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Psychological Treatment Targeting Acceptance and Compassion in Chronic Pain Patients

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ClinicalTrials.gov Identifier: NCT03504904
Recruitment Status : Completed
First Posted : April 20, 2018
Last Update Posted : April 20, 2018
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 ]
    Change from baseline in acceptance

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

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


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

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

  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

  4. Multidimensional Pain Inventory (MPI) [ Time Frame: At 8 weeks (post-treatment) and 6 months follow-up ]
    Change from baseline in different pain dimensions

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



Information from the National Library of Medicine

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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     History of Changes
Other Study ID Numbers: 214/248
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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