Randomized Controlled TrialSPINE-ACTNCT05634122
Efficacy of ACT in Patients Scheduled for Lumbar Spine Surgery
A study testing Acceptance and Commitment Therapy (ACT) and Treatment as Usual (TAU) in people with Randomized Controlled Trial, run by Parc de Salut Mar at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Randomized Controlled Trial
- What is being tested?
- Acceptance and Commitment Therapy (ACT) and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 26 Nov 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
- Kinesiophobia base ≥27, see measurement instruments section)
- Have an internet connection on a mobile phone, tablet, computer, etc. to be able to carry out group psychological therapy online.
- Give authorization by signing an informed consent
Who cannot join
- 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
- NOT present psychosocial risk factors for chronic post-surgical pain (see inclusion criteria: anxiety, catastrophizing, depression, kinesiophobia)
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Parc Salut Mar
Barcelona, 08003
Juan Ramón Castaño-Asins, MD, +34932483000 ext. 3175, jrcastano@psmar.cat
About this study
Official title: Efficacy of Acceptance and Commitment Therapy in Patients Scheduled for Lumbar Spine Surgery (SPINE-ACT Project)
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).
Read more
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.
Read the detailed description
The Spine-ACT project's main objective is to determine the effectiveness of adding to the standard care (TAU) of preoperative patients with degenerative lumbar pathology plus psychosocial risk factors related to post-surgical chronic pain, a group-based form of ACT. In this regard, assessing patients' results after surgery at proximal or distal improvement on pain-related variables compared with TAU surgery patients would be addressed. The Spine-ACT project will assess the usefulness of ACT therapy applied before surgery to improve pain-related variables and quality of life in preoperative degenerative lumbar pathology patients with psychosocial risk factors of developing chronic or post-surgical pain. This project will significantly expand the limited knowledge available about preoperative pain-related improvement through ACT therapy and how this psychological therapy could prevent post-surgical chronic pain. Thus, it is expected that ACT therapy can improve the various pain-related and quality-of-life variables in developing chronic pain in preoperative patients diagnosed with degenerative lumbar pathology plus psychosocial risk factors of post-surgical chronic pain.
- Conditions
- Randomized Controlled Trial
- Being tested
- Acceptance and Commitment Therapy (ACT), Treatment as Usual (TAU)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy (ACT)Behavioural
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.
Treatment as Usual (TAU)Behavioural
Standard pharmacological treatment for patients with chronic pain
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of 2 years
Secondary outcomes (7)
Hospital Anxiety and Depression Scale (HADS)
A scale of 14 items was created to assess symptoms of anxiety and depression. The total score ranges from 0 to 42, and each subscale (HADS-Anxiety and HADS-Depression) includes 7 items with scores ranging from 0 to 21. Higher scores indicate higher symptom severity.
Measured: Through study completion, an average of 2 years
Pain Catastrophising Scale (PCS)
The scale of 13 items comprises three dimensions: rumination over pain, magnification of pain, and helplessness in the ace of pain symptoms. The PCS total score and subscale scores are computed as the sum of ratings for each item. This study used the total score, which can vary from 0 to 52 with higher scores indicating greater pain catastrophizing.
Measured: Through study completion, an average of 2 years
Psychological Inflexibility in Pain Scale (PIPS)
12-item scale that assesses psychological inflexibility in patients with pain and includes two factors: avoidance and cognitive fusion with pain. For this study, only the total score is used; it ranges from 12 to 84, with higher scores indicating higher level of psychological inflexibility.
Measured: Through study completion, an average of 2 years
Tampa Kinesiophobia Scale (TSK-11SV)
It is a questionnaire that allows us to measure the fear of moving or being injured/(re)injured, in patients with pain. The final score can be at least 11 and a maximum of 44 points; the higher the score, the higher the degree of kinesiophobia. It is considered that a score ≥18 is already indicative of a fear of movement, which increases in severity as the score increases.
Measured: Through study completion, an average of 2 years
Chronic Pain Acceptance Questionnaire (CPAQ-20)
It consists of 20 items organized in a factorial structure of two subscales. The maximum possible total score is 120, so that higher scores indicate a higher level of the acceptance construct in the process.
Measured: Through study completion, an average of 2 years
Short Form 12 Health Survey (SF-12)
This scale includes measures of health-related quality of life. It is made up of a subset of 12 items, with 8 dimensions, and 2 summative components (physical and mental). The items are coded, added, and transformed into a scale that ranges from 0 (the worst state of health for that dimension) to 100 (the best state of health).
Measured: Through study completion, an average of 2 years
Oswestry Low Back Pain Disability Scale (OLBPDQ)
The scale consists of 10 questions with 6 response possibilities each. The total score, expressed as a percentage (0 to 100%), is obtained as the sum of the estimates for each element divided by the maximum possible score multiplied by 100. High values describe greater functional limitations.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start26 Nov 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Randomized Controlled TrialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel-group, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Ramon Castaño, Parc de Salut Mar
- Investigators
- Antonio Montes-Pérez, PhD, Study director, Parc Salut MarVíctor Pérez-Solà, PhD, Study director, Parc Salut MarLuis Miguel Martín-López, PhD, Study chair, Parc Salut MarAlejandro Del Arco-Churruca, PhD, Study director, Parc Salut MarJesús Lafuente Baraza, PhD, Study chair, Parc Salut MarJuan V. Luciano, PhD, Study director, Parc Sanitari Sant Joan de DéuJuan Ramón Castaño-Asins, MD, Principal investigator, Parc Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634122
- Sponsor's protocol ID
- 2021/9998/I
- Acronym
- SPINE-ACT
- Status last verified
- Dec 2022
- First submitted
- 21 Nov 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acceptance and Commitment Therapy in Patients Scheduled for Lumbar Spine Surgery (SPINE-ACT Project)
- ClinicalTrials.gov ID
- NCT05634122
- Acronym / sponsor ID
- SPINE-ACT / 2021/9998/I
- Conditions
- Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 26 Nov 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Spine-ACT project's main objective is to determine the effectiveness of adding to the standard care (TAU) of preoperative patients with degenerative lumbar pathology plus psychosocial risk factors related to post-surgical chronic pain, a group-based form of ACT. In this regard, assessing patients' results after surgery at proximal or distal improvement on pain-related variables compared with TAU surgery patients would be addressed. The Spine-ACT project will assess the usefulness of ACT therapy applied before surgery to improve pain-related variables and quality of life in preoperative degenerative lumbar pathology patients with psychosocial risk factors of developing chronic or post-surgical pain. This project will significantly expand the limited knowledge available about preoperative pain-related improvement through ACT therapy and how this psychological therapy could prevent post-surgical chronic pain. Thus, it is expected that ACT therapy can improve the various pain-related and quality-of-life variables in developing chronic pain in preoperative patients diagnosed with degenerative lumbar pathology plus psychosocial risk factors of post-surgical chronic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- parallel-group, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| TAU + Acceptance and Commitment Therapy (ACT) | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT)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. |
| Treatment as Usual (TAU) | Active comparator | Behavioral: Treatment as Usual (TAU)Standard care. The standard treatment would generally be pharmacological to address chronic pain, adjusted to the symptomatic profile of each patient. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
- Laminectomy. Foraminoplasty. Laminectomy and posterior arthrodesis. previous arthrodesis.
- Presence of psychosocial risk factors for chronic post-surgical pain:
Key exclusion criteria (9 listed)
- 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
- NOT present psychosocial risk factors for chronic post-surgical pain (see inclusion criteria: anxiety, catastrophizing, depression, kinesiophobia)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment Therapy (ACT)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. | Behavioural | TAU + Acceptance and Commitment Therapy (ACT) |
| Treatment as Usual (TAU)Standard pharmacological treatment for patients with chronic pain | Behavioural | Treatment as Usual (TAU) |
Primary outcome
Brief Pain Inventory (BPI)
Time frame: Through study completion, an average of 2 years
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
7 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
Time frame: Through study completion, an average of 2 years
Pain Catastrophising Scale (PCS)
Time frame: Through study completion, an average of 2 years
Psychological Inflexibility in Pain Scale (PIPS)
Time frame: Through study completion, an average of 2 years
Tampa Kinesiophobia Scale (TSK-11SV)
Time frame: Through study completion, an average of 2 years
Chronic Pain Acceptance Questionnaire (CPAQ-20)
Time frame: Through study completion, an average of 2 years
Short Form 12 Health Survey (SF-12)
Time frame: Through study completion, an average of 2 years
Oswestry Low Back Pain Disability Scale (OLBPDQ)
Time frame: Through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Montes-Pérez, PhD study director
Parc Salut Mar
Víctor Pérez-Solà, PhD study director
Parc Salut Mar
Luis Miguel Martín-López, PhD study chair
Parc Salut Mar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy (ACT) and Treatment as Usual (TAU) in people with Randomized Controlled Trial, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Ramón Castaño-Asins, MD (+34932483000 ext. 3175, jrcastano@psmar.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory (BPI) (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.