Emotion, Aging, and Forgiveness: Protocol for a Feasibility of Randomized Controlled Trial

November 10, 2024 updated by: Bernardo Almeida, University of Maia

Emotion, Aging and Forgiveness: Protocol of a Feasibility and Acceptability Study of Emotion-Focused Therapy for Older Individuals

Over recent decades, Emotion-Focused Therapy, aging, and forgiveness have garnered significant attention in the field of psychology. However, there is a lack of studies on Emotion-Focused Therapy and forgiveness specifically tailored for older adults. This article describes a protocol to assess the feasibility and acceptability of a Randomized Controlled Trial of Emotion-Focused Therapy for the resolution of emotional injury in individuals over the age of 65 in the context of interpersonal offenses. The study is structured as a two-arm, parallel-group randomized trial with a waiting list control. We propose recruiting a sample of 70 participants, randomly assigned to either an immediate intervention group, which will receive Emotion-Focused Therapy over twelve weekly sessions, or a control group that will receive the same therapy after a twelve-week waiting period. Data will be collected in the beginning, middle, and at the end of therapy, and in two planned follow-ups (three and six months after therapy). Once this protocol is implemented, if the therapy proves to be feasible, acceptable, and shows promising results, the findings will inform a large-scale randomized clinical trial to advance the understanding of psychotherapy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Bernardo Almeida Bernardo Dr, PhD
  • Phone Number: 00351911795393
  • Email: A037791@umaia.pt

Study Contact Backup

Study Locations

  • Portugal
    • Castelo Da Maia
      • Maia, Castelo Da Maia, Portugal, 4475-690
        • Av. Carlos Oliveira Campos - Castelo da Maia 4475-690 Avioso S. Pedro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Our eligibility criteria include being 65 years or older, having experienced an interpersonal offense, residing at home or in a senior residence, stable prescribed medication use, scoring ≥ 26 on the MoCA (Montreal Cognitive Assessment), and fluency in Portuguese or English.

Exclusion Criteria:

  • Exclusion criteria include reporting an offense which is less than a year old, severe emotional injuries (such as being a victim of domestic violence or abuse), psychiatric disorders, suicidal ideation, parasuicidal behavior, recent loss of a loved one, involvement in other therapies or clinical studies, current alcohol or drug abuse, living with another participant, and frequent hospitalizations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 35 participants randomly assigned to the EFT intervention
The research will include 35 individuals aged 65 years or older, of both genders, who meet the study's inclusion criteria. Therapy sessions will be conducted individually and in person, in offices suited for psychological practice. Participants residing in senior housing will have the option, subject to agreement with their institution, to have sessions conducted in their facilities. Each session will last one hour and occur weekly over a three-month period, resulting in a total of 12 sessions per participant, in accordance with the EFT protocol for resolving emotional injuries established by Meneses and Greenberg (2019) and adjusted for this population/purposes by Almeida and Cunha (2024);
Other: Emotion-Focused Therapy
This feasibility protocol is a two-arm, parallel, double-blinded, RCT aimed at informing a future trial assessing the effectiveness of EFT in resolving emotional injuries in older adults in the context of interpersonal offenses.
No Intervention: 35 participants include in a control group (CG).
35 participants included in a control group (CG), in the form of a waitlist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enright Forgiveness Inventory-EFI
Time Frame: From enrollment to the end of treatment at 12 weeks
EFI is a self-report measure designed to measure the level of forgiveness in response to a specific offense. The EFI consists of 60 items divided into three 20-item subscales that assess affect, behavior, and cognition related to forgiveness, using a 6-point Likert scale. Scores range from 60 to 360, with higher scores indicating higher levels of forgiveness.
From enrollment to the end of treatment at 12 weeks
Letting Go (assessed through the Letting Go Measure; Greenberg et al., 2008):
Time Frame: From enrollment to the end of treatment at 12 weeks
The Letting Go is a self-report instrument comprising a single item that evaluates the extent to which individuals have released their negative emotions toward the injurer. Responses are measured on a Likert scale ranging from 1 to 5.
From enrollment to the end of treatment at 12 weeks
The Unfinished Business Feelings and Needs Scale (UFB FN-Greenberg et al., 2008;)
Time Frame: From enrollment to the end of treatment at 12 weeks
The Unfinished Business Feelings and Needs Scale (UFB FN-Greenberg et al., 2008; Singh, 1994) consists of a 6-item scale designed to measure the extent to which an individual who has experienced an unfair situation feels acceptance and empathy toward the person who has harmed them, utilizing a 5-point Likert scale.
From enrollment to the end of treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The European Portuguese World Health Organization Quality of Life Assessment in Older Adults (WHOQOL-OLD)
Time Frame: From enrollment to the end of treatment at 12 weeks
The European Portuguese World Health Organization Quality of Life Assessment in Older Adults (WHOQOL-OLD) (Power et al., 2005; Vilar et al., 2016) comprises 28 items classified on a five-point scale and encompassing seven domains: sensory, autonomy, activities, social, death, intimacy, and family life (Vilar et al., 2016).
From enrollment to the end of treatment at 12 weeks
The Geriatric Depression Scale-15 (GDS-15; Matos et al., 2019; Yesavage & Sheikh, 1986)
Time Frame: From enrollment to the end of treatment at 12 weeks
The Geriatric Depression Scale-15 (GDS-15; Matos et al., 2019; Yesavage & Sheikh, 1986) is specifically designed for screening depressive symptoms in older adults. It consists of 15 straightforward questions, each requiring a simple Yes or No response. The scale ranges from zero (indicating no depressive symptoms) to 15 points (representing the highest severity of depressive symptoms), with each affirmative response scored as 1 point. The cut-off points are defined as follows: 0 to 4 for the absence of depressive symptoms, 5 to 8 for mild symptoms, 9 to 11 for moderate symptoms, and 12 to 15 for severe symptoms.
From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maia

Investigators

  • Study Chair: Carla Cunha Alexandra Dr, PhD, University of Maia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 5, 2024

First Submitted That Met QC Criteria

November 5, 2024

First Posted (Actual)

November 7, 2024

Study Record Updates

Last Update Posted (Estimated)

November 13, 2024

Last Update Submitted That Met QC Criteria

November 10, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • University Maia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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