[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626243":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":50,"studyPopulation":45,"armGroups":51,"interventions":67,"overallOfficials":45,"centralContacts":81,"locations":88,"responsibleParty":105,"collaborators":45,"id":107,"slug":45,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":108,"sex":114,"minAge":115,"maxAge":45,"enrollmentInfo":116,"targetDuration":45,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":133,"whyStopped":45,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Prolonged Grief Scale - Revised (PG13-R)","The PG-13-R is a 13-item self-report measure assessing Prolonged Grief Disorder symptoms according to DSM-5-TR criteria. Items are rated on a 5-point Likert scale (1 = not at all to 5 = several times a day\u002Foverwhelmingly).Total scores are calculated as the sum of all items. Total score range: 13-65. Higher scores indicate greater severity of prolonged grief symptoms. Diagnostic criteria include symptom duration (≥12 months) and functional impairment.","Baseline (T0), Post-intervention at 3 months (T1), and Follow-up at 6 months (T2).",[14],{"measure":15,"description":16,"timeFrame":17},"Depression, Anxiety and Stress Scales - Short Form (DASS-21)","The DASS-21 is a 21-item self-report questionnaire assessing depression, anxiety, and stress symptoms over the previous week. Each item is rated on a 4-point Likert scale (0 = did not apply to me at all; 3 = applied to me very much or most of the time). The measure consists of three subscales (Depression, Anxiety, and Stress), each comprising 7 items rated on a 4-point scale (0 to 3). Subscale scores are calculated as the sum of the 7 corresponding items.\n\nScore range (per subscale): 0 to 21. Higher scores indicate greater symptom severity in the respective domain.","Baseline (T0), Post-intervention at 3 months (T1), and Follow-up at 6 months (T2)",[19,23,27,31,34,37],{"measure":20,"description":21,"timeFrame":22},"Sociodemographic and death-related questionnaire","A sociodemographic and death-related questionnaire will assess: (a) social and demographic characteristics; (b) death-related characteristics (e.g., type of death, relationship with the deceased, previous care status); and (c) post-death impacts (e.g., living status, relationship-status change). Engagement and completion of the intervention tasks will also be quantitatively assessed.","[Screening]",{"measure":24,"description":25,"timeFrame":26},"The Prolonged Grief Screening Tool (PGST)","Prolonged Grief Screening Tool (PGST), a 5-item self-report screening instrument developed to identify bereaved adults at elevated risk of developing Prolonged Grief Disorder. Items assess loss-related anger and guilt, perceived closeness to the deceased, concurrent stressfu. Items are rated on a 5-point scale (1 to 5). Total score is calculated as the sum of all items. Score range: 5 to 25. Higher scores indicate greater risk of prolonged grief.","At screening (prior to randomization)",{"measure":28,"description":29,"timeFrame":30},"Grief Relational Needs Scale (GRNS)","Grief Relational Needs Scale (GRNS) is a 11 item self-report, assessing perceived relational support needs in grief across different components (e.g., security, validation, appreciation). The GRNS comprises two subscales: Need for Protection and Validation (9 items) and Need for Mutuality (3 items). Items are rated on a 5-point Likert scale (1 = \"nothing\" to 5 = \"extremely\"). Score range: 11 to 55. Higher scores indicate greater unmet relational needs.","At screening (prior to randomization).",{"measure":32,"description":33,"timeFrame":12},"Adult attachment","Experiences in Close Relationships - Relationship Structures Questionnaire (ECR-RS), adapted to assess attachment to the deceased. Items are rated on a seven-point Likert scale that ranges from 1 (strongly disagree) to 7 (strongly agree). Its 9 items are grouped into 2 dimensions: attachment-related anxiety (items 1-6) and avoidance (items 7-9). Scores for each dimension (attachment anxiety and attachment avoidance) are calculated as the mean of the corresponding items. Higher scores indicate higher attachment avoidance or anxiety. Score range (mean per dimension): 1 to 7.",{"measure":35,"description":36,"timeFrame":12},"Social Support","Multidimensional Scale of Perceived Social Support (MSPSS). The MSPSS is a 12-item self-report measure assessing perceived support from family, friends, and significant others. Items are rated on a 7-point Likert scale (1 to 7). Total score is calculated as the sum of all items. Score range (total): 12 to 84. Higher scores indicate greater perceived social support.",{"measure":38,"description":39,"timeFrame":17},"Traumatic stress symptoms","Impact of Event Scale - 6 item version (IES-6). The IES-6 assesses distress related to a specific stressful life event. Items are rated on a 5-point scale (0 to 4). Total score is calculated as the sum of all items. Score range (total): 0 to 24.\n\nHigher scores indicate greater traumatic stress symptom severity.",{"allocation":41,"interventionModel":42,"interventionModelDescription":43,"primaryPurpose":44,"observationalModel":45,"timePerspective":45,"maskingInfo":46},"RANDOMIZED","PARALLEL","Arm 1 - Information and Grief Literacy (IGLiteracy):\n\nA low-intensity intervention with one group psychoeducation session on grief reactions and available support, followed by bi-weekly SMS reminders for three months. It represents the minimum active support.\n\nArm 2 - Individual Self-Help Program (ISelfHP):\n\nA digital self-help program promoting emotional regulation and adaptive grief processing through psychoeducation and exercises. Participants complete activities over three months, supported by reminders and brief phone contacts. Printed materials are available if needed.\n\nArm 3 - Moderated Self-Help Groups (MSHGroups):\n\nWeekly psychologist-led peer groups for three months, focusing on emotional expression, acceptance, meaning-making, and coping, using a standardized protocol.\n\nMatching Logic (GriefDiff):\n\nLow-risk participants receive IGLiteracy; moderate\u002Fhigh-risk with low relational needs receive ISelfHP; moderate\u002Fhigh-risk with high relational needs receive MSHGroups. Randomization","PREVENTION",null,{"masking":47,"maskingDescription":45,"whoMasked":48},"SINGLE",[49],"PARTICIPANT","Introduction Grief in later life is a common yet under-recognized public health issue. Although most older adults adapt to bereavement without formal intervention, a significant minority develop Prolonged Grief Disorder (PGD), characterized by persistent yearning, emotional pain, and functional impairment. Older adults are particularly vulnerable due to cumulative losses, declining health, social isolation, and reduced access to psychosocial resources. Despite the documented psychological, physical, and social consequences of adverse grief reactions, prevention and early intervention remain marginal in health and social care systems.\n\nCurrent responses to grief are often reactive and clinically oriented, focusing primarily on individuals who already present severe symptoms. This approach overlooks a large group of bereaved individuals experiencing substantial distress that does not yet meet diagnostic thresholds and limits opportunities for prevention. Furthermore, most existing interventions are hospital-based and individual-focused, while community-based and scalable approaches remain underdeveloped.\n\nIn line with international policy frameworks, including the World Health Organization's stepped-care model for mental health, differentiated models of grief support propose that interventions should be matched to individuals' levels of need. Such models are typically organized as a pyramid, ranging from low-intensity informational support to more structured and specialized interventions. This approach aims to optimize resource allocation, increase accessibility, and promote equity in mental health care.\n\nAims The primary objective of the GriefDiff study is to implement and evaluate the effectiveness of a differentiated, tiered model of grief intervention in reducing prolonged grief symptoms and psychological distress among older bereaved adults. Specifically, the study compares three intervention levels-IGLiteracy, ISelfHP, and MSHGroups-in terms of their impact on grief outcomes.\n\nA secondary objective is to test the added value of matching interventions to participants' risk levels and relational needs, examining whether matched allocations lead to superior outcomes compared to non-matched conditions. The study also aims to identify predictors of engagement and response to intervention, including attachment patterns, social support, and traumatic stress. Ultimately, this research seeks to inform public health strategies by providing evidence for a cost-effective, community-centred, and preventive model of bereavement care.\n\nProcedures Participants will be recruited through community and health organizations, including a national grief association and partner institutions. Individuals referred by these entities will undergo a screening process assessing eligibility, risk of PGD, and relational needs. Eligible participants will receive detailed information about the study and will provide written informed consent prior to participation.\n\nData collection will follow strict ethical and confidentiality standards. All data will be anonymized and securely stored. Participants will be informed of their right to withdraw at any time without consequences.\n\nTo promote retention and minimize attrition, several strategies will be implemented, including flexible scheduling, regular contact with the research team, reminders for assessment points, and the availability of both digital and non-digital intervention formats. A feedback mechanism will be established to allow participants to share their experiences and concerns throughout the study.\n\nAll interventions will be delivered within a community-based framework and will be supported by standardized manuals and materials. Intervention providers will receive specific training and ongoing supervision to ensure fidelity and consistency across conditions.\n\nTrial Design The GriefDiff study is a rater-blinded, randomized controlled trial with three parallel intervention arms. Following baseline assessment, participants will be stratified according to risk of prolonged grief and relational needs and then randomized to one of the three intervention conditions: IGLiteracy, ISelfHP, or MSHGroups.\n\nRandomization will be conducted using block randomization within predefined risk-by-needs strata to ensure balanced allocation across conditions. Allocation concealment will be maintained through the use of a computer-generated random sequence, managed by an independent member of the research team.\n\nOutcome assessors will be blinded to participants' allocation. Participants will be assessed at baseline (T0), post-intervention at three months (T1), and follow-up at six months (T2). In addition to evaluating overall intervention effects, the design allows for the examination of matching effects by comparing outcomes between participants who were allocated to matched versus non-matched intervention conditions. This trial provides a rigorous methodological framework to test a differentiated, community-based model of grief care, with the potential to inform future service organization and policy in bereavement support.",[52,57,62],{"label":53,"type":6,"description":54,"interventionNames":55},"Arm 1: Information and Grief Literacy (IGLiteracy)","Assigned Intervention: Information and Grief Literacy Participants allocated to this arm will receive a low-intensity informational intervention aimed at enhancing grief literacy and normalizing the bereavement experience. IGLiteracy consists of a single group session (delivered online or in person) focused on psychoeducation about common and uncommon grief reactions, the grieving process, and available resources for support.\n\nFollowing the session, participants will receive bi-weekly brief reminders (via SMS or equivalent) over a three-month period, reinforcing key concepts and providing practical information and self-care suggestions. This arm represents the minimum active intervention and serves as a universal, low-intensity support condition.",[56],"Behavioral: IGLiteracy",{"label":58,"type":6,"description":59,"interventionNames":60},"Arm 2: Individual Self-Help Program (ISelfHP)","Assigned Intervention: Individual Self-Help Program Participants allocated to this arm will receive a structured, low-intensity psychological self-help intervention delivered through a digital WebApp designed for older adults. The ISelfHP aims to promote emotional regulation, psychological well-being, and adaptive grief processing.\n\nThe intervention includes three main components:\n\n1. psychoeducation about grief and emotional processes;\n2. emotional regulation and well-being promotion;\n3. grief elaboration and acceptance-based exercises. Participants are encouraged to complete at least one activity per week over a three-month period, although no fixed sequence or minimum dosage is imposed, allowing flexibility according to individual needs and preferences. Engagement is supported through automated reminders and brief motivational contacts by phone from the research team.\n\nParticipants with low digital literacy - a non-digital alternative (printed materials with equivalent content)",[61],"Behavioral: Arm 2 - Individual Self-Help Program (ISelfHP)",{"label":63,"type":6,"description":64,"interventionNames":65},"Arm 3: Moderated Self-Help Groups (MSHGroups)","Assigned Intervention: Moderated Self-Help Groups Participants allocated to this arm will take part in a manualized group-based intervention facilitated by a trained psychologist. MSHGroups are semi-structured peer support groups aimed at fostering shared understanding, emotional expression, and social connection in grief.\n\nThe intervention consists of weekly group sessions over a three-month period. Each session addresses key themes related to the grief process, including emotional regulation, acceptance, guilt, meaning-making, and coping strategies. Sessions are designed to last approximately three hours and follow a standardized protocol to ensure consistency across groups.\n\nThe final session focuses on relapse prevention and the promotion of ongoing adaptive coping. Attendance and participant feedback will be systematically recorded. Group facilitators will receive specific training and ongoing supervision to ensure fidelity to the intervention model.",[66],"Other: Arm 3 - Moderated Self-Help Groups (MSHGroups)",[68,73,77],{"type":69,"name":70,"description":71,"armGroupLabels":72,"otherNames":45},"BEHAVIORAL","IGLiteracy","A low-intensity intervention with one group psychoeducation session on grief reactions and available support, followed by bi-weekly SMS reminders for three months. It represents the minimum active support.",[53],{"type":69,"name":74,"description":75,"armGroupLabels":76,"otherNames":45},"Arm 2 - Individual Self-Help Program (ISelfHP)","A digital self-help program promoting emotional regulation and adaptive grief processing through psychoeducation and exercises. Participants complete activities over three months, supported by reminders and brief phone contacts. Printed materials are available if needed.",[58],{"type":6,"name":78,"description":79,"armGroupLabels":80,"otherNames":45},"Arm 3 - Moderated Self-Help Groups (MSHGroups)","Weekly psychologist-led peer groups for three months, focusing on emotional expression, acceptance, meaning-making, and coping, using a standardized protocol.",[63],[82,87],{"name":83,"role":84,"phone":85,"phoneExt":45,"email":86},"David Neto, PhD","CONTACT","+351933220520","dneto@ispa.pt",{"name":83,"role":84,"phone":45,"phoneExt":45,"email":86},[89],{"facility":90,"status":45,"city":91,"state":45,"zip":45,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":99,"contacts":100},"InLuto Association","Lisbon","Portugal","PT",{"type":95,"coordinates":96},"Point",[97,98],-9.1498,38.72509,{"lat":98,"lon":97},[101],{"name":102,"role":84,"phone":103,"phoneExt":45,"email":104},"Alexandra Coelho, PhD","+351919957534","alexandra.moura.coelho@gmail.com",{"type":106,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR","100626243",false,"NCT07433101","Understanding and Responding to Grief-Related Needs: A Differentiated Community Approach","Responding to Grief-Related Needs: Study Protocol for a Pilot Randomized Controlled Trial","GriefDiff","Inclusion Criteria:\n\n* Portuguese adults aged 60 years or older\n* Bereaved 1 to 12 months prior to recruitment\n\nExclusion Criteria:\n\n* Recent serious mental illness\n* Significant cognitive impairment at screening","ALL","60 Years",{"count":117,"type":118},246,"ESTIMATED","INTERVENTIONAL",[121],"NA","The GriefDiff study is a randomized controlled trial evaluating a differentiated, community-based model of grief support for older adults. It compares three intervention levels-Information and Grief Literacy (IGLiteracy), Individual Self-Help Program (ISelfHP), and Moderated Self-Help Groups (MSHGroups)-to assess their effectiveness in reducing prolonged grief and psychological distress. Participants are screened for risk of Prolonged Grief Disorder and relational needs, then randomized to matched or non-matched interventions. Outcomes are measured at baseline, post-intervention (3 months), and follow-up (6 months), focusing primarily on prolonged grief symptoms and secondarily on depression, anxiety, stress, attachment, social support, and traumatic stress. The study aims to provide evidence for a cost-effective, scalable, and preventive public health model of bereavement care.",[124],"Prolonged Grief Disorder (PGD)",[126,127,128,129,130,131,132],"Prolonged grief disorder","Bereavement","Older adults","Tiered intervention","Community-based care","Self-help","Randomized controlled trial","NOT_YET_RECRUITING","2026-02-19",{"date":136,"type":137},"2026-02-25","ACTUAL",{"date":139,"type":118},"2026-03-01",{"date":141,"type":118},"2028-12-31",{"name":5,"class":6},1]