Cost-utility and Physiological Effects of ACT and BATD in Patients With Chronic Pain and Depression
Condition: Randomized Controlled Trial
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      Objectives: (1) To analyze the effectiveness of adding a group-based form of Acceptance and
      Commitment Therapy (ACT) or a behavioural activation program for depression (TACD) to the
      treatment as usual (TAU) for patients diagnosed of chronic pain and comorbid mild-moderate
      major depression; (2) To examine the cost-utility of these psychological treatments from
      healthcare and societal perspectives; (3) To measure a set of biomarkers alongside the RCT in
      order to know the physiological underpinnings of these psychological therapies and to
      identify potential predictors of treatment response.

      Methodology: 12-month multisite, randomised, controlled trial (RCT) Centres: Parc Sanitari
      Sant Joan de Déu (St. Boi de Llobregat) and Hospital del Mar (Barcelona).

      Participants. 225 adult patients with chronic pain that meet the diagnostic criteria for
      mild-moderate major depression will be randomly assigned to one of the three study arms: TAU
      + ACT vs. TAU + TACD vs. TAU.

      Primary outcome: Quality of life. Secondary outcomes: pain intensity, depression severity,
      anxiety symptoms, pain catastrophising, and pain acceptance. Costs to the healthcare system
      and to society and quality adjusted life years (QALYs). In addition, the empirically
      validated app Multicenter Pain Monitor® will be used to monitor participants alongside the
      treatments (ecological momentary assessment). Biomarkers: hair cortisol and cortisone,
      corticosteroid-binding globulin (CBG), ACTH and cortisol in plasma, and genotyping of 5
      polymorphisms in the FKBP5 gene involved in the regulation of the
      hypothalamic-pituitary-adrenal axis activity, cytokines, Th1: IL-6, IL-8, TNF-α; cytokines
      Th2: IL-10 + hsCRP test, and vitamin D levels. Main statistical analyses: Intention-to-Treat
      analyses that will include all participants who undergo random allocation, using multiple
      imputation to replace missing values. Linear mixed-effects models will be performed using
      Restricted Maximum Likelihood to estimate the parameters. Calculation of between-groups
      effect sizes using Cohen's d and of the number-needed-to-treat. Economic evaluation:
      cost-utility ratios evaluated by applying bootstrapping techniques, acceptability curves, and
      sensitivity analyses.
    

Detailed description: 
      The IMPACT Project's main objective is to determine the effectiveness of adding to the
      standard care of patients with chronic pain and mild to moderate major depression a group
      programme based on ACT or a group programme based on BATD and analyse the cost-utility of
      these psychological treatments from a health and social perspective. Likewise, both in
      chronic pain and in other usually associated psychiatric diseases, there is a ubiquitous lack
      of knowledge about what specific psychological and physiological mechanisms are modified by
      these third generation psychotherapies and how they relate to the observed clinical results.
      The potential predictors of response to these treatments are also unknown. In chronic
      musculoskeletal pain where central sensitization plays an important role, alterations have
      been found in different markers associated with an increased experience of pain. Some of
      these alterations in markers (e.g. high levels of pro-inflammatory cytokines) would also
      appear to be shared with other psychiatric diseases (major depression), a fact that would
      suggest a possible common mechanism involved in the etiopathogenesis of these diseases. Third
      generation psychotherapies have proven effective for pain management and regulation of the
      immune response. The IMPACT Multicentre Project (Improving Pain and Depression with ACT and
      BATD) will significantly expand the limited knowledge available about how ACT and BATD
      therapies exert their effects on relevant clinical improvement variables and will try to
      identify response predictive factors to these treatments.
    

Intervention name(s): Acceptance and Commitment Therapy (ACT); Behavioral Activation Therapy for Depression (BATD); Treatment as Usual (TAU)
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): Group treatment protocol of 8 weekly 90 minute sessions. Session 1: Presentation of the general concept of ACT therapy. Session 2: Value analysis I. Session 3: Value analysis II. Session 4: Value analysis III. Session 5: Values and feelings. Session 6: Taking a direction. Session 7: Dare and change. Session 8: Ready to act with ACT.; Group treatment protocol of 8 weekly 90 minute sessions. Session 1: Collection of information regarding areas of activity and interaction contexts.
Session 2: Identification of information related to depressive behaviours. Session 3 Obtaining complementary information regarding the characteristics of the history of patient interactions and any contexts.
Session 4: Explanation of the hypotheses of problematic behaviour, its maintenance and change throughout the intervention.
Session 5: Once the 10 target activities have been identified, a record is made to track and their progress weekly.
Session 6: Discussion of what was obtained from the records in general and of the satisfaction obtained, and explanation of the contexts and reinforcers.
Session 7: Psycho-education Session 8: New behaviours, the goals achieved and the maintenance of the weekly activity are inquired about.; Standard pharmacological treatment usually provided to patients suffering chronic pain and mild-moderate depression.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-blind, parallel-group, randomized controlled trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment