on exploring the experiences of their conditions and pain rehabilitation. Interviewees will also complete an obsession directed self-report measure (Obsessive Beliefs Questionnaire 44 [OBQ-44]) to assist in providing clinical understanding of participant experiences regarding obsessions. Interviews will primarily look to be conducted face-to-face at a venue suitable to both the interviewer and interviewee, with consideration of personal/cultural factors. Video-conferencing options may also be considered in light of distance/travel related issues. It is anticipated that the interview will take approximately 60 minutes in length, with a further 20 minutes to complete the OBQ-44.

Intervention code [1] 320000 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326898 0
Determine proportion of participants with total scores on the Obsessive Compulsive Inventory-Revised (OCI-R) equal to or above 21
Timepoint [1] 326898 0
Cumulative participant responses will be assessed at the end of the recruitment period on 30th June 2023
Primary outcome [2] 326899 0
Chronic Pain complexity, pain intensity, and daily life interference will be assessed using a composite of responses to intake electronic Persistent Pain Outcome Collaboration (ePPOC) data sets, including healthcare utilization questions, as well as scores for Brief Pain Inventory (BPI), Pain Catastrophizing Scale (PCS), and Pain Self-Efficacy Questionnaire (PSEQ). OCD tendency will be assessed using total scores for the Obsessive Compulsive Inventory-Revised (OCI-R).
Timepoint [2] 326899 0
Cumulative participant responses will be assessed at the end of the recruitment period on 30th June 2023
Primary outcome [3] 326900 0
Need for clinical input (i.e. level of service resources utilized) will be based on the identification of whether a Pain Programme has required a transition to a Community Service Stage 2 during its course. Pain outcome will be assessed through responses to completion electronic Persistent Pain Outcome Collaboration (ePPOC) data set questions regarding reported change in pain and reported change in physical abilities. OCD tendencies will be assessed using total scores for the Obsessive Compulsive Inventory-Revised (OCI-R).
Timepoint [3] 326900 0
Cumulative participant responses will be assessed at the end of the recruitment period on 30th June 2023
Secondary outcome [1] 393041 0
Composite of semi-structured interviews and responses on the Obsessive Beliefs Questionnaire-44 (OBQ-44) will be used assess how individuals make sense of experiences of Chronic Pain and OCD, and how accounts of obsessions and compulsions contribute to pain rehabilitation experiences. Interviews will be conducted one-on-one, and will be audio-recorded and transcribed verbatim.
Timepoint [1] 393041 0
Set for 30th June 2023

Eligibility
Key inclusion criteria
(i) Involvement in an active Community Pain Service programme with Habit Health (private rehabilitation-focused company)
(ii) 18 years and older.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Inability to independently complete report measures due to lack of proficiency with English Language.
(i) Inability to obtain consent

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
OCI-R scores for each participant will be analysed. To answer the question of prevalence rate, an OCI-R total score of 21 will be set as a cutoff mark to dichotomize between OCD presence and non-presence. The OCD prevalence rate of participants will be estimated with 95% ‘Wilson’ binomial confidence intervals (CI), and rates will be considered greater than the general population if the lower bound of the 95% CI exceeds 3%. Three per cent was chosen as it denotes the upper limit of OCD prevalence rates identified amongst general population studies.
Associations between OCD and experiences of chronic pain will be explored through generalized linear regression models, with individuals’ OCI-R total scores included as the explanatory independent variable. Outcomes of interest include those measured via the ePPOC at baseline; pain catastrophizing (PCS), pain intensity and interference ratings (BPI), pain self-efficacy (PSEQ), and length of time that pain has been present. Reported change in pain and in physical abilities between service entry and discharge will be modelled without adjustment for baseline differences. The proportion of participants who transition into Pain Service stage 2 will be determined, and compared by OCI-R using log-binomial or logistic regression models.
Count outcome variables will be analysed through use of Poisson regression model. These will include: Number of times seeing a GP and Number of times consulting health professionals prior to the start of the Pain Service.
Non-linear associations between OCI-R and outcomes variables will be modeled using restricted cubic splines. In addition to univariable models, multivariable models will be run with, and adjustment for, potential confounders. The study identifies various confounding variables include: Age; Gender; Ethnicity; depression (DASS-21); and Medication use (Benzodiazepines and Opioids).

We estimate we will be able to enroll 150 participants during the study recruitment period. This sample size will allow us to estimate the prevalence of OCD with 95% CI of approximately 5% in width.

Detailed case-by-case analysis will be done of individual interview transcripts from a sample of 7 to 10 participants, according to an Interpretative Phenomenological Analysis (IPA) approach.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
Other reasons
Practical considerations
Date of first participant enrolment
Anticipated
Actual
6/06/2020
Date of last participant enrolment
Anticipated
30/04/2023
Actual
30/04/2023
Date of last data collection
Anticipated
30/06/2023
Actual
30/06/2023
Sample size
Target
150
Accrual to date
Final
103
Recruitment outside Australia
Country [1] 23547 0
New Zealand
State/province [1] 23547 0

Funding & Sponsors
Funding source category [1] 308114 0
Self funded/Unfunded
Name [1] 308114 0
Study is funded solely by the Primary Researcher
Country [1] 308114 0
Primary sponsor type
University
Name
Otago University
Address
Department of Anaesthesia
University of Otago
2 Riccarton Avenue
Christchurch Central City
Christchurch
8011
Country
New Zealand
Secondary sponsor category [1] 308868 0
None
Name [1] 308868 0
Address [1] 308868 0
Country [1] 308868 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308099 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 308099 0
Ethics committee country [1] 308099 0
New Zealand
Date submitted for ethics approval [1] 308099 0
Approval date [1] 308099 0
20/04/2020
Ethics approval number [1] 308099 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109534 0
Mr Chad Sloley
Address 109534 0
Department of Anaesthesia
University of Otago, Christchurch
2 Riccarton Avenue
PO Box 4345
Christchurch
8140
Country 109534 0
New Zealand
Phone 109534 0
+64 22 431 4013
Fax 109534 0
Email 109534 0
[email protected]
Contact person for public queries
Name 109535 0
Chad Sloley
Address 109535 0
Department of Anaesthesia
University of Otago, Christchurch
2 Riccarton Avenue
PO Box 4345
Christchurch
8140
Country 109535 0
New Zealand
Phone 109535 0
+64 22 431 4013
Fax 109535 0
Email 109535 0
[email protected]
Contact person for scientific queries
Name 109536 0
Chad Sloley
Address 109536 0
Department of Anaesthesia
University of Otago, Christchurch
2 Riccarton Avenue
PO Box 4345
Christchurch
8140
Country 109536 0
New Zealand
Phone 109536 0
+64 22 431 4013
Fax 109536 0
Email 109536 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlying published results only, after de-identification
When will data be available (start and end dates)?
Immediately following publication,. No end date determined.
Available to whom?
Case-by-case basis at the discretion of the Principal Investigator
Available for what types of analyses?
To achieve aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by the Principal Investigator ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProtocol for a mixed-method cohort study investigating the prevalence and impact of obsessive-compulsive disorder (OCD) in chronic pain rehabilitation.2021https://dx.doi.org/10.1136/bmjopen-2021-052288
N.B. These documents automatically identified may not have been verified by the study sponsor.