Efficacy of ACT in Patients Scheduled for Lumbar Spine Surgery

NCT05634122 | Unknown

• 1 other identifier: 2021/9998/I
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: (1) To analyze the effectiveness of adding a group-based form of Acceptance and Commitment Therapy (ACT) to the treatment as usual (TAU) for preoperative patients diagnosed with degenerative lumbar pathology plus psychosocial risk factors related to post-surgical chronic pain at baseline and after psychological treatment. (2) To examine the effectiveness of ACT on the improvement of pain interference, pain-related and behavioral variables in degenerative lumbar pathology preoperative patients after lumbar spine surgery in comparison with TAU. (3) To measure the proximal and distal effects of ACT in preoperative patients with degenerative lumbar pathology who had the surgery after ACT program completion in comparison with proximal and distal TAU surgery effects on pain related variables. Method: A 12-month randomized controlled trial (RCT) will be conducted at Hospital del Mar (Barcelona). Only those preoperative degenerative lumbar pathology patients with psychosocial risk factors for chronic post-surgical pain will be randomized to pre-surgical ACT group or to TAU. Evaluations will be completed before treatment (baseline), after ACT therapy (3 months), a first follow-up (6 months from baseline alias 3 months after surgery), second follow-up (9 months from baseline alias 6 months after surgery), and final follow-up (15 months from baseline alias 12 months from surgery). Participants: 80 adult preoperative patients with degenerative lumbar pathology plus psychosocial risk factors related to post-surgical chronic pain will be randomly assigned to two arms: ACT + TAU vs TAU. Primary outcome: Pain interference. Secondary outcomes: pain intensity, pain catastrophising, pain acceptance, pain disability, kinesiophobia, depression symptoms, anxiety symptoms, psychological flexibility, and quality of life. Main statistical analyses: Intention-to-Treat analyses that will include all participants who undergo random allocation, using multiple imputation to replace missing values. General 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.

Conditions

Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory (BPI)

  It is a questionnaire that assesses chronic pain in a multidimensional way. It provides information on the intensity of the pain and on the degree of interference in the functioning and daily activities of the patients. It has 11 items. The first 4 items evaluate the intensity of pain in the last 24 hours. Subsequently, 7 items that report the degree of involvement of chronic pain in various areas of the person's functioning are evaluated. The higher the score in the areas of the questionnaire, the greater the intensity of perceived pain, as well as the greater degree of involvement of chronic pain in the functioning of the person in the various areas explored

  Through study completion, an average of 2 years

Secondary Outcomes (7)

• Hospital Anxiety and Depression Scale (HADS)

  Through study completion, an average of 2 years

• Pain Catastrophising Scale (PCS)

  Through study completion, an average of 2 years

• Psychological Inflexibility in Pain Scale (PIPS)

  Through study completion, an average of 2 years

• Tampa Kinesiophobia Scale (TSK-11SV)

  Through study completion, an average of 2 years

• Chronic Pain Acceptance Questionnaire (CPAQ-20)

  Through study completion, an average of 2 years

Other Outcomes (1)

• Socio-demographic questionnaire

  Baseline

Study Arms (2)

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)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

Standard care. The standard treatment would generally be pharmacological to address chronic pain, adjusted to the symptomatic profile of each patient.

Behavioral: Treatment as Usual (TAU)

Interventions

Acceptance and Commitment Therapy (ACT) BEHAVIORAL

Group treatment protocol of 8 weeks of 90 minutes sessions Session 1: Presentation of the general ACT therapy concept. Session 2: Value analysis I. Session 3: Value analysis II. Session 4: Value analysis third Session 5: Values and feelings. Session 6: Drink one direction. Session 7: Dare and change. Session 8: Ready to act with ACT. Treatment as usual (TAU) Standard pharmacological treatment for patients with chronic pain.

TAU + Acceptance and Commitment Therapy (ACT)

Treatment as Usual (TAU) BEHAVIORAL

Standard pharmacological treatment for patients with chronic pain

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18- 80 years
• Possess an adequate understanding of Spanish or Catalan
• Meet the diagnostic criteria for lumbar pain/degenerative lumbar pathology candidates for surgical treatment.
• Diagnoses:
• Lumbar canal stenosis.
• Foraminal stenosis.
• Lumbar spondylolisthesis.
• Lumbar degenerative disc disease.
• Degenerative scoliosis.
• Lumbar kyphosis.
• Procedures:
• Laminectomy. Foraminoplasty. Laminectomy and posterior arthrodesis. previous arthrodesis.
• Presence of psychosocial risk factors for chronic post-surgical pain:
• Mild-moderate anxiety/depression symptoms (HADS hospital anxiety and depression sub-scales≥11, see measurement instruments section) and/or
• Presence of catastrophizing (PCS catastrophizing scale (0-52) ≥24, see measurement instruments section), and/or

You may not qualify if:

• Cognitive impairment that in the clinician's judgment prevents you from participating in therapy
• Presenting chronic pain not related to the diagnosis of low back pain that is a candidate for surgical treatment
• Patients in litigation or who are pending legal claims for compensation
• Severe or decompensated psychiatric disorder (depression, schizophrenia, bipolar disorder, personality disorder) that in the clinician's judgment prevents you from participating in therapy
• Suicidal ideation
• Consumption of toxic substances in abuse/dependence, except for smoking
• Patients with a language barrier (Spanish/Catalan)
• Patients who do not authorize it voluntarily and do not want to participate

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Parc Salut Mar

Barcelona, 08003, Spain

RECRUITING

MeSH Terms

Interventions

Acceptance and Commitment Therapy; Therapeutics

Intervention Hierarchy (Ancestors)

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

Study Officials

• Antonio Montes-Pérez, PhD

  Parc Salut Mar

  STUDY DIRECTOR

• Víctor Pérez-Solà, PhD

  Parc Salut Mar

  STUDY DIRECTOR

• Luis Miguel Martín-López, PhD

  Parc Salut Mar

  STUDY CHAIR

• Alejandro Del Arco-Churruca, PhD

  Parc Salut Mar

  STUDY DIRECTOR

• Jesús Lafuente Baraza, PhD

  Parc Salut Mar

  STUDY CHAIR

• Juan V. Luciano, PhD

  Parc Sanitari Sant Joan de Déu

  STUDY DIRECTOR

• Juan Ramón Castaño-Asins, MD

  Parc Salut Mar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Ramón Castaño-Asins, MD

CONTACT

+34932483000; jrcastano@psmar.cat

Ariadna Colomer-Carbonell, MSc

CONTACT

+34936406350; ariadna.colomer@sjd.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: parallel-group, randomized controlled trial

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 1, 2022
• Study Start: November 26, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: December 7, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)