A Hybrid Emotion-focused Treatment for Chronic Pain Patients With Emotional Problems
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

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.
    

Intervention name(s): Hybrid; internet Cognitive Behavior Therapy (iCBT)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; A state-of-the-art CBT pain treatment, delivered via the internet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment