Chronic Pain Clinical Trial
— ACTsmartOfficial title:
ACTsmart - Feasibility of Smart Phone Delivered ACT Treatment for Adults With Longstanding Pain
Verified date | January 2020 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
1. ACTsmart will be a feasible and accessable treatment delivery form
2. ACTsmart will improve function and quality of life
Status | Completed |
Enrollment | 34 |
Est. completion date | December 23, 2019 |
Est. primary completion date | December 23, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska institutet | Stockholm | Stockholms Län |
Lead Sponsor | Collaborator |
---|---|
Rikard Wicksell | AFA Insurance |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Interference Index (changes between assessments) | Self rated measure of daily functioning related to pain | Baseline, 8 weekly ratings, post (8 weeks), follow ups three, six and twelve months post treatment | |
Secondary | 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. | Baseline, 8 weekly ratings, post (8 weeks), follow ups three, six and twelve months post treatment | |
Secondary | 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. | Baseline, 8 weekly ratings, post (8 weeks), follow ups three, six and twelve months post treatment | |
Secondary | 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. | Baseline, post (8 weeks), follow ups three, six and twelve months post treatment | |
Secondary | 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. | Baseline, post (8 weeks), follow ups three, six and twelve months post treatment | |
Secondary | Insomnia Severity Index (changes) | Self rated degree of insomnia | Baseline, post (8 weeks), follow ups three, six and twelve months post treatment | |
Secondary | Pain intensity (changes) | Self rated degree of pain during last week on a scale from 0-10 | Baseline, post (8 weeks), follow ups three, six and twelve months post treatment | |
Secondary | Occupational status (changes) | Self reported occupational status indicated on a pre specified list, including sick leave and/or sick retirement | Baseline, post (8 weeks), follow ups three, six and twelve months post treatment | |
Secondary | Generalized Anxiety Disorder - 7 (changes) | Self rated symptoms of anxiety | Baseline, post (8 weeks), follow ups three, six and twelve months post treatment | |
Secondary | Medication use (changes) | Self reported medicine use | Baseline, post (8 weeks), follow ups three, six and twelve months post treatment |
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