Coping After Loss Through Mindfulness in Adults With Prolonged Grief Disorder

NCT06017765 | Recruiting

• 2 other identifiers: 22-02452022-A02603-40
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to pilot the effectiveness of an 8-week standardized Mindfulness Training program to decrease the psychiatric and somatic symptoms of prolonged grief disorder (PGD) and to examine changes in physiological and neuroimaging biomarkers of bereavement-related stress reactivity that are associated with Mindfulness Training in grieving adult patients (men and women, aged 18-60) who are diagnosed with PGD. The main questions it aims to answer are:

• randomly assigned to immediately receiving an 8-week Mindfulness Training program or after a 12-week waitlist.
• assessed for psychiatric and somatic symptoms and for physiological responses during a baseline, midpoint and endpoint visit, and at a one-month follow-up visit.
• assessed for functional neuroimaging biomarkers of bereavement-related and general stress reactivity at the baseline and endpoint visits using a script-driven imagery task (which induces bereavement-related stress reactivity during an imagery of a personal situation related to the death compared to imagery of a neutral personal situation), and loud tones stress task (which induces general stress reactivity). Researchers will compare the Mindfulness Training group (which consists of patients with PGD who will receive the Mindfulness Training immediately) with the waitlist control group (which consists of patients with PGD who are waiting on a waitlist to receive the training after the Mindfulness Training group) to investigate if they differ in PGD symptom severity as well as physiological and neuroimaging biomarkers of stress reactivity.

Conditions

Prolonged Grief Disorder

Keywords

Prolonged Grief Disorder; Bereavement; Mindfulness Training; Script-driven Imagery; Stress Reactivity; Neuroimaging

Outcome Measures

Primary Outcomes (1)

• Mean change in Prolonged Grief Disorder (PGD) symptom severity from the pre-intervention baseline to the post-intervention endpoint visit.

  PGD symptom severity is assessed by the Inventory of Complicated Grief (ICG) questionnaire.

  Assessed during the pre-intervention baseline (week 0), post-intervention endpoint (week 8), and one-month follow-up visit (week 12).

Secondary Outcomes (15)

• Mean change in Prolonged Grief Disorder (PGD) symptom severity from the pre-intervention baseline to the post-intervention endpoint, and one-month follow-up visit.

  Assessed during the pre-intervention baseline (week 0), post-intervention endpoint (week 8), and one-month follow-up visit (week 12).

• Mean change in Posttraumatic Stress Disorder (PTSD) symptom severity in relation to the death, from the pre-intervention baseline to the post-intervention endpoint, and one-month follow-up visit.

  Assessed during the pre-intervention baseline (week 0), post-intervention endpoint (week 8), and one-month follow-up visit (week 12).

• Mean change in Depression symptom severity from the pre-intervention baseline to the post-intervention endpoint, and one-month follow-up visit.

  Assessed during the pre-intervention baseline (week 0), post-intervention endpoint (week 8), and one-month follow-up visit (week 12).

• Mean change in somatic complaints from the pre-intervention baseline to the post-intervention endpoint, and one-month follow-up visit.

  Assessed during the pre-intervention baseline (week 0), post-intervention endpoint (week 8), and one-month follow-up visit (week 12).

• Mean change in the ability to cope with stress from the pre-intervention baseline to the post-intervention endpoint, and one-month follow-up visit.

  Assessed during the pre-intervention baseline (week 0), post-intervention endpoint (week 8), and one-month follow-up visit (week 12).

Other Outcomes (9)

• Characteristics of the death.

  Assessed during the screening visit (week-4 until 0).

• The absence of diagnostic exclusion criteria and co-occurring Axis-I psychiatric disorders.

  Assessed during the screening visit (week-4 until 0).

• Socio-demographic variables.

  Assessed during the screening visit (week-4 until 0).

Study Arms (2)

Immediate Meditation Training group

EXPERIMENTAL

The Immediate Meditation Training group will immediately receive 8 weekly sessions of Mindfulness Training within 4 weeks after the Baseline visit (V0, during which participants are randomized).

Behavioral: Meditation Training

Waitlist Control group

OTHER

The Waitlist Control group will receive the Mindfulness Training after a waiting time of 12 weeks. Participants in this group will not receive any type of intervention before this and will wait till the Immediate Meditation Training group finished all assessment visits (including the follow-up visit in week 12 (V3)).

Behavioral: Waitlist

Interventions

Meditation Training BEHAVIORAL

The Meditation Training consists of 8 weekly sessions of Mindfulness Training and is adapted from the group-based Stress Management and Resiliency Training - Relaxation Response Resiliency Program, SMART-3RP. This training is structured around the following four goals: 1. Education about stress response 2. Elicitation of the Relaxation Response through Mindfulness Training 3. Creating adaptive perspectives 4. Coping strategiest.

Also known as: Mindfulness Training, SMART

Immediate Meditation Training group

Waitlist BEHAVIORAL

The waitlist consists of a waiting time of 12 weeks during which participants will nog receive any type of intervention.

Waitlist Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Must have lost a loved one (spouse, romantic partner, parent, child, sibling, close friend)
• Must have a score \>29 on the Inventory of Complicated Grief (ICG)
• Clinical diagnosis of Prolonged Grief Disorder as assessed by the Structured Clinical Interview for Complicated Grief (SCI-CG)

You may not qualify if:

• History of a lifetime clinical diagnosis of schizophrenia
• History of a lifetime clinical diagnosis of bipolar disorder
• History of a lifetime clinical diagnosis of a psychotic disorder
• Current diagnosis of substance or alcohol use disorder within the past 12 months
• History of a neurologic disease, seizures, stroke or head injury resulting in prolonged loss of consciousness and/or neurological sequelae
• Current pregnancy as assessed by a urinary pregnancy test at screening during the Screening (week -4 until 0), Baseline (week 0) or Endpoint visit (week 8), or lack of use approved methods birth control for women of childbearing age
• Currently practice of mind-body techniques at least once a week (e.g., yoga) in the past 3 months
• Currently undergoing concomitant psychotherapy for grief (any psychotherapy)
• Left-handedness
• Current use of medications that would affect cerebral metabolism
• Any contraindications to Magnetic Resonance Imaging (MRI)
• Being under legal guardianship

Sponsors & Collaborators

• University Hospital, Caen: lead
• Northeastern University: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Cyceron: collaborator
• Université de Caen Normandie: collaborator

Study Sites (1)

CHU de Caen et Université de Caen Normandie - Centre Esquirol Adult Psychiatry

Caen, Calvados, 14000, France

RECRUITING

Related Publications (51)

• Benson H, Greenwood MM, Klemchuk H. The relaxation response: psychophysiologic aspects and clinical applications. Int J Psychiatry Med. 1975;6(1-2):87-98. doi: 10.2190/376W-E4MT-QM6Q-H0UM.

  PMID: 773864 BACKGROUND

• Borysenko, J. (1988). Minding the Body Mending the Mind. New York, Bantam.

  BACKGROUND

• Bowlby, J. (1980). Attachment and loss, volume 3: loss; sadness and depression.

  BACKGROUND

• Bui E, Mauro C, Robinaugh DJ, Skritskaya NA, Wang Y, Gribbin C, Ghesquiere A, Horenstein A, Duan N, Reynolds C, Zisook S, Simon NM, Shear MK. THE STRUCTURED CLINICAL INTERVIEW FOR COMPLICATED GRIEF: RELIABILITY, VALIDITY, AND EXPLORATORY FACTOR ANALYSIS. Depress Anxiety. 2015 Jul;32(7):485-92. doi: 10.1002/da.22385. Epub 2015 Jun 9.

  PMID: 26061724 BACKGROUND

• Bui E, Blackburn AM, Brenner LH, Laifer LM, Park ER, Fricchione GL, Sylvia LG. Military and Veteran Caregivers' Perspectives of Stressors and a Mind-Body Program. Issues Ment Health Nurs. 2018 Oct;39(10):850-857. doi: 10.1080/01612840.2018.1485796. Epub 2018 Sep 13.

  PMID: 30212258 BACKGROUND

• Eric Bui, Ilana Ander & Clara Jaussaud. (2021). Grief in the time of COVID-19: An editorial, International Journal of Mental Health, 50:1, 1-3, DOI: 10.1080/00207411.2020.1870847

  BACKGROUND

• Carson MA, Metzger LJ, Lasko NB, Paulus LA, Morse AE, Pitman RK, Orr SP. Physiologic reactivity to startling tones in female Vietnam nurse veterans with PTSD. J Trauma Stress. 2007 Oct;20(5):657-66. doi: 10.1002/jts.20218.

  PMID: 17955532 BACKGROUND

• Currier JM, Neimeyer RA, Berman JS. The effectiveness of psychotherapeutic interventions for bereaved persons: a comprehensive quantitative review. Psychol Bull. 2008 Sep;134(5):648-661. doi: 10.1037/0033-2909.134.5.648.

  PMID: 18729566 BACKGROUND

• Dawson, M.E., Schell, A.M., and Filion, D.L. (2017). The electrodermal system. In J.T. Cacioppo, L.G. Tassinary, G.G. Berntson (Eds.), Handbook of Psychophysiology, Cambridge University Press, New York, NY, pp. 217-243.

  BACKGROUND

• Guy W. (1979). ECDEU Assessment Manual for Psychopharmacology. Rockville, MD, U.S. Department of Health, Education, and Welfare.

  BACKGROUND

• Hoge EA, Bui E, Marques L, Metcalf CA, Morris LK, Robinaugh DJ, Worthington JJ, Pollack MH, Simon NM. Randomized controlled trial of mindfulness meditation for generalized anxiety disorder: effects on anxiety and stress reactivity. J Clin Psychiatry. 2013 Aug;74(8):786-92. doi: 10.4088/JCP.12m08083.

  PMID: 23541163 BACKGROUND

• Hoge EA, Bui E, Palitz SA, Schwarz NR, Owens ME, Johnston JM, Pollack MH, Simon NM. The effect of mindfulness meditation training on biological acute stress responses in generalized anxiety disorder. Psychiatry Res. 2018 Apr;262:328-332. doi: 10.1016/j.psychres.2017.01.006. Epub 2017 Jan 26.

  PMID: 28131433 BACKGROUND

• Hoge EA, Bui E, Mete M, Dutton MA, Baker AW, Simon NM. Mindfulness-Based Stress Reduction vs Escitalopram for the Treatment of Adults With Anxiety Disorders: A Randomized Clinical Trial. JAMA Psychiatry. 2023 Jan 1;80(1):13-21. doi: 10.1001/jamapsychiatry.2022.3679.

  PMID: 36350591 BACKGROUND

• Kabat-Zinn, J. (1990). Full Catastrophe Living: Using the Wisdom of Your Body and Mind to Face Stress, Pain, and Illness, Bantam Dell.

  BACKGROUND

• Kang, Y., Gruber, J., & Gray, J. R. (2013). Mindfulness and De-Automatization. Emotion Review, 5(2), 192-201. https://doi.org/10.1177/1754073912451629

  BACKGROUND

• Khoury B, Lecomte T, Fortin G, Masse M, Therien P, Bouchard V, Chapleau MA, Paquin K, Hofmann SG. Mindfulness-based therapy: a comprehensive meta-analysis. Clin Psychol Rev. 2013 Aug;33(6):763-71. doi: 10.1016/j.cpr.2013.05.005. Epub 2013 Jun 7.

  PMID: 23796855 BACKGROUND

• Lang PJ. Presidential address, 1978. A bio-informational theory of emotional imagery. Psychophysiology. 1979 Nov;16(6):495-512. doi: 10.1111/j.1469-8986.1979.tb01511.x. No abstract available.

  PMID: 515293 BACKGROUND

• Latham AE, Prigerson HG. Suicidality and bereavement: complicated grief as psychiatric disorder presenting greatest risk for suicidality. Suicide Life Threat Behav. 2004 Winter;34(4):350-62. doi: 10.1521/suli.34.4.350.53737.

  PMID: 15585457 BACKGROUND

• Laurie A, Neimeyer RA. African Americans in bereavement: grief as a function of ethnicity. Omega (Westport). 2008;57(2):173-93. doi: 10.2190/OM.57.2.d.

  PMID: 18680889 BACKGROUND

• LeBlanc NJ, Unger LD, McNally RJ. Emotional and physiological reactivity in Complicated Grief. J Affect Disord. 2016 Apr;194:98-104. doi: 10.1016/j.jad.2016.01.024. Epub 2016 Jan 13.

  PMID: 26803781 BACKGROUND

• Lichtenthal WG, Nilsson M, Kissane DW, Breitbart W, Kacel E, Jones EC, Prigerson HG. Underutilization of mental health services among bereaved caregivers with prolonged grief disorder. Psychiatr Serv. 2011 Oct;62(10):1225-9. doi: 10.1176/ps.62.10.pss6210_1225.

  PMID: 21969652 BACKGROUND

• Marchand WR. Neural mechanisms of mindfulness and meditation: Evidence from neuroimaging studies. World J Radiol. 2014 Jul 28;6(7):471-9. doi: 10.4329/wjr.v6.i7.471.

  PMID: 25071887 BACKGROUND

• Moon JR, Kondo N, Glymour MM, Subramanian SV. Widowhood and mortality: a meta-analysis. PLoS One. 2011;6(8):e23465. doi: 10.1371/journal.pone.0023465. Epub 2011 Aug 17.

  PMID: 21858130 BACKGROUND

• Newson RS, Boelen PA, Hek K, Hofman A, Tiemeier H. The prevalence and characteristics of complicated grief in older adults. J Affect Disord. 2011 Jul;132(1-2):231-8. doi: 10.1016/j.jad.2011.02.021. Epub 2011 Mar 12.

  PMID: 21397336 BACKGROUND

• O'Connor MF. Immunological and neuroimaging biomarkers of complicated grief. Dialogues Clin Neurosci. 2012 Jun;14(2):141-8. doi: 10.31887/DCNS.2012.14.2/mfoconnor.

  PMID: 22754286 BACKGROUND

• O'Connor MF, Wellisch DK, Stanton AL, Eisenberger NI, Irwin MR, Lieberman MD. Craving love? Enduring grief activates brain's reward center. Neuroimage. 2008 Aug 15;42(2):969-72. doi: 10.1016/j.neuroimage.2008.04.256. Epub 2008 May 10.

  PMID: 18559294 BACKGROUND

• Oltjenbruns KA. Ethnicity and the grief response: Mexican American versus Anglo American college students. Death Stud. 1998;22(2):141-55. doi: 10.1080/074811898201641.

  PMID: 10182423 BACKGROUND

• Orr SP, Pitman RK, Lasko NB, Herz LR. Psychophysiological assessment of posttraumatic stress disorder imagery in World War II and Korean combat veterans. J Abnorm Psychol. 1993 Feb;102(1):152-9. doi: 10.1037//0021-843x.102.1.152.

  PMID: 8436691 BACKGROUND

• Park ER, Traeger L, Vranceanu AM, Scult M, Lerner JA, Benson H, Denninger J, Fricchione GL. The development of a patient-centered program based on the relaxation response: the Relaxation Response Resiliency Program (3RP). Psychosomatics. 2013 Mar-Apr;54(2):165-74. doi: 10.1016/j.psym.2012.09.001. Epub 2013 Jan 22.

  PMID: 23352048 BACKGROUND

• Pole N, Neylan TC, Best SR, Orr SP, Marmar CR. Fear-potentiated startle and posttraumatic stress symptoms in urban police officers. J Trauma Stress. 2003 Oct;16(5):471-9. doi: 10.1023/A:1025758411370.

  PMID: 14584631 BACKGROUND

• Prigerson HG, Maciejewski PK, Reynolds CF 3rd, Bierhals AJ, Newsom JT, Fasiczka A, Frank E, Doman J, Miller M. Inventory of Complicated Grief: a scale to measure maladaptive symptoms of loss. Psychiatry Res. 1995 Nov 29;59(1-2):65-79. doi: 10.1016/0165-1781(95)02757-2.

  PMID: 8771222 BACKGROUND

• Prigerson HG, Bierhals AJ, Kasl SV, Reynolds CF 3rd, Shear MK, Day N, Beery LC, Newsom JT, Jacobs S. Traumatic grief as a risk factor for mental and physical morbidity. Am J Psychiatry. 1997 May;154(5):616-23. doi: 10.1176/ajp.154.5.616.

  PMID: 9137115 BACKGROUND

• Rauch SAM, Kim HM, Lederman S, Sullivan G, Acierno R, Tuerk PW, Simon NM, Venners MR, Norman SB, Allard CB, Porter KE, Martis B, Bui E, Baker AW; PROGrESS Team. Predictors of Response to Prolonged Exposure, Sertraline, and Their Combination for the Treatment of Military PTSD. J Clin Psychiatry. 2021 Jun 15;82(4):20m13752. doi: 10.4088/JCP.20m13752.

  PMID: 34133087 BACKGROUND

• Reynolds CF 3rd, Miller MD, Pasternak RE, Frank E, Perel JM, Cornes C, Houck PR, Mazumdar S, Dew MA, Kupfer DJ. Treatment of bereavement-related major depressive episodes in later life: a controlled study of acute and continuation treatment with nortriptyline and interpersonal psychotherapy. Am J Psychiatry. 1999 Feb;156(2):202-8. doi: 10.1176/ajp.156.2.202.

  PMID: 9989555 BACKGROUND

• Rostila M, Saarela J, Kawachi I, Hjern A. Testing the anniversary reaction: causal effects of bereavement in a nationwide follow-up study from Sweden. Eur J Epidemiol. 2015 Mar;30(3):239-47. doi: 10.1007/s10654-015-9989-5. Epub 2015 Jan 17.

  PMID: 25595319 BACKGROUND

• Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, Markowitz JC, Ninan PT, Kornstein S, Manber R, Thase ME, Kocsis JH, Keller MB. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003 Sep 1;54(5):573-83. doi: 10.1016/s0006-3223(02)01866-8.

  PMID: 12946886 BACKGROUND

• Samuelson M, Foret M, Baim M, Lerner J, Fricchione G, Benson H, Dusek J, Yeung A. Exploring the effectiveness of a comprehensive mind-body intervention for medical symptom relief. J Altern Complement Med. 2010 Feb;16(2):187-92. doi: 10.1089/acm.2009.0142.

  PMID: 20180692 BACKGROUND

• Sbarra DA, Hazan C. Coregulation, dysregulation, self-regulation: an integrative analysis and empirical agenda for understanding adult attachment, separation, loss, and recovery. Pers Soc Psychol Rev. 2008 May;12(2):141-67. doi: 10.1177/1088868308315702.

  PMID: 18453476 BACKGROUND

• Selye, H. (1956). The stress of life. McGraw-Hill.

  BACKGROUND

• Shear K, Frank E, Houck PR, Reynolds CF 3rd. Treatment of complicated grief: a randomized controlled trial. JAMA. 2005 Jun 1;293(21):2601-8. doi: 10.1001/jama.293.21.2601.

  PMID: 15928281 BACKGROUND

• Shear MK, Ghesquiere A, Glickman K. Bereavement and complicated grief. Curr Psychiatry Rep. 2013 Nov;15(11):406. doi: 10.1007/s11920-013-0406-z.

  PMID: 24068457 BACKGROUND

• Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.

  PMID: 9881538 BACKGROUND

• Shin LM, Orr SP, Carson MA, Rauch SL, Macklin ML, Lasko NB, Peters PM, Metzger LJ, Dougherty DD, Cannistraro PA, Alpert NM, Fischman AJ, Pitman RK. Regional cerebral blood flow in the amygdala and medial prefrontal cortex during traumatic imagery in male and female Vietnam veterans with PTSD. Arch Gen Psychiatry. 2004 Feb;61(2):168-76. doi: 10.1001/archpsyc.61.2.168.

  PMID: 14757593 BACKGROUND

• Shor E, Roelfs DJ, Curreli M, Clemow L, Burg MM, Schwartz JE. Widowhood and mortality: a meta-analysis and meta-regression. Demography. 2012 May;49(2):575-606. doi: 10.1007/s13524-012-0096-x.

  PMID: 22427278 BACKGROUND

• Simon NM, Hofmann SG, Rosenfield D, Hoeppner SS, Hoge EA, Bui E, Khalsa SBS. Efficacy of Yoga vs Cognitive Behavioral Therapy vs Stress Education for the Treatment of Generalized Anxiety Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Jan 1;78(1):13-20. doi: 10.1001/jamapsychiatry.2020.2496.

  PMID: 32805013 BACKGROUND

• Thompson LW, Breckenridge JN, Gallagher D, Peterson J. Effects of bereavement on self-perceptions of physical health in elderly widows and widowers. J Gerontol. 1984 May;39(3):309-14. doi: 10.1093/geronj/39.3.309.

  PMID: 6715808 BACKGROUND

• Vranceanu AM, Riklin E, Merker VL, Macklin EA, Park ER, Plotkin SR. Mind-body therapy via videoconferencing in patients with neurofibromatosis: An RCT. Neurology. 2016 Aug 23;87(8):806-14. doi: 10.1212/WNL.0000000000003005. Epub 2016 Jul 22.

  PMID: 27449066 BACKGROUND

• Waller A, Turon H, Mansfield E, Clark K, Hobden B, Sanson-Fisher R. Assisting the bereaved: A systematic review of the evidence for grief counselling. Palliat Med. 2016 Feb;30(2):132-48. doi: 10.1177/0269216315588728. Epub 2015 Sep 28.

  PMID: 26415735 BACKGROUND

• Wittouck C, Van Autreve S, De Jaegere E, Portzky G, van Heeringen K. The prevention and treatment of complicated grief: a meta-analysis. Clin Psychol Rev. 2011 Feb;31(1):69-78. doi: 10.1016/j.cpr.2010.09.005. Epub 2010 Sep 24.

  PMID: 21130937 BACKGROUND

• Zisook S, Shear K. Grief and bereavement: what psychiatrists need to know. World Psychiatry. 2009 Jun;8(2):67-74. doi: 10.1002/j.2051-5545.2009.tb00217.x.

  PMID: 19516922 BACKGROUND

• American Psychiatric Association, DSM-5 Task Force. (2013). Diagnostic and statistical manual of mental disorders: DSM-5™ (5th ed.). American Psychiatric Publishing, Inc.. https://doi.org/10.1176/appi.books.9780890425596

  BACKGROUND

Related Links

• Weathers, F., B. Litz, T. Keane, P. Palmieri, B. Marx and P. Schnurr (2013). The PTSD Checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD.

MeSH Terms

Conditions

Prolonged Grief Disorder

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Eric BUI, Professor

  CHU de Caen, Université de Caen Normandie, INSERM U1237, PhIND

  PRINCIPAL INVESTIGATOR

• Annick Haelewyn-Razafimandimby, Associate Pr

  INSERM U1237, PhIND

  STUDY DIRECTOR

• Charlotte Hilberdink, Postdoc

  INSERM U1237, PhIND

  STUDY CHAIR

Central Study Contacts

BUI

CONTACT

023-106-4440; bui-th@chu-caen.fr

Annick Haelewyn-Razafimandimby, Associate Pr

CONTACT

023-156-5029; annick.haelewyn@unicaen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will be assessed for psychiatric symptoms (primary objective) by blinded Independent Evaluators, who will not be involved in the mindfulness training sessions. Participants will be instructed to keep their evaluators blinded to the randomization. Blinded Independent Evaluators will be clinical psychologists who are fully trained in assessing the different measures.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study model is a pilot randomized waitlist controlled trial of an 8-session mindfulness training program (i.e., Stress Management and Resiliency Training, SMART program) delivered weekly for Prolonged Grief Disorder, either within 4 weeks (immediate) or after 12 weeks (waitlist). After participants have completed the baseline assessment (V0), they will be randomly assigned (1:1 randomization) to either the immediate mindfulness training group or the waitlist control group. The waitlist control group will wait for 12 weeks (when the immediate intervention group finished all study procedures, including the follow-up assessment) before receiving the mindfulness training, which is the same intervention as employed in the immediate intervention group.

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 30, 2023
• Study Start: August 1, 2023
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)