NCT07207512

Brief Summary

The goal of this clinical trial is to learn if Emotion-Focused Therapy (EFT) works to reduce symptoms of Prolonged Grief Disorder (PGD) in adults. PGD happens when the pain of losing a loved one lasts a long time and causes serious problems in daily life.

  • All participants will complete questionnaires on grief, mood, and well-being before starting, during the study, at the end of treatment (12 weeks), and again at 5 months and 12 months after starting.
  • In the EFT group, the therapeutic relationship will also be measured during sessions 3 and 8.
  • Why this study is important: Most current treatments for grief are based on cognitive-behavioral therapy, but not everyone benefits from them. EFT is a promising therapy that focuses on emotions and has shown positive results for other mental health problems. This trial will test if EFT can be an effective treatment for people struggling with prolonged grief.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 6, 2025

Completed
11 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

December 4, 2025

Status Verified

September 1, 2025

Enrollment Period

Same day

First QC Date

September 26, 2025

Last Update Submit

November 26, 2025

Conditions

Keywords

griefbereavementprolonged grief disordergrief with complicationsEmotion-Focused TherapyPGDRandomized Controlled TrialRCTstudy protocolTreatment Effectiveness

Outcome Measures

Primary Outcomes (1)

  • Prolonged Grief Scale 13 - Revised

    Higher scores indicate greater symptomatology of Prolonged Grief Disorder; a score of 30 or higher meets the clinical threshold for Prolonged Grief Disorder.

    From enrollment to the end of the research at 1 year follow-up

Secondary Outcomes (4)

  • Centrality of Event Scale

    From enrollment to the end of the reserch at 1 year follow-up

  • Clinical Outcomes in Routine Evaluation-10

    From enrollment to the end of the reserch at 1 year follow-up

  • Patients Health Questionnarie 9

    From enrollment to the end of the reserch at 1 year follow-up

  • Generalized Anxiety Disorder-7 Scale

    From enrollment to the end of the reserch at 1 year follow-up

Study Arms (2)

Emotion-Focused Therapy for Grief

EXPERIMENTAL
Behavioral: Emotion-Focused Therapy for Grief

self-help intervention based on Emotion-Focused Therapy

PLACEBO COMPARATOR
Behavioral: Self-help intervention based on EFT

Interventions

The EFT intervention will follow the model described in EFT for grief. Its main goal is to transform core emotional pain (e.g., chronic shame) by activating change-inducing emotions (e.g., assertive anger), a process described as "changing emotion with emotion." This work takes place within a safe and supportive therapeutic relationship, characterized by the therapist's empathic, accepting, and compassionate stance. Therapists remain attuned to emotional markers (e.g., self-criticism, unfinished business) that signal opportunities for targeted work on specific affective problems, which are usually addressed through experiential tasks such as the Empty-Chair for Unfinished Business. Although EFT is transdiagnostic, grief work has certain distinctive features, such as the central role of experiencing grief-related sadness and fostering a sense of connection with the deceased.

Emotion-Focused Therapy for Grief

The self-help intervention consists of 10 written exercises designed to address different aspects of grief. These include psychoeducation, emotional regulation, focusing on bodily awareness, softening self-criticism, reducing avoidance, managing anxiety and fear, clarifying confusing emotional reactions, processing trauma, imaginal dialogues with the deceased, and cultivating compassion.

self-help intervention based on Emotion-Focused Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (≥18 years).
  • Undergoing a grief process (including perinatal grief).
  • Meeting diagnostic criteria for Prolonged Grief Disorder (bereavement occurring six months or more prior to the loss; PG-13-R score ≥30).
  • Provision of informed consent.
  • Stable psychopharmacological medication for at least six weeks prior to therapy onset, with physician approval to maintain stability during the intervention.

You may not qualify if:

  • Concurrent psychological treatment
  • Bereavement occurring less than six months prior to the loss
  • Substance abuse
  • Eating disorder
  • Psychosis;
  • Organic brain syndrome
  • Suicide risk
  • Risk of harm to others.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unidad Clínica de Psicología de la Universidad Pontificia Comillas (UNINPSI)

Madrid, Madrid, 28036, Spain

Location

MeSH Terms

Conditions

Prolonged Grief Disorder

Interventions

Emotion-Focused Therapy

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • José Gamoneda, PhD

    Universidad Pontificia Comillas

    PRINCIPAL INVESTIGATOR

Central Study Contacts

José Gamoneda, PhD

CONTACT

Rafael Jódar, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 26, 2025

First Posted

October 6, 2025

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

December 4, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Locations