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

May 15, 2023 updated by: Örebro University, Sweden

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Generalised Anxiety Disorder (GAD-7) change
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.
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
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.
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
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.
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
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.
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
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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Multidimensional Pain Inventory (MPI) change
Time Frame: 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)
Baseline, 5 months and 11 months
Montgomery Åsberg Depression Rating Scale (MADRS) change
Time Frame: Baseline, 5 months and 11 months
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
Time Frame: Baseline, 5 months and 11 months
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
Time Frame: 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)
Baseline, 5 months and 11 months
Work limitation questionnaire-16 change
Time Frame: 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).
Baseline, 5 months and 11 months
Insomnia Sleep Inventory (ISI) change
Time Frame: Baseline, 5 months and 11 months
change in insomnia. Scale range 0-28 (higher values worse outcome)
Baseline, 5 months and 11 months
EQ5-D change
Time Frame: Baseline, 5 months and 11 months
Health related quality of life. Scale range 0-100 (higher values worse outcome)
Baseline, 5 months and 11 months
Mini international neuropsychiatric interview (MINI)
Time Frame: Baseline, 5 months
Diagnostic screening interview-DSM-V
Baseline, 5 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
adverse effects
Time Frame: 5 months
adverse treatment effects
5 months
Treatment satisfaction questionnaire
Time Frame: 5 months
self reported satisfaction with treatment
5 months
sick leave and medication use
Time Frame: Baseline, 5 months and 11 months
self reported and national register derived information of sickleave and medication use. related to symptoms
Baseline, 5 months and 11 months
experience of treatment
Time Frame: 5 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Örebro University, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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