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Chronic PainDOLORSENTNCT07915440

Application of Meaning-Based Psychotherapy to a Sample of Patients With Chronic Pain

A study testing Meaning Based Group Psychotherapy and Cognitive Behavioural Psychotherapy in people with Chronic Pain, run by Hospital Clinico Universitario San Cecilio at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The aimes of this study is to determine whether Meaning-Based Psychotherapy (MBP) is an effective therapy for improving sense of purpose, reducing depression, and improving quality of life in people with chronic pain and to verify the effectiveness of the MBP intervention for participants in a randomized controlled… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chronic Pain
What is being tested?
Meaning Based Group Psychotherapy and Cognitive Behavioural Psychotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
1 siteSpain
Study dates
10 Jul 2025to May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Participants will be adults;
  • Patients treated at Mental Health Service for anxiety and depressive symptoms related to chronic non-cancer pain; the diagnosis will be recorded according to the ICD-10 criteria identified in their medical records.
  • Tendency to catastrophize pain (score greater than 30 on the Pain Catastrophizing Questionnaire (García-Campayo, J., 2008));
  • Low sense of purpose or lack of a defined sense of purpose in life (score less than 105 on the Purpose in Life Test (PIL) (Crumbaugh \& Maholick, 1969).

Who cannot join

  • Diagnoses of a severe mental disorder (schizophrenia, substance dependence, dementia, or cognitive impairment) identified through information obtained in a clinical interview or digital health record.
  • Severe suicidal ideation or a suicide attempt within the last 6 months. This will be assessed using responses to item 9 of the Beck Depression Inventory (2nd ed.). This item is commonly used in clinical studies to identify suicidal ideation and has proven to be a good predictor of suicidal intent and risk (Green et al. 2015, von Brachel et al. 2018). Participants with recent suicide attempts or whose response to item 3 ("I would commit suicide if I had the opportunity") will be excluded, as this indicates suicidal intent and a higher risk of suicide (Green et al. 2015). In such cases, referral to the appropriate mental health service will be prioritized according to protocol.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Leyre Hidalgo-Lopez, Clinical Psychologist contact

+34665755444

leire.hidalgo.sspa@juntadeandalucia.es

Jorge Alcazar Beltran, Clinical Psychologist contact

+34652196523

jralcazar@gmail.com

Spain1 site, 1 recruiting
  • Hospital Universitario San Cecilio

    Granada, Granada, 18008

    Leyre Hidalgo Lopez, Clinical Psychologist, +34665755444, leire.hidalgo.sspa@juntadeandalucia.es

    Recruiting

Other trials in Spain

About this study

Official title: APPLICATION OF MEANING-BASED PSYCHOTHERAPY TO A SAMPLE OF PATIENTS WITH CHRONIC PAIN

The aimes of this study is to determine whether Meaning-Based Psychotherapy (MBP) is an effective therapy for improving sense of purpose, reducing depression, and improving quality of life in people with chronic pain and to verify the effectiveness of the MBP intervention for participants in a randomized controlled trial (RCT) by comparing it with the optimized usual care (Cognitive-behavioural Psychotherapy por chronic pain).

Read the detailed description

Psychological interventions aimed at pain management arise from the need to provide a comprehensive treatment approach that addresses the multidimensional nature of the pain experience: sensory-discriminative, cognitive-evaluative, and affective-emotional dimensions. The goal of these interventions is to enable individuals with chronic pain to understand the factors that modulate their pain experience, to be able to live with and cope with its associated difficulties, and to strengthen their personal resources and coping skills.

Meaning-based psychotherapy (MBP) is designed to help people cope with unexpected or chronic adverse situations, so that participants can, despite their circumstances, build a fulfilling life. Recent studies on the effectiveness of MBP have found that it is effective in reducing depressive and anxious symptoms and increasing a sense of purpose in vulnerable individuals. Logotherapy and MBP are effective in improving meaning in life, spiritual well-being, and quality of life, as well as in reducing depression and anxiety in people with depression, people with complex grief, vulnerable individuals , people with cancer, and people with chronic illnesses. These results, along with those found in meta-analysis studies, suggest that MBP is effective in improving meaning in life, hope, optimism, self-efficacy, well-being, quality of life, and reducing stress

Conditions
Chronic Pain
Being tested
Meaning Based Group Psychotherapy, Cognitive Behavioural Psychotherapy
Keywords
Chronic pain, Meaning Based Psychotherapy, Randomized Control Trial, Cognitive-behabioural Therapy, Meaning in Life, Depression
Medical subject headings
Chronic Pain, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Meaning Based Group PsychotherapyBehavioural

    Module 1: Introduction to MBP. Acquired illnesses and the loss of meaning in life. How can we develop a low sense of purpose in life? Module 2: Psychoeducation on MBP. Module 3: Human experiences occur in three dimensions: biological, psychological, and the noetic/meaning dimension. Sources of meaning.

    Module 4: Creative sources of meaning and experiential sources of meaning. Module 5: The noetic/meaning dimension is the compass of our life. Module 6: Sources of attitudinal meaning. Transforming an unexpected situation into a personal triumph.

    Module 7: Responsibility as a source of meaning. Module 8: The past is a potential source of enduring meaning. Module 9: The capacity for self-transcendence Module 10: Development and processing of your book of Life.

  • Cognitive Behavioural PsychotherapyBehavioural

    Module 1: Understanding the multidimensional experience of pain Module 2: Identifying emotions and aspects related to pain I Module 3: Identifying emotions and aspects related to pain II Module 4: Emotional regulation strategies Module 5: Cognitive restructuring and flexibility Module 6: Mindfulness exercises Module 7: Participation in graded activities Module 8: Interpersonal Problem and Conflict Resolution Module 9: Relaxation Exercises Module 10: Relapse Prevention

Study groups in NCT07915440
Study groupRoleWhat they receive
Meaning Based Group PsychotherapyExperimentalMeaning-Based Psychotherapy (MBP) Protocol. The intervention consists of 10 modules of treatment defined in 15 sessions held over 4 months, in a group format of two hours each, on a weekly basis
Receives: Behavioral: Meaning Based Group Psychotherapy
Cognitive-Behavioural TherapyActive comparatorCognitive Behavioral Therapy for pain will be applied, including: psychoeducational content, training in emotional regulation strategies, attention and relaxation exercises, and problem and conflict resolution. 10 modules will be implemented over 15 sessions following Kovacs and Moix Cognitive Behavioural Therapy for Chronic Pain
Receives: Behavioral: Cognitive Behavioural Psychotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Beck Depression Inventory

    The Beck Depression Inventory (BDI; Beck et al., 1996), consisting of 21 items with four response options (0-4), assesses depressive symptoms. It establishes different quantitative ranges of depression: absent or minimal depression (< 13), mild to moderate depression (14-19), moderate depression (20-28), and severe depression (>28). We will use the Spanish version (Sanz et al., 2005), which has adequate reliability (α = .93). It includes two subscales: a cognitive-affective subscale and a somatic-motivational subscale.

    Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 3-month follow-up

  2. Meaning in Life Questionnaire (MLQ)

    The MLQ is a self-reported questionnaire made up of 10 items, and it was developed to assess the two main dimensions of meaning in life: presence and search for meaning in life. The items are rated on a 7-point scale ranging from 1 (absolutely false) to 7 (absolutely true). The factors of Presence and Search were correlated (r = -.19), and internal consistency was good for Presence (.86) and Search (.87). One-month test-retest reliability coefficients were .70 for Presence and .73 for Search.

    Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 3-month follow-up

  3. The Multidimensional Existential Meaning Scale (MEMS)

    The MEMS assesses the dimensions of meaning in life: Understanding, Purpose, and Significance, with a total of 15 items. Likert-type responses are given on a 7-point scale (1 = Strongly disagree; 7 = Strongly agree). We will use the Spanish version (Marco et al., 2022), where the three MEMS subscales showed adequate internal consistency: Understanding (ϖ = .91), Purpose (ϖ = .92), and Significance (ϖ = .86).

    Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow up

  4. Purpose In Life (PIL)

    In this study, we used Part A of the PIL, which consists of 20 items with a Likert-type scale (1 to 7). It provides a measure of the level of achievement of meaning in life. Items include: "Life seems completely boring to me," with a Likert-type response (ranging from "1 = completely routine" to "7 = always exciting"). Scores range from 20 to 140 points, with three levels: scores below 90 indicate a level of existential emptiness, scores between 90 and 105 indicate a level of uncertainty regarding the meaning of life, and scores above 105 indicate a level of achievement of meaning. We used the Spanish version (Noblejas de la Flor, 2000), which has adequate reliability (α = .88).

    Measured: [Time Frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 3-month follow up

  5. Pain Catastrophizing Scale

    Validation of the Spanish version of the Pain Catastrophizing Scale in fibromyalgia. Medicina Clínica, 131(13), 487-492. It measures the tendency to have exaggerated negative thoughts about pain, such as ruminating about suffering or feeling hopeless. It consists of 13 items grouped into three subscales: rumination, magnification, and helplessness. It is useful for predicting pain intensity, disability, and response to treatment. A validated Spanish version exists for patients with fibromyalgia and chronic pain with a reliability of (α = 0.79).

    Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 3-month follow up

Secondary outcomes (2)
  1. Overall Anxiety Severity and Impairment Scale (OASIS)

    The OASIS is a five-item instrument that assesses the frequency and intensity of anxiety symptoms during the past week. In addition, it measures interference in work and academic, social, and daily life domains, as well as avoidance behaviors. The items are rated on a Likert-type scale (0-4). The psychometric properties are good in terms of internal consistency (α= 0.86), convergent and discriminant validity, and sensitivity to change (α= 0.86).

    Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 3-month follow-up

  2. Chronic Pain Acceptance Questionnaire

    Validation of the Spanish version of the Chronic Pain Acceptance Questionnaire (CPAQ) for the assessment of acceptance in fibromyalgia. Health and Quality of Life Outcomes, 8, 37. https://doi.org/10.1186/1477-7525-8-37). It assesses acceptance of chronic pain, including willingness to experience pain and maintain activities. It measures behavioral flexibility and functional adaptation to pain. Higher levels of acceptance have been shown to be associated with less depression and better functioning. It is available in a Spanish version, including a short, 8-item version with adequate reliability (α = 0.83).

    Measured: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 3-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2026
  2. Study start10 Jul 2025
  3. Primary completionFeb 2028 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

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
Randomized Trial Efficacy study
Masking
Single blind
Who is masked
Participant
Enrolment
118 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07915440
Sponsor's protocol ID
SICEIA-2025-002883
Acronym
DOLORSENT
Status last verified
Feb 2026
First submitted
29 Oct 2026
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Moix J, Kovacs FM, Martin A, Plana MN, Royuela A; Spanish Back Pain Research Network. Catastrophizing, state anxiety, anger, and depressive symptoms do not correlate with disability when variations of trait anxiety are taken into account. a study of chronic low back pain patients treated in Spanish pain units [NCT00360802]. Pain Med. 2011 Jul;12(7):1008-17. doi: 10.1111/j.1526-4637.2011.01155.x. Epub 2011 Jun 13.

    PubMed 21668743
  • Winger JG, Ramos K, Kelleher SA, Somers TJ, Steinhauser KE, Porter LS, Kamal AH, Breitbart WS, Keefe FJ. Meaning-Centered Pain Coping Skills Training: A Pilot Feasibility Trial of a Psychosocial Pain Management Intervention for Patients with Advanced Cancer. J Palliat Med. 2022 Jan;25(1):60-69. doi: 10.1089/jpm.2021.0081. Epub 2021 Aug 12.

    PubMed 34388037
  • Breitbart W, Poppito S, Rosenfeld B, Vickers AJ, Li Y, Abbey J, Olden M, Pessin H, Lichtenthal W, Sjoberg D, Cassileth BR. Pilot randomized controlled trial of individual meaning-centered psychotherapy for patients with advanced cancer. J Clin Oncol. 2012 Apr 20;30(12):1304-9. doi: 10.1200/JCO.2011.36.2517. Epub 2012 Feb 27.

    PubMed 22370330
  • van der Spek N, Vos J, van Uden-Kraan CF, Breitbart W, Cuijpers P, Holtmaat K, Witte BI, Tollenaar RAEM, Verdonck-de Leeuw IM. Efficacy of meaning-centered group psychotherapy for cancer survivors: a randomized controlled trial. Psychol Med. 2017 Aug;47(11):1990-2001. doi: 10.1017/S0033291717000447. Epub 2017 Apr 4.

    PubMed 28374663
  • Breitbart W, Rosenfeld B, Pessin H, Kaim M, Funesti-Esch J, Galietta M, Nelson CJ, Brescia R. Depression, hopelessness, and desire for hastened death in terminally ill patients with cancer. JAMA. 2000 Dec 13;284(22):2907-11. doi: 10.1001/jama.284.22.2907.

    PubMed 11147988
  • Marco JH, Alonso S, Banos R. Meaning-making as a mediator of anxiety and depression reduction during cognitive behavioral therapy intervention in participants with adjustment disorders. Clin Psychol Psychother. 2021 Mar;28(2):325-333. doi: 10.1002/cpp.2506. Epub 2020 Sep 10.

    PubMed 32881109

Questions about this trial

What is this clinical trial studying?

A study testing Meaning Based Group Psychotherapy and Cognitive Behavioural Psychotherapy in people with Chronic Pain, run by Hospital Clinico Universitario San Cecilio 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Leyre Hidalgo-Lopez, Clinical Psychologist (+34665755444, leire.hidalgo.sspa@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Beck Depression Inventory (time frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 3-month follow-up). The study lists 5 primary outcomes in all. 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 NCT07915440, which also lists 6 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 4 Nov 2026.

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