Smartphone-Based Cognitive Emotion Regulation Training for Caregiver Stress

Overseen By Bryan Denny, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bryan Denny

Disqualifiers: Psychotherapy, Visual impairment, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

270 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help family members caring for someone with Alzheimer's or related dementias manage stress more effectively. It tests a smartphone-based training program called Cognitive Emotion Regulation Training, which teaches emotion regulation techniques such as distancing (viewing a situation objectively) and reinterpretation (imagining a better outcome). Participants will be randomly assigned to learn one of these techniques or join a control group. The study seeks unpaid primary caregivers who feel at least a little stressed and have a smartphone. As an unphased trial, it offers caregivers an opportunity to learn valuable stress management techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on psychological training rather than medication changes.

What prior data suggests that this smartphone-based cognitive emotion regulation training is safe for caregivers?

Previous studies have shown that emotion regulation training, like the techniques used in this trial, is safe for participants. Research indicates that psychological distancing helps reduce stress, anxiety, and depression in caregivers of patients with schizophrenia. No significant negative effects were reported, suggesting it is well-tolerated.

For the reinterpretation technique, studies have demonstrated that it helps people manage stress by changing their perspective on situations. This method is considered safe, with no major negative side effects reported in similar settings.

Both techniques aim to help caregivers better manage their emotions. They have been tested in other groups without significant safety concerns, suggesting they are likely safe for participants in this trial as well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about cognitive emotion regulation training for caregiver stress because it leverages smartphone technology to deliver psychological interventions in a convenient and accessible way. Unlike traditional therapy sessions that require in-person appointments, these interventions can be delivered via videoconference, allowing caregivers to receive support without leaving their homes. The two strategies, reinterpretation and distancing, provide caregivers with structured methods to manage stress by reimagining outcomes or viewing situations objectively, which could offer more immediate and practical benefits compared to standard stress management techniques. This approach has the potential to empower caregivers with tools to handle stress more effectively, improving their well-being and quality of life.

What evidence suggests that this trial's treatments could be effective for caregiver stress?

Research shows that training in managing emotions can help caregivers handle stress better. In this trial, participants will receive either "psychological distancing" or "reinterpretation" training. Earlier studies have shown that those who practiced "psychological distancing," which involves viewing emotional situations as if they were outsiders, felt less negative and stressed. This technique helps reduce stress and build resilience. Another method, "reinterpretation," involves imagining more positive outcomes and has been shown to aid emotional coping. A review of multiple studies found that these skills can protect against stress and challenges, making them promising for caregivers of Alzheimer's patients. Both methods aim to improve mental well-being by changing how emotions are processed. ^{1 2 5 6 7}

Who Is on the Research Team?

Bryan Denny, Ph.D.

Principal Investigator

William Marsh Rice University

Are You a Good Fit for This Trial?

This trial is for unpaid primary caregivers of Alzheimer's patients who are over 18, speak English, provide at least 4 hours of care daily, and experience some stress. They must be generally healthy with no major psychological diagnoses except certain mood or anxiety disorders. Participants need a smartphone to receive training and complete assessments.

Inclusion Criteria

I am the main caregiver for someone with Alzheimer's and I do not get paid.

I provide at least 4 hours of daily care in the recipient's home.

Must be at least minimally-stressed (i.e., CES-D score of at least 16)

Exclusion Criteria

I am currently in therapy for caregiver stress or learning to change my thoughts.

Has formerly participated in a study from our lab involving the same or essentially same design (e.g., former participants who provided pilot/preliminary data for this study)

I have no major issues with seeing, hearing, or thinking that would stop me from understanding and completing tasks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Participants receive structured cognitive emotion regulation training via smartphone for one week

1 week

Daily virtual interactions

Follow-up

Participants are monitored for changes in psychological and psychophysiological outcomes

3 months

Assessments at 2 weeks, 4 weeks, and 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Emotion Regulation Training via Psychological Distancing
• Cognitive Emotion Regulation Training via Reinterpretation

Trial Overview

The study tests two types of cognitive emotion regulation training delivered via smartphone: one focuses on reinterpreting situations positively (Reinterpretation), the other on viewing them from an emotionally detached perspective (Psychological Distancing). Caregivers will be randomly assigned to one of these trainings or a control group without regulation guidance.

How Is the Trial Designed?

Group I: Distancing Experimental Treatment 1 Intervention

Participants will receive structured cognitive emotion regulation training from an experimenter during an approximately 10-minute interaction via videoconference in which detailed instructions for implementation of the distancing strategy is explained (i.e. appraising an emotional stimulus as an objective, impartial observer).

Group II: Reinterpretation Active Control 1 Intervention

Participants will receive structured cognitive emotion regulation training from an experimenter during an approximately 10-minute interaction via videoconference in which detailed instructions for implementation of the reinterpretation strategy is explained (i.e. imagining a better outcome than what initially seemed apparent).

Group III: No regulation "Look Only" Active Control 1 Intervention

The No Regulation "Look Only" Control group will serve as a habituation and natural history control; they will see the same emotional images, but they will only be cued to look and respond naturally for all trials.

Who Is Running the Clinical Trial?

Bryan Denny

Lead Sponsor

Trials

2

Recruited

350+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

The 18-item version of the Cognitive Emotion Regulation Questionnaire (CERQ-18) demonstrated better internal structure and reliability compared to the 27-item version (CERQ-27) in a study involving the Argentinean population.

Both versions of the CERQ showed similar associations with the Difficulties in Emotion Regulation Scale (DERS), but the CERQ-18 is recommended for use due to its more consistent psychometric properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric Analysis of Two Brief Versions of the CERQ in the Argentinean Population: CERQ-18 and CERQ-27. Dominguez-Lara, S., Moretti, L., Ezequiel Flores-Kanter, P., et al.[2023]

A multi-site randomized trial is being conducted with 200 family caregivers of cancer patients to compare the effectiveness of two adapted therapies, Emotion Regulation Therapy for Caregivers (ERT-C) and Cognitive Behavioral Therapy for Caregivers (CBT-C), in reducing caregiver distress.

The study aims to assess not only the psychological outcomes like anxiety and depression but also the impact of these interventions on the caregivers' quality of life and potential biological markers of stress, providing a comprehensive understanding of caregiver support needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of emotion regulation therapy for cancer caregivers: A mechanism-targeted approach to addressing caregiver distress. Applebaum, AJ., Loschiavo, M., Morgan, K., et al.[2023]

The Brazilian version of the Cognitive Emotion Regulation Questionnaire (CERQ) has been validated as a reliable tool for measuring cognitive strategies in response to stress, showing high internal consistency with Cronbach's alpha values between 0.71 and 0.88 based on a sample of 445 university students.

The study confirmed that the nine-factor model of the CERQ is valid, but the second-order model, which groups the strategies, did not fit the data well, suggesting that the individual strategies should be assessed separately.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric properties of the Brazilian version of the Cognitive Emotion Regulation Questionnaire. Schäfer, JL., Cibils Filho, BR., de Moura, TC., et al.[2022]

Training to regulate emotions can be approached in two ways: directly managing emotional responses or enhancing cognitive control skills like working memory and attention, which help in future emotional regulation.

Research indicates that effective training should be personalized to the individual's emotional context, and it influences brain systems involved in emotional control, particularly the amygdala, suggesting a complex interaction between cognitive processes and emotional responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From Surviving to Thriving in the Face of Threats: The Emerging Science of Emotion Regulation Training. Cohen, N., Ochsner, KN.[2023]

Emotion Regulation Therapy adapted for cancer informal caregivers (ERT-C) was well tolerated and showed promising initial efficacy, with 31 participants completing eight weekly sessions and reporting significant reductions in depression, anxiety, and perseverative negative thinking (PNT).

Despite the reduction in emotional distress, caregiver burden remained unchanged; however, participants felt more capable of facing caregiving challenges, indicating that ERT-C may help improve coping strategies for informal caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emotion regulation therapy for cancer caregivers-an open trial of a mechanism-targeted approach to addressing caregiver distress. Applebaum, AJ., Panjwani, AA., Buda, K., et al.[2021]

The Italian short version of the Cognitive Emotion Regulation Questionnaire (CERQ-IS) has been validated for use in young adults and adolescents, demonstrating a strong nine-factor structure and good reliability across its subscales.

The CERQ-IS shows good criterion and discriminant validity, making it a promising tool for assessing cognitive emotion regulation strategies in clinical and research settings for ages 14 to 21.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Emotion Regulation Questionnaire-Short: Reliability, Validity, and Measurement Invariance of the Italian Version. Cerolini, S., Zagaria, A., Vacca, M., et al.[2022]

Repeated practice of reappraisal strategies, specifically psychological distancing, can significantly reduce negative emotions over time, as shown in a study with participants practicing this technique across four sessions.

Participants who practiced psychological distancing not only reported lower negative affect during the tasks but also experienced less perceived stress in their daily lives, indicating a lasting benefit from this emotion regulation strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral effects of longitudinal training in cognitive reappraisal. Denny, BT., Ochsner, KN.[2021]

The Cognitive Emotion Regulation Questionnaire (CERQ) was successfully adapted for a Tunisian Arabic-speaking population, maintaining its original nine-factor structure and demonstrating satisfactory psychometric properties.

The Tunisian version of the CERQ showed strong reliability and validity, comparable to the original version, making it a useful tool for measuring cognitive emotion regulation strategies in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive emotion regulation questionnaire: Psychometric properties of the Tunisian version. Ouerchefani, R., Ouerchefani, N., Ben Rejeb, MR., et al.[2021]

The group intervention 'Managing Emotions: Emotions under control' effectively teaches emotion regulation strategies, showing large effect sizes in increasing reappraisal and acceptance while reducing rumination among 18 participants.

Participants with higher levels of mental strain experienced a significant reduction in overall psychopathology, with an effect size of 0.63, indicating the intervention's potential benefits for those struggling with severe emotional challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Managing emotions--emotions under control]. Barnow, S., Löw, CA., Dodek, A., et al.[2014]

In a randomized controlled trial involving 81 informal caregivers, Emotion Regulation Therapy adapted for caregivers (ERT-C) significantly reduced psychological distress, worry, and caregiver burden, with medium to large effect sizes, particularly post-treatment.

Caregivers who participated in ERT-C also reported a large increase in quality of life for themselves and the cancer patients they cared for, highlighting the therapy's potential benefits in comprehensive cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of Emotion Regulation Therapy for Psychologically Distressed Caregivers of Cancer Patients. O'Toole, MS., Mennin, DS., Applebaum, A., et al.[2022]

Distancing is an effective emotion regulation strategy that can change how we perceive and react to emotional stimuli, making it a valuable tool for clinical applications.

The proposed neurocognitive model identifies three key processes involved in distancing—self-projection, affective self-reflection, and cognitive control—supported by a meta-analysis of neuroimaging studies, which helps clarify the brain mechanisms behind this technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulating emotion through distancing: A taxonomy, neurocognitive model, and supporting meta-analysis. Powers, JP., LaBar, KS.[2021]

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