ANZCTR - Registration

Registration number

ACTRN12616001318471p

Ethics application status

Submitted, not yet approved

Date submitted

15/09/2016

Date registered

20/09/2016

Date last updated

20/09/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

Does attention bias predict which pain patients benefits from mindfulness and distraction

Scientific title

A comparison of the efficacy of mindfulness interoceptive exposure and distraction in the management of chronic pain: The moderating role of attentional bias

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

n/a

Trial acronym

n/a

Linked study record

n/a

Health condition

Health condition(s) or problem(s) studied:

Chronic pain

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Mindfulness Interoceptive Exposure Task: This is a mindfulness-based procedure which encourages participants to mindfully focus on their pain and monitor changes in four fundamental characteristics of body sensation, namely mass, temperature, motion and cohesiveness/solidity). Participants are trained by a clinical psychologist in this technique in a single, 45 minute face-to-face session and the asked to practice daily over a period of two weeks. Adherence will be determined by logs retrieved from the patient. A booklet to describe the task and record practice will be given. As it is a single, brief intervention no check for fidelity will be made.

Intervention code [1]

Treatment: Other

Comparator / control treatment

There are two control groups (1) a wait-list control group; and (2) a distraction group. The latter is an active control group.

The control group will continue to have their usual care, but will not have any psychosocial intervention during the treatment period.

Distraction: This technique encourages participants to use distraction based around visualisation of a relaxing scene, such as imagining themselves on a beach. Participants are trained in this technique in a single, 45 minute session and the asked to practice over a period of two weeks. All aspects of this intervention are matched to the mindfulness intervention described above.

Control group

Active

Outcomes

Primary outcome [1]

Pain Intensity: The pain intensity subscale of the Brief Pain Inventory will be used to measure pain.

Timepoint [1]

Two weeks following the initial session where the skills are taught is considered to be the post-treatment outcome point and this is the primary timepoint for this outcome. Also measured at 1 month, 3 month and 6 months' post-intervention.

Primary outcome [2]

Disablity: We will administer the modified Roland-Morris Disablity Scale. In the modified version, participants are asked questions in relation to 'your pain", rather than "your back pain".

Timepoint [2]

Three months following the initial session where the skills are taught is considered to be the primary outcome point afor this outcome. Also measured at 1 month, 3 month and 6 months' post-intervention.

Secondary outcome [1]

Pain Interference: The pain interference subscale of the Brief Pain Inventory will be used to assess pain interference.

Timepoint [1]

Two weeks following the initial session where the skills are taught is considered to be the post-treatment outcome point and this is the primary timepoint for this outcome. Also measured at 1 month, 3 month and 6 months' post-intervention.

Secondary outcome [2]

Pain Catastrophizing Scale

Timepoint [2]

Two weeks following the initial session where the skills are taught is considered to be the post-treatment outcome point and this is the primary timepoint for this outcome. Also measured at 1 month, 3 month and 6 months' post-intervention.

Secondary outcome [3]

McGill Pain Questionnaire

Timepoint [3]

Two weeks following the initial session where the skills are taught is considered to be the post-treatment outcome point and this is the primary timepoint for this outcome. Also measured at 1 month, 3 month and 6 months' post-intervention.

Secondary outcome [4]

Depression: The depression subscale of the Depression Anxiety and Stress Scales.

Timepoint [4]

Two weeks following the initial session where the skills are taught is considered to be the post-treatment outcome point and this is the primary timepoint for this outcome. Also measured at 1 month, 3 month and 6 months' post-intervention.

Secondary outcome [5]

Anxiety. The anxiety subscale of the Depression Anxiety and Stress Scales.

Timepoint [5]

Two weeks following the initial session where the skills are taught is considered to be the post-treatment outcome point and this is the primary timepoint for this outcome. Also measured at 1 month, 3 month and 6 months' post-intervention.

Secondary outcome [6]

Stress: the stress subscale of the Depression Anxiety and Stress Scales.

Timepoint [6]

Two weeks following the initial session where the skills are taught is considered to be the post-treatment outcome point and this is the primary timepoint for this outcome. Also measured at 1 month, 3 month and 6 months' post-intervention.

Secondary outcome [7]

Philadelphia Mindfulness Scale

Timepoint [7]

Two weeks following the initial session where the skills are taught is considered to be the post-treatment outcome point and this is the primary timepoint for this outcome. However, we are interested in this measure as a potential mediator of outcome. Also measured at 1 month, 3 month and 6 months' post-intervention.

Secondary outcome [8]

Self-Attention check: This is a single item assessment to ascertain whether attention is focused internally or externally before and after the mindfulness interoceptive exposure or distraction task. This measure will not be given to the control group.

Timepoint [8]

Immediately following the training at the end of the initial session where the skills are taught is considered to be the post-treatment outcome point and this is the primary timepoint for this outcome. However, we are interested in this measure as a potential mediator of outcome.

Secondary outcome [9]

Attention bias: This is an experimental paradigm based on the dot-probe task, with sensory pain words. During this task which presents two competing stimuli (one sensory pain word/one neutral word) on the screen simultaneously for 1250 msecs, participants are asked to read both words. The words are then replaced by a probe (i.e. a p or q) and participants are asked to discriminate between the probes. We will monitor gaze behaviour during the task and will use the duration of first fixation on the pain word as an indicator of difficulty disengaging from pain. This will be a moderating variable, such that it is expected that participants who have more difficulty disengaging from the task will be less likely to benefit from the mindfulness interoceptive exposure. This measure will not be given to the control group.

Timepoint [9]

Immediately following the training at the end of the initial session where the skills are taught is considered to be the post-treatment outcome point and this is the primary timepoint for this outcome. However, we are interested in this measure as a potential moderator of outcome.

Eligibility

Key inclusion criteria

1. A diagnosis of chronic pain for at least three months
2. A current pain rating of > 3/10 on a 11 point numeric pain scale
3. Over the age of 18

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

1. People with a history of serious psychiatric disorder (e.g. psychosis) or current suicidality that requires immediate treatment.
2. People with substance abuse problems

Study design

Statistical methods / analysis

We will use a 2 (time: pre and post-treatment/3 month follow-up for disability) x 3 (Treatment: Mindfulness vs distraction vs control) ANOVA to assess the primary end-points. In order to assess moderation effects, we will conduct a 2 (Attention bias: high and low) x 2 (Treatment: Mindfulness vs distraction) ANOVA on change in pain between pre and post-intervention. Outcomes over times for the two groups, will be compared using linear mixed models. We will also determine whether (a) change in mindfulness mediates the relationship between group and change in pain intensity; and (b) whether change in pain intensity mediates the relationship between group and change in disability at three months follow-up.

Sample size estimates were calculated on the basis of G-power, given the effect size found on pain outcomes from a previous study in our lab where we found an effect size of f = 0.38. According to g-power we needed 87 participants to find this effect if present with an alpha of 0.05 and 80% power.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

3/10/2016

Actual

Date of last participant enrolment

Anticipated

2/10/2017

Actual

Date of last data collection

Anticipated

1/05/2018

Actual

Sample size

Target

87

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2007 - Ultimo

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Sydney

Country [1]

Australia

Primary sponsor type

University

Name

The University of Sydney

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Country [1]

Other collaborator category [1]

University

Name [1]

University of Technology Sydney

Country [1]

Australia

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

The University of Sydney

Ethics committee address [1]

Jane Foss Russell Building
City Rd
The University of Sydney
NSW 
2006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/06/2016

Approval date [1]

Ethics approval number [1]

Ethics committee name [2]

University of Technology Sydney

Ethics committee address [2]

67 Thomas St
Ultimo
NSW 2007

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

05/09/2016

Approval date [2]

Ethics approval number [2]

Summary

Brief summary

This study aims to determine (a) whether a mindfulness interoceptive exposure task is more efficacious than distraction and no treatment for people with chronic pain problems; and (b) whether attentional bias towards pain-related stimuli moderates the efficacy of mindfulness versus distraction. Participants with chronic pain problems will be randomized to receive one of two active interventions (either mindfulness interoceptive exposure or distraction) or a control condition. Prior to the single-session intervention, those in the active intervention groups will complete a measure of attention bias using the dot-probe with eye tracking technology at the beginning of a single-session intervention. Participants will then complete the intervention within the session and be asked to practice at home. Participants will complete a assessment of attention bias (and self-attention check; as well as pain ratings) immediately before and after the intervention is administered. They will then be asked to practice either the mindfulness or distraction task for two weeks, before completing the outcome questionnaires. The primary outcome point for the intervention is two weeks after the intervention is administered, except for disability where it is anticipated positive outcomes will not be seen until three months post-intervention. Measures will be given at pre-treatment; post-treatment (i.e. two weeks); one, three and six months later.

Trial website

not applicable

Public notes

Nil

Contacts

Principal investigator

Name

Prof Louise Sharpe

Address

Brennan MacCallum Building A18
The University of Sydney
NSW 2006

Country

Australia

Phone

+61293514558

Email

[email protected]

Contact person for public queries

Name

Alice Shires

Address

67 Thomas St.
Graduate School of Health
University Technology Sydney
NSW 2007

Country

Australia

Phone

+61295141448

Email

[email protected]

Contact person for scientific queries

Name

Alice Shires

Address

67 Thomas St.
Graduate School of Health
University Technology Sydney
NSW 2007

Country

Australia

Phone

+61295141448

Email

[email protected]

Trial Review

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