Emotion-Focused TherapyNCT06679452
Emotion, Aging, and Forgiveness: Protocol for a Feasibility of Randomized Controlled Trial
A study testing Emotion-Focused Therapy in people with Emotion-Focused Therapy and Aging, run by University of Maia at 1 site in Portugal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Emotion-Focused Therapy, Aging, Forgiveness
- What is being tested?
- Emotion-Focused Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Apr 2025to 31 Dec 2025
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Carla Cunha Alexandra Dr, PhD contact
Portugal1 site
Av. Carlos Oliveira Campos - Castelo da Maia 4475-690 Avioso S. Pedro
Maia, Castelo Da Maia, 4475-690
About this study
Official title: 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.
- Conditions
- Emotion-Focused Therapy, Aging, Forgiveness
- Being tested
- Emotion-Focused Therapy
- Keywords
- Emotion-Focused Therapy; Forgiveness; Aging; Randomized Controlled Trial; Feasibility Protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion-Focused TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 35 participants randomly assigned to the EFT intervention | Experimental | 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); Receives: Other: Emotion-Focused Therapy |
| 35 participants include in a control group (CG). | No intervention | 35 participants included in a control group (CG), in the form of a waitlist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enright Forgiveness Inventory-EFI
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.
Measured: From enrollment to the end of treatment at 12 weeks
Letting Go (assessed through the Letting Go Measure; Greenberg et al., 2008):
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.
Measured: From enrollment to the end of treatment at 12 weeks
The Unfinished Business Feelings and Needs Scale (UFB FN-Greenberg et al., 2008;)
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.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (2)
The European Portuguese World Health Organization Quality of Life Assessment in Older Adults (WHOQOL-OLD)
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).
Measured: From enrollment to the end of treatment at 12 weeks
The Geriatric Depression Scale-15 (GDS-15; Matos et al., 2019; Yesavage & Sheikh, 1986)
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.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start1 Apr 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Emotion-Focused TherapyStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernardo Almeida, University Institute of Maia
- Investigators
- Carla Cunha Alexandra Dr, PhD, Study chair, University of Maia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679452
- Sponsor's protocol ID
- University Maia
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Buzgova R, Kozakova R, Bobcikova K, Zelenikova R. Predictors of life satisfaction in elders living at home in the Czech Republic. PLoS One. 2023 Mar 30;18(3):e0283772. doi: 10.1371/journal.pone.0283772. eCollection 2023.
PubMed 36996129Lopez J, Serrano MI, Gimenez I, Noriega C. Forgiveness Interventions for Older Adults: A Review. J Clin Med. 2021 Apr 26;10(9):1866. doi: 10.3390/jcm10091866.
PubMed 33925790Band-Winterstein T, Eisikovits Z, Brownell P, King A. Introduction: exploring older women's perspectives on lifetime abuse. J Elder Abuse Negl. 2024; 36(2):91-92. 10.1080/08946566.2024.2332141.
Toussaint LL, Worthington EL, Williams DR, eds. Forgiveness and Health: Scientific Evidence and Theories Relating Forgiveness to Better Health. Springer; 2015. doi: 10.1007/978-94-017-9993-5.
Greenberg LJ, Warwar SH, Malcolm WM. Differential effects of Emotion-Focused Therapy and psychoeducation in facilitating forgiveness and letting go of emotional injuries. J Couns Psychol. 2008; 55(2):185-96. doi: 10.1037/0022-0167.55.2.185.
Almeida, B., Cunha, C. Time, resentment, and forgiveness: Impact on the well-being of older adults. Trends in Psychology. 2023. https://doi.org/10.1007/s43076-023-00343-2
Enright RD, Fitzgibbons RP. Forgiveness therapy: An empirical guide for resolving anger and restoring hope. American Psychological Association; 2015. doi: 10.1037/14526-000.
Meneses CW, Greenberg LS. Forgiveness and letting go in Emotion-Focused Therapy. American Psychological Association; 2019. doi: 10.1037/0000144-000.
Worthington EL, Wade NG, eds. Handbook of forgiveness. 2nd ed. Routledge; 2020.
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion, Aging and Forgiveness: Protocol of a Feasibility and Acceptability Study of Emotion-Focused Therapy for Older Individuals
- ClinicalTrials.gov ID
- NCT06679452
- Acronym / sponsor ID
- University Maia
- Conditions
- Emotion-Focused Therapy, Aging, Forgiveness
- Keywords
- Emotion-Focused Therapy; Forgiveness; Aging; Randomized Controlled Trial; Feasibility Protocol
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of MaiaUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Nov 2024 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 35 participants randomly assigned to the EFT intervention | Experimental | Other: Emotion-Focused TherapyThe 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); |
| 35 participants include in a control group (CG). | No intervention | –35 participants included in a control group (CG), in the form of a waitlist. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 TherapyThis 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. | Other | 35 participants randomly assigned to the EFT intervention |
Primary outcome
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.
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.
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.
2 secondary outcomes
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 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
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 13 Nov 2024.
- Background: PubMed 36996129Buzgova R, Kozakova R, Bobcikova K, Zelenikova R. Predictors of life satisfaction in elders living at home in the Czech Republic. PLoS One. 2023 Mar 30;18(3):e0283772. doi: 10.1371/journal.pone.0283772. eCollection 2023.
- Background: PubMed 33925790Lopez J, Serrano MI, Gimenez I, Noriega C. Forgiveness Interventions for Older Adults: A Review. J Clin Med. 2021 Apr 26;10(9):1866. doi: 10.3390/jcm10091866.
- BackgroundBand-Winterstein T, Eisikovits Z, Brownell P, King A. Introduction: exploring older women's perspectives on lifetime abuse. J Elder Abuse Negl. 2024; 36(2):91-92. 10.1080/08946566.2024.2332141.
- BackgroundToussaint LL, Worthington EL, Williams DR, eds. Forgiveness and Health: Scientific Evidence and Theories Relating Forgiveness to Better Health. Springer; 2015. doi: 10.1007/978-94-017-9993-5.
- BackgroundGreenberg LJ, Warwar SH, Malcolm WM. Differential effects of Emotion-Focused Therapy and psychoeducation in facilitating forgiveness and letting go of emotional injuries. J Couns Psychol. 2008; 55(2):185-96. doi: 10.1037/0022-0167.55.2.185.
- BackgroundAlmeida, B., Cunha, C. Time, resentment, and forgiveness: Impact on the well-being of older adults. Trends in Psychology. 2023. https://doi.org/10.1007/s43076-023-00343-2
- BackgroundEnright RD, Fitzgibbons RP. Forgiveness therapy: An empirical guide for resolving anger and restoring hope. American Psychological Association; 2015. doi: 10.1037/14526-000.
- BackgroundMeneses CW, Greenberg LS. Forgiveness and letting go in Emotion-Focused Therapy. American Psychological Association; 2019. doi: 10.1037/0000144-000.
- BackgroundWorthington EL, Wade NG, eds. Handbook of forgiveness. 2nd ed. Routledge; 2020.
- The present study explores how resentment and forgiveness can affect older people and how resentment can be alleviated or intensified over time. The investigation is based on a qualitative methodology, using life history interviews, carried out in two moLink provided by the sponsor.
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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.
Carla Cunha Alexandra Dr, PhD contact
Carla Cunha Alexandra Dr, PhD study chair
University of Maia
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 in people with Emotion-Focused Therapy and Aging, run by University of Maia at 1 site in Portugal.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 13 Nov 2024. 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 Portugal. 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. 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 Bernardo Almeida Bernardo Dr, PhD (00351911795393, A037791@umaia.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enright Forgiveness Inventory-EFI (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 3 primary outcomes in all. 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 NCT06679452, which also lists 9 linked publications.
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 13 Nov 2024.