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

29 października 2026 zaktualizowane przez: Leyre Hidalgo Lopez, Hospital Clinico Universitario San Cecilio

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).

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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

Typ studiów

Interwencyjne

Zapisy (Szacowany)

118

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

  • Nazwa: Jorge Alcazar Beltran, Clinical Psychologist
  • Numer telefonu: +34652196523
  • E-mail: jralcazar@gmail.com

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 70 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  1. Participants will be adults;
  2. 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.
  3. Tendency to catastrophize pain (score greater than 30 on the Pain Catastrophizing Questionnaire (García-Campayo, J., 2008));
  4. 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).

Exclusion Criteria:

  1. 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.
  2. 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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Meaning Based Group Psychotherapy

Meaning-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

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.

Aktywny komparator: Cognitive-Behavioural Therapy

Cognitive 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

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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Beck Depression Inventory
Ramy czasowe: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 3-month follow-up

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.

Changes will be assessed from pre-treatment to immediately after the intervention, and also at 3-month follow-up
Meaning in Life Questionnaire (MLQ)
Ramy czasowe: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 3-month follow-up

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.

Changes will be assessed from pre-treatment to immediately after the intervention, and also at 3-month follow-up
The Multidimensional Existential Meaning Scale (MEMS)
Ramy czasowe: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow up

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).

Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow up
Purpose In Life (PIL)
Ramy czasowe: [Time Frame: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 3-month follow up

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).

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

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).

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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Overall Anxiety Severity and Impairment Scale (OASIS)
Ramy czasowe: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 3-month follow-up

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).

Changes will be assessed from pre-treatment to immediately after the intervention, and also at 3-month follow-up
Chronic Pain Acceptance Questionnaire
Ramy czasowe: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 3-month follow-up

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).

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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Współpracownicy

Śledczy

  • Dyrektor Studium: Heliodoro Marco Salvador, Ph.D, University of Valencia
  • Dyrektor Studium: Soledad Quero Castellano, Ph.D, University Jaume I

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

10 lipca 2025

Zakończenie podstawowe (Szacowany)

1 lutego 2028

Ukończenie studiów (Szacowany)

1 maja 2028

Daty rejestracji na studia

Pierwszy przesłany

29 października 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 października 2026

Pierwszy wysłany (Rzeczywisty)

4 listopada 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 października 2026

Ostatnia weryfikacja

1 lutego 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • SICEIA-2025-002883

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .