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

NCT ID: NCT02808286

Last Updated: 2019-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-09-30

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hybrid

The hybrid emotion-focused treatment consists of 10-15 individual 1/1,5 hour sessions. It includes the following stages (examples of methods in parathesis)

Stage I. Analysis of emotions and pain (Validation, Compassion, Chain analysis, Values & goals).

Stage II. Developing skills (Dialectics, Self-validation, Self-compassion, emotion regulation skills).

Stage III. Exposure training (Exposure for emotionally sensitive stimuli, exposure in vivo for avoided movements).

Stage IV. Maintenance (Identifying key elements, Planning for flare-ups).

Group Type: EXPERIMENTAL

Hybrid

Intervention Type: 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)

CBT pain treatment, delivered via the internet consists of 8, weekly, modules and includes topics such as pain education, pain coping strategies (e.g. pacing), relaxation, cognitive restructuring, problem solving, stress and sleep management, conflict resolution. Patients read materials included in each module and do homework tasks on which they report back to the therapist via the internet. The therapist gives written feedback and guidance after each module. See reference for details.

Group Type: ACTIVE_COMPARATOR

internet Cognitive Behavior Therapy (iCBT)

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

internet Cognitive Behavior Therapy (iCBT)

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Linkoeping University

OTHER_GOV

Sponsor Role: collaborator

Örebro University, Sweden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katja Boersma, PhD

Role: PRINCIPAL_INVESTIGATOR

Örebro University, Sweden

Locations

Smärt- och rehabiliteringscentrum Linköping

Linköping, , Sweden

Center for Health and Medical Psychology

Örebro, , Sweden

Countries

Sweden

References

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.

Reference Type: BACKGROUND

PMID: 21533329 (View on PubMed)

Other Identifiers

HYBRID

Identifier Type: -

Identifier Source: org_study_id