270 Participants Needed

Smartphone-Based Cognitive Emotion Regulation Training for Caregiver Stress

BD
Overseen ByBryan Denny, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Bryan Denny
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.12567

Who Is on the Research Team?

BD

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)
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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.
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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?
3Treatment groups
Experimental Treatment
Active Control
Group I: DistancingExperimental Treatment1 Intervention
Group II: ReinterpretationActive Control1 Intervention
Group III: No regulation "Look Only"Active Control1 Intervention

Find a Clinic Near You

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

Citations

Smartphone-Based Cognitive Emotion Regulation Training ...Participants who practiced psychological distancing not only reported lower negative affect during the tasks but also experienced less perceived stress in their ...
The effect of the emotion regulation training on ...The mean scores of the resilience increased in the control and intervention groups at the end of the study. A significant difference was found ...
Randomized controlled trial of a positive emotion ...These findings suggest that a positive emotion regulation intervention could successfully decrease the impact of caregiving stress on the ...
(PDF) The Effect of Emotion Regulation Training on Stress, ...The results showed that stress, anxiety and depression scores significantly reduced in the intervention group compared to the control group.
A randomized controlled trial of emotion regulation therapy ...This trial compares CBT vs. ERT, both adapted for cancer caregivers. Analyses will examine efficacy for caregivers and effects on patients' QOL.
Coping with Emotional Distress via Self-Disclosure to RobotsThis study introduces a novel long-term intervention designed to help informal caregivers cope with emotional distress by self-disclosing towards a social ...
Randomized controlled trial of a positive emotion regulation ...These findings suggest that a positive emotion regulation intervention could successfully decrease the impact of caregiving stress on the ...
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