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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Maia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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