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Chronic PainNCT03924687

Evaluating the Effectiveness of an ACT-Based Bibliotherapy Intervention Among Adults Living With Chronic Pain

A study testing Acceptance and Commitment Therapy (ACT) bibliotherapy for chronic pain in people with Chronic Pain, run by Université du Québec à Trois-Rivières.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Chronic pain has a significant impact on the physical and psychological functioning of those living with this condition. It is now recognized that Acceptance and Commitment Therapy (ACT) is an effective intervention in managing chronic pain; however, several barriers limit its accessibility. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Chronic Pain
What is being tested?
Acceptance and Commitment Therapy (ACT) bibliotherapy for chronic pain
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
No sites listed yet
Study dates
28 Mar 2016to Aug 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • being 18 years of age or older
  • having suffered from daily pain for more than three months
  • having reading and writing abilities in French equivalent or superior to grade 8
  • having access to Internet at home and having a valid e-mail address
  • not having previously completed an ACT-type psychotherapy, not having practiced mindfulness meditation regularly and not having read a bibliotherapy on ACT for pain
  • having stable medication for at least one month, if applicable.

Who cannot join

  • -

About this study

Official title: A Randomized Controlled Trial Evaluating the Effectiveness of an Acceptance and Commitment Therapy-Based Bibliotherapy Intervention Among Adults Living With Chronic Pain

Chronic pain has a significant impact on the physical and psychological functioning of those living with this condition. It is now recognized that Acceptance and Commitment Therapy (ACT) is an effective intervention in managing chronic pain; however, several barriers limit its accessibility.

The current study aims to evaluate the effectiveness of an eight-week bibliotherapy-type self-administered psychological intervention with minimal therapeutic contact, based on ACT, in the management of chronic pain.

This study is a randomized controlled trial with two groups (one experimental group and one wait-list control group). Participants will be randomly assigned to each condition and measures will be taken at pretest, posttest and three months following the intervention.

Read the detailed description

The purpose of this randomized controlled trial was to assess the effectiveness of an eight-week self-administered intervention program (bibliotherapy) based on Acceptance and Commitment Therapy with minimal therapeutic support in the management of chronic pain.

This study was based on the following hypotheses. In comparison to the control group, from pre to post, the self-help program will:

  1. significantly reduce pain-related disability (primary variable);
  2. improve depressive symptoms related to CP (secondary variable);
  3. increase the level of pain acceptance;
  4. reduce psychological inflexibility linked to painful symptoms (process variables). It was also expected that:
  5. the improvements would be maintained at three-month follow-up;
  6. participants would have an overall impression of a positive change following the intervention.
Conditions
Chronic Pain
Being tested
Acceptance and Commitment Therapy (ACT) bibliotherapy for chronic pain
Keywords
chronic pain, Acceptance or Commitment Therapy (ACT), self-help, pain-related disability, psychological inflexibility, depression, pain acceptance, bibliotherapy
Medical subject headings
Chronic Pain, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acceptance and Commitment Therapy (ACT) bibliotherapy for chronic painBehavioural

    The intervention consisted of the book "Libérez-vous de la douleur par la méditation et l'ACT" (Dionne, 2014) and a participant workbook, along with two phone calls of approximately 15 minutes each and weekly e-mails presenting the week's content. Participants also had access to audio meditation exercises on the book's website (http://liberezvousdeladouleur.com/meditations/).

Study groups in NCT03924687
Study groupRoleWhat they receive
ACT groupExperimentalACT group: participants receiving the 8-week bibliotherapy intervention based on Acceptance and Commitment Therapy
Receives: Behavioral: Acceptance and Commitment Therapy (ACT) bibliotherapy for chronic pain
control groupNo interventionWait-list control condition: participants placed on a wait-list (and receiving the intervention following the 9 week duration of the intervention)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Pain-related disability

    Brief Pain Inventory (BPI; Interference subscale; Cleeland \& Ryan 1994; Poundja, Fikretoglu, Guay, \& Brunet 2007; Tyler, Jensen, Engel, \& Schwartz 2002)

    Measured: Change from week 1 to week 9

  2. Change in Pain-related disability

    Brief Pain Inventory (BPI; Interference subscale; Cleeland \& Ryan 1994; Poundja, Fikretoglu, Guay, \& Brunet 2007; Tyler, Jensen, Engel, \& Schwartz 2002)

    Measured: Change from week 9 and week 21 (ACT group only)

Secondary outcomes (7)

  1. Change in Depressive symptoms

    The Beck Depression Inventory (BDI - Short Form: Beck, Rial, \& Rickels 1974)

    Measured: Change from week 1 to week 9

  2. Change in Depressive symptoms

    The Beck Depression Inventory (BDI - Short Form: Beck, Rial, \& Rickels 1974)

    Measured: Change from week 9 and week 21 (ACT group only)

  3. Change in Pain acceptance

    Chronic Pain Acceptance Questionnaire (CPAQ-8: Fish, McGuire, Hogan, Morrison, \& Stewart 2010). The CPAQ-8 is an 8-item measure that evaluates acceptance of pain according to two sub-scales: activity engagement and pain willingness. Items are rated on a Likert scale from 0 = never true to 6 = always true. Total scores range from 0 to 48 and higher scores reflect greater acceptance of pain.

    Measured: Change from week 1 to week 9

  4. Change in Pain acceptance

    Chronic Pain Acceptance Questionnaire (CPAQ-8: Fish, McGuire, Hogan, Morrison, \& Stewart 2010). The CPAQ-8 is an 8-item measure that evaluates acceptance of pain according to two sub-scales: activity engagement and pain willingness. Items are rated on a Likert scale from 0 = never true to 6 = always true. Total scores range from 0 to 48 and higher scores reflect greater acceptance of pain.

    Measured: Change from week 9 and week 21 (ACT group only)

  5. Change in Psychological inflexibility

    Psychological Inflexibility in Pain Scale (PIPS; Wicksell, Lekander, et al. 2010). The PIPS is composed of 12 items that evaluate two dimensions: avoidance and cognitive fusion. Items are rated on a Likert scale from 1 = never true to 7 = always true, to evaluate the level of inflexibility associated to pain. Scores range from 12 to 84, with higher scores revealing greater psychological inflexibility.

    Measured: Change from week 1 to week 9

  6. Change in Psychological inflexibility

    Psychological Inflexibility in Pain Scale (PIPS; Wicksell, Lekander, et al. 2010). The PIPS is composed of 12 items that evaluate two dimensions: avoidance and cognitive fusion. Items are rated on a Likert scale from 1 = never true to 7 = always true, to evaluate the level of inflexibility associated to pain. Scores range from 12 to 84, with higher scores revealing greater psychological inflexibility.

    Measured: Change from week 9 and week 21 (ACT group only)

  7. Participants' impression of change

    Patient Global Impression of Change (PGIC: Guy et al. 1976)

    Measured: week 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2019
  2. Study start28 Mar 2016
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03924687
Sponsor's protocol ID
CER-15-215-07.23
Status last verified
Apr 2019
First submitted
8 Apr 2019
Last updated
23 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hann, K. E. J., & McCracken, L. M. (2014). A systematic review of randomized controlled trials of Acceptance and Commitment Therapy for adults with chronic pain: Outcome domains, design quality, and efficacy. Journal of Contextual Behavioral Science, 3(4), 217-227. http://dx.doi.org/http://dx.doi.org/10.1016/j.jcbs.2014.10.001

  • Hughes LS, Clark J, Colclough JA, Dale E, McMillan D. Acceptance and Commitment Therapy (ACT) for Chronic Pain: A Systematic Review and Meta-Analyses. Clin J Pain. 2017 Jun;33(6):552-568. doi: 10.1097/AJP.0000000000000425.

    PubMed 27479642

  • Boulanger, A., Charbonneau, C., Choinière, M., Laliberté, J., & St-Hilaire, F. (2015). Renforcer les services de première ligne, développer les connaissances et les compétences des patients et des professionnels de la santé afin de mieux prévenir et traiter la douleur chronique.

  • Hogg MN, Gibson S, Helou A, DeGabriele J, Farrell MJ. Waiting in pain: a systematic investigation into the provision of persistent pain services in Australia. Med J Aust. 2012 Apr 2;196(6):386-90. doi: 10.5694/mja12.10140.

    PubMed 22471539

  • Jamison RN, Gintner L, Rogers JF, Fairchild DG. Disease management for chronic pain: barriers of program implementation with primary care physicians. Pain Med. 2002 Jun;3(2):92-101. doi: 10.1046/j.1526-4637.2002.02022.x.

    PubMed 15102155

  • Hayes, S. C., Strosahl, K. D., & Wilson, K., G. (2012). Acceptance and commitment therapy : the process and practice of mindful change (2nd ed.). New York: Guilford Press.

  • Veillette J, Martel ME, Dionne F. A randomized controlled trial evaluating the effectiveness of an acceptance and commitment therapy-based bibliotherapy intervention among adults living with chronic pain. Can J Pain. 2019 Nov 26;3(1):209-225. doi: 10.1080/24740527.2019.1678113. eCollection 2019.

    PubMed 35005411

Questions about this trial

What is this clinical trial studying?

A study testing Acceptance and Commitment Therapy (ACT) bibliotherapy for chronic pain in people with Chronic Pain, run by Université du Québec à Trois-Rivières.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain-related disability (time frame: Change from week 1 to week 9). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03924687, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019.

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