NCT02808286

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

An Randomized Controlled Trial (RCT) Testing the Effectiveness of a Hybrid Emotion-focused Treatment for Chronic Pain Patients With Co-occurring Emotional Problems

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Örebro University, Sweden · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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)?

Detailed 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.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
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.
BEHAVIORAL	internet Cognitive Behavior Therapy (iCBT)	A state-of-the-art CBT pain treatment, delivered via the internet.

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2016-06-21
• Last updated: 2019-01-02

Locations

2 sites across 1 country: Sweden