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Chronic PainNCT03504904

Psychological Treatment Targeting Acceptance and Compassion in Chronic Pain Patients

A study testing Internet-Delivered ACT and CFT in people with Chronic Pain and Self-Criticism, run by Uppsala University at 1 site in Sweden.

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

This trial is a randomized controlled study aiming to investigate the effect of an 8-week internet-based intervention focused on acceptance and compassion or a wait-list control group. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chronic Pain, Self-Criticism
What is being tested?
Internet-Delivered ACT and CFT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
1 siteSweden
Study dates
13 Nov 2014to 23 Jan 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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • have experienced pain for more than three months,
  • have been medically investigated (within the past year)
  • be at least 18 years of age
  • have regular access to a computer and the internet
  • reported self-criticism measured with the Self-Compassion Scale.

Who cannot join

  • planned surgery
  • ongoing medical investigation that could impede participation in the study,
  • suffering from acute physical or psychological conditions,
  • very severe symptoms of depression (i.e., defined as a score of >2 on item 9 on MADRS-S and information from telephone screening)
  • ongoing psychological treatment,
  • not being fluent with the Swedish language since all the material would be in Swedish.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Department of Psychology, Uppsala University

    Uppsala, Uppland, 75236

Other trials in Sweden

About this study

Official title: Psychological Treatment Targeting Acceptance and Compassion in Chronic Pain Patients: a Randomized Controlled, Internet Delivered, Treatment Trial.

This trial is a randomized controlled study aiming to investigate the effect of an 8-week internet-based intervention focused on acceptance and compassion or a wait-list control group. Primary treatments outcomes are Chronic Pain Acceptance Questionnaire (CPAQ), Self-Compassion Scale (SCS) and Pain Disability index (PDI). Secondary outcomes were Montgomery Åsberg Depression Rating Scale (MADRS-S), Anxiety sensitivity index (ASI), Quality of Life Inventory (QOLI), Multidimensional Pain Inventory (MPI) and Perseverative Thinking Questionnaire (PTQ). A six month follow-up was conducted. Findings showed significantly greater levels of acceptance (CPAQ), self-compassion (SCS) and reduction in activity limitation (PDI) measured with the primary outcomes for the treatment group after the intervention with effect sizes raging from small to moderate and these results were maintained at six-month follow-up.

Read the detailed description

The purpose of this study was to explore if a psychological treatment fusing ACT and CFT principles and therapeutic techniques could improve outcome in chronic pain patients with high levels of self-criticism in comparison to a wait-list control group. The treatment was delivered via the internet, guided by trained professional. Internet delivered cognitive behavior therapy (CBT) and ACT treatments have shown similar efficacy as compared to face-to-face treatments in a variety of problem areas and across a large range of outcomes. Participants were recruited from a clinical setting. The treatment program consisted of eight sections and was based on a manual based on ACT developed for chronic pain (Buhrman et al., 2013) and a CFT-manual for chronic pain.

Following a screening interview participants deemed eligible were asked to complete an assessment battery online. All correspondence concerning treatment was held through a web portal including the online questionnaires and a secure e-mail service. The system handled security issues with two factor authentication. The participants logged in with electronic identification which is a secure service used by banks and in clinical settings.

Measures were obtained pre- and post- intervention and administered via the internet. A sixth month follow-up of the treatment group was administered. Mediation measures were also obtained.

Being tested
Internet-Delivered ACT and CFT
Keywords
Chronic pain, Self-criticism, Internet-based treatment, ACT, CFT, Guided self-help, Acceptance, Compassion
Medical subject headings
Chronic Pain

What participants receive

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

  • Internet-Delivered ACT and CFTBehavioural

    An 8-week internet-based intervention focused on acceptance and compassion. Psychological intervention based on Acceptance and commitment therapy and compassion focused therapy

Study groups in NCT03504904
Study groupRoleWhat they receive
Internet-delivered ACT and CFTExperimental8 week, guided internet- delivered acceptance and commitment therapy (ACT) and compassion focused therapy (CFT)
Receives: Behavioral: Internet-Delivered ACT and CFT
Wait list control groupNo interventionWait list control group, received treatment at later point.

What is being measured

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

  1. Chronic Pain Acceptance Questionnaire (CPAQ)

    Chronic pain acceptance questionnaire (CPAQ) measures acceptance. The measure consists of two scales; willingness and activity engagement. Items are rated on a scale from 0 (never true) to 6 (always true).Higher scores denote greater activity engagement and pain willingness.The total score is also reported

    Measured: At 3, 8 weeks (post-treatment) and 6 months follow-up

  2. Self-Compassion Scale (SCS)

    Change from baseline in compassion. The items in Self-Compassion Scale (SCS) are rated on a likert scale from 1(almost never) to 5 (almost always). The scale is divided into six subscales: self-kindness (higher values are considered better), self-judgement (lower values are considered better), common humanity (higher values are considered better), isolation(lower values are considered better), mindfulness (highervalues are considered better) and over-identified (lower values are considered better).Higher scores in the total scale indicate higher levels of compassion. l scale.Results can be presented for the different subclass or a total score. To compute a total self-compassion score, you reverse the negative scales items (self-judgment, isolation, and over-identification ) before computing the grand mean. Subscale scores are computed by calculating the mean of subscale item responses. Higher scores indicate higher levels of self-compassion. A total score can also be reported.

    Measured: At 3, 8 weeks (post-treatment) and 6 months follow-up

  3. Pain Disability index (PDI)

    Change from baseline in disability. It measures the degree to which pain. Every item score can range from 0 (no interference) to 10 (total interference). The total PDI score can range from 0 to 70, a higher score indicating more interference interferes with functioning across a range of activities.

    Measured: At 8 weeks (post-treatment) and 6 months follow-up

Secondary outcomes (5)

  1. Montgomery Åsberg Depression Rating Scale (MADRS-S)

    Change from baseline in depression.The respondents rate their symptoms on a scale that ranges from 0 to 6, where a higher value indicates a higher level of depressive symptoms. The score can range from 0-54, higher scores indicate more severe depressive symptoms e.g. a score >35 indicates a severe depression. The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts

    Measured: At 8 weeks (post-treatment) and 6 months follow-up

  2. Anxiety sensitivity index (ASI)

    Change from baseline in anxiety sensitivity. The ASI total score is the sum of the responses across the 16 items. Higher scores indicate level of anxiety.

    Measured: At 8 weeks (post-treatment) and 6 months follow-up

  3. Quality of Life Inventory (QOLI)

    Change from baseline in quality of life. The assessment yields an overall score and profile in 16 areas of life; health, self-esteem, goals and values, money, work, play, learning, creativity, helping, love, friends, children, relatives, home, neighbourhood, and community. Higher scores indicate higher level of quality of life.

    Measured: At 8 weeks (post-treatment) and 6 months follow-up

  4. Multidimensional Pain Inventory (MPI)

    Change from baseline in different pain dimensions. The Swedish version of MPI (MPI-S) consists of 34 items divided into 8 scales. The values on each scale ranges from 0.0-6.0. In some scales higher levels indicate more negative consequences of pain e.g the pain intensity and in other higher scores are positive e.g. life control.

    Measured: At 8 weeks (post-treatment) and 6 months follow-up

  5. Perseverative Thinking Questionnaire (PTQ)

    Change from baseline in perseverative thinking. It consist of 15 items, every statements are assessed in a likert scale that ranges from 0 (never) to 4 (almost always) and these are divided in three subscales. The subscales are Core characteristics of repetitive negative thinking (RNT), Perceived unproductiveness and Mental capacity. Lower scores indicate lower levels of preservative thinking.

    Measured: At 3, 8 weeks (post-treatment) and 6 months follow-up

Timeline

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

  1. First posted20 Apr 2018
  2. Study start13 Nov 2014
  3. Primary completion23 Jan 2016
  4. Study completion23 Jan 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
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03504904
Sponsor's protocol ID
214/248
Status last verified
Aug 2019
First submitted
12 Apr 2018
Last updated
22 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Internet-Delivered ACT and CFT in people with Chronic Pain and Self-Criticism, run by Uppsala University at 1 site in Sweden.

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 5 inclusion and 6 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 22 Aug 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 Sweden. 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?

Chronic Pain Acceptance Questionnaire (CPAQ) (time frame: At 3, 8 weeks (post-treatment) and 6 months follow-up). The study lists 3 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 NCT03504904.

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 22 Aug 2019.

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