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A Hybrid Emotion-focused Treatment for Chronic Pain Patients With Emotional Problems

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Hybrid
internet Cognitive Behavior Therapy (iCBT)
Sponsored by
Örebro University, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Sites / Locations

  • Smärt- och rehabiliteringscentrum Linköping
  • Center for Health and Medical Psychology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hybrid

internet Cognitive Behavior Therapy (iCBT)

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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)
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)
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).
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).

Secondary Outcome Measures

Difficulties in Emotion Regulation Scale (DERS) change
change in emotion regulation (from pretreatment, to mid- and post treatment)
The Behavior Activation for Depression Scale (BADS) change
change in behavioral activation (from pretreatment, to mid- and post treatment)
Self-Compassion scale-12 (SCS) change
change in self compassion (from pretreatment to post treatment)
Insomnia Severity Index (ISI) change
change in insomnia (from pretreatment to post treatment)
Tampa Scale for Kinesiophobia (TSK) change
change in fear avoidance (from pretreatment to post treatment)
Chronic Pain Acceptance Questionnaire (CPAQ) change
change in pain acceptance (from pretreatment to post treatment)
Lisat 11 change
change in quality of life (from pretreatment to post treatment and follow up)

Full Information

First Posted
June 1, 2016
Last Updated
December 29, 2018
Sponsor
Örebro University, Sweden
Collaborators
Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT02808286
Brief Title
A Hybrid Emotion-focused Treatment for Chronic Pain Patients With Emotional Problems
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Örebro University, Sweden
Collaborators
Linkoeping University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hybrid
Arm Type
Experimental
Arm Description
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).
Arm Title
internet Cognitive Behavior Therapy (iCBT)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Hybrid
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
internet Cognitive Behavior Therapy (iCBT)
Intervention Description
A state-of-the-art CBT pain treatment, delivered via the internet.
Primary Outcome Measure Information:
Title
Montgomery Asberg depression rating scale (MADRS) change
Description
change in self rated depression (from pretreatment, to post treatment and follow up) Scale range 0-60 (higher values worse outcome)
Time Frame
baseline, 3 months, 12 months
Title
Multidimensional Pain Inventory (MPI) change
Description
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)
Time Frame
baseline, 3 months, 12 months
Title
Pain Catastrophizing Scale (PCS) change
Description
change in pain catastrophizing (from pretreatment, to post treatment and follow up). Scale range 0-52 (higher values worse outcome).
Time Frame
baseline, 3 months, 12 months
Title
Generalised Anxiety Disorder 7-item Scale (GAD-7) change
Description
change in general anxiety (from pretreatment, to post treatment and follow up). Scale range 0-27 (higher values worse outcome).
Time Frame
baseline, 3 months, 12 months
Secondary Outcome Measure Information:
Title
Difficulties in Emotion Regulation Scale (DERS) change
Description
change in emotion regulation (from pretreatment, to mid- and post treatment)
Time Frame
baseline, 1.5 months, 3 months
Title
The Behavior Activation for Depression Scale (BADS) change
Description
change in behavioral activation (from pretreatment, to mid- and post treatment)
Time Frame
baseline, 1.5 months, 3 months
Title
Self-Compassion scale-12 (SCS) change
Description
change in self compassion (from pretreatment to post treatment)
Time Frame
baseline, 3 months
Title
Insomnia Severity Index (ISI) change
Description
change in insomnia (from pretreatment to post treatment)
Time Frame
baseline, 3 months
Title
Tampa Scale for Kinesiophobia (TSK) change
Description
change in fear avoidance (from pretreatment to post treatment)
Time Frame
baseline, 3 months
Title
Chronic Pain Acceptance Questionnaire (CPAQ) change
Description
change in pain acceptance (from pretreatment to post treatment)
Time Frame
baseline, 3 months
Title
Lisat 11 change
Description
change in quality of life (from pretreatment to post treatment and follow up)
Time Frame
baseline, 3 months, 12 months
Other Pre-specified Outcome Measures:
Title
adverse effects
Description
adverse treatment effects, measured post treatment
Time Frame
3 months
Title
treatment satisfaction questionnaire
Description
self report satisfaction with treatment measured at post treatment
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katja Boersma, PhD
Organizational Affiliation
Örebro University, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Smärt- och rehabiliteringscentrum Linköping
City
Linköping
ZIP/Postal Code
58185
Country
Sweden
Facility Name
Center for Health and Medical Psychology
City
Örebro
ZIP/Postal Code
70182
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21533329
Citation
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.
Results Reference
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A Hybrid Emotion-focused Treatment for Chronic Pain Patients With Emotional Problems

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