Prolonged Grief Disorder (PGD)EFT-PGDNCT07207512
Emotion-Focused Therapy in the Treatment of Prolonged Grief Disorder
A study testing Emotion-Focused Therapy for Grief and Self-help intervention based on EFT in people with Prolonged Grief Disorder (PGD), run by Universidad Pontificia Comillas at 1 site in Spain.
Trial 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. The main questions this study aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prolonged Grief Disorder (PGD)
- What is being tested?
- Emotion-Focused Therapy for Grief and Self-help intervention based on EFT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteSpain
- Study dates
- 6 Apr 2026to 1 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years).
- Undergoing a grief process (including perinatal grief).
- Meeting ICD-11 diagnostic criteria for Prolonged Grief Disorder, assessed with the Traumatic Grief Inventory - Clinician Administered (TGI-CA); death occurred six months or more prior to assessment; 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Unidad Clínica de Psicología de la Universidad Pontificia Comillas (UNINPSI)
Madrid, Madrid, 28036
José Gamoneda, PhD, 636894995, jgamoneda@comillas.edu
About this study
Official title: Emotion-Focused Therapy in the Treatment of Prolonged Grief Disorder: Study Protocol for a Randomised Controlled Trial
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.
- The main questions this study aims to answer are:
Read more
- Does EFT lower grief symptoms in adults with PGD?
- Does EFT also help with related problems, such as anxiety, depression, trauma, and overall distress?
- Who can take part:
Adults (18 years or older) who lost a loved one at least 6 months ago and meet the criteria for PGD.
- What will happen in the study:
Participants will be randomly assigned to one of two groups:
- EFT group: 8 to 10 weekly, face-to-face therapy sessions with a trained therapist.
- Self-help group: 10 weekly self-help exercises based on EFT, completed on their own.
- 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.
- Conditions
- Prolonged Grief Disorder (PGD)
- Being tested
- Emotion-Focused Therapy for Grief, Self-help intervention based on EFT
- Keywords
- grief, bereavement, prolonged grief disorder, grief with complications, Emotion-Focused Therapy, PGD, Randomized Controlled Trial, RCT, study protocol, Treatment Effectiveness
- Medical subject headings
- Prolonged Grief Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion-Focused Therapy for GriefBehavioural
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.
Self-help intervention based on EFTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Emotion-Focused Therapy for Grief | Experimental | Not described Receives: Behavioral: Emotion-Focused Therapy for Grief |
| self-help intervention based on Emotion-Focused Therapy | Placebo comparator | Not described Receives: Behavioral: Self-help intervention based on EFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of the research at 1 year follow-up
Secondary outcomes (5)
Centrality of Event Scale
Higher scores indicate greater trauma symptomatology
Measured: From enrollment to the end of the reserch at 1 year follow-up
Clinical Outcomes in Routine Evaluation-10
Higher scores indicate greater psychological distress
Measured: From enrollment to the end of the reserch at 1 year follow-up
Patients Health Questionnarie 9
Higher scores indicate greater psychological distress
Measured: From enrollment to the end of the reserch at 1 year follow-up
Generalized Anxiety Disorder-7 Scale
Higher scores indicate greater GAD symptomatology
Measured: From enrollment to the end of the reserch at 1 year follow-up
TGI-CA
Proportion of participants no longer meeting ICD-11 diagnostic criteria for prolonged grief disorder, assessed with the Traumatic Grief Inventory - Clinician Administered (TGI-CA).
Measured: Post-treatment (12 weeks), 5-month and 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start6 Apr 2026
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prolonged Grief Disorder (PGD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Pontificia Comillas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Gamoneda Larripa, Universidad Pontificia Comillas
- Investigators
- José Gamoneda, PhD, Principal investigator, Universidad Pontificia Comillas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207512
- Sponsor's protocol ID
- UPComillas-EFT-PGD
- Acronym
- EFT-PGD
- Status last verified
- Aug 2026
- First submitted
- 26 Sep 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Gamoneda J, Caperos JM, Cancer PF, Jodar R. Emotion-focused therapy in the treatment of prolonged grief disorder: study protocol for a randomized controlled trial. Trials. 2026 Sep 21;27(1):589. doi: 10.1186/s13063-026-10005-0.
PubMed 42816884
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion-Focused Therapy in the Treatment of Prolonged Grief Disorder: Study Protocol for a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07207512
- Acronym / sponsor ID
- EFT-PGD / UPComillas-EFT-PGD
- Conditions
- Prolonged Grief Disorder (PGD)
- Keywords
- grief, bereavement, prolonged grief disorder, grief with complications, Emotion-Focused Therapy, PGD, Randomized Controlled Trial, RCT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Universidad Pontificia ComillasUniversity, hospital or other
- Study start
- 6 Apr 2026 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- The main questions this study aims to answer are:
- Does EFT lower grief symptoms in adults with PGD?
- Does EFT also help with related problems, such as anxiety, depression, trauma, and overall distress?
- Who can take part:
Adults (18 years or older) who lost a loved one at least 6 months ago and meet the criteria for PGD.
- What will happen in the study:
Participants will be randomly assigned to one of two groups:
- EFT group: 8 to 10 weekly, face-to-face therapy sessions with a trained therapist.
- Self-help group: 10 weekly self-help exercises based on EFT, completed on their own.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (≥18 years).
- Undergoing a grief process (including perinatal grief).
- Meeting ICD-11 diagnostic criteria for Prolonged Grief Disorder, assessed with the Traumatic Grief Inventory - Clinician Administered (TGI-CA); death occurred six months or more prior to assessment; 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.
Key exclusion criteria (8 listed)
- Concurrent psychological treatment
- Bereavement occurring less than six months prior to the loss
- Substance abuse
- Eating disorder
- Psychosis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotion-Focused Therapy for GriefThe 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. | Behavioural | Emotion-Focused Therapy for Grief |
| Self-help intervention based on EFTThe 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. | Behavioural | self-help intervention based on Emotion-Focused Therapy |
Primary outcome
Prolonged Grief Scale 13 - Revised
Time frame: From enrollment to the end of the research at 1 year follow-up
Higher scores indicate greater symptomatology of Prolonged Grief Disorder; a score of 30 or higher meets the clinical threshold for Prolonged Grief Disorder.
5 secondary outcomes
Centrality of Event Scale
Time frame: From enrollment to the end of the reserch at 1 year follow-up
Clinical Outcomes in Routine Evaluation-10
Time frame: From enrollment to the end of the reserch at 1 year follow-up
Patients Health Questionnarie 9
Time frame: From enrollment to the end of the reserch at 1 year follow-up
Generalized Anxiety Disorder-7 Scale
Time frame: From enrollment to the end of the reserch at 1 year follow-up
TGI-CA
Time frame: Post-treatment (12 weeks), 5-month and 12-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Derived from this study: PubMed 42816884Gamoneda J, Caperos JM, Cancer PF, Jodar R. Emotion-focused therapy in the treatment of prolonged grief disorder: study protocol for a randomized controlled trial. Trials. 2026 Sep 21;27(1):589. doi: 10.1186/s13063-026-10005-0.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
José Gamoneda, PhD principal investigator
Universidad Pontificia Comillas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotion-Focused Therapy for Grief and Self-help intervention based on EFT in people with Prolonged Grief Disorder (PGD), run by Universidad Pontificia Comillas at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact José Gamoneda, PhD (+34636894995, jgamoneda@comillas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prolonged Grief Scale 13 - Revised (time frame: From enrollment to the end of the research at 1 year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07207512, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.