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Psychological Treatment Targeting Acceptance and Compassion in Chronic Pain Patients

Primary Purpose

Chronic Pain, Self-Criticism

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-Delivered ACT and CFT
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Chronic pain, Self-criticism, Internet-based treatment, ACT, CFT, Guided self-help, Acceptance, Compassion

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Psychology, Uppsala University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Internet-delivered ACT and CFT

Wait list control group

Arm Description

8 week, guided internet- delivered acceptance and commitment therapy (ACT) and compassion focused therapy (CFT)

Wait list control group, received treatment at later point.

Outcomes

Primary Outcome Measures

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
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.
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.

Secondary Outcome Measures

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
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.
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.
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.
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.

Full Information

First Posted
April 12, 2018
Last Updated
August 20, 2019
Sponsor
Uppsala University
Collaborators
Uppsala University Hospital, Örebro University, Sweden, Karlstad University
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1. Study Identification

Unique Protocol Identification Number
NCT03504904
Brief Title
Psychological Treatment Targeting Acceptance and Compassion in Chronic Pain Patients
Official Title
Psychological Treatment Targeting Acceptance and Compassion in Chronic Pain Patients: a Randomized Controlled, Internet Delivered, Treatment Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 13, 2014 (Actual)
Primary Completion Date
January 23, 2016 (Actual)
Study Completion Date
January 23, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
Collaborators
Uppsala University Hospital, Örebro University, Sweden, Karlstad University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Self-Criticism
Keywords
Chronic pain, Self-criticism, Internet-based treatment, ACT, CFT, Guided self-help, Acceptance, Compassion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet-delivered ACT and CFT
Arm Type
Experimental
Arm Description
8 week, guided internet- delivered acceptance and commitment therapy (ACT) and compassion focused therapy (CFT)
Arm Title
Wait list control group
Arm Type
No Intervention
Arm Description
Wait list control group, received treatment at later point.
Intervention Type
Behavioral
Intervention Name(s)
Internet-Delivered ACT and CFT
Intervention Description
An 8-week internet-based intervention focused on acceptance and compassion. Psychological intervention based on Acceptance and commitment therapy and compassion focused therapy
Primary Outcome Measure Information:
Title
Chronic Pain Acceptance Questionnaire (CPAQ)
Description
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
Time Frame
At 3, 8 weeks (post-treatment) and 6 months follow-up
Title
Self-Compassion Scale (SCS)
Description
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.
Time Frame
At 3, 8 weeks (post-treatment) and 6 months follow-up
Title
Pain Disability index (PDI)
Description
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.
Time Frame
At 8 weeks (post-treatment) and 6 months follow-up
Secondary Outcome Measure Information:
Title
Montgomery Åsberg Depression Rating Scale (MADRS-S)
Description
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
Time Frame
At 8 weeks (post-treatment) and 6 months follow-up
Title
Anxiety sensitivity index (ASI)
Description
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.
Time Frame
At 8 weeks (post-treatment) and 6 months follow-up
Title
Quality of Life Inventory (QOLI)
Description
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.
Time Frame
At 8 weeks (post-treatment) and 6 months follow-up
Title
Multidimensional Pain Inventory (MPI)
Description
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.
Time Frame
At 8 weeks (post-treatment) and 6 months follow-up
Title
Perseverative Thinking Questionnaire (PTQ)
Description
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.
Time Frame
At 3, 8 weeks (post-treatment) and 6 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica Buhrman, PhD
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katja Boersma, PhD
Organizational Affiliation
Örebro University, Sweden
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maria Tillfors, PhD
Organizational Affiliation
Karlstad University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fredrik Holländare, PhD
Organizational Affiliation
Örebro University, Sweden
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Psychology, Uppsala University
City
Uppsala
State/Province
Uppland
ZIP/Postal Code
75236
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Psychological Treatment Targeting Acceptance and Compassion in Chronic Pain Patients

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