Emotional Problemhybrid-scedNCT05082922
Implementation of the Hybrid Treatment in Clinical Care. A SCED.
A study testing Hybrid treatment in people with Emotional Problem and Chronic Pain, run by Örebro University, Sweden at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emotional Problem, Chronic Pain
- What is being tested?
- Hybrid treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
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.
- Conditions
- Emotional Problem, Chronic Pain
- Being tested
- Hybrid treatment
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid treatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| No treatment waiting period | No intervention | Participants are randomized to a 4, 5, or 6 week waiting period. Weekly measurements are collected throughout this period. |
| Hybrid treatment | Experimental | Hybrid treatment. Weekly measurements are collected throughout treatment. Receives: Behavioral: Hybrid treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generalised Anxiety Disorder (GAD-7) change
change in self rated anxiety. Scale range 0-27 (higher values worse outcome)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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 outcomes (8)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: Baseline, 5 months and 11 months
Insomnia Sleep Inventory (ISI) change
change in insomnia. Scale range 0-28 (higher values worse outcome)
Measured: Baseline, 5 months and 11 months
EQ5-D change
Health related quality of life. Scale range 0-100 (higher values worse outcome)
Measured: Baseline, 5 months and 11 months
Mini international neuropsychiatric interview (MINI)
Diagnostic screening interview-DSM-V
Measured: Baseline, 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start1 Oct 2021
- Primary completion1 May 2023
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082922
- Sponsor's protocol ID
- HYBRID2.0
- Acronym
- hybrid-sced
- Status last verified
- May 2023
- First submitted
- 1 Oct 2021
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT05082922
- Acronym / sponsor ID
- hybrid-sced / HYBRID2.0
- Conditions
- Emotional Problem, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| No treatment waiting period | No intervention | –Participants are randomized to a 4, 5, or 6 week waiting period. Weekly measurements are collected throughout this period. |
| Hybrid treatment | Experimental | Behavioral: Hybrid treatmentHybrid treatment. Weekly measurements are collected throughout treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- > 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid treatmentTransdiagnostic 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. | Behavioural | Hybrid treatment |
Primary outcome
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)
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)
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)
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)
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)
8 secondary outcomes
Multidimensional Pain Inventory (MPI) change
Time frame: Baseline, 5 months and 11 months
Montgomery Åsberg Depression Rating Scale (MADRS) change
Time frame: Baseline, 5 months and 11 months
Difficulties in Emotion Regulation Scale (DERS-16) change
Time frame: Baseline, 5 months and 11 months
Psychological Inflexibility in Pain Scale (PIPS) change
Time frame: Baseline, 5 months and 11 months
Work limitation questionnaire-16 change
Time frame: Baseline, 5 months and 11 months
Insomnia Sleep Inventory (ISI) change
Time frame: Baseline, 5 months and 11 months
EQ5-D change
Time frame: Baseline, 5 months and 11 months
Mini international neuropsychiatric interview (MINI)
Time frame: Baseline, 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid treatment in people with Emotional Problem and Chronic Pain, run by Örebro University, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.