Chronic PainNCT03711851

Managing Chronic Pain Through Self-Help

A study testing Self-help Acceptance and commitment therapy (Web-based) and Self-help Acceptance and commitment therapy (bibliotherapy) in people with Chronic Pain, run by Université du Québec à Trois-Rivières at 1 site in Canada.

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

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Chronic Pain
What is being tested?: Self-help Acceptance and commitment therapy (Web-based) and Self-help Acceptance and commitment therapy (bibliotherapy)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 297 participants
Where: 1 siteCanada
Study dates: 1 Oct 2018to 28 Jun 2019
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 or older;
Residing in Canada;
Having daily pain for at least 6 months;
Having a reading and writing ability equivalent or superior to grade 8;
Having access to internet at home and a valid e-mail address;
Not having previously engaged in an ACT-based psychotherapy and/or regularly meditated and/or read "Libérez-vous de la douleur" by Frédérick Dionne;

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Not being in an unstable psychological situation (severe suicidal thoughts or severe/persistent mental health disorder);
Having an average level of pain of at least 4/10 within the past week;
Having non-cancer related pain;
Having stable medication for at least one month.
Participants were excluded if they did not meet any of the above criteria.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Université du Québec à Trois-Rivières
Trois-Rivières, Quebec, G8Z 4M3

Other trials in Canada

About this study

Official title: Managing Chronic Pain Through Self-Help: A Randomized Controlled Trial Comparing Guided Self-Help Programs Based on Acceptance and Commitment Therapy (ACT) to Education

Chronic pain has a significant impact on the physical and emotional functioning of those living with this condition. It is now recognized that Acceptance and Commitment Therapy (ACT) is an effective treatment in managing chronic pain; however, several barriers limit its accessibility. Therefore, self-help versions of ACT are promising because they offer a cost-effective treatment option that usually require little support from a therapist, and can be widely accessed.

The current study aims to evaluate the effectiveness of predominantly self-help ACT interventions (web-based and bibliotherapy programs) in comparison to an education intervention among adults living with chronic pain.

The current study was a randomized controlled trial (RCT) with two experimental groups and an active control group. The first experimental group received access to an internet platform with videos, interactive content and exercises based on ACT. The second experimental group received a copy of a self-help book based on ACT for chronic pain and had access to this book's website which includes audio mindfulness exercises. The third group consisted of an active control group, in which participants received pamphlet style pdf documents of education for pain (without any ACT components) as well as related practical exercises.

Read the detailed description

This study aimed to evaluate the effectiveness of a web-based ACT intervention program with minimal therapeutic contact, compared to an ACT-based bibliotherapy and a pain education program (active control group) among adults with chronic pain. Participants were randomly assigned to each group. We hypothesized that:

both ACT interventions would lead to significant reductions in pain-related disability (primary variable), greater than the control group (education), and that the web-based program would lead to greater reductions in disability than the bibliotherapy group;
both ACT interventions would lead to significant improvements in quality of life (secondary variable), greater than the control group (education), and that the web-based program would lead to greater improvements in quality of life than the bibliotherapy group;
both ACT interventions would lead to significant reductions in anxiety and depressive symptoms (secondary variables), greater than the control group (education), and that the web-based program would lead to greater reductions in anxiety and depressive symptoms than the bibliotherapy group;
Improvements on primary (pain-related disability) and secondary variables (quality of life, anxiety/depressive symptoms) for the ACT groups will be maintained at 3 and 6 months and will remain superior to the control group (education);
Participants from both ACT groups would have a positive impressions of change following the intervention (as measured by the PGIC scale).

Some of the questionnaires described in the following section were administered and will be subject to subsequent analyses examining patient trajectories of change and profiles of patients who respond well or not to these treatment modalities.

Conditions: Chronic Pain
Being tested: Self-help Acceptance and commitment therapy (Web-based), Self-help Acceptance and commitment therapy (bibliotherapy), Self-help Education pamphlets on pain (active control group)
Keywords: Chronic pain, Self-help, Bibliotherapy, Web-based interventions, Acceptance and commitment therapy, Psychological flexibility
Medical subject headings: Chronic Pain

What participants receive

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

Self-help Acceptance and commitment therapy (Web-based)Behavioural
9 week program with minimal contact with therapist (predominantly self-help)
Self-help Acceptance and commitment therapy (bibliotherapy)Behavioural
9 week program with contact with therapist (predominantly self-help)
Self-help Education pamphlets on pain (active control group)Other
9 week program with contact with therapist (predominantly self-help)

Study groups in NCT03711851
Study group	Role	What they receive
Web-based	Experimental	Self-help Acceptance and commitment therapy (Web-based) Receives: Behavioral: Self-help Acceptance and commitment therapy (Web-based)
Bibliotherapy	Experimental	Self-help Acceptance and commitment therapy (bibliotherapy) Receives: Behavioral: Self-help Acceptance and commitment therapy (bibliotherapy)
Education pamphlets on pain	Active comparator	Self-help Education on Chronic pain (pamphlet style pdf documents) Receives: Other: Self-help Education pamphlets on pain (active control group)

What is being measured

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

Change in Pain interference
The Brief Pain Inventory (BPI) evaluates the severity and interference of pain in daily activities (Cleeland \& Ryan, 1994; Tyler et al., 2002; French version: Poundja et al., 2007). The instrument consists of 10 items rated on a Likert scale ranging from 0 = does not interfere to 10 = interferes completely, and participants are asked to rate the degree to which pain interfered with various activities in the past week (e.g., social activities, work, mood, etc.). Higher scores represent higher levels of pain interference. This questionnaire has shown good reliability across a variety of populations (e.g. French speaking fibromyalgia patients; Bourgault et al., 2015). The BPI is extensively used in chronic pain research, has strong psychometric properties and is recommended as an outcome in clinical trials of patients with chronic pain (Dworkin et al., 2005). The French version has shown to have good internal consistency (Poundja et al., 2007).
Measured: Change from week start of treatment (week 0) to end of treatment (week 9), 3-month follow-up (week 22) and 6-month follow-up (week 35)

Secondary outcomes (2)

Change in Anxiety and Depression symptoms
The Hospital Anxiety Depression Scale (HADS; Zigmond \& Snaith, 1983; French version: Bocéréan \& Dupret, 2014) is a 14-item questionnaire which evaluates psychological distress according to two 7-item subscales measuring anxiety and depressive symptoms in non-psychiatric hospital contexts. Items are scored on a 4-point Likert scale ranging from 0 to 3. An example of items is "I feel tense or wound up". A higher score reflects a higher level of anxiety or depression.
Measured: Change from week start of treatment (week 0) to end of treatment (week 9), 3-month follow-up (week 22) and 6-month follow-up (week 35)
Change in Quality of life measure
The World Health Organization Quality of Life-Brief (WHOQOL-BRIEF; WHOQOL; Group, 1998) is a self-reported measure of 26 items assessing quality of life in terms of physical and psychological health, social relationships and social functioning. Items are rated from 1 = very poor to 5 = very good, with higher scores reflect higher quality of life. This instrument has demonstrated good levels of internal consistency for its subscales (α = .66 to α = .80) and adequate test-retest reliability (r = .75). The French version of the instrument offers high internal consistency (Baumann, Erpelding, Régat, Collin, \& Briançon, 2010).
Measured: Change from week start of treatment (week 0) to end of treatment (week 9), 3-month follow-up (week 22) and 6-month follow-up (week 35)

Timeline

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

1 Oct 201828 Jun 2019

First posted19 Oct 2018
Study start1 Oct 2018
Primary completion27 Jun 2019
Study completion28 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 297 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03711851
Sponsor's protocol ID: CDERS-17-11-06.05
Status last verified: Jul 2019
First submitted: 9 Oct 2018
Last updated: 11 Jul 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Managing Chronic Pain Through Self-Help: A Randomized Controlled Trial Comparing Guided Self-Help Programs Based on Acceptance and Commitment Therapy (ACT) to Education
ClinicalTrials.gov ID: NCT03711851
Acronym / sponsor ID: CDERS-17-11-06.05
Conditions: Chronic Pain
Keywords: Chronic pain, Self-help, Bibliotherapy, Web-based interventions, Acceptance and commitment therapy, Psychological flexibility
Study type: Interventional
Recruitment status: Completed
Enrolment: 297 participants (actual)
Lead sponsor: Université du Québec à Trois-RivièresUniversity, hospital or other
Collaborators: Quebec Pain Research Network, Fonds de la Recherche en Santé du Québec
Study start: 1 Oct 2018 (actual)
Primary completion: 27 Jun 2019 (actual)
Study completion: 28 Jun 2019 (actual)
First posted: 19 Oct 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

both ACT interventions would lead to significant reductions in pain-related disability (primary variable), greater than the control group (education), and that the web-based program would lead to greater reductions in disability than the bibliotherapy group;
both ACT interventions would lead to significant improvements in quality of life (secondary variable), greater than the control group (education), and that the web-based program would lead to greater improvements in quality of life than the bibliotherapy group;
both ACT interventions would lead to significant reductions in anxiety and depressive symptoms (secondary variables), greater than the control group (education), and that the web-based program would lead to greater reductions in anxiety and depressive symptoms than the bibliotherapy group;
Improvements on primary (pain-related disability) and secondary variables (quality of life, anxiety/depressive symptoms) for the ACT groups will be maintained at 3 and 6 months and will remain superior to the control group (education);
Participants from both ACT groups would have a positive impressions of change following the intervention (as measured by the PGIC scale).

Some of the questionnaires described in the following section were administered and will be subject to subsequent analyses examining patient trajectories of change and profiles of patients who respond well or not to these treatment modalities.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Web-based	Experimental	Behavioral: Self-help Acceptance and commitment therapy (Web-based)Self-help Acceptance and commitment therapy (Web-based)
Bibliotherapy	Experimental	Behavioral: Self-help Acceptance and commitment therapy (bibliotherapy)Self-help Acceptance and commitment therapy (bibliotherapy)
Education pamphlets on pain	Active comparator	Other: Self-help Education pamphlets on pain (active control group)Self-help Education on Chronic pain (pamphlet style pdf documents)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Being 18 years or older;
Residing in Canada;
Having daily pain for at least 6 months;
Having a reading and writing ability equivalent or superior to grade 8;
Having access to internet at home and a valid e-mail address;

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Self-help Acceptance and commitment therapy (Web-based)9 week program with minimal contact with therapist (predominantly self-help)	Behavioural	Web-based
Self-help Acceptance and commitment therapy (bibliotherapy)9 week program with contact with therapist (predominantly self-help)	Behavioural	Bibliotherapy
Self-help Education pamphlets on pain (active control group)9 week program with contact with therapist (predominantly self-help)	Other	Education pamphlets on pain

Primary outcome

Change in Pain interference
Time frame: Change from week start of treatment (week 0) to end of treatment (week 9), 3-month follow-up (week 22) and 6-month follow-up (week 35)
The Brief Pain Inventory (BPI) evaluates the severity and interference of pain in daily activities (Cleeland \& Ryan, 1994; Tyler et al., 2002; French version: Poundja et al., 2007). The instrument consists of 10 items rated on a Likert scale ranging from 0 = does not interfere to 10 = interferes completely, and participants are asked to rate the degree to which pain interfered with various activities in the past week (e.g., social activities, work, mood, etc.). Higher scores represent higher levels of pain interference. This questionnaire has shown good reliability across a variety of populations (e.g. French speaking fibromyalgia patients; Bourgault et al., 2015). The BPI is extensively used in chronic pain research, has strong psychometric properties and is recommended as an outcome in clinical trials of patients with chronic pain (Dworkin et al., 2005). The French version has shown to have good internal consistency (Poundja et al., 2007).

2 secondary outcomes

Change in Anxiety and Depression symptoms
Time frame: Change from week start of treatment (week 0) to end of treatment (week 9), 3-month follow-up (week 22) and 6-month follow-up (week 35)
Change in Quality of life measure
Time frame: Change from week start of treatment (week 0) to end of treatment (week 9), 3-month follow-up (week 22) and 6-month follow-up (week 35)

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Frederick Dionne, Ph.D. study director

Université du Québec à Trois-Rivières

Marie-Eve Martel, Psy.D. principal investigator

Université du Québec à Trois-Rivières

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 inclusion and 0 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 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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 interference (time frame: Change from week start of treatment (week 0) to end of treatment (week 9), 3-month follow-up (week 22) and 6-month follow-up (week 35)). 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 NCT03711851.

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 11 Jul 2019.