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

Sponsor

Örebro University, Sweden (Other)

Overall Status

Recruiting

CT.gov ID

NCT05082922

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Emotional Problem Chronic Pain	Behavioral: Hybrid treatment	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

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.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:

Single (Outcomes Assessor)

Masking Description:

Data is collected using a secure digital platform. Outcome assessors will be blinded to baseline length allocations.

Primary Purpose:

Treatment

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).

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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)
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)
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)
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)

Secondary Outcome Measures

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

Other Outcome Measures

adverse effects [5 months]
adverse treatment effects
Treatment satisfaction questionnaire [5 months]
self reported satisfaction with treatment
sick leave and medication use [Baseline, 5 months and 11 months]
self reported and national register derived information of sickleave and medication use. related to symptoms
experience of treatment [5 months]
semi structured interviews probing qualitative aspects of the treatment experience, and the experience of implementation of patients, treating practitioners and clinical managers

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Health and Medical Psychology	Örebro		Sweden	70182

Sponsors and Collaborators

Örebro University, Sweden

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Örebro University, Sweden

ClinicalTrials.gov Identifier:

NCT05082922

Other Study ID Numbers:

HYBRID2.0

First Posted:

Oct 19, 2021

Last Update Posted:

Nov 22, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Chronic Pain

Study Results

No Results Posted as of Nov 22, 2021