Chronic Pain, Emotional Problem
Conditions
Brief summary
In society today, mental health problems, specifically stress-, anxiety- and depressive disorders, are a primary cause of long-term sick leave, leading to significant societal costs and suffering. One important issue hindering implementation of successful treatments is that there is a marked co-occurrence between these problems and somatic health problems, such as different types of pain. An important key to solving this problem is to develop a more integrated conceptualization of, and treatment model for, these patients' health problems. Specifically, one way to understand the co-occurrence between mental and somatic health problems is offered by the 'transdiagnostic' perspective. The aim of this project is to implement and evaluate the effectiveness of a transdiagnostic emotion-focused treatment protocol in clinical context. The treatment addresses comorbid mental (stress, anxiety- and depressive) and somatic health (pain) problems and targets core emotion regulation processes that are hypothesized to maintain and exacerbate these problems.
Interventions
BEHAVIORALHybrid treatment
Transdiagnostic emotion-focused treatment provided by a psychologist with, when needed, support of a medical doctor (ensuring adherence to medical guidelines) and a physiotherapist (providing assessment and treatment support in exposure for physical activities). Depending on the length of the waiting period (randomly assigned to be either 4, 5 or 6 weeks), the treatment period varies between 14-16 weeks and contains 10-15 sessions.
Sponsors
Örebro University, Sweden
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Data is collected using a secure digital platform. Outcome assessors will be blinded to baseline length allocations.
Intervention model description
This study employs a sequential single-case experimental AB design with randomized waiting period lengths (4, 5 or 6 weeks). Included in the design is also standardized pre-post and follow up measurement allowing for single group analysis of change. In addition, we collect qualitative data from patients, practitioners and clinical managers, detailing how the treatment and its implementation are experienced.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \> 11 points on the anxiety or depression subscale, Hospital Anxiety and Depression scale * somatic health problems (pain \> 3 months) with functional impairment (\>3 on question 2 of the Multidimensional Pain Inventory, MPI, OR \> 20 points on question 21-24 of the Örebro Musculoskeletal Pain Questionnaire, ÖMPQ)
Exclusion criteria
* severe psychiatric problems requiring immediate other treatment * current psychological treatment * recently started psychopharmacological treatment for anxiety or depression (\<3 months prior to planned treatment) * insufficient mastery of the Swedish language
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire (PHQ-9) change | repeated weekly through phase A (randomly assigned to be 4, 5 or 6 weeks) and treatment phase B (14 to 16 weeks). Total time frame of assessment is 20 weeks. | change in self rated depression. Scale range 0-27 (higher values worse outcome) |
| Pain coping change | repeated weekly through phase A (randomly assigned to be 4, 5 or 6 weeks) and treatment phase B (14 to 16 weeks). Total time frame of assessment is 20 weeks. | change in pain worry (scale 0-6) and avoidance (scale range 0-8) (higher values worse outcome) |
| Pain change | repeated weekly through phase A (randomly assigned to be 4, 5 or 6 weeks) and treatment phase B (14 to 16 weeks). Total time frame of assessment is 20 weeks. | change in pain intensity (scale 0-6) and interference. Scale range 0-6 (higher values worse outcome) |
| Symptom Catastrophizing Scale (SCS) change | Baseline, 5 months and 11 months as well as repeated weekly through phase A (randomly assigned to be 4, 5 or 6 weeks) and treatment phase B (14 to 16 weeks). Total time frame of assessment is 20 weeks. | Change in catastrophic interpretation of symptoms. Scale range 0-14 (higher values worse outcome) |
| Generalised Anxiety Disorder (GAD-7) change | repeated weekly through phase A (randomly assigned to be 4, 5 or 6 weeks) and treatment phase B (14 to 16 weeks). Total time frame of assessment is 20 weeks. | change in self rated anxiety. Scale range 0-27 (higher values worse outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Sleep Inventory (ISI) change | Baseline, 5 months and 11 months | change in insomnia. Scale range 0-28 (higher values worse outcome) |
| EQ5-D change | Baseline, 5 months and 11 months | Health related quality of life. Scale range 0-100 (higher values worse outcome) |
| Mini international neuropsychiatric interview (MINI) | Baseline, 5 months | Diagnostic screening interview-DSM-V |
| Work limitation questionnaire-16 change | Baseline, 5 months and 11 months | change in thoughts and adaptations regarding work limitations due to symptoms. Scale range 16-80 (higher values worse outcomes). |
| Multidimensional Pain Inventory (MPI) change | Baseline, 5 months and 11 months | change in pain intensity and interference. Subscale pain intensity range 0-12, subscale pain interference range 0-66 (for both sub scales higher values worse outcome) |
| Montgomery Åsberg Depression Rating Scale (MADRS) change | Baseline, 5 months and 11 months | change in self rated depression. Scale range 0-60 (higher values worse outcome) |
| Difficulties in Emotion Regulation Scale (DERS-16) change | Baseline, 5 months and 11 months | change in emotion regulation abilities. Scale range 16-80 (higher values worse outcome) |
| Psychological Inflexibility in Pain Scale (PIPS) change | Baseline, 5 months and 11 months | change in avoidance of pain (scale range 8-56) and fusion with pain thoughts (scale range 4-28) (higher values worse outcomes) |
Other
| Measure | Time frame | Description |
|---|---|---|
| adverse effects | 5 months | adverse treatment effects |
| experience of treatment | 5 months | semi structured interviews probing qualitative aspects of the treatment experience, and the experience of implementation of patients, treating practitioners and clinical managers |
| sick leave and medication use | Baseline, 5 months and 11 months | self reported and national register derived information of sickleave and medication use. related to symptoms |
| Treatment satisfaction questionnaire | 5 months | self reported satisfaction with treatment |
Countries
Sweden
Outcome results
None listed