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| Name | Class |
|---|---|
| Linkoeping University | OTHER_GOV |
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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)?
Design. A randomized controlled trial in which chronic pain patients with co-occurring emotional problems will receive either:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 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). | 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). | baseline, 3 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Difficulties in Emotion Regulation Scale (DERS) change | change in emotion regulation (from pretreatment, to mid- and post treatment) | baseline, 1.5 months, 3 months |
| The Behavior Activation for Depression Scale (BADS) change |
| Measure | Description | Time Frame |
|---|---|---|
| adverse effects | adverse treatment effects, measured post treatment | 3 months |
| treatment satisfaction questionnaire | self report satisfaction with treatment measured at post treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katja Boersma, PhD | Örebro University, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Smärt- och rehabiliteringscentrum Linköping | Linköping | 58185 | Sweden | |||
| Center for Health and Medical Psychology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21533329 | Background | 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. |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| internet Cognitive Behavior Therapy (iCBT) | Behavioral | A state-of-the-art CBT pain treatment, delivered via the internet. |
|
change in behavioral activation (from pretreatment, to mid- and post treatment)
| baseline, 1.5 months, 3 months |
| Self-Compassion scale-12 (SCS) change | change in self compassion (from pretreatment to post treatment) | baseline, 3 months |
| Insomnia Severity Index (ISI) change | change in insomnia (from pretreatment to post treatment) | baseline, 3 months |
| Tampa Scale for Kinesiophobia (TSK) change | change in fear avoidance (from pretreatment to post treatment) | baseline, 3 months |
| Chronic Pain Acceptance Questionnaire (CPAQ) change | change in pain acceptance (from pretreatment to post treatment) | baseline, 3 months |
| Lisat 11 change | change in quality of life (from pretreatment to post treatment and follow up) | baseline, 3 months, 12 months |
| 3 months |
| Örebro |
| 70182 |
| Sweden |