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NCT Number: NCT06679452

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Av. Carlos Oliveira Campos - Castelo da Maia 4475-690 Avioso S. Pedro

Maia, Castelo Da Maia, 4475-690, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Emotion-Focused Therapy

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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).

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bernardo Almeida Bernardo Dr, PhD

CONTACT

[email protected]

00351911795393

Carla Cunha Alexandra Dr, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Maia

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 7, 2024
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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