Randomized Controlled TrialIMPACTNCT04140838
Cost-utility and Physiological Effects of ACT and BATD in Patients With Chronic Pain and Depression
A study testing Acceptance and Commitment Therapy (ACT), Behavioral Activation Therapy for Depression (BATD) and Treatment as Usual (TAU) in people with Randomized Controlled Trial, run by Fundació Sant Joan de Déu at 2 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Randomized Controlled Trial
- What is being tested?
- Acceptance and Commitment Therapy (ACT), Behavioral Activation Therapy for Depression (BATD) 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
- 234 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jul 2020to 31 Dec 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- Patients with scheduled surgical intervention or other interventions.
- Inability to attend group treatment sessions.
- Additional exclusion criteria for the study of biomarkers (50% of subjects in each branch):
- 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
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Parc de Salut Mar
Barcelona, 08003
Parc Sanitari Sant Joan de Déu (PSSJD)
Sant Boi de Llobregat, Barcelona, 08830
About this study
Official title: Cost-utility and Physiological Effects of Acceptance and Commitment Therapy and Behavior Activation in Patients With Chronic Pain and Comorbid Major Depression (IMPACT Project)
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).
Read more
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.
Read the 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.
- Conditions
- Randomized Controlled Trial
- Being tested
- Acceptance and Commitment Therapy (ACT), Behavioral Activation Therapy for Depression (BATD), 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 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.
Behavioral Activation Therapy for Depression (BATD)Behavioural
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.
| 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); 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. Receives: 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. Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
Numerical pain scale
Patients evaluate their pain in a continuum from 0 to 10, where 0 is absence of pain and 0 is the worst possible pain.
Measured: Through study completion, an average of 1 year
Hospital Anxiety and Depression Scale (HADS)
Scale of 14 items 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 1 year.
Pain Catastrophising Scale (PCS)
Scale of 13 items comprising three dimensions: rumination over pain, magnification of pain and helplessness in the face 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 catastrophising.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start1 Jul 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Single-blind, parallel-group, randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Collaborators
- Carlos III Health Institute
- Responsible party
- Principal investigator, Juan Vicente Luciano, Fundació Sant Joan de Déu
- Investigators
- Juan V. Luciano, PhD, Principal investigator, Fundació Sant Joan de Déu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140838
- Sponsor's protocol ID
- PI19/00112
- Acronym
- IMPACT
- Status last verified
- Jul 2023
- First submitted
- 22 Oct 2019
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32709656Sanabria-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.
PubMed 37105508Sanabria-Mazo JP, Royuela-Colomer E, Navarrete J, Rodriguez-Freire C, Robles B, McCracken LM, Feliu-Soler A, Luciano JV. Predicting adherence and clinical response of cognitive behavioral therapy among individuals with chronic low back pain plus depressive symptoms: a secondary analysis of a randomized controlled trial. Pain Med. 2025 Aug 1;26(8):459-467. doi: 10.1093/pm/pnaf020.
PubMed 40065516Sanabria-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.
PubMed 38242333Sanabria-Mazo JP, Colomer-Carbonell A, Gandara-Urrutia N, Perez-Sutil JM, Noboa-Rocamora G, Fernandez-Vazquez O, Val-Mariano G, Fontana-McNally M, Cardona-Ros G, Feliu-Soler A, McCracken LM, Edo S, Sanz A, Luciano JV. Experiences of patients with chronic low back pain plus comorbid depressive symptoms in a videoconference group acceptance and commitment therapy or behavioral activation treatment for depression: a qualitative study. Disabil Rehabil. 2024 Oct;46(21):5052-5063. doi: 10.1080/09638288.2023.2298265. Epub 2023 Dec 27.
PubMed 38149834
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-utility and Physiological Effects of Acceptance and Commitment Therapy and Behavior Activation in Patients With Chronic Pain and Comorbid Major Depression (IMPACT Project)
- ClinicalTrials.gov ID
- NCT04140838
- Acronym / sponsor ID
- IMPACT / PI19/00112
- Conditions
- Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Collaborators
- Carlos III Health Institute
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 28 Oct 2019 (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) 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Single-blind, parallel-group, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| TAU + Acceptance and Commitment Therapy (ACT) | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT), Other: Treatment as Usual (TAU)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. |
| TAU + Behavioral Activation Therapy for Depression (BATD) | Experimental | Behavioral: Behavioral Activation Therapy for Depression (BATD), Other: Treatment as Usual (TAU)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. |
| Treatment as Usual (TAU) | Active comparator | Other: Treatment as Usual (TAU)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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
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 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. | Behavioural | TAU + Acceptance and Commitment Therapy (ACT) |
| Behavioral Activation Therapy for Depression (BATD)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. | Behavioural | TAU + Behavioral Activation Therapy for Depression (BATD) |
| Treatment as Usual (TAU)Standard pharmacological treatment usually provided to patients suffering chronic pain and mild-moderate depression. | Other | TAU + Acceptance and Commitment Therapy (ACT), TAU + Behavioral Activation Therapy for Depression (BATD), Treatment as Usual (TAU) |
Primary outcome
Aggregate score of the Physical Function, Body Pain and Vitality subscales of the SF-36
Time frame: Through study completion, an average of 1 year
The range of scores is 15 to 65. Higher scores indicate better quality of life.
3 secondary outcomes
Numerical pain scale
Time frame: Through study completion, an average of 1 year
Hospital Anxiety and Depression Scale (HADS)
Time frame: Through study completion, an average of 1 year.
Pain Catastrophising Scale (PCS)
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Background: PubMed 32709656Sanabria-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.
- Results publication: PubMed 37105508Sanabria-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.
- Derived from this study: PubMed 40065516Sanabria-Mazo JP, Royuela-Colomer E, Navarrete J, Rodriguez-Freire C, Robles B, McCracken LM, Feliu-Soler A, Luciano JV. Predicting adherence and clinical response of cognitive behavioral therapy among individuals with chronic low back pain plus depressive symptoms: a secondary analysis of a randomized controlled trial. Pain Med. 2025 Aug 1;26(8):459-467. doi: 10.1093/pm/pnaf020.
- Derived from this study: PubMed 38242333Sanabria-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.
- Derived from this study: PubMed 38149834Sanabria-Mazo JP, Colomer-Carbonell A, Gandara-Urrutia N, Perez-Sutil JM, Noboa-Rocamora G, Fernandez-Vazquez O, Val-Mariano G, Fontana-McNally M, Cardona-Ros G, Feliu-Soler A, McCracken LM, Edo S, Sanz A, Luciano JV. Experiences of patients with chronic low back pain plus comorbid depressive symptoms in a videoconference group acceptance and commitment therapy or behavioral activation treatment for depression: a qualitative study. Disabil Rehabil. 2024 Oct;46(21):5052-5063. doi: 10.1080/09638288.2023.2298265. Epub 2023 Dec 27.
- 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.
Juan V. Luciano, PhD principal investigator
Fundació Sant Joan de Déu
2 sites 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), Behavioral Activation Therapy for Depression (BATD) and Treatment as Usual (TAU) in people with Randomized Controlled Trial, run by Fundació Sant Joan de Déu at 2 sites 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 7 inclusion and 15 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: finished, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aggregate score of the Physical Function, Body Pain and Vitality subscales of the SF-36 (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04140838, which also lists 5 linked publications.
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 19 Jul 2023.