Improving emotional regulation: a study on a brief focusing intervention for better mental health
| ISRCTN | ISRCTN16974329 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16974329 |
- Submission date
- 20/07/2023
- Registration date
- 24/08/2023
- Last edited
- 20/11/2024
- Recruitment status
- Suspended
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background study and aims
Affective dysregulation (impaired ability to regulate or tolerate negative emotional states) affects many people with mental disorders. Two mechanisms that have been frequently associated with emotional regulation are immersion and distancing. Focusing is a task that combines these two mechanisms of emotion regulation through the phase of creating a working distance and subsequently the phase of reassigning meaning. However, the benefit of its use for the promotion of mental health in populations without moderate to severe symptoms remains unclear. The aim of this study is to test the effectiveness of a brief intervention based on Focusing.
Who can participate?
Participants aged between 18 and 65 years who wish to improve their awareness and understanding of their emotions
What does the study involve?
Participants will be randomly allocated into two groups: the intervention group (IG) and the control group (CG; waiting list). The IG will have access to two Focusing sessions and the CG will only have access to the intervention about 4 weeks later. Both groups will be evaluated at five different times. Positive and negative affect, attitudes toward focusing (emotions and bodily sensations), the ability to perform focusing, and emotion regulation are assessed, as well as mental health and psychological well-being, depressive/anxiety symptomatology, and self-esteem.
What are the possible benefits and risks of participating?
There are no intended direct benefits of participating, besides the hypothetical benefits of the intervention for mental health and well-being. Regarding possible risks, getting too involved in the task can be emotionally challenging at times. However, it is normal to feel some discomfort during the task and emotional responses are often a necessary part of understanding and practising the task. Therapists involved in the study will be trained and experienced in supporting individuals through these difficult thoughts and emotions and will work with patients to help them deal with these feelings. If, at the end of the intervention, someone feels they need more support, a referral will be provided.
Where is the study run from?
It will take place in the Laboratory of Psychotherapy Research, located at the University of Maia (Maia, Portugal), which is affiliated with the Center of Psychology at the University of Porto (Porto, Portugal)
When is the study starting and how long is it expected to run for?
October 2022 to August 2025
Who is funding the study?
Foundation for Science and Technology (Portugal)
Who is the main contact?
1. Dr João Salgado, jsalgado@umaia.pt
2. Dr Clara Aguiar, cpaguiar@umaia.pt
Contact information
Principal Investigator
Avenida Carlos de Oliveira Campos
Maia
4475-690
Portugal
 ORCID ID |
0000-0003-0822-9267 |
|---|---|
| Phone | +351 (0)229 866 000 |
| jsalgado@umaia.pt |
Scientific
Avenida Carlos de Oliveira Campos
Maia
4475-690
Portugal
| ORCID ID |
0009-0005-7055-6818 |
|---|---|
| Phone | +351 (0)229 866 000 |
| cpaguiar@umaia.pt |
Study information
| Study design | Cluster randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | University/medical school/dental school, Other |
| Study type | Quality of life, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Effectiveness of a brief focusing intervention on emotion regulation and mental health: a randomized clinical trial in a community sample |
| Study acronym | BFI-RCT |
| Study objectives | The participants who undergo the Brief Focusing Intervention (BFI) will demonstrate significant improvements in emotion regulation skills and mental health outcomes compared to the control group (waiting list): 1. The intervention group will exhibit greater improvements in emotion regulation abilities, compared to the control group by the end of the intervention; 2. The intervention group will decrease levels of clinical symptoms, including anxiety and depressive symptoms, compared to the control group by the end of the intervention; 3. The intervention group will have higher levels of subjective well-being and overall psychological well-being, compared to the control group by the end of the intervention; 4. The intervention group will have high levels of satisfaction with the intervention and perceived usefulness of focusing as an emotion regulation strategy. |
| Ethics approval(s) |
Approved 27/02/2023, Ethics and Deontology Council of the University of Maia (Avenida Carlos de Oliveira Campos, Maia, 4475-690, Portugal; +351 (0)22 986 6000; info@umaia.pt), ref: 105/2023 |
| Health condition(s) or problem(s) studied | Promotion of emotional regulation in adults without clinical symptoms or with mild symptoms of psychopathology |
| Intervention | Eligible participants will be randomized into two conditions: (1) intervention group (IG); (2) control group (CG). Both groups will complete the same online questionnaires, but the CG group will wait for approximately 4 weeks, being evaluated at 3 times during this waiting time. IG will have immediate access to the Brief Focusing Intervention, being evaluated at 5 different times. Cluster randomization will be performed by an independent researcher not involved in data collection using an automated computer-based random intergenerator. The Brief Focusing Intervention (BFI) is based on the book by Kwatra and colleagues (2022). The BFI consists of two sessions, each lasting approximately 90 minutes, with a 1-week interval between them. These sessions are conducted online using the Microsoft Teams platform. In the initial phase of the sessions, participants are invited to connect with their internal experience through the Clear a Space (focusing preparatory task ) and Focusing. Afterwards, participants will have the opportunity to share their task experience with the group. Participants will be asked to repeat the task at home between sessions, and audio and text instructions will be provided for this purpose. Throughout the intervention process, participants will undergo assessment moments by filling out questionnaires before and after each session. Additionally, 2 weeks after the second session, participants will complete some questionnaires as part of the follow-up assessment. |
| Intervention type | Behavioural |
| Primary outcome measure | Focusing attitudes assessed using the Focusing Manner Scale (FMS) at T1, T4, and T5 Note. T1 = Evaluation moment before session Nº1; T2 = Evaluation moment at the end of session Nº1; T3 = Evaluation moment before session Nº2; T4 = Moment of evaluation at the end of session Nº2; T5 = Assessment time 15 days after T4 (follow-up). |
| Secondary outcome measures | 1. Positive and negative affect assessed using the Positive and Negative Affect Program (PANAS) at T1, T2, T3, and T4 2. Ability to focus assessed using the Post-Focusing Checklist 2 (PFC-2) at T2 and T4 3. Propensity to use six emotion regulation strategies to decrease their experience of negative emotions: a) distraction, b) rumination, c) reappraisal, d) suppression, e) engagement, and f) arousal control, assessed using the Survey on the Regulation of Emotional Systems (RESS) at T1, T4, and T5 4. Mental health and psychological well-being assessed using the Clinical Outcome Routine Evaluation – Outcome Measure (CORE-OM) at T1, T3, and T5 5. Subjective well-being assessed using the Psychological Well-Being Scale - Short Version (EBEP - VR) at T1 and T5 6. Depressive symptoms assessed using the Patient Health Questionnaire (PHQ-9) at T1, T3, and T5 7. Anxiety symptomatology assessed using the General Anxiety Disorder (GAD-7) at T1, T3, and T5 8. Self-esteem assessed using the Rosenberg Self-Esteem Scale (RSES) at T1 and T5 Note. T1 = Evaluation moment before session Nº1; T2 = Evaluation moment at the end of session Nº1; T3 = Evaluation moment before session Nº2; T4 = Moment of evaluation at the end of session Nº2; T5 = Assessment time 15 days after T4 (follow-up). |
| Overall study start date | 03/10/2022 |
| Completion date | 01/08/2025 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 68 |
| Key inclusion criteria | 1. Age between 18 and 65 years old 2. Having an interest in clarifying their emotions 3. Having digital literacy to use internet-based videoconference (Microsoft Teams) |
| Key exclusion criteria | 1. Changes in their therapeutic plan with psychopharmaceuticals in the last month 2. Currently undergoing a psychological treatment 3. Moderate to severe psychopathology 4. Not having internet access and/or conditions to carry out the sessions with privacy |
| Date of first enrolment | 01/09/2023 |
| Date of final enrolment | 01/06/2025 |
Locations
Countries of recruitment
- Portugal
Study participating centres
Maia
4475-690
Portugal
Porto
4200-135
Portugal
Sponsor information
University/education
Av. Carlos Oliveira Campos
Maia
4475-694
Portugal
| Phone | +351 (0)22 9866000 |
|---|---|
| info@umaia.pt | |
| Website | https://www.umaia.pt |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Foundation for Science and Technology, Portuguese Science and Technology Foundation, Fundacao para a Ciencia e a Tecnologia, FCT
- Location
- Portugal
Results and Publications
| Intention to publish date | 01/10/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-review scientific journal (Q1) with a high impact factor. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study may be available upon reasonable request to Clara Aguiar (focusing@umaia.pt). All information collected about the participants will be kept confidential and anonymous. The data will be kept in a pseudo-anonymized format. Specifically, participants will receive an alphanumeric code that will serve for their identification throughout the study, and it will only be known by themselves, the evaluator, and the responsible researcher. The only personal identifying information that will be kept will be the email address provided by the participant, along with their alphanumeric code. This will be kept on paper in a safe at our laboratory, with access only allowed to those responsible for contacts, and destroyed after the completion of the study, or immediately if an immediate exclusion is required. All databases created will be stored encrypted on the OneDrive platform, according to a security protocol guaranteed by the IT services of the University of Maia. Access to the database with sociodemographic elements will be limited through a password, held by the Responsible Investigator. In this way, the identity of the person will be protected while ensuring that, if requested by the participant, their data can be deleted. After properly curating the databases created, without any identifying data, may be subject to open access for the scientific community. Sociodemographic data will be recorded in a separate database from the other data in terms of hardware and software. Additionally, weekly, during periods of new participant intake, sociodemographic data will be exported to a separate database, and the data will be deleted from the original database. Regarding data collection through questionnaires, participants will have access to detailed information about the study and an informed consent form with terms and conditions that they must agree to. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Statistical Analysis Plan | 24/07/2023 | No | No | ||
| Protocol article | 12/11/2024 | 20/11/2024 | Yes | No |
Additional files
Editorial Notes
20/11/2024: Publication reference added.
23/11/2023: Recruitment has been paused until the trialist is able to resume recruitment.
24/07/2023: Study's existence confirmed by the Ethics and Deontology Council of the University of Maia.
