Emotion-Focused Therapy in the Treatment of Prolonged Grief Disorder (EFT-PGD)

Universidad Pontificia Comillas

Status: Begins enrollment in 6 months

Conditions: Prolonged Grief Disorder (PGD)

Treatments: Behavioral: Emotion-Focused Therapy for Grief; Behavioral: Self-help intervention based on EFT

Study type: Interventional

Funder types: Other

Identifiers

NCT07207512

UPComillas-EFT-PGD

Details and patient eligibility

About

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. Does EFT lower grief symptoms in adults with PGD?
  2. 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:

1. EFT group: 8 to 10 weekly, face-to-face therapy sessions with a trained therapist.

2. 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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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128 participants in 2 patient groups, including a placebo group

Emotion-Focused Therapy for Grief

Experimental group

Treatment:

Behavioral: Emotion-Focused Therapy for Grief

self-help intervention based on Emotion-Focused Therapy

Placebo Comparator group

Treatment:

Behavioral: Self-help intervention based on EFT