Implementation of the Hybrid Treatment in Clinical Care. A SCED. (hybrid-sced)

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).

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Pain; Emotional Problem
• Intervention / Treatment: Behavioral: Hybrid treatment

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Örebro, Sweden, 70182
    • Center for Health and Medical Psychology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No treatment waiting period; Participants are randomized to a 4, 5, or 6 week waiting period. Weekly measurements are collected throughout this period.
Experimental: Hybrid treatment; Hybrid treatment. Weekly measurements are collected throughout treatment.	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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse effects	adverse treatment effects	5 months
Treatment satisfaction questionnaire	self reported satisfaction with treatment	5 months
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
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

Collaborators and Investigators

• Sponsor: Örebro University, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): May 1, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: October 1, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: HYBRID2.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No