Clinical trial NCT05082922: Implementation of the Hybrid Treatment in Clinical Care. A SCED.
Official title: 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).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emotional Problem
Chronic Pain
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Generalised Anxiety Disorder (GAD-7) change
timeFrame: 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.
measure: Patient Health Questionnaire (PHQ-9) change
timeFrame: 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.
measure: Pain change
timeFrame: 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.
measure: Pain coping change
timeFrame: 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.
measure: Symptom Catastrophizing Scale (SCS) change
timeFrame: 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 outcomes:
measure: Multidimensional Pain Inventory (MPI) change
timeFrame: Baseline, 5 months and 11 months
measure: Montgomery Åsberg Depression Rating Scale (MADRS) change
timeFrame: Baseline, 5 months and 11 months
measure: Difficulties in Emotion Regulation Scale (DERS-16) change
timeFrame: Baseline, 5 months and 11 months
measure: Psychological Inflexibility in Pain Scale (PIPS) change
timeFrame: Baseline, 5 months and 11 months
measure: Work limitation questionnaire-16 change
timeFrame: Baseline, 5 months and 11 months
measure: Insomnia Sleep Inventory (ISI) change
timeFrame: Baseline, 5 months and 11 months
measure: EQ5-D change
timeFrame: Baseline, 5 months and 11 months
measure: Mini international neuropsychiatric interview (MINI)
timeFrame: Baseline, 5 months
Other outcomes:
measure: adverse effects
timeFrame: 5 months
measure: Treatment satisfaction questionnaire
timeFrame: 5 months
measure: sick leave and medication use
timeFrame: Baseline, 5 months and 11 months
measure: experience of treatment
timeFrame: 5 months
Locations:
city: Örebro
country: Sweden
facility: Center for Health and Medical Psychology
Study officials:
References: