Clinical trial NCT02808286: A Hybrid Emotion-focused Treatment for Chronic Pain Patients With Emotional Problems
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
Collaborators: name: Linkoeping University
First posted: 2016-06-21
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Montgomery Asberg depression rating scale (MADRS) change
timeFrame: baseline, 3 months, 12 months
measure: Multidimensional Pain Inventory (MPI) change
timeFrame: baseline, 3 months, 12 months
measure: Pain Catastrophizing Scale (PCS) change
timeFrame: baseline, 3 months, 12 months
measure: Generalised Anxiety Disorder 7-item Scale (GAD-7) change
timeFrame: baseline, 3 months, 12 months
Secondary outcomes:
measure: Difficulties in Emotion Regulation Scale (DERS) change
timeFrame: baseline, 1.5 months, 3 months
measure: The Behavior Activation for Depression Scale (BADS) change
timeFrame: baseline, 1.5 months, 3 months
measure: Self-Compassion scale-12 (SCS) change
timeFrame: baseline, 3 months
measure: Insomnia Severity Index (ISI) change
timeFrame: baseline, 3 months
measure: Tampa Scale for Kinesiophobia (TSK) change
timeFrame: baseline, 3 months
measure: Chronic Pain Acceptance Questionnaire (CPAQ) change
timeFrame: baseline, 3 months
measure: Lisat 11 change
timeFrame: baseline, 3 months, 12 months
Other outcomes:
measure: adverse effects
timeFrame: 3 months
measure: treatment satisfaction questionnaire
timeFrame: 3 months
Locations:
city: Linköping
country: Sweden
facility: Smärt- och rehabiliteringscentrum Linköping
city: Örebro
country: Sweden
facility: Center for Health and Medical Psychology
Study officials:
affiliation: Örebro University, Sweden
name: Katja Boersma, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.