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Psychological Treatment Targeting Acceptance and Compassion in Chronic Pain Patients

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03504904
Recruitment Status : Completed
First Posted : April 20, 2018
Last Update Posted : August 22, 2019
Sponsor:
Collaborators:
Uppsala University Hospital
Örebro University, Sweden
Karlstad University
Information provided by (Responsible Party):
Uppsala University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Chronic Pain Self-Criticism Behavioral: Internet-Delivered ACT and CFT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Psychological Treatment Targeting Acceptance and Compassion in Chronic Pain Patients: a Randomized Controlled, Internet Delivered, Treatment Trial.
Actual Study Start Date : November 13, 2014
Actual Primary Completion Date : January 23, 2016
Actual Study Completion Date : January 23, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Internet-delivered ACT and CFT
8 week, guided internet- delivered acceptance and commitment therapy (ACT) and compassion focused therapy (CFT)
Behavioral: Internet-Delivered ACT and CFT
An 8-week internet-based intervention focused on acceptance and compassion. Psychological intervention based on Acceptance and commitment therapy and compassion focused therapy

No Intervention: Wait list control group
Wait list control group, received treatment at later point.



Primary Outcome Measures :
  1. Chronic Pain Acceptance Questionnaire (CPAQ) [ Time Frame: At 3, 8 weeks (post-treatment) and 6 months follow-up ]
    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

  2. Self-Compassion Scale (SCS) [ Time Frame: At 3, 8 weeks (post-treatment) and 6 months follow-up ]
    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.

  3. Pain Disability index (PDI) [ Time Frame: At 8 weeks (post-treatment) and 6 months follow-up ]
    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.


Secondary Outcome Measures :
  1. Montgomery Åsberg Depression Rating Scale (MADRS-S) [ Time Frame: At 8 weeks (post-treatment) and 6 months follow-up ]
    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

  2. Anxiety sensitivity index (ASI) [ Time Frame: At 8 weeks (post-treatment) and 6 months follow-up ]
    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.

  3. Quality of Life Inventory (QOLI) [ Time Frame: At 8 weeks (post-treatment) and 6 months follow-up ]
    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.

  4. Multidimensional Pain Inventory (MPI) [ Time Frame: At 8 weeks (post-treatment) and 6 months follow-up ]
    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.

  5. Perseverative Thinking Questionnaire (PTQ) [ Time Frame: At 3, 8 weeks (post-treatment) and 6 months follow-up ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504904


Locations
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Sweden
Department of Psychology, Uppsala University
Uppsala, Uppland, Sweden, 75236
Sponsors and Collaborators
Uppsala University
Uppsala University Hospital
Örebro University, Sweden
Karlstad University
Investigators
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Principal Investigator: Monica Buhrman, PhD Uppsala University
Study Chair: Katja Boersma, PhD Örebro University, Sweden
Study Chair: Maria Tillfors, PhD Karlstad University
Study Chair: Fredrik Holländare, PhD Örebro University, Sweden

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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT03504904    
Other Study ID Numbers: 214/248
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Uppsala University:
Chronic pain
Self-criticism
Internet-based treatment
ACT
CFT
Guided self-help
Acceptance
Compassion
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms