- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07915440
Application of Meaning-Based Psychotherapy to a Sample of Patients With Chronic Pain (DOLORSENT)
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).
Přehled studie
Postavení
Podmínky
Detailní popis
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 studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Leyre Hidalgo-Lopez, Clinical Psychologist
- Telefonní číslo: +34665755444
- E-mail: leire.hidalgo.sspa@juntadeandalucia.es
Studijní záloha kontaktů
- Jméno: Jorge Alcazar Beltran, Clinical Psychologist
- Telefonní číslo: +34652196523
- E-mail: jralcazar@gmail.com
Studijní místa
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Granada
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Granada, Granada, Španělsko, 18008
- Nábor
- Hospital Universitario San Cecilio
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Kontakt:
- Leyre Hidalgo Lopez, Clinical Psychologist
- Telefonní číslo: +34665755444
- E-mail: leire.hidalgo.sspa@juntadeandalucia.es
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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. |
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Aktivní komparátor: 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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Beck Depression Inventory
Časové okno: 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)
Časové okno: 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)
Časové okno: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow up
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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
|
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Purpose In Life (PIL)
Časové okno: [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
|
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Pain Catastrophizing Scale
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Overall Anxiety Severity and Impairment Scale (OASIS)
Časové okno: Changes will be assessed from pre-treatment to immediately after the intervention, and also at 3-month follow-up
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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
|
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Chronic Pain Acceptance Questionnaire
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Ředitel studie: Heliodoro Marco Salvador, Ph.D, University of Valencia
- Ředitel studie: Soledad Quero Castellano, Ph.D, University Jaume I
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Termíny studijních záznamů
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Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
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První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
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Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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