Acceptance and Commitment Therapy and Cognitive Behavioral Therapy for Chronic Pain

NCT02778737 | Unknown

• 1 other identifier: K3_K1_0b
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic pain is a long-term condition which is related to a number of negative consequences including reduced productivity at work, increased number of sick leave , depression and emotional difficulties among others. Psychological interventions, particular Cognitive Behavioral therapies (CBT) are deemed effective in reducing the negative consequences following a diagnosis of a chronic pain condition. Though research provides substantial evidence for the CBT effectiveness, not all patients manage to reduce pain intensity or improve their physical and psychosocial functioning. Also, CBT appears with only small effect sizes on variables considered to be core domains in chronic pain. Finally, there are criticism targets on the lack of clear mechanisms underlying the process of change in CBT. New CBT therapeutic approaches, such as Acceptance and Commitment Therapy (ACT) focus on changing individuals' relation with their inner experiences. They utilize mindfulness and acceptance processes, instead of directly changing or controlling the content of internal experiences, as CBT does. ACT has received support for its effectiveness in chronic pain but there are very few clinical randomized trials to compare it with traditional CBT. The purpose of this study is to determine whether an ACT-based intervention when compared with a CBT-based intervention designed for chronic pain patients is efficacious in reducing pain interference, pain-related disability, and psychological distress. Also this study aims to examine whether any therapeutic effects result due to the effect of acceptance, for those participating in the ACT group or control appraisal, for those participating in the CBT group. Better knowledge of the mechanism of therapeutic change can help us to recognize which patients can be benefit from which approach.

Conditions

Chronic Pain

Keywords

ACT, CBT, Randomized controlled trial, Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Change in pain intensity as assessed with the Greek Brief Pain Inventory (G-BPI)

  is an 11-item measure of intensity and interference of pain in 7 life dimensions: work, mood, activity, sleep, relationships, walking and enjoyment, rated on a scale with 0="no pain" and 10="pain as bad as you can imagine". The G-BPI has shown good reliability, Cronbach's alpha=.80 and sufficient validity with constructs considered theoretically related.

  Change from baseline pain intensity through study completion, an average of 1 year

Secondary Outcomes (3)

• Change in the Quality of life as assessed with the Short Form Health Survey (SF-36; Greek version 1.0; Pappa, Kontodimopoulos & Niakas, 2005)

  Change in levels of QoL from baseline through study completion, an average of 1 year

• Change in insomnia as assessed with the Athens Insomnia Scale (AIS; Soldatos, Digeos, Paparrigopoulos, 2000)

  Change in insomnia from baseline through study completion, an average of 1 year

• Change in the levels of psychological distress as assessed with the Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983)

  Changes in the levels of psychological distress from baseline through study completion, an average of 1 year

Other Outcomes (6)

• Changes in the levels of pain acceptance as assessed via the Greek Chronic Pain Acceptance Questionnaire (G-CPAQ; Vasiliou, Karekla, Michaelides, & Kasinopoulos, under review)

  Changes in pain acceptance from baseline through study completion, an average of 1 year

• Changes in avoidance of pain levels as assessed via the Greek version of the Psychological Inflexibility in Pain Scale (G-PIPS-II; Vasiliou, Karekla, Michaelides, & Kasinopoulos, in preparation; Wicksell, Lekander, Sorjonen & Olsson, 2010)

  Changes in pain avoidance from baseline through study completion, an average of 1 year

• Changes in experiential avoidance as assessed via the Acceptance and Action Questionnaire- Greek version (AAQ-II; Karekla & Michaelides, under review)

  Changes in experiential avoidance from baseline through study completion, an average of 1 year

Study Arms (2)

ACT-based intervention

EXPERIMENTAL

The Acceptance and Commitment Therapy + MTAU consists of an unpublished manual developed for the purposes of the project (Karekla et al., 2013). The 8, 90-min weekly group sessions focus in fostering psychological flexibility or the capacity to engage or change behaviors based on what a situation affords and an individual's goals, needs, and desires (Hayes et al., 2004). The ACT protocol involves helping patients to engage in values-based behaviors while remain in contact with pain, especially, when efforts to control or reduce it fail or contribute to suffering.

Behavioral: ACT-based intervention

CBT-based intervention

ACTIVE COMPARATOR

The Cognitive Behavioral group + MTAU consists of an unpublished manual developed by Kalantzi-Azizi \& Karademas (2003). It includes 8, 90-min weekly group session and primarily focuses on teaching patients to manage their pain by utilizing various techniques, such as activity pacing, muscle relaxation(i.e., progressive muscle relaxation, diaphragmatic breathing, guided imagery), pain recording, thought challenging, problem solving skills, relapse prevention, etc. The CBT protocol involves helping patients to learn to control their pain and to modify dysfunctional thoughts that accompany it.

Behavioral: CBT-based intervention

Interventions

ACT-based intervention BEHAVIORAL

Treatment sessions will be conducted weekly by two co-therapists in groups of approximately 8-10 participants for 1 ½ hours. Although each session has specific objectives, therapists within the time frame, are encouraged to accommodate participants' discussion or other group dynamic issues that may arise. Participants will receive their AP-ACT handbook including outlines of each session, activity plan assignments, and a CD with recorded mindfulness exercises. Session highlights and AP-ACT activities relevant to each session will be given at each meeting, so that participants will follow along with the treatment protocol. Individuals missing more than two consecutive sessions will be considered as dropouts.

ACT-based intervention

CBT-based intervention BEHAVIORAL

Treatment sessions will be conducted weekly by two co-therapists in groups of approximately 8-10 participants for 1 ½ hours. Although each session has specific objectives, therapists within the time frame, are encouraged to accommodate participants' discussion or other group dynamic issues that may arise. Participants will receive their AP-CBT handbook including outlines of each session, activity plan assignments, and a CD with recorded relaxation exercises. Session highlights and AP-CBT activities relevant to each session will be given at each meeting, so that participants will follow along with the treatment protocol. Individuals missing more than two consecutive sessions will be considered as dropouts.

CBT-based intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presentation of chronic pain episodes
• Significant impact of the chronic pain condition on quality of life
• Having a medical diagnosis of chronic pain
• Stable medical treatment for at least 2 months
• Reading ability sufficient to comprehend self-monitoring forms as well as competence in the Greek language

You may not qualify if:

• An active non pharmacologically-controlled psychotic spectrum condition or manic episode, suicidal ideation/ intent or substance use problems within the 6 months prior to recruitment
• Having a severe medical condition in the present (e.g. cancer)
• No significant cognitive impairment, as assessed using the Mini-mental Status Examination (MMSE).
• Age under 18 or above 70 years
• Receiving any other psychological intervention which is based on CBT

Sponsors & Collaborators

• University of Cyprus: lead
• University of Crete: collaborator

Study Sites (1)

University of Crete

Rethymno, Crete, 74 100, Greece

Location

MeSH Terms

Conditions

Chronic Pain; Color Vision Defects

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vision Disorders; Sensation Disorders; Nervous System Diseases; Cone Dystrophy; Eye Diseases, Hereditary; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Licensed Clinical Psychologist, Assistant Professor, Peer reviewed ACT trainer

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: May 20, 2016
• Study Start: September 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 23, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

GR (1)