Smartphone-Based Cognitive Emotion Regulation Training for Caregiver Stress
Recruiting in Palo Alto (17 mi)
Overseen byBryan Denny, Ph.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Bryan Denny
Disqualifiers: Psychotherapy, Visual impairment, Cognitive impairment, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
23678How 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.
3691011Eligibility 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)
+5 more
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.
+3 more
Trial 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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Active Control
Group I: DistancingExperimental Treatment1 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: ReinterpretationActive Control1 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 Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Rice UniversityHouston, TX
Loading ...
Who Is Running the Clinical Trial?
Bryan DennyLead Sponsor
National Institute on Aging (NIA)Collaborator
References
Emotion regulation therapy for cancer caregivers-an open trial of a mechanism-targeted approach to addressing caregiver distress. [2021]Informal caregivers (ICs) are integral to care provided to patients facing life-threatening or incurable illnesses. This responsibility causes considerable burden, as approximately one half of ICs report clinically significant symptoms of depression and/or anxiety that persist when left untreated. Psychosocial interventions containing efficacious treatment principles (e.g., cognitive behavior therapy [CBT]) show disappointing results in reducing anxiety and depression in ICs. This may reflect failure of these interventions to specifically target crucial mechanisms underlying the central feature of distress caused by the patient's illness-notably, perseverative negative thinking (PNT). Emotion Regulation Therapy (ERT) is an efficacious CBT developed to explicitly target mechanisms underlying PNT and the emotional concomitants that arise in response to stressful situations. This open trial was conducted to evaluate the acceptability and initial efficacy of ERT adapted to the experience of cancer ICs (ERT-C). Thirty-one ICs provided informed consent and completed eight weekly individual sessions of ERT-C. Participants completed self-report measures of depression and anxiety symptoms, PNT, emotion regulation deficits, and caregiver burden before and after treatment. ERT-C was well tolerated as indicated by 22 treatment completers and feedback provided in exit interviews. ICs demonstrated reduced depression and anxiety symptoms, PNT, and emotion regulation deficits with moderate to large effect sizes (Hedge's g range: 0.36-0.92). Notably, caregiver burden was not reduced but ICs expressed more ability to confront caregiving-related challenges. Findings offer promising but preliminary support for ERT-C as a conceptual model and treatment modality for distressed cancer ICs.
Behavioral effects of longitudinal training in cognitive reappraisal. [2021]Although recent emotion regulation research has identified effective regulatory strategies that participants can employ during single experimental sessions, a critical but unresolved question is whether one can increase the efficacy with which one can deploy these strategies through repeated practice. To address this issue, we focused on one strategy, reappraisal, which involves cognitively reframing affective events in ways that modulate one's emotional response to them. With a commonly used reappraisal task, we assessed the behavioral correlates of four laboratory sessions of guided practice in down-regulating responses to aversive photos. Two groups received practice in one of two types of reappraisal tactics: psychological distancing and reinterpretation. A third no-regulation control group viewed images in each session without instructions to regulate. Three key findings were observed. First, both distancing and reinterpretation training resulted in reductions over time in self-reported negative affect. Second, distancing participants also showed a reduction over time in negative affect on baseline trials in which they responded naturally. Only distancing group participants showed such a reduction over and above the reduction observed in the no-regulation control group, indicating that it was not attributable to habituation. Third, only participants who distanced reported less perceived stress in their daily lives. The present results provide the first evidence for the longitudinal trainability of reappraisal in healthy adults using short courses of reappraisal practice, particularly using psychological distancing.
Cognitive Emotion Regulation Questionnaire-Short: Reliability, Validity, and Measurement Invariance of the Italian Version. [2022]The Cognitive Emotion Regulation Questionnaire (CERQ) is a widely used instrument to assess cognitive emotion regulation strategies. The study aimed to test the psychometric properties of the Italian short version of the CERQ (CERQ-IS).
A randomized controlled trial of emotion regulation therapy for cancer caregivers: A mechanism-targeted approach to addressing caregiver distress. [2023]Caregivers of patients with cancer play a crucial role in the health of the person they care for, and in the healthcare system at large. Family caregivers receive minimal support, despite being at greater risk for anxiety and depression than patients themselves. Cognitive behavioral therapy (CBT), an effective therapy for anxiety and depression, has shown mixed efficacy when delivered to cancer caregivers. Emotion Regulation Therapy (ERT), a contemporary CBT, may uniquely target processes underlying distress associated with caregiving. Therefore, we adapted both CBT and ERT to target the needs of caregivers (i.e., CBT-C and ERT-C) and are conducting a multi-site randomized trial to examine the comparative efficacy of these interventions.
A Randomized Controlled Trial of Emotion Regulation Therapy for Psychologically Distressed Caregivers of Cancer Patients. [2022]Previous cognitive behavioral therapies for informal caregivers (ICs) have produced negligible effects. The purpose of this study was to evaluate, in a randomized controlled trial, the efficacy of Emotion Regulation Therapy adapted for caregivers (ERT-C) on psychological and inflammatory outcomes in psychologically distressed ICs and the cancer patients cared for.
Psychometric properties of the Brazilian version of the Cognitive Emotion Regulation Questionnaire. [2022]The Cognitive Emotion Regulation Questionnaire (CERQ) was developed to measure nine cognitive strategies referring to what someone thinks after the experience of threatening or stressful events. The main purpose of this study was to evaluate the validity of the Brazilian version of the CERQ.
Psychometric Analysis of Two Brief Versions of the CERQ in the Argentinean Population: CERQ-18 and CERQ-27. [2023]Emotion Regulation (ER) involves any explicit or implicit process that may alter the emotion felt, its duration and expression, and is a transdiagnostic factor of vulnerability involved in the etiology and maintenance of different emotional disorders. The Cognitive Emotion Regulation Questionnaire (CERQ) assesses nine cognitive strategies involved in ER and is a valuable tool. Its popularity and wide use led to the development of two abbreviated versions: a version with 18 items (two items per factor) and a 27-item version (three items per factor).
[Managing emotions--emotions under control]. [2014]Emotion regulation processes are of central importance to mental and physical health. Based on this relationship we developed the group intervention "Managing Emotions: Emotions under control" (German: "Gefühle im Griff"), which systematically teaches participants specific emotion regulation strategies. Structure and content of the intervention program as well as preliminary results of efficacy are presented (n=18). Using the H-FERST, large effect sizes resulted for the increase of reappraisal and acceptance and for the reduction of rumination, a medium effect size could be shown for the reduction of avoidance, and a small effect size resulted for the increase of activity and social support. Overall psychopathology by means of the BSI was reduced with an effect size of d=0.63 in participants with more severe mental strain (GSI ≥ 0.6).
Regulating emotion through distancing: A taxonomy, neurocognitive model, and supporting meta-analysis. [2021]Distancing is a type of emotion regulation that involves simulating a new perspective to alter the psychological distance and emotional impact of a stimulus. The effectiveness and versatility of distancing relative to other types of emotion regulation make it a promising tool for clinical applications. However, the neurocognitive mechanisms of this tactic are unclear, and inconsistencies in terminology and methods across studies make it difficult to synthesize the literature. To promote more effective research, we propose a taxonomy of distancing within the broader context of emotion regulation strategies; review the effects of this tactic; and offer a preliminary neurocognitive model describing key cognitive processes and their neural bases. Our model emphasizes three components-self-projection, affective self-reflection, and cognitive control. Additionally, we present results from a supporting meta-analysis of neuroimaging studies of distancing. These efforts are presented within the overarching goals of supporting effective applications of distancing in laboratory, clinical, and other real-world contexts, and advancing understanding of the relevant high-level cognitive functions in the brain.
From Surviving to Thriving in the Face of Threats: The Emerging Science of Emotion Regulation Training. [2023]A key survival skill is the ability to regulate your emotions so as to respond adaptively to life's challenges. As such, it is essential to understand how we can improve this ability through training. While this is still a new area of research, to date, behavioral and brain studies have taken one of two approaches: either training individuals to implement strategies that directly impact current emotional responses, or training a cognitive control ability (like working memory, selective attention, response inhibition) to strengthen or tune control processes that can support regulation to subsequently encountered events. Behavioral data highlight the importance of tailoring training to an individual and their emotional situation. Brain data suggest that training impacts domain general cognitive control systems and their interaction with subcortical regions (mainly the amygdala). Future progress will depend on systematic examination of the mechanisms involved in training effectiveness and the populations that may benefit from training.
Cognitive emotion regulation questionnaire: Psychometric properties of the Tunisian version. [2021]This study investigated the psychometric properties of the Cognitive Emotion Regulation Questionnaire in a Tunisian Arabic-Speaking population.