Chronic PainNCT02808286
A Hybrid Emotion-focused Treatment for Chronic Pain Patients With Emotional Problems
A study testing Hybrid and internet Cognitive Behavior Therapy (iCBT) in people with Chronic Pain, run by Örebro University, Sweden at 2 sites in Sweden.
Trial summary
The aim of this project is to evaluate a hybrid emotion-focused treatment protocol, specifically developed for individuals who suffer from co-occurring chronic pain and clinical levels of anxiety and/or depressive symptoms. Specific questions relating to treatment outcome: 1. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Hybrid and internet Cognitive Behavior Therapy (iCBT)
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 2 sitesSweden
- Study dates
- Jan 2016to Sep 2018
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic musculoskeletal pain (> 6 months duration), not emanating from malignancies, systemic diseases (e.g. rheumatoid arthritis) or localized single-joint osteoarthritic conditions in the lower extremities (e.g. knee-osteoarthritis, hip- osteoarthritis).
- Functional problems due to pain (defined as > 10 points on question 21-24 of the Orebro Musculoskeletal Pain Questionnaire).
- Emotional problems (defined as >7 points (cut-off for a probable case) on at least one of the two subscales (anxiety and depression) of the Hospital Anxiety and Depression Scale).
Who cannot join
- Severe psychiatric disorders that may require immediate other treatment (alcohol abuse, bipolar disorder, psychotic disorders),
- Currently in psychological treatment elsewhere,
- Recently been started on psychopharmacological treatment for depression and/or anxiety (cut off criterion: < 3 months prior to planned treatment start),
- Insufficient mastery of the Swedish language written as well as spoken,
- No personal computer available.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Smärt- och rehabiliteringscentrum Linköping
Linköping, 58185
Center for Health and Medical Psychology
Örebro, 70182
About this study
Official title: An Randomized Controlled Trial (RCT) Testing the Effectiveness of a Hybrid Emotion-focused Treatment for Chronic Pain Patients With Co-occurring Emotional Problems
The aim of this project is to evaluate a hybrid emotion-focused treatment protocol, specifically developed for individuals who suffer from co-occurring chronic pain and clinical levels of anxiety and/or depressive symptoms.
Specific questions relating to treatment outcome:
- Does a hybrid emotion-focused treatment lead to a decrease in comorbid emotional symptoms (pain-related fear, anxiety, depression)?
- Does a hybrid emotion-focused treatment lead to an increase in functional ability, improvement in work status and decrease in medication use?
- Does a hybrid emotion-focused treatment lead to better treatment effect on the above outcome variables compared to an active comparison group? Specific questions relating to the process of change:
- Are therapeutic effects of the hybrid emotion-focused treatment mediated by changes in proposed transdiagnostic emotion regulation process variables (worry, rumination, cognitive and behavioral avoidance, emotional suppression)?
Read the detailed description
Design. A randomized controlled trial in which chronic pain patients with co-occurring emotional problems will receive either:
- A hybrid individual treatment combining emotion regulation focused Dialectical Behavior Therapy (DBT) with standard exposure methodology. The treatment targets the transdiagnostic psychological processes that have been shown to maintain emotional dysregulation.
- An active control condition receiving internet-delivered pain management treatment based on Cognitive Behavioral principles. This treatment is evidence-based and thus provides a credible and ethical active comparison group.
Selection. N=84 (ES=.5, p=.05 and ß=.80; based on an estimated between group difference on the Hospital Anxiety and Depression Scale, and compensating for an approximate drop out rate of 20% per condition). Patients will be recruited through pain rehabilitation units in Orebro and Linkoping and via advertisements in the local newspapers.
Procedure. Patients will be examined and screened by trained professionals to exclude individuals with red flags (serious medical illnesses that explain pain conditions), a risk of suicide, and/or need of emergency psychiatric care. After screening and baseline assessment, participants will be randomized to receive either the individual face-to-face hybrid emotion focused treatment (10-15 weekly or biweekly sessions) or the individual, guided, internet-based Cognitive Behavior Therapy (iCBT) treatment for pain (10 weekly sessions). The internet treatment is therapist guided through email contact. The hybrid treatment will be conducted by a trained and supervised licensed clinical psychologist and the internet guidance will be provided by trained and supervised clinical psychologists in their final stage of clinical training. The hybrid emotion-focused treatment integrates procedures from exposure and DBT with a clear uniting conceptualization focused on targeting underlying processes that maintain co-occurring chronic pain and emotional problems.
- Conditions
- Chronic Pain
- Being tested
- Hybrid, internet Cognitive Behavior Therapy (iCBT)
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HybridBehavioural
The hybrid emotion-focused treatment integrates procedures from exposure and dialectical behavior therapy (DBT) with a clear uniting conceptualization focused on targeting underlying processes that maintain co-occurring chronic pain and emotional problems.
internet Cognitive Behavior Therapy (iCBT)Behavioural
A state-of-the-art CBT pain treatment, delivered via the internet.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid | Experimental | The hybrid emotion-focused treatment consists of 10-15 individual 1/1,5 hour sessions. It includes the following stages (examples of methods in parathesis)
Stage I. Analysis of emotions and pain (Validation, Compassion, Chain analysis, Values \& goals).
Stage II. Developing skills (Dialectics, Self-validation, Self-compassion, emotion regulation skills).
Stage III. Exposure training (Exposure for emotionally sensitive stimuli, exposure in vivo for avoided movements).
Stage IV. Maintenance (Identifying key elements, Planning for flare-ups). Receives: Behavioral: Hybrid |
| internet Cognitive Behavior Therapy (iCBT) | Active comparator | CBT pain treatment, delivered via the internet consists of 8, weekly, modules and includes topics such as pain education, pain coping strategies (e.g. pacing), relaxation, cognitive restructuring, problem solving, stress and sleep management, conflict resolution. Patients read materials included in each module and do homework tasks on which they report back to the therapist via the internet. The therapist gives written feedback and guidance after each module. See reference for details. Receives: Behavioral: internet Cognitive Behavior Therapy (iCBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery Asberg depression rating scale (MADRS) change
change in self rated depression (from pretreatment, to post treatment and follow up) Scale range 0-60 (higher values worse outcome)
Measured: baseline, 3 months, 12 months
Multidimensional Pain Inventory (MPI) change
change in pain intensity and interference (from pretreatment, to post treatment and follow up). Subscale pain intensity range 0-12, subscale pain interference range 0-66 (for both subscales higher values worse outcome)
Measured: baseline, 3 months, 12 months
Pain Catastrophizing Scale (PCS) change
change in pain catastrophizing (from pretreatment, to post treatment and follow up). Scale range 0-52 (higher values worse outcome).
Measured: baseline, 3 months, 12 months
Generalised Anxiety Disorder 7-item Scale (GAD-7) change
change in general anxiety (from pretreatment, to post treatment and follow up). Scale range 0-27 (higher values worse outcome).
Measured: baseline, 3 months, 12 months
Secondary outcomes (7)
Difficulties in Emotion Regulation Scale (DERS) change
change in emotion regulation (from pretreatment, to mid- and post treatment)
Measured: baseline, 1.5 months, 3 months
The Behavior Activation for Depression Scale (BADS) change
change in behavioral activation (from pretreatment, to mid- and post treatment)
Measured: baseline, 1.5 months, 3 months
Self-Compassion scale-12 (SCS) change
change in self compassion (from pretreatment to post treatment)
Measured: baseline, 3 months
Insomnia Severity Index (ISI) change
change in insomnia (from pretreatment to post treatment)
Measured: baseline, 3 months
Tampa Scale for Kinesiophobia (TSK) change
change in fear avoidance (from pretreatment to post treatment)
Measured: baseline, 3 months
Chronic Pain Acceptance Questionnaire (CPAQ) change
change in pain acceptance (from pretreatment to post treatment)
Measured: baseline, 3 months
Lisat 11 change
change in quality of life (from pretreatment to post treatment and follow up)
Measured: baseline, 3 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University
- Responsible party
- Sponsor
- Investigators
- Katja Boersma, PhD, Principal investigator, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808286
- Sponsor's protocol ID
- HYBRID
- Status last verified
- Dec 2018
- First submitted
- 1 Jun 2016
- Last updated
- 2 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Buhrman M, Nilsson-Ihrfeldt E, Jannert M, Strom L, Andersson G. Guided internet-based cognitive behavioural treatment for chronic back pain reduces pain catastrophizing: a randomized controlled trial. J Rehabil Med. 2011 May;43(6):500-5. doi: 10.2340/16501977-0805.
PubMed 21533329
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Randomized Controlled Trial (RCT) Testing the Effectiveness of a Hybrid Emotion-focused Treatment for Chronic Pain Patients With Co-occurring Emotional Problems
- ClinicalTrials.gov ID
- NCT02808286
- Acronym / sponsor ID
- HYBRID
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Collaborators
- Linkoeping University
- Study start
- Jan 2016
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 21 Jun 2016 (estimated)
- 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.
The aim of this project is to evaluate a hybrid emotion-focused treatment protocol, specifically developed for individuals who suffer from co-occurring chronic pain and clinical levels of anxiety and/or depressive symptoms.
Specific questions relating to treatment outcome:
- Does a hybrid emotion-focused treatment lead to a decrease in comorbid emotional symptoms (pain-related fear, anxiety, depression)?
- Does a hybrid emotion-focused treatment lead to an increase in functional ability, improvement in work status and decrease in medication use?
- Does a hybrid emotion-focused treatment lead to better treatment effect on the above outcome variables compared to an active comparison group? Specific questions relating to the process of change:
- Are therapeutic effects of the hybrid emotion-focused treatment mediated by changes in proposed transdiagnostic emotion regulation process variables (worry, rumination, cognitive and behavioral avoidance, emotional suppression)?
Detailed description
Design. A randomized controlled trial in which chronic pain patients with co-occurring emotional problems will receive either:
- A hybrid individual treatment combining emotion regulation focused Dialectical Behavior Therapy (DBT) with standard exposure methodology. The treatment targets the transdiagnostic psychological processes that have been shown to maintain emotional dysregulation.
- An active control condition receiving internet-delivered pain management treatment based on Cognitive Behavioral principles. This treatment is evidence-based and thus provides a credible and ethical active comparison group.
Selection. N=84 (ES=.5, p=.05 and ß=.80; based on an estimated between group difference on the Hospital Anxiety and Depression Scale, and compensating for an approximate drop out rate of 20% per condition). Patients will be recruited through pain rehabilitation units in Orebro and Linkoping and via advertisements in the local newspapers.
Procedure. Patients will be examined and screened by trained professionals to exclude individuals with red flags (serious medical illnesses that explain pain conditions), a risk of suicide, and/or need of emergency psychiatric care. After screening and baseline assessment, participants will be randomized to receive either the individual face-to-face hybrid emotion focused treatment (10-15 weekly or biweekly sessions) or the individual, guided, internet-based Cognitive Behavior Therapy (iCBT) treatment for pain (10 weekly sessions). The internet treatment is therapist guided through email contact. The hybrid treatment will be conducted by a trained and supervised licensed clinical psychologist and the internet guidance will be provided by trained and supervised clinical psychologists in their final stage of clinical training. The hybrid emotion-focused treatment integrates procedures from exposure and DBT with a clear uniting conceptualization focused on targeting underlying processes that maintain co-occurring chronic pain and emotional problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid | Experimental | Behavioral: HybridThe hybrid emotion-focused treatment consists of 10-15 individual 1/1,5 hour sessions. It includes the following stages (examples of methods in parathesis) Stage I. Analysis of emotions and pain (Validation, Compassion, Chain analysis, Values \& goals). Stage II. Developing skills (Dialectics, Self-validation, Self-compassion, emotion regulation skills). Stage III. Exposure training (Exposure for emotionally sensitive stimuli, exposure in vivo for avoided movements). Stage IV. Maintenance (Identifying key elements, Planning for flare-ups). |
| internet Cognitive Behavior Therapy (iCBT) | Active comparator | Behavioral: internet Cognitive Behavior Therapy (iCBT)CBT pain treatment, delivered via the internet consists of 8, weekly, modules and includes topics such as pain education, pain coping strategies (e.g. pacing), relaxation, cognitive restructuring, problem solving, stress and sleep management, conflict resolution. Patients read materials included in each module and do homework tasks on which they report back to the therapist via the internet. The therapist gives written feedback and guidance after each module. See reference for details. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic musculoskeletal pain (> 6 months duration), not emanating from malignancies, systemic diseases (e.g. rheumatoid arthritis) or localized single-joint osteoarthritic conditions in the lower extremities (e.g. knee-osteoarthritis, hip- osteoarthritis).
- Functional problems due to pain (defined as > 10 points on question 21-24 of the Orebro Musculoskeletal Pain Questionnaire).
- Emotional problems (defined as >7 points (cut-off for a probable case) on at least one of the two subscales (anxiety and depression) of the Hospital Anxiety and Depression Scale).
Key exclusion criteria (5 listed)
- Severe psychiatric disorders that may require immediate other treatment (alcohol abuse, bipolar disorder, psychotic disorders),
- Currently in psychological treatment elsewhere,
- Recently been started on psychopharmacological treatment for depression and/or anxiety (cut off criterion: < 3 months prior to planned treatment start),
- Insufficient mastery of the Swedish language written as well as spoken,
- No personal computer available.
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 |
|---|---|---|
| HybridThe hybrid emotion-focused treatment integrates procedures from exposure and dialectical behavior therapy (DBT) with a clear uniting conceptualization focused on targeting underlying processes that maintain co-occurring chronic pain and emotional problems. | Behavioural | Hybrid |
| internet Cognitive Behavior Therapy (iCBT)A state-of-the-art CBT pain treatment, delivered via the internet. | Behavioural | internet Cognitive Behavior Therapy (iCBT) |
Primary outcome
Montgomery Asberg depression rating scale (MADRS) change
Time frame: baseline, 3 months, 12 months
change in self rated depression (from pretreatment, to post treatment and follow up) Scale range 0-60 (higher values worse outcome)
Multidimensional Pain Inventory (MPI) change
Time frame: baseline, 3 months, 12 months
change in pain intensity and interference (from pretreatment, to post treatment and follow up). Subscale pain intensity range 0-12, subscale pain interference range 0-66 (for both subscales higher values worse outcome)
Pain Catastrophizing Scale (PCS) change
Time frame: baseline, 3 months, 12 months
change in pain catastrophizing (from pretreatment, to post treatment and follow up). Scale range 0-52 (higher values worse outcome).
Generalised Anxiety Disorder 7-item Scale (GAD-7) change
Time frame: baseline, 3 months, 12 months
change in general anxiety (from pretreatment, to post treatment and follow up). Scale range 0-27 (higher values worse outcome).
7 secondary outcomes
Difficulties in Emotion Regulation Scale (DERS) change
Time frame: baseline, 1.5 months, 3 months
The Behavior Activation for Depression Scale (BADS) change
Time frame: baseline, 1.5 months, 3 months
Self-Compassion scale-12 (SCS) change
Time frame: baseline, 3 months
Insomnia Severity Index (ISI) change
Time frame: baseline, 3 months
Tampa Scale for Kinesiophobia (TSK) change
Time frame: baseline, 3 months
Chronic Pain Acceptance Questionnaire (CPAQ) change
Time frame: baseline, 3 months
Lisat 11 change
Time frame: baseline, 3 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2019.
- Background: PubMed 21533329Buhrman M, Nilsson-Ihrfeldt E, Jannert M, Strom L, Andersson G. Guided internet-based cognitive behavioural treatment for chronic back pain reduces pain catastrophizing: a randomized controlled trial. J Rehabil Med. 2011 May;43(6):500-5. doi: 10.2340/16501977-0805.
- Individual participant dataSharing planned: No
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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.
Katja Boersma, PhD principal investigator
Örebro University, Sweden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid and internet Cognitive Behavior Therapy (iCBT) in people with Chronic Pain, run by Örebro University, Sweden at 2 sites 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 2 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Montgomery Asberg depression rating scale (MADRS) change (time frame: baseline, 3 months, 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02808286, which also lists 1 linked publication.
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 2 Jan 2019.