Implementation of the Hybrid Treatment in Clinical Care. A SCED.

Study Overview
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Brief Summary
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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.

Official Title
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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).

Conditions
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Emotional Problem, Chronic Pain

Intervention / Treatment
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* Behavioral: Hybrid treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No treatment waiting period<br>Participants are randomized to a 4, 5, or 6 week waiting period. Weekly measurements are collected throughout this period. | |
| Experimental: Hybrid treatment<br>Hybrid treatment. Weekly measurements are collected throughout treatment. | Behavioral: Hybrid treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generalised Anxiety Disorder (GAD-7) change | change in self rated anxiety. Scale range 0-27 (higher values worse outcome) | 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. | 
| Patient Health Questionnaire (PHQ-9) change | change in self rated depression. Scale range 0-27 (higher values worse outcome) | 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. | 
| Pain change | change in pain intensity (scale 0-6) and interference. Scale range 0-6 (higher values worse outcome) | 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. | 
| Pain coping change | change in pain worry (scale 0-6) and avoidance (scale range 0-8) (higher values worse outcome) | 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. | 
| Symptom Catastrophizing Scale (SCS) change | Change in catastrophic interpretation of symptoms. Scale range 0-14 (higher values worse outcome) | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multidimensional Pain Inventory (MPI) change | 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) | Baseline, 5 months and 11 months | 
| Montgomery Åsberg Depression Rating Scale (MADRS) change | change in self rated depression. Scale range 0-60 (higher values worse outcome) | Baseline, 5 months and 11 months | 
| Difficulties in Emotion Regulation Scale (DERS-16) change | change in emotion regulation abilities. Scale range 16-80 (higher values worse outcome) | Baseline, 5 months and 11 months | 
| Psychological Inflexibility in Pain Scale (PIPS) change | change in avoidance of pain (scale range 8-56) and fusion with pain thoughts (scale range 4-28) (higher values worse outcomes) | Baseline, 5 months and 11 months | 
| Work limitation questionnaire-16 change | change in thoughts and adaptations regarding work limitations due to symptoms. Scale range 16-80 (higher values worse outcomes). | Baseline, 5 months and 11 months | 
| Insomnia Sleep Inventory (ISI) change | change in insomnia. Scale range 0-28 (higher values worse outcome) | Baseline, 5 months and 11 months | 
| EQ5-D change | Health related quality of life. Scale range 0-100 (higher values worse outcome) | Baseline, 5 months and 11 months | 
| Mini international neuropsychiatric interview (MINI) | Diagnostic screening interview-DSM-V | Baseline, 5 months |