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

Trial Summary

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 data supports the effectiveness of the treatment Cognitive Emotion Regulation Training for caregiver stress?

Research shows that Emotion Regulation Therapy (ERT), which includes strategies like cognitive reappraisal and psychological distancing, can reduce symptoms of depression and anxiety in caregivers. Studies found that these strategies help caregivers manage stress better by changing how they think about stressful situations, leading to less negative emotions and perceived stress. ^{1 2 3 4 5}

Is smartphone-based cognitive emotion regulation training safe for humans?

Research on cognitive emotion regulation training, including methods like psychological distancing and reinterpretation, shows that these strategies can be practiced safely in healthy adults. Participants in studies reported reduced negative emotions and stress over time, indicating that the training is generally safe. ^{2 3 6 7 8}

How is the treatment Cognitive Emotion Regulation Training for Caregiver Stress different from other treatments?

This treatment is unique because it uses smartphone-based training to help caregivers manage stress by teaching them cognitive strategies like psychological distancing and reinterpretation, which involve changing how they think about stressful situations to reduce emotional impact. Unlike traditional therapies, this approach leverages technology for accessibility and focuses on cognitive techniques to alter emotional responses. ^{3 6 9 10 11}

What is the purpose of this trial?

This trial tests a smartphone app designed to help unpaid caregivers of Alzheimer's patients manage their emotions better. The app teaches techniques to view stressful situations more objectively and imagine better outcomes, aiming to reduce stress and improve overall well-being.

Research Team

Bryan Denny, Ph.D.

Principal Investigator

William Marsh Rice University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Emotion regulation therapy for cancer caregivers-an open trial of a mechanism-targeted approach to addressing caregiver distress. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Behavioral effects of longitudinal training in cognitive reappraisal. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Cognitive Emotion Regulation Questionnaire-Short: Reliability, Validity, and Measurement Invariance of the Italian Version. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of emotion regulation therapy for cancer caregivers: A mechanism-targeted approach to addressing caregiver distress. [2023]

5. England pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of Emotion Regulation Therapy for Psychologically Distressed Caregivers of Cancer Patients. [2022]

6. Brazil pubmed.ncbi.nlm.nih.gov

Psychometric properties of the Brazilian version of the Cognitive Emotion Regulation Questionnaire. [2022]

7. Russia (Federation) pubmed.ncbi.nlm.nih.gov

Psychometric Analysis of Two Brief Versions of the CERQ in the Argentinean Population: CERQ-18 and CERQ-27. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

[Managing emotions--emotions under control]. [2014]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. Netherlands pubmed.ncbi.nlm.nih.gov

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

11. France pubmed.ncbi.nlm.nih.gov

Cognitive emotion regulation questionnaire: Psychometric properties of the Tunisian version. [2021]