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

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02808286
• Other study ID #: HYBRID
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: September 2018

Study information

• Verified date: December 2018
• Source: Örebro University, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Does a hybrid emotion-focused treatment lead to a decrease in comorbid emotional symptoms (pain-related fear, anxiety, depression)?

2. Does a hybrid emotion-focused treatment lead to an increase in functional ability, improvement in work status and decrease in medication use?

3. 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:

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)?

Description:

Design. A randomized controlled trial in which chronic pain patients with co-occurring emotional problems will receive either:

1. 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.

2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Hybrid
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)
A state-of-the-art CBT pain treatment, delivered via the internet.

Locations

Country	Name	City	State
Sweden	Smärt- och rehabiliteringscentrum Linköping	Linköping
Sweden	Center for Health and Medical Psychology	Örebro

Sponsors (2)

Lead Sponsor	Collaborator
Örebro University, Sweden	Linkoeping University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Buhrman M, Nilsson-Ihrfeldt E, Jannert M, Ström 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	adverse effects	adverse treatment effects, measured post treatment	3 months
Other	treatment satisfaction questionnaire	self report satisfaction with treatment measured at post treatment	3 months
Primary	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
Primary	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
Primary	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
Primary	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	Difficulties in Emotion Regulation Scale (DERS) change	change in emotion regulation (from pretreatment, to mid- and post treatment)	baseline, 1.5 months, 3 months
Secondary	The Behavior Activation for Depression Scale (BADS) change	change in behavioral activation (from pretreatment, to mid- and post treatment)	baseline, 1.5 months, 3 months
Secondary	Self-Compassion scale-12 (SCS) change	change in self compassion (from pretreatment to post treatment)	baseline, 3 months
Secondary	Insomnia Severity Index (ISI) change	change in insomnia (from pretreatment to post treatment)	baseline, 3 months
Secondary	Tampa Scale for Kinesiophobia (TSK) change	change in fear avoidance (from pretreatment to post treatment)	baseline, 3 months
Secondary	Chronic Pain Acceptance Questionnaire (CPAQ) change	change in pain acceptance (from pretreatment to post treatment)	baseline, 3 months
Secondary	Lisat 11 change	change in quality of life (from pretreatment to post treatment and follow up)	baseline, 3 months, 12 months