Study Results
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Basic Information
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COMPLETED
NA
92 participants
INTERVENTIONAL
2021-01-02
2023-04-01
Brief Summary
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Detailed Description
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The investigators adapted MCP for Spanish participants with cancer. The Spanish MCP is an adaptation of the MCP developed by Breitbart as an eight-session group therapy for patients with advanced cancer. This paper presents the study protocol. The study design consists of a two-arm RCT with two conditions: MCP and CBT, where participants will be randomized to one of the two groups. Participants will be adults with stage I, II, and III cancer who have completed their medical treatment (surgery, radiotherapy, or chemotherapy). Participants will be assessed at pretreatment, post-treatment, and 6-month follow-up. The intention-to-treat principle will be used when analyzing data, using mixed-effects models with full information and maximum likelihood estimation
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Meaning-Centered Group Psychotherapy (MCP).
The intervention lasts two months and includes eight sessions that follow a two-hour group format on a weekly basis. The investigators will follow the manualized MCP for patients with advanced cancer.
Meaning-Centered Group Psychotherapy (MCP).
The MCP program is divided into eight sessions:
Session1: Psychoeducation about Meaning in life, Sources of Meaning, etc. Session 2: Cancer illness and meaning. Session 3: Historical Sources of Meaning (the past) Session 4: Historical Sources of Meaning (present and future). Session 5: Attitudinal Sources of Meaning. Session 6: Creative Sources of Meaning. Session 7: Experimental Sources of Meaning. Session 8: End of psychotherapy, farewell, and facing the future with hope.
Cognitive Behavioral Psychotherapy (CBT).
The intervention lasts two months and includes eight sessions that follow a two-hour group format on a weekly basis, with the following sessions. The investigators will follow the manualized CBT or patients with advanced cancer.
Cognitive Behavioral Psychotherapy (CBT).
The CBT divided into eight sessions:
Session1: Presentation of psychotherapy, establishing the goals of psychotherapy. Presentation of the participants. Updated information about psychological consequences of cancer.
Session 2. Increase in enjoyable activities. Behavioral activation. Progressive muscle relaxation training. Slow breathing training.
Session 3. Cognitive model of coping with cancer. Psychoeducation on negative thoughts. Training in detecting negative thoughts. Presentation of cognitive distortions Session 4. Training in cognitive restructuring techniques. Session 5. Training in problem-solving skills. Session 6. Being aware of participants needs. Self-care. Assertiveness skills training.
Session 7. Setting goals for the future. Session 8. Summary, relapse prevention, and end of psychotherapy.
Interventions
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Meaning-Centered Group Psychotherapy (MCP).
The MCP program is divided into eight sessions:
Session1: Psychoeducation about Meaning in life, Sources of Meaning, etc. Session 2: Cancer illness and meaning. Session 3: Historical Sources of Meaning (the past) Session 4: Historical Sources of Meaning (present and future). Session 5: Attitudinal Sources of Meaning. Session 6: Creative Sources of Meaning. Session 7: Experimental Sources of Meaning. Session 8: End of psychotherapy, farewell, and facing the future with hope.
Cognitive Behavioral Psychotherapy (CBT).
The CBT divided into eight sessions:
Session1: Presentation of psychotherapy, establishing the goals of psychotherapy. Presentation of the participants. Updated information about psychological consequences of cancer.
Session 2. Increase in enjoyable activities. Behavioral activation. Progressive muscle relaxation training. Slow breathing training.
Session 3. Cognitive model of coping with cancer. Psychoeducation on negative thoughts. Training in detecting negative thoughts. Presentation of cognitive distortions Session 4. Training in cognitive restructuring techniques. Session 5. Training in problem-solving skills. Session 6. Being aware of participants needs. Self-care. Assertiveness skills training.
Session 7. Setting goals for the future. Session 8. Summary, relapse prevention, and end of psychotherapy.
Eligibility Criteria
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Inclusion Criteria
* Participants will have to express a need for psychological care.
* Participants will have low meaning in life.
Exclusion Criteria
* Diagnosis of a serious mental disorder (schizophrenia, substance dependence, dementia, or cognitive impairment).
18 Years
ALL
Yes
Sponsors
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University of Valencia
OTHER
Responsible Party
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Principal Investigators
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Pilar Llombart, Ph.D.Student
Role: PRINCIPAL_INVESTIGATOR
Valencian Institute of Oncology Foundation (IVO)
Sandra Perez, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Valencia
Veronica Guillen Botella, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Valencia
Joaquin Garcia-Alandete, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Valencia
Rosa Baños, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Valencia
Jose Heliodoro Marco Salvador, Ph. D.
Role: STUDY_CHAIR
University of Valencia
Locations
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University of Valencia
Valencia, , Spain
Countries
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References
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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.
Vos J, Vitali D. The effects of psychological meaning-centered therapies on quality of life and psychological stress: A metaanalysis. Palliat Support Care. 2018 Oct;16(5):608-632. doi: 10.1017/S1478951517000931. Epub 2018 Sep 24.
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.
Rosenfeld B, Saracino R, Tobias K, Masterson M, Pessin H, Applebaum A, Brescia R, Breitbart W. Adapting Meaning-Centered Psychotherapy for the palliative care setting: Results of a pilot study. Palliat Med. 2017 Feb;31(2):140-146. doi: 10.1177/0269216316651570. Epub 2016 Jul 21.
Lichtenthal WG, Catarozoli C, Masterson M, Slivjak E, Schofield E, Roberts KE, Neimeyer RA, Wiener L, Prigerson HG, Kissane DW, Li Y, Breitbart W. An open trial of meaning-centered grief therapy: Rationale and preliminary evaluation. Palliat Support Care. 2019 Feb;17(1):2-12. doi: 10.1017/S1478951518000925. Epub 2019 Jan 26.
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.
Marco JH, Llombart P, Romero R, Garcia-Conde A, Corral V, Guillen V, Perez S. Meaning-Centered Psychotherapy Versus Cognitive Behavioral Therapy for Cancer Survivors: A Randomized Controlled Trial☆. Behav Ther. 2024 Sep;55(5):1071-1083. doi: 10.1016/j.beth.2024.03.005. Epub 2024 Apr 10.
Marco JH, Llombart P, Guillen V, Banos RM, Romero R, Garcia-Conde A, Perez Rodriguez S. Spanish Adaptation of Meaning-Centered Psychotherapy for Participants With Cancer: Study Protocol of a Randomized Control Trial. Front Psychiatry. 2022 Jul 7;13:892573. doi: 10.3389/fpsyt.2022.892573. eCollection 2022.
Other Identifiers
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CEIM:2019-17
Identifier Type: -
Identifier Source: org_study_id
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