Cost-utility and Physiological Effects of ACT and BATD in Patients With Chronic Pain and Depression

NCT04140838 | Completed

• 1 other identifier: PI19/00112
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Aggregate score of the Physical Function, Body Pain and Vitality subscales of the SF-36

  The range of scores is 15 to 65. Higher scores indicate better quality of life.

  Through study completion, an average of 1 year

Secondary Outcomes (3)

• Numerical pain scale

  Through study completion, an average of 1 year

• Hospital Anxiety and Depression Scale (HADS)

  Through study completion, an average of 1 year.

• Pain Catastrophising Scale (PCS)

  Through study completion, an average of 1 year

Other Outcomes (9)

• Psychological Inflexibility in Pain Scale (PIPS)

  Through study completion, an average of 1 year

• EuroQoL (EQ-5D-5L)

  Through study completion, an average of 1 year

• Behavioral Activation for Depression Scale (BADS) - short-form

  Through study completion, an average of 1 year

Study Arms (3)

TAU + Acceptance and Commitment Therapy (ACT)

EXPERIMENTAL

This therapy is based, as the name implies, on the acceptance (not avoidance) of negative experiences as a coping strategy, and on committing to life values or objectives. ACT has been used for various conditions, including chronic pain. Since avoidance is a strategy frequently used by patients suffering from pain, the application of this therapy seems very appropriate. In fact, it has been proven that patients who accept their pain more are those who score lower in pain intensity, have less negative emotions and enjoy a better quality of life.

Behavioral: Acceptance and Commitment Therapy (ACT); Other: Treatment as Usual (TAU)

TAU + Behavioral Activation Therapy for Depression (BATD)

EXPERIMENTAL

Behavioural and structured treatment based on the application of learning principles. Its objective is to counteract depressive symptoms and, as a consequence, to ensure that patients regain a productive and emotionally satisfying life. Its basic methodology consists in activating subjects with depression through programming and conduct of behaviours that are likely to increase the positive reinforcement of their context.

Behavioral: Behavioral Activation Therapy for Depression (BATD); Other: Treatment as Usual (TAU)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

Standard Care. Although there is no treatment considered as the gold standard for chronic pain and comorbid major depression, the standard treatment is usually mainly pharmacological and conforms to the symptomatic profile of each patient.

Other: Treatment as Usual (TAU)

Interventions

Acceptance and Commitment Therapy (ACT) BEHAVIORAL

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.

TAU + Acceptance and Commitment Therapy (ACT)

Behavioral Activation Therapy for Depression (BATD) BEHAVIORAL

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.

TAU + Behavioral Activation Therapy for Depression (BATD)

Treatment as Usual (TAU) OTHER

Standard pharmacological treatment usually provided to patients suffering chronic pain and mild-moderate depression.

TAU + Acceptance and Commitment Therapy (ACT); TAU + Behavioral Activation Therapy for Depression (BATD); Treatment as Usual (TAU)

Eligibility Criteria

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

You may qualify if:

• Patients who have been visited in the last 3 years in the participating centres and who have been given a diagnosis of chronic non-cancer musculoskeletal pain. In telephone screening, it will be evaluated whether the current pain intensity is at least moderate and PHQ-9 will be administered to confirm the presence of mild to moderate active depression.
• Patients between 18 and 70 years of age.
• Diagnosis of chronic pain (≥ 3 months) according to medical history (current pain ≥ 4 out of 10)
• Diagnosis of mild to moderate depression according to PHQ-9 (score between 5 and 19).
• Understanding of Spanish.
• Access to a Smartphone (with Android operating system).
• Written informed consent.

You may not qualify if:

• Presence of cognitive impairment according to MMSE (≤ 24 out of 30).
• Previous (last year) or current psychological treatment.
• Presence of severe mental disorder (e.g. psychotic disorder) related to substance dependence/abuse or another disease that affects the CNS (organic brain pathology or head trauma of any severity).
• Presence of serious, uncontrolled or degenerative medical disease that may interfere with affective symptoms.
• Risk of suicide (Item 9 score of PHQ-9 ≥ 2).
• Patients involved in legal proceedings with employers in relation to their illness.
• Patients with scheduled surgical intervention or other interventions.
• Inability to attend group treatment sessions.
• Cold/infection symptoms on the day of blood collection.
• Needle phobia.
• BMI \> 36 kg/m2 or weight \> 110 kg
• Consumption \> 8 units of caffeine per day (maximum 1 drink with caffeine on the day of testing).
• Smoker \> 5 cigarettes a day.
• Being pregnant or breastfeeding

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead
• Carlos III Health Institute: collaborator

Study Sites (2)

Parc Sanitari Sant Joan de Déu (PSSJD)

Sant Boi de Llobregat, Barcelona, 08830, Spain

Location

Parc de Salut Mar

Barcelona, 08003, Spain

Location

Related Publications (3)

• Sanabria-Mazo JP, Forero CG, Cristobal-Narvaez P, Suso-Ribera C, Garcia-Palacios A, Colomer-Carbonell A, Perez-Aranda A, Andres-Rodriguez L, McCracken LM, D'Amico F, Estivill-Rodriguez P, Carreras-Marcos B, Montes-Perez A, Comps-Vicente O, Esteve M, Grasa M, Rosa A, Cuesta-Vargas AI, Maes M, Borras X, Edo S, Sanz A, Feliu-Soler A, Castano-Asins JR, Luciano JV. Efficacy, cost-utility and physiological effects of Acceptance and Commitment Therapy (ACT) and Behavioural Activation Treatment for Depression (BATD) in patients with chronic low back pain and depression: study protocol of a randomised, controlled trial including mobile-technology-based ecological momentary assessment (IMPACT study). BMJ Open. 2020 Jul 23;10(7):e038107. doi: 10.1136/bmjopen-2020-038107.

  PMID: 32709656 BACKGROUND

• Sanabria-Mazo JP, Colomer-Carbonell A, Borras X, Castano-Asins JR, McCracken LM, Montero-Marin J, Perez-Aranda A, Edo S, Sanz A, Feliu-Soler A, Luciano JV. Efficacy of Videoconference Group Acceptance and Commitment Therapy (ACT) and Behavioral Activation Therapy for Depression (BATD) for Chronic Low Back Pain (CLBP) Plus Comorbid Depressive Symptoms: A Randomized Controlled Trial (IMPACT Study). J Pain. 2023 Aug;24(8):1522-1540. doi: 10.1016/j.jpain.2023.04.008. Epub 2023 Apr 25.

  PMID: 37105508 RESULT

• Sanabria-Mazo JP, D'Amico F, Cardenosa E, Ferrer M, Edo S, Borras X, McCracken LM, Feliu-Soler A, Sanz A, Luciano JV. Economic Evaluation of Videoconference Group Acceptance and Commitment Therapy and Behavioral Activation Therapy for Depression Versus Usual Care Among Adults With Chronic Low Back Pain Plus Comorbid Depressive Symptoms. J Pain. 2024 Jul;25(7):104472. doi: 10.1016/j.jpain.2024.01.337. Epub 2024 Jan 18.

  PMID: 38242333 DERIVED

MeSH Terms

Interventions

Acceptance and Commitment Therapy; Therapeutics

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Juan V. Luciano, PhD

  Fundació Sant Joan de Déu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single-blind, parallel-group, randomized controlled trial

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 28, 2019
• Study Start: July 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)