Implementation of a Transdiagnostic Emotion-focused Treatment for Comorbid Emotional Problems and Chronic Pain in Clinical Care. A Sequential Replicated and Randomized Single Case Experimental Design (SCED).
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Emotional Problem
- Sponsor
- Örebro University, Sweden
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Patient Health Questionnaire (PHQ-9) change
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Patient Health Questionnaire (PHQ-9) change
Time Frame: 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 change
Time Frame: 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)
Generalised Anxiety Disorder (GAD-7) change
Time Frame: 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)
Symptom Catastrophizing Scale (SCS) change
Time Frame: 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)
Pain coping change
Time Frame: 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)
Secondary Outcomes
- Psychological Inflexibility in Pain Scale (PIPS) change(Baseline, 5 months and 11 months)
- Mini international neuropsychiatric interview (MINI)(Baseline, 5 months)
- EQ5-D change(Baseline, 5 months and 11 months)
- Montgomery Åsberg Depression Rating Scale (MADRS) change(Baseline, 5 months and 11 months)
- Difficulties in Emotion Regulation Scale (DERS-16) change(Baseline, 5 months and 11 months)
- Work limitation questionnaire-16 change(Baseline, 5 months and 11 months)
- Multidimensional Pain Inventory (MPI) change(Baseline, 5 months and 11 months)
- Insomnia Sleep Inventory (ISI) change(Baseline, 5 months and 11 months)