NCT02808286

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:

  1. 1.Does a hybrid emotion-focused treatment lead to a decrease in comorbid emotional symptoms (pain-related fear, anxiety, depression)?
  2. 2.Does a hybrid emotion-focused treatment lead to an increase in functional ability, improvement in work status and decrease in medication use?
  3. 3.Does a hybrid emotion-focused treatment lead to better treatment effect on the above outcome variables compared to an active comparison group?
  4. 4.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)?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable chronic-pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

January 2, 2019

Status Verified

December 1, 2018

Enrollment Period

2.7 years

First QC Date

June 1, 2016

Last Update Submit

December 29, 2018

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (7)

  • Difficulties in Emotion Regulation Scale (DERS) change

    baseline, 1.5 months, 3 months

  • The Behavior Activation for Depression Scale (BADS) change

    baseline, 1.5 months, 3 months

  • Self-Compassion scale-12 (SCS) change

    baseline, 3 months

  • Insomnia Severity Index (ISI) change

    baseline, 3 months

  • Tampa Scale for Kinesiophobia (TSK) change

    baseline, 3 months

  • +2 more secondary outcomes

Other Outcomes (2)

  • adverse effects

    3 months

  • treatment satisfaction questionnaire

    3 months

Study Arms (2)

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).

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.

Behavioral: internet Cognitive Behavior Therapy (iCBT)

Interventions

HybridBEHAVIORAL

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.

Hybrid
internet Cognitive Behavior Therapy (iCBT)BEHAVIORAL

A state-of-the-art CBT pain treatment, delivered via the internet.

internet Cognitive Behavior Therapy (iCBT)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Smärt- och rehabiliteringscentrum Linköping

Linköping, 58185, Sweden

Location

Center for Health and Medical Psychology

Örebro, 70182, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 21533329BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Katja Boersma, PhD

    Örebro University, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2016

First Posted

June 21, 2016

Study Start

January 1, 2016

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

January 2, 2019

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

SE(2)