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

Not Applicable

Active, not recruiting

• Conditions: Emotional Problem; Chronic Pain
• Interventions: Behavioral: Hybrid treatment

• Registration Number: NCT05082922
• Lead Sponsor: Örebro University, Sweden

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2021-10-01
• Study First Submitted QC: 2021-10-15
• Study First Posted: 2021-10-19
• Status Verified: 2023-05
• Primary Completion: 2023-05-01
• Last Update Submitted: 2023-05-15
• Last Update Posted: 2023-05-16
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hybrid treatment	Hybrid treatment	Hybrid treatment. Weekly measurements are collected throughout treatment.

Primary Outcome Measures

Name	Time	Method
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 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)
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)
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)
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)

Secondary Outcome Measures

Name	Time	Method
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)
Mini international neuropsychiatric interview (MINI)	Baseline, 5 months	Diagnostic screening interview-DSM-V
EQ5-D change	Baseline, 5 months and 11 months	Health related quality of life. Scale range 0-100 (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)
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)
Insomnia Sleep Inventory (ISI) change	Baseline, 5 months and 11 months	change in insomnia. Scale range 0-28 (higher values worse outcome)

Trial Locations

Locations (1)

Center for Health and Medical Psychology; 🇸🇪 Örebro, Sweden