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

Chronic Pain Clinical Trial

— hybrid-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).

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05082922
• Other study ID #: HYBRID2.0
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: Örebro University, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Emotional Problem

Intervention

Behavioral:
• Hybrid 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.

Locations

Country	Name	City	State
Sweden	Center for Health and Medical Psychology	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Örebro University, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	adverse effects	adverse treatment effects	5 months
Other	Treatment satisfaction questionnaire	self reported satisfaction with treatment	5 months
Other	sick leave and medication use	self reported and national register derived information of sickleave and medication use. related to symptoms	Baseline, 5 months and 11 months
Other	experience of treatment	semi structured interviews probing qualitative aspects of the treatment experience, and the experience of implementation of patients, treating practitioners and clinical managers	5 months
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Insomnia Sleep Inventory (ISI) change	change in insomnia. Scale range 0-28 (higher values worse outcome)	Baseline, 5 months and 11 months
Secondary	EQ5-D change	Health related quality of life. Scale range 0-100 (higher values worse outcome)	Baseline, 5 months and 11 months
Secondary	Mini international neuropsychiatric interview (MINI)	Diagnostic screening interview-DSM-V	Baseline, 5 months