Clinical trial NCT02778737: Acceptance and Commitment Therapy and Cognitive Behavioral Therapy for Chronic Pain
Official title: An Innovative Psychosocial Intervention for the Treatment of Chronic Pain Patients and Their Families
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Keywords: ACT, CBT, Randomized controlled trial, Chronic Pain
Lead sponsor: University of Cyprus
Sponsor class: OTHER
Collaborators: name: University of Crete
First posted: 2016-05-20
Enrollment: 200
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: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in pain intensity as assessed with the Greek Brief Pain Inventory (G-BPI)
timeFrame: 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)
timeFrame: Change in levels of QoL from baseline through study completion, an average of 1 year
measure: Change in insomnia as assessed with the Athens Insomnia Scale (AIS; Soldatos, Digeos, Paparrigopoulos, 2000)
timeFrame: Change in insomnia from baseline through study completion, an average of 1 year
measure: Change in the levels of psychological distress as assessed with the Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983)
timeFrame: Changes in the levels of psychological distress from baseline through study completion, an average of 1 year
Other outcomes:
measure: Changes in the levels of pain acceptance as assessed via the Greek Chronic Pain Acceptance Questionnaire (G-CPAQ; Vasiliou, Karekla, Michaelides, & Kasinopoulos, under review)
timeFrame: Changes in pain acceptance from baseline through study completion, an average of 1 year
measure: 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)
timeFrame: Changes in pain avoidance from baseline through study completion, an average of 1 year
measure: Changes in experiential avoidance as assessed via the Acceptance and Action Questionnaire- Greek version (AAQ-II; Karekla & Michaelides, under review)
timeFrame: Changes in experiential avoidance from baseline through study completion, an average of 1 year
measure: Changes in mindfulness as assessed via the Cognitive Affective Mindfulness Scale-Revised (CAMS-R; Feldman, Hayes, Kumar, Greeson, & Laurenceau, 2007)
timeFrame: Changes in mindfulness levels from baseline through study completion, an average of 1 year
measure: Changes in goal-directed behaviors as assessed via the Committed Action Questionnaire (CAQ; McCracken et al., 2014)
timeFrame: Changes in goal-directed behaviors from baseline through study completion, an average of 1 year
measure: Changes in living composite values as assessed via the Valued Living Questionnaire (VLQ; Wilson, Sandoz, Kitchens, & Roberts, 2010)
timeFrame: Changes in living composite values levels from baseline through study completion, an average of 1 year
Locations:
city: Rethymnon
country: Greece
facility: University of Crete
state: Crete
Study officials:
References: