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

Primary Purpose

Emotional Problem, Chronic Pain

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Hybrid treatment
Sponsored by
Örebro University, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emotional Problem

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Health and Medical Psychology

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No treatment waiting period

Hybrid treatment

Arm Description

Participants are randomized to a 4, 5, or 6 week waiting period. Weekly measurements are collected throughout this period.

Hybrid treatment. Weekly measurements are collected throughout treatment.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
Montgomery Åsberg Depression Rating Scale (MADRS) change
change in self rated depression. Scale range 0-60 (higher values worse outcome)
Difficulties in Emotion Regulation Scale (DERS-16) change
change in emotion regulation abilities. Scale range 16-80 (higher values worse outcome)
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)
Work limitation questionnaire-16 change
change in thoughts and adaptations regarding work limitations due to symptoms. Scale range 16-80 (higher values worse outcomes).
Insomnia Sleep Inventory (ISI) change
change in insomnia. Scale range 0-28 (higher values worse outcome)
EQ5-D change
Health related quality of life. Scale range 0-100 (higher values worse outcome)
Mini international neuropsychiatric interview (MINI)
Diagnostic screening interview-DSM-V

Full Information

First Posted
October 1, 2021
Last Updated
May 15, 2023
Sponsor
Örebro University, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT05082922
Brief Title
Implementation of the Hybrid Treatment in Clinical Care. A SCED.
Acronym
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).
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Örebro University, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotional Problem, Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Outcomes Assessor
Masking Description
Data is collected using a secure digital platform. Outcome assessors will be blinded to baseline length allocations.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No treatment waiting period
Arm Type
No Intervention
Arm Description
Participants are randomized to a 4, 5, or 6 week waiting period. Weekly measurements are collected throughout this period.
Arm Title
Hybrid treatment
Arm Type
Experimental
Arm Description
Hybrid treatment. Weekly measurements are collected throughout treatment.
Intervention Type
Behavioral
Intervention Name(s)
Hybrid treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Generalised Anxiety Disorder (GAD-7) change
Description
change in self rated anxiety. Scale range 0-27 (higher values worse outcome)
Time Frame
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.
Title
Patient Health Questionnaire (PHQ-9) change
Description
change in self rated depression. Scale range 0-27 (higher values worse outcome)
Time Frame
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.
Title
Pain change
Description
change in pain intensity (scale 0-6) and interference. Scale range 0-6 (higher values worse outcome)
Time Frame
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.
Title
Pain coping change
Description
change in pain worry (scale 0-6) and avoidance (scale range 0-8) (higher values worse outcome)
Time Frame
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.
Title
Symptom Catastrophizing Scale (SCS) change
Description
Change in catastrophic interpretation of symptoms. Scale range 0-14 (higher values worse outcome)
Time Frame
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 Measure Information:
Title
Multidimensional Pain Inventory (MPI) change
Description
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)
Time Frame
Baseline, 5 months and 11 months
Title
Montgomery Åsberg Depression Rating Scale (MADRS) change
Description
change in self rated depression. Scale range 0-60 (higher values worse outcome)
Time Frame
Baseline, 5 months and 11 months
Title
Difficulties in Emotion Regulation Scale (DERS-16) change
Description
change in emotion regulation abilities. Scale range 16-80 (higher values worse outcome)
Time Frame
Baseline, 5 months and 11 months
Title
Psychological Inflexibility in Pain Scale (PIPS) change
Description
change in avoidance of pain (scale range 8-56) and fusion with pain thoughts (scale range 4-28) (higher values worse outcomes)
Time Frame
Baseline, 5 months and 11 months
Title
Work limitation questionnaire-16 change
Description
change in thoughts and adaptations regarding work limitations due to symptoms. Scale range 16-80 (higher values worse outcomes).
Time Frame
Baseline, 5 months and 11 months
Title
Insomnia Sleep Inventory (ISI) change
Description
change in insomnia. Scale range 0-28 (higher values worse outcome)
Time Frame
Baseline, 5 months and 11 months
Title
EQ5-D change
Description
Health related quality of life. Scale range 0-100 (higher values worse outcome)
Time Frame
Baseline, 5 months and 11 months
Title
Mini international neuropsychiatric interview (MINI)
Description
Diagnostic screening interview-DSM-V
Time Frame
Baseline, 5 months
Other Pre-specified Outcome Measures:
Title
adverse effects
Description
adverse treatment effects
Time Frame
5 months
Title
Treatment satisfaction questionnaire
Description
self reported satisfaction with treatment
Time Frame
5 months
Title
sick leave and medication use
Description
self reported and national register derived information of sickleave and medication use. related to symptoms
Time Frame
Baseline, 5 months and 11 months
Title
experience of treatment
Description
semi structured interviews probing qualitative aspects of the treatment experience, and the experience of implementation of patients, treating practitioners and clinical managers
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Center for Health and Medical Psychology
City
Örebro
ZIP/Postal Code
70182
Country
Sweden

12. IPD Sharing Statement

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

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