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Smart Phone ACT Treatment for Adults With Longstanding Pain - a Pilot Study (ACTsmart)

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
ACTsmart
Sponsored by
Rikard Wicksell
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Acceptance and Commitment therapy, ACT, CBT, Smart phone, Internet, Intervention

Eligibility Criteria

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

Inclusion Criteria:

  • a pain duration of ≥ 6 months;
  • able to read and write in Swedish
  • have access to a smart phone with internet access
  • no planned changes in medication use, or any other changes in interventions for their pain planned

Exclusion Criteria:

  • injury or illness that require immediate assessment or different treatment, or that is expected to progress significantly during the next 6 months
  • unstable medication (planned changes in medication during next 4 months)
  • ACT or CBT treatment during the past 3 months
  • severe psychiatric co-morbidity (e.g. high risk of suicide) as assessed by the psychologist in a semi-structured interview

Sites / Locations

  • Karolinska institutet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ACTsmart

Arm Description

ACT treatment via a smart phone application

Outcomes

Primary Outcome Measures

Pain Interference Index (changes between assessments)
Self rated measure of daily functioning related to pain

Secondary Outcome Measures

Psychological Inflexibility in Pain Scale (changes)
Self rated psychological inflexibility related to pain. Total score min 12, max 84, lower values are interpreted as higher psychological flexibility, higher values interpreted as lower psychological flexibility. Two subscales; fusion (4-28) and avoidance (8-56) are summed to compute a total score.
Valuing Questionnaire (changes)
Self rated progress and obstacles in valued actions. The Valuing Questionnaire consists of two subscales: progress (0-30) och obstacles (0-30). No total score is computed. On the obstacle subscale higher scores are worse, and on the progress subscale higher scores are better.
Patient Health Questionnaire 9 (changes)
Self rated depressive symptoms. Score is summed to a possible range of 0 to 27. Higher scores are interpreted as worse.
European Quality of Life Five Dimensions Questionnaire (changes)
Self rated quality of life. Scores are calculated to a number between 0 and 1, where 0 in theory is equal to death, and 1 is considered equal to perfect quality of life.
Insomnia Severity Index (changes)
Self rated degree of insomnia
Pain intensity (changes)
Self rated degree of pain during last week on a scale from 0-10
Occupational status (changes)
Self reported occupational status indicated on a pre specified list, including sick leave and/or sick retirement
Generalized Anxiety Disorder - 7 (changes)
Self rated symptoms of anxiety
Medication use (changes)
Self reported medicine use

Full Information

First Posted
November 14, 2017
Last Updated
January 20, 2020
Sponsor
Rikard Wicksell
Collaborators
AFA Insurance
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1. Study Identification

Unique Protocol Identification Number
NCT03344926
Brief Title
Smart Phone ACT Treatment for Adults With Longstanding Pain - a Pilot Study
Acronym
ACTsmart
Official Title
ACTsmart - Feasibility of Smart Phone Delivered ACT Treatment for Adults With Longstanding Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 23, 2017 (Actual)
Primary Completion Date
December 23, 2019 (Actual)
Study Completion Date
December 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rikard Wicksell
Collaborators
AFA Insurance

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
The aims are to test feasibility and preliminary effects of a smart phone delivered ACT treatment for adults with longstanding pain. The hypotheses are that ACTsmart will be a feasible and accessable treatment delivery form ACTsmart will improve function and quality of life
Detailed Description
Chronic pain affects 12-30% of the population and often results in depression, disability, and reduced daily function and quality of life. Medical strategies are often ineffective or insufficient to alleviate symptoms and increase functioning. Instead, the empirical support for cognitive behavior therapy (CBT) is today well established, and such interventions are commonly seen as critically important for patients with chronic pain. However, modest effects sizes calls for further improvements. Recent developments within CBT, particularly Acceptance and Commitment Therapy (ACT), have suggested the utility of acceptance and mindfulness strategies to manage pain and distress. The body of evidence for ACT has grown rapidly during the past decade, and ACT is today listed by the American Psychological Association as a treatment for chronic pain, with strong empirical support. Internet-delivered ACT Despite the increased empirical support for ACT the availability is still very limited, and a large number of patients do not receive this treatment. In other domains, the accessibility of empirically supported treatments has increased during the past decade due to the development of methods to deliver the treatment via internet. For example, a large number of studies illustrate the utility of internet-delivered CBT for anxiety, insomnia and depression, with treatment effects similar to those obtained in studies with face-to-face treatment. Few studies have yet evaluated internet-delivered ACT (iACT) for chronic pain, but a recent pilot study from our group with participants suffering from fibromyalgia (n=41) illustrated very promising results that warrant further studies to evaluate the effects of this treatment. To make treatment more accessible and present in patients' daily life we will use a smart phone application to deliver treatment. Recruitment Patients will be recruited through self referral. Information regarding the study will be provided through newspapers and social media, as well as in direct communication with pain clinics and primary care units, including instructions regarding e.g. eligibility and how to sign up. Once patients have been found eligible and expressed interest in study participation they will be assessed by a psychologist, and when needed by a pain physician, via semi-structured interviews to confirm eligibility and to ensure that the patient meet the study criteria. Informed consent is obtained from all participants prior to the assessment. Statistical methods Evaluations of treatment effects are primarily based on intent-to-treat analyses. The statistical approach will primarily be based on linear multilevel modeling (LMM), which takes into account dependencies between repeated measures and differences between patients in pre-treatment status and treatment response (i.e. random effects modeling) and also provide means of handling missing data. More traditional methods, such as ANOVA and hierarchical regression, may also be utilized when appropriate. Interviews Evaluations of feasibility and as a base for further development of the smart phone application will be done via semi structured interviews during and after treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Acceptance and Commitment therapy, ACT, CBT, Smart phone, Internet, Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot study of treatment delivery in a new format.
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACTsmart
Arm Type
Experimental
Arm Description
ACT treatment via a smart phone application
Intervention Type
Behavioral
Intervention Name(s)
ACTsmart
Intervention Description
Participant receive ACT treatment via a smart phone application, including psychologist support via a message function within the application. Treatment content is divided into four modules: education about pain behaviors, exposure and acceptance and commitment therapy education about pain physiology exercises on changing behaviors, acceptance, mindfulness, defusion and exposure value based exposure in the participant's daily life
Primary Outcome Measure Information:
Title
Pain Interference Index (changes between assessments)
Description
Self rated measure of daily functioning related to pain
Time Frame
Baseline, 8 weekly ratings, post (8 weeks), follow ups three, six and twelve months post treatment
Secondary Outcome Measure Information:
Title
Psychological Inflexibility in Pain Scale (changes)
Description
Self rated psychological inflexibility related to pain. Total score min 12, max 84, lower values are interpreted as higher psychological flexibility, higher values interpreted as lower psychological flexibility. Two subscales; fusion (4-28) and avoidance (8-56) are summed to compute a total score.
Time Frame
Baseline, 8 weekly ratings, post (8 weeks), follow ups three, six and twelve months post treatment
Title
Valuing Questionnaire (changes)
Description
Self rated progress and obstacles in valued actions. The Valuing Questionnaire consists of two subscales: progress (0-30) och obstacles (0-30). No total score is computed. On the obstacle subscale higher scores are worse, and on the progress subscale higher scores are better.
Time Frame
Baseline, 8 weekly ratings, post (8 weeks), follow ups three, six and twelve months post treatment
Title
Patient Health Questionnaire 9 (changes)
Description
Self rated depressive symptoms. Score is summed to a possible range of 0 to 27. Higher scores are interpreted as worse.
Time Frame
Baseline, post (8 weeks), follow ups three, six and twelve months post treatment
Title
European Quality of Life Five Dimensions Questionnaire (changes)
Description
Self rated quality of life. Scores are calculated to a number between 0 and 1, where 0 in theory is equal to death, and 1 is considered equal to perfect quality of life.
Time Frame
Baseline, post (8 weeks), follow ups three, six and twelve months post treatment
Title
Insomnia Severity Index (changes)
Description
Self rated degree of insomnia
Time Frame
Baseline, post (8 weeks), follow ups three, six and twelve months post treatment
Title
Pain intensity (changes)
Description
Self rated degree of pain during last week on a scale from 0-10
Time Frame
Baseline, post (8 weeks), follow ups three, six and twelve months post treatment
Title
Occupational status (changes)
Description
Self reported occupational status indicated on a pre specified list, including sick leave and/or sick retirement
Time Frame
Baseline, post (8 weeks), follow ups three, six and twelve months post treatment
Title
Generalized Anxiety Disorder - 7 (changes)
Description
Self rated symptoms of anxiety
Time Frame
Baseline, post (8 weeks), follow ups three, six and twelve months post treatment
Title
Medication use (changes)
Description
Self reported medicine use
Time Frame
Baseline, post (8 weeks), follow ups three, six and twelve months post treatment

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: a pain duration of ≥ 6 months; able to read and write in Swedish have access to a smart phone with internet access no planned changes in medication use, or any other changes in interventions for their pain planned Exclusion Criteria: injury or illness that require immediate assessment or different treatment, or that is expected to progress significantly during the next 6 months unstable medication (planned changes in medication during next 4 months) ACT or CBT treatment during the past 3 months severe psychiatric co-morbidity (e.g. high risk of suicide) as assessed by the psychologist in a semi-structured interview
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rikard Wicksell
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska institutet
City
Stockholm
State/Province
Stockholms Län
ZIP/Postal Code
171 77
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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Smart Phone ACT Treatment for Adults With Longstanding Pain - a Pilot Study

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