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Trial registered on ANZCTR


Registration number
ACTRN12618001374257
Ethics application status
Approved
Date submitted
13/08/2018
Date registered
16/08/2018
Date last updated
19/06/2019
Date data sharing statement initially provided
14/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive Bias Modification for interpretation and Expectancy in Patients with Chronic Pain
Scientific title
A randomized controlled trial of cognitive bias modification for interpretation and expectancy in patients with chronic pain
Secondary ID [1] 295737 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic pain 309137 0
Condition category
Condition code
Musculoskeletal 308015 308015 0 0
Osteoarthritis
Musculoskeletal 308016 308016 0 0
Other muscular and skeletal disorders
Neurological 308111 308111 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive Bias Modification for Interpretation (CBM-I); 4 x 20 minute CBM-I sessions over 2 weeks.
Participants will be randomly presented with 30 individual scenarios as a paragraph of text online. Participants will be able to access a link to the intervention from their home computer. The program is automated. Each scenario will be ambiguous, such that it could be interpreted to be pain or illness related, or neutral in its meaning until resolution of a final word fragment. Participants will be instructed to imagine they are the person being described, and must use their understanding of the paragraph to guide solution of the word fragment. There is only one solution that fits the possible interpretation of the preceding paragraph, and given the nature of the intervention, the scenarios will be solved to reveal a neutral (non-pain related) meaning. Once the word fragment is solved, a comprehension question will follow, which can only be correctly answered by having the appropriate interpretation of the previous paragraph.

Expectancy intervention: If participants are randomized to the psychoeducation condition, they will learn about the rationale for CBM-I on two occasions. The first occasion will occur prior to receiving CBM-I intervention. Participants will see the following information:

The intervention you will receive over the course of this study is called Cognitive Bias Modification (CBM).
Cognitive Bias Modification (CBM) has had promising results in previous research, reducing symptoms of depression and anxiety in both healthy and clinical populations. It has also been helpful in reducing fears about dying from cancer, therefore reducing anxiety in people with cancer.
In a study from our laboratory, CBM significantly reduced the amount of time university students spent avoiding a painful task. However, CBM has not been trialed with people experiencing chronic pain. Due to the success of CBM in other populations, we believe CBM will be helpful for you. It is a novel, promising intervention, and you are the first ones to have the opportunity to try it.
Then, they will view a short animated video with a voice over, explaining the basic mechanisms and theory behind the development of chronic pain, and the central role of interpretation biases.

Prior to commencing the second training session, participants in the psychoeducation condition will be asked if they recall watching a video in the previous session. If they say no, they will be directed to re-watch the original video. If they say yes, they will be asked a multiple choice question "What does interpretation bias mean?" If participants correctly identify the definition, they will be directed to watch an abridged re-cap version of the animated video. If they are incorrect, they will be directed to watch the original video.

Participants allocated to proceed with the intervention as usual will not view any of the psychoeducation. Instead, they will be only be presented with instructions for completing the training.

.
Intervention code [1] 312062 0
Behaviour
Comparator / control treatment
CBM-I placebo (4 x 20 minute CBM-I sessions over 2 weeks; i.e. matched to the CBM-I group).: The placebo condition will be structured identically to CBM-I. However, the scenarios in this case will not include emotional content or ambiguity. Resolution of the final word fragment and answering the comprehension question will not require any interpretation of the paragraph.

Expectancy control: The control for the expectancy intervention is a no-intervention control. That is, 50% of participants allocated to CBM-I will get the expectancy intervention and the remainder will not. Similarly, 50% of the placebo CBM group will get the expectancy intervention and the remainder will not.
Control group
Active

Outcomes
Primary outcome [1] 307008 0
Brief Pain Inventory: Intensity subscale This measure will be used to evaluate the severity of participants’ pain (BPI). It will be administered pre-training, after each subsequent (i.e. 3/4) training sessions, at follow-up point 1 (14 days post-baseline) and at follow-up point 2 (28 days post baseline).
Timepoint [1] 307008 0
1. pre-training 2. after each training session 3. follow-up point 1 (14 days post-baseline) [primary timepoint] 4. follow-up point 2 (28 days post-baseline)
Primary outcome [2] 307052 0
Brief Pain Inventory: Interference Subscale
This measure will be used to evaluate the severity of participants’ pain and the impact of this pain on their daily functioning (BPI). It will be administered pre-training, after each subsequent (i.e. 3/4) training sessions (x3), at follow-up point 1 (7 days post-baseline) and at follow-up point 2 (14 days post baseline).
Timepoint [2] 307052 0
1. pre-training 2. after each training session 3. follow-up point 1 (14 days post-baseline) [primary timepoint] 4. follow-up point 2 (28 days post-baseline)
Secondary outcome [1] 350501 0
Fear of Movement
The Tampa Scale for Kinesiophobia (TSK) will be used. This measure will assess how fearful participants are of moving, which is often associated with pain-related disability in this sample. It will be administered pre-training, at follow-up point 1 (7 days post-baseline) and at follow-up point 2 (14 days post baseline).
Timepoint [1] 350501 0
1. pre-training 2. follow-up point 1 (14 days post-baseline) 3. follow-up point 2 (28 days post-baseline)
Secondary outcome [2] 350502 0
Pain Catastrophising
The Pain Catastrophising Scale (PCS) will be used. This measure will help quantify participants’ attitudes towards and emotional distress related to pain. It will be administered pre-training, at follow-up point 1 (7 days post-baseline) and at follow-up point 2 (14 days post baseline).
Timepoint [2] 350502 0
1. pre-training 2. follow-up point 1 (14 days post-baseline) 3. follow-up point 2 (28 days post-baseline)
Secondary outcome [3] 350503 0
Depression and Anxiety
Depression and anxiety are often comorbid with a chronic pain diagnosis, and are usually predictive of more severe and disruptive pain experience. As such, it is important to measure whether changes in pain are associated with changes in either depression or anxiety. The DASS-21 will be administered pre-training, at follow-up point 1 (7 days post-baseline) and at follow-up point 2 (14 days post baseline).
Timepoint [3] 350503 0
1. pre-training 2. follow-up point 1 (14 days post-baseline) 3. follow-up point 2 (28 days post-baseline)
Secondary outcome [4] 350561 0
Interpretation Bias
The Recognition Task will be used to assess interpretation bias. This is hypothesised to be the primary mechanism of change from the CBM-I intervention, and as such will be measured to determine whether CBM-I successfully modified targeted biases compared to placebo. Essentially this is a manipulation check for the CBM-I intervention.

Participants will be presented with ten ambiguous pain/health-related paragraphs, each uniquely identified by a title, that require completion of the final word fragment. A filler task will then be administered. Then, in a randomized order, the identifying title of each scenario followed by four alternative versions of the final sentence will be presented to participants. Participants will be asked to rate each sentence, independently of all others, for its similarity in meaning to the original
Timepoint [4] 350561 0
Follow-up point 1 (14 days post-baseline)
Secondary outcome [5] 350563 0
Treatment credibility
This will be measured by the first 3 questions in the Credibility/Expectancy questionnaire.
This measure will be used to evaluate the impact of the psychoeducation on participants' beliefs about how credible and valid they think the CBM-I training is. Essentially, this measure is a manipulation check for the expectancy manipulation. It will be administered pre-training, after administering the expectancy manipulation.
Timepoint [5] 350563 0
Immediately following the psychoeducation component but before CBM-I or pre-training for the control condition (day 1).
Secondary outcome [6] 350658 0
Treatment expectancy
This will be measured by 3 questions in the Credibility/Expectancy questionnaire.
This measure will be used to evaluate the impact of the psychoeducation on participants' beliefs about how effective they think CBM-I training will be. Essentially, this measure is a manipulation check for the expectancy manipulation. It will be administered pre-training, after administering the expectancy manipulation.
Timepoint [6] 350658 0
Immediately following the psychoeducation component but before CBM-I or pre-training for the control condition (day 1).
Secondary outcome [7] 371554 0
Homograph Task: This is another measure of interpretation bias that requires participants to enter the first word that comes into their mind when they see certain words: e.g. "back". Participants' responses can be categorised into either pain related or neutral, e.g. "back - pain" or "back - front". The task contains 14 ambiguous words for participants to respond to.
Timepoint [7] 371554 0
Follow-up point 1 (14 days post-baseline)

Eligibility
Key inclusion criteria
- Chronic pain (pain > 4/10 on more days that not over the last 3 months)
- Internet access
- Computer literacy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
N/A. It is anticipated that the self-selecting nature of the study will exclude participants who would otherwise not be deemed appropriate (e.g. not able to use the computer due to pain, significant cognitive deficits)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
The program 'Qualtrics' will be used to deliver the entire study. There is an inbuilt feature whereby every time a participant consents to the study, they will be randomly allocated to one of the 4 conditions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on our previous CBM-I study (Jones & Sharpe, 2014) that found the training significantly affected participant’s avoidance of an ensuing pain task, an effect size of 0.35 is expected. It is estimated that with an alpha of 0.05 and 80% power that a sample size of 110 per training group (CBM-I vs placebo) will be sufficient to detect an effect. Therefore, we will aim to recruit 220 people in total (55 per condition).

Primary analyses will be a series of 5 (time) x 2 (training) x 2 (expectancy) ANOVAs conducted on the primary outcomes of the BPI: pain interference and pain intensity.

The secondary analyses will be a series of 2 (time) x 2 (training) x 2 (expectancy) mixed model ANOVAs conducted on the other pain outcome measures to determine pre and post change scores.

It is also of interest to determine whether changes in interpretation bias are associated with pain outcomes. Hence, an interpretive bias score will be calculated and a multiple regression will be conducted to determine whether interpretive bias is the mechanisms of change for the observed changes in pain outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/08/2019
Actual
Date of last participant enrolment
Anticipated
28/10/2019
Actual
Date of last data collection
Anticipated
4/11/2019
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 300329 0
University
Name [1] 300329 0
University of Sydney
Country [1] 300329 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
School of Psychology
Brennan MacCallum Building A18,
Manning Rd,
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 299816 0
None
Name [1] 299816 0
Address [1] 299816 0
Country [1] 299816 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301140 0
The University of Sydney Human Research Ethics Committee (HREC)
Ethics committee address [1] 301140 0
Ethics committee country [1] 301140 0
Australia
Date submitted for ethics approval [1] 301140 0
Approval date [1] 301140 0
11/07/2018
Ethics approval number [1] 301140 0
2018/381

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2962 2962 0 0
/AnzctrAttachments/375733-2018_381 Approval.pdf (Ethics approval)
Attachments [2] 2964 2964 0 0
/AnzctrAttachments/375733-PIS_V2_clean.pdf (Participant information/consent)
Attachments [3] 2971 2971 0 0
/AnzctrAttachments/375733-Participant Consent Form.pdf (Participant information/consent)
Attachments [4] 2974 2974 0 0
/AnzctrAttachments/375733(v13-08-2018-13-05-40)-Protocol_V2_clean.pdf (Protocol)

Contacts
Principal investigator
Name 85990 0
Prof Louise Sharpe
Address 85990 0
Room 450
Brennan MacCallum (A18)
The University of Sydney
NSW, 2006
Country 85990 0
Australia
Phone 85990 0
+61 2 9351 4558
Fax 85990 0
Email 85990 0
louise.sharpe@sydney.edu.au
Contact person for public queries
Name 85991 0
Emma Jones
Address 85991 0
Room 466
Griffith Taylor Building (A19)
The University of Sydney
NSW 2006
Country 85991 0
Australia
Phone 85991 0
+61 2 9351 4257
Fax 85991 0
Email 85991 0
emma.jones@sydney.edu.au
Contact person for scientific queries
Name 85992 0
Louise Sharpe
Address 85992 0
Room 450
Brennan MacCallum (A18)
The University of Sydney
NSW, 2006
Country 85992 0
Australia
Phone 85992 0
+61 2 9351 4558
Fax 85992 0
Email 85992 0
louise.sharpe@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All raw, unidentifiable data (using participant identification numbers).
When will data be available (start and end dates)?
Following publication of the RCT.
No end date
Available to whom?
Researchers who specifically request the data.
Available for what types of analyses?
Meta-analyses
How or where can data be obtained?
The researcher must contact the authors to ask for this data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2124Informed consent form    375733-(Uploaded-16-05-2019-13-59-18)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA double-blind phase II randomized controlled trial of an online cognitive bias modification for interpretation program with and without psychoeducation for people with chronic pain.2023https://dx.doi.org/10.1097/j.pain.0000000000002784
N.B. These documents automatically identified may not have been verified by the study sponsor.