Trial Review

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000682741
Ethics application status
Approved
Date submitted
12/06/2013
Date registered
21/06/2013
Date last updated
21/06/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Behavioural Activation for Chronic Pain
Scientific title
The effect of behavioural activation and behavioural relaxation on pain anxiety, depression, pain intensity and interference, activity levels, rate of reinforcement, and quality of life in participants with chronic neck pain.
Secondary ID [1] 282659 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Neck Pain 289360 0
Condition category
Condition code
Anaesthesiology 289696 289696 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will consist of Behavioural Activation Treatment (BAT) and Behavioural Relaxation Training (BRT). The intervention program will consist of 10 weekly, 1-hour sessions. The treatment protocol will be adapted from the Behavioural Activation Treatment for Depression- Revised (BATD-R) manual. BATD-R will consist of psychoeducation for chronic pain, daily monitoring of activities, selection and graded hierarchy of activities and goals based on individual values, and contacting other individuals. Homework tasks are given at the end of each session. These homework tasks will include a daily monitoring of activity level, completing a Life Areas, Values, and Activity Inventory (selecting important life areas and values and selecting corresponding activities), and towards later sessions daily monitoring with activity planning.
BRT is comprised of ten postures and activities that are characteristic and can be observed in a relaxed person. The participant is guided through each of the ten postures and activities by demonstration, modelling, and correction by the therapist as to how the relaxed posture should feel and look. Once the participant has acquired these ten postures, the therapist observes how relaxed the participant is and can also provide feedback. Observations continue to be made over successive training periods to gauge progress in acquiring relaxed behaviours.
BRT will be included in the 10 weekly 1 hour sessions along with BATD-R. Homework will consist of 20 minutes of relaxation per day. The homework will require the participant to practice each of the 10 postures at a convenient time in their day. The therapist will be trained to deliver BRT. To ensure accuracy, independent observers will observe and report the same events during training to ensure reliable observation of BRT. The observers should attain an agreement of 85% or better on the Behavioural Relaxation Scale. The therapist will be periodically assessed for maintenance of skills.
The intervention will be provided by a post-graduate Master's student who will receive weekly supervision from a registered clinical psychologist who has been in practice for 16 years, has a behaviour therapy background, and experience in delivering Behavioural Activation therapy.
Sessions will be video recorded and 30% of videotaped sessions will be assessed for their adherence to session checklists. Observer agreement of the Behavioural Relaxation Scale will also be periodically assessed with the help of a volunteer to perform the relaxed behaviours.
Intervention code [1] 287325 0
Behaviour
Comparator / control treatment
N/A- This is a single group study.
There will be a 4-6 week staggered baseline period during which participants will be monitored on outcomes but no feedback or treatment will be given.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289791 0
Total score on the Behavioural Activation for Depression Scale- Short Form (BADS-SF; Manos, Kanter, & Luo, 2011).
Timepoint [1] 289791 0
weekly during baseline (4-6 weeks prior to intervention), weekly during intervention, at 3-months post-intervention, and at 6-months post-intervention
Primary outcome [2] 289792 0
Total score on Pain Intensity Numerical Scale
Timepoint [2] 289792 0
daily during baseline (4-6 weeks prior to intervention), daily during intervention, at 3-months post-intervention, and at 6-months post-intervention
Primary outcome [3] 289793 0
Total score on Depression Anxiety Stress Scale-21 (DASS-21; Lovibond & Lovibond, 1995)
Timepoint [3] 289793 0
weekly during baseline (4-6 weeks prior to intervention), weekly during intervention, at 3-months post-intervention, and at 6-months post-intervention
Secondary outcome [1] 303248 0
Total score on Pain Anxiety Symptom Scale-20 (PASS-20; McCracken & Dhingra, 2002)
Timepoint [1] 303248 0
weekly during baseline (4-6 weeks prior to intervention), weekly during intervention, at 3-months post-intervention, and at 6-months post-intervention
Secondary outcome [2] 303249 0
Total score on Response Probability Index
Timepoint [2] 303249 0
pre-intervention (one week prior to the intervention), mid-intervention (5 weeks), post-intervention (after 10 weeks), 3-months post-intervention, and 6-months post-intervention
Secondary outcome [3] 303250 0
Total score on Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)
Timepoint [3] 303250 0
pre-intervention (one week prior to the intervention), mid-intervention (5 weeks), post-intervention (after 10 weeks), 3-months post-intervention, and 6-months post-intervention
Secondary outcome [4] 303251 0
Total score on Brief Pain Inventory (BPI).
Timepoint [4] 303251 0
pre-intervention (one week prior to the intervention), mid-intervention (5 weeks), post-intervention (after 10 weeks), 3-months post-intervention, and 6-months post-intervention
Secondary outcome [5] 303252 0
Observational measure.
The percentage of relaxed behaviours is calculated based on the number of relaxed or unrelaxed behaviours observed using the Behavioural Relaxation Scale (BRS, Poppen, 1988).
Timepoint [5] 303252 0
During the intervention phase (assessed weekly during the intervention phase- for 10 weeks)

Eligibility
Key inclusion criteria
Participants who have experienced chronic neck pain for at least 3 months. Participants must report experiencing neck pain of a sufficient intensity. Specifically, participants must report an average pain intensity level of more than 3/10 over the previous 2 weeks. Participants will also have to experience a moderate to severe level of disability.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have any other diseases (e.g. cancer), high suicidality, any major psychopathology (e.g. schizophrenia or bipolar), or alcohol and substance abuse.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
The study is a multiple baseline across subjects design.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Outcomes measured will be analysed by computing a reliable change score (RC) for each participant. A RC score of 1.96 or greater is considered to reflect a reliable change (Jacobson & Traux, 1991). Observational data will be analysed using the split-line method in conjunction with the binomial test (Portney & Watkins, 2000).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/06/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
4
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 287444 0
University
Name [1] 287444 0
Curtin University
Country [1] 287444 0
Australia
Primary sponsor type
Individual
Name
Trevor Mazzucchelli
Address
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Perth, Western Australia 6845
Country
Australia
Secondary sponsor category [1] 286187 0
Individual
Name [1] 286187 0
Melissa Da Silva
Address [1] 286187 0
Curtin University
Kent St, Bentley W.A. 6102
Country [1] 286187 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289418 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 289418 0
The Secretary, HREC
Office of Research and Development
Curtin University
GPO Box U 1987
Perth, Western Australia, 6845
Ethics committee country [1] 289418 0
Australia
Date submitted for ethics approval [1] 289418 0
Approval date [1] 289418 0
07/06/2013
Ethics approval number [1] 289418 0
HR 71/2013

Summary
Brief summary
This project will consist of a case series trial of an intervention for chronic pain. The intervention, based on behavioural principles, has previously been successfully applied to treat major depression, anxiety disorders, and chronic fibromyalgia pain. This project aims to extend the existing research by applying the treatment to a small number of individuals with chronic neck pain. It is expected that there will be a clinically significant decrease in pain anxiety, depression, and pain intensity, and increases in activity levels, rate of reinforcement, and quality of life at post-treatment, and at 3 month and 6 month follow-up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40702 0
Dr Trevor Mazzucchelli
Address 40702 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Perth, Western Australia, 6845
Country 40702 0
Australia
Phone 40702 0
+61 8 92667182
Fax 40702 0
Email 40702 0
[email protected]
Contact person for public queries
Name 40703 0
Miss Melissa Da Silva
Address 40703 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Perth, Western Australia, 6845
Country 40703 0
Australia
Phone 40703 0
+61437310173
Fax 40703 0
Email 40703 0
[email protected]
Contact person for scientific queries
Name 40704 0
Dr Trevor Mazzucchelli
Address 40704 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Perth, Western Australia, 6845
Country 40704 0
Australia
Phone 40704 0
+61 8 92667182
Fax 40704 0
Email 40704 0
[email protected]

No information has been provided regarding IPD availability


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
No additional documents have been identified.