Overview

This trial is active, not recruiting.

Condition chronic pain
Treatments act-based intervention, cbt-based intervention
Sponsor University of Cyprus
Collaborator University of Crete
Start date September 2013
End date June 2016
Trial size 200 participants
Trial identifier NCT02778737, K3_K1_0b

Summary

Chronic pain is a long-term condition which is related to a number of negative consequences including reduced productivity at work (Gatchel & Okifuiji, 2006), increased number of sick leave (Gatchel & Okifuiji, 2006), depression and emotional difficulties (Von Korff et al., 2005) 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 (Kerns et al., 2011; Morley, 2011). Though research provides substantial evidence for the CBT effectiveness (Eccleston et al., 2009), not all patients manage to reduce pain intensity or improve their physical and psychosocial functioning (Williams et al., 2012). Also, CBT appears with only small effect sizes on variables considered to be core domains in chronic pain (e.g. Dworkin et al., 2005). Finally, there are criticism targets on the lack of clear mechanisms underlying the process of change in CBT (McCracken & Morley, 2014).

New CBT therapeutic approaches, such as Acceptance and Commitment Therapy (ACT; Hayes et al., 2012) 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose treatment
Arm
(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.
act-based intervention
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.
(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.
cbt-based intervention
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.

Primary Outcomes

Measure
Change in pain intensity as assessed with the Greek Brief Pain Inventory (G-BPI)
time frame: Change from baseline pain intensity through study completion, an average of 1 year

Secondary Outcomes

Measure
Change in the Quality of life as assessed with the Short Form Health Survey (SF-36; Greek version 1.0; Pappa, Kontodimopoulos & Niakas, 2005)
time frame: 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)
time frame: 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)
time frame: Changes in the levels of psychological distress from baseline through study completion, an average of 1 year

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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

Additional Information

Official title An Innovative Psychosocial Intervention for the Treatment of Chronic Pain Patients and Their Families
Description For more than 30 years cognitive behavior therapy has been the mainstream treatment approach for chronic pain patients and research evidence supporting its effectiveness . Review demonstrate that CBT for chronic pain leads in lowered pain, less emotional distress and pain-related disability, reduced medication use and healthcare utilization, and better improvement in physical and psychosocial functioning. Though CBT for chronic pain is effective, recent evidence suggest that not all patients succeed in lowering pain or improving their physical and psychosocial functioning. Also, research shows only small effects on disability and criticisms targets on the lack of clear mechanisms underlying the process of change in CBT. Researchers argue that the problem with CBT effectiveness lies on its methods. CBT attempts to manage various problems that chronic pain patients face utilizing different methods in combination. This expansion of CBT methods has created concerns among researchers and clinicians as it is not clear what works for whom. More comprehensive and integrated theoretical models encompassing various pain coping responses call for new research that can buffer the CBT expansion. Following the CBT criticisms, new treatment approaches stemming from the third wave of cognitive behavior therapy abandon traditional approaches to directly change or control the content of internal experiences, and give more emphasis on changing individuals' relation with their inner experience. In doing so, they use mindfulness and acceptance approached along with value-committed actions to produce behavioral changes. One of these approaches, known as Acceptance and Commitment Therapy, has extensively researched in the area of chronic pain and recently the division 12 of the APA listed ACT as an empirically treatment with strong research support for general chronic pain conditions. Indeed, ACT has received amounting evidence in chronic pain and research outcomes demonstrate strong effects on physical and psychosocial disability, mood and daily functioning. Though ACT has received support for its effectiveness in chronic pain, there are yet very few clinical randomized trials to compare it with traditional CBT. The primary aim of the Algea study is to investigate the efficacy of an ACT-based intervention designed for general chronic pain patients and compare it with a CBT intervention. Specific hypotheses include: (1) ACT will demonstrate improvements in pain indices (pain severity and interference), psychological distress, and quality of life when compared with the CBT group; (2) ACT will present with long-term effects (i.e., 6 months) and patients will report better satisfaction with this treatment than the CBT group; and (3) pain acceptance and values-based actions are considered mechanism of change variables that mediate treatment response in ACT, while control appraisal will mediate treatment response in CBT. Better knowledge of the differences and similarities of the two CBT approaches (i.e., traditional CBT for chronic pain and ACT) in managing chronic pain can help us formulate treatments that can be tailored to patients needs.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Cyprus.