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Completed

NCT Number: NCT02808286

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

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)?

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Smärt- och rehabiliteringscentrum Linköping, Linköping, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hybrid

Behavioral

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)

Behavioral

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

Primary outcomes

  1. Montgomery Asberg depression rating scale (MADRS) change

    Time frame: baseline, 3 months, 12 months

    change in self rated depression (from pretreatment, to post treatment and follow up) Scale range 0-60 (higher values worse outcome)

  2. Multidimensional Pain Inventory (MPI) change

    Time frame: baseline, 3 months, 12 months

    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)

  3. Pain Catastrophizing Scale (PCS) change

    Time frame: baseline, 3 months, 12 months

    change in pain catastrophizing (from pretreatment, to post treatment and follow up). Scale range 0-52 (higher values worse outcome).

  4. Generalised Anxiety Disorder 7-item Scale (GAD-7) change

    Time frame: baseline, 3 months, 12 months

    change in general anxiety (from pretreatment, to post treatment and follow up). Scale range 0-27 (higher values worse outcome).

Secondary outcomes

  1. Difficulties in Emotion Regulation Scale (DERS) change

    Time frame: baseline, 1.5 months, 3 months

    change in emotion regulation (from pretreatment, to mid- and post treatment)

  2. The Behavior Activation for Depression Scale (BADS) change

    Time frame: baseline, 1.5 months, 3 months

    change in behavioral activation (from pretreatment, to mid- and post treatment)

  3. Self-Compassion scale-12 (SCS) change

    Time frame: baseline, 3 months

    change in self compassion (from pretreatment to post treatment)

  4. Insomnia Severity Index (ISI) change

    Time frame: baseline, 3 months

    change in insomnia (from pretreatment to post treatment)

  5. Tampa Scale for Kinesiophobia (TSK) change

    Time frame: baseline, 3 months

    change in fear avoidance (from pretreatment to post treatment)

  6. Chronic Pain Acceptance Questionnaire (CPAQ) change

    Time frame: baseline, 3 months

    change in pain acceptance (from pretreatment to post treatment)

  7. Lisat 11 change

    Time frame: baseline, 3 months, 12 months

    change in quality of life (from pretreatment to post treatment and follow up)

Other outcomes

  1. adverse effects

    Time frame: 3 months

    adverse treatment effects, measured post treatment

  2. treatment satisfaction questionnaire

    Time frame: 3 months

    self report satisfaction with treatment measured at post treatment

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Collaborators

  • Linkoeping University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 21, 2016
Registry last updated
Jan 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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