Emotion regulation skills training enhances the efficacy of inpatient cognitive behavioral therapy for major depressive disorder: a randomized controlled trial.
Matthias Berking, David Ebert, Pim Cuijpers...
https://pubmed.ncbi.nlm.nih.gov/23712210/Actively Recruiting
Led by Bryan Denny · Updated on 2026-05-29
270
Participants Needed
1
Research Sites
4 weeks
Total Duration
Researchers are studying unpaid primary caregivers of persons with Alzheimers Disease and related dementias ADADRD to test a new, smartphone-based cognitive emotion regulation training. The aim is to improve psychological outcomes like reducing stress, caregiver burden, and depressive symptoms, and to explore potential benefits for the care recipients quality of life. This Phase I, Stage I clinical trial evaluates two emotion regulation strategies psychological distancing and reinterpretation, compared to a control group with no regulation training. Participants will be randomly assigned to one of three groups distancing training, reinterpretation training, or a no regulation control group. Each participant receives a brief, one-week intervention delivered via smartphone with structured training sessions conducted by experimenters over videoconference. The interventions focus on teaching caregivers how to change their emotional responses using either distancing viewing emotional events objectively or reinterpretation imagining better outcomes. Follow-up assessments occur at 2 weeks, 4 weeks, and 3 months after the initial training. During the study, caregivers will complete self-reported assessments of positive and negative emotions, perceived stress, caregiver burden, depressive symptoms, and quality of life. Heart rate variability HRV data is collected remotely using a pre-mailed chest strap device. Researchers will also gather daily ecological momentary assessments through smartphone prompts to track emotional states and stress levels. The study lasts several months with multiple evaluations to understand how the training affects psychological and physiological health in caregivers and care recipients.
CONDITIONS
Smartphone-based Cognitive Emotion Regulation Training for Unpaid Primary Caregivers of Persons With Alzheimer's Disease
B
Bryan Denny, Ph.D.
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Bryan Denny
Lead Sponsor
National Institute on Aging (NIA)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Smartphone-based emotion regulation training (psychological distancing) | Smartphone-based emotion regulation training (reinterpretation) | Technology-based supportive interventions (external context) |
|---|---|---|---|
| What it is | A smartphone-based cognitive emotion regulation intervention where caregivers are trained to use psychological distancing techniques, aiming to help them view negative emotional situations more objectively. | A smartphone-based cognitive emotion regulation intervention where caregivers are trained to reinterpret emotional situations by imagining more positive outcomes. | Current-care digital programs for dementia caregivers range from online education, coping-skills training, and support forums to web-based psychoeducation and technology-driven interventions provided outside the context of this specific trial. |
| Role in study | Randomized intervention arm. | Randomized intervention arm. | Not a randomized arm in this study; represents current digital supportive care options available to dementia caregivers in the community. |
| Primary use | Help caregivers reduce negative emotions and stress by practicing psychological distancing during challenging experiences. | Help caregivers manage stress and difficult emotions by actively reinterpreting situations in a more positive light. | Reduce stress, depressive symptoms, and burden while improving coping and well-being among dementia caregivers using online education, psychosocial support, and skills programs. |
| How it is given or performed | Delivered via interactive smartphone-based app. Participants are guided to reappraise emotional stimuli by practising objective, observer-based techniques in daily life over a specified course. | Delivered via smartphone-based app. Caregivers are encouraged to reinterpret emotional challenges by imagining better or positive outcomes. | Varies: may include access to structured web-based programs, asynchronous educational modules, interactive online support groups, or phone/video-based skills training delivered through commercial or academic platforms. |
| Evidence status | Effectiveness for reducing stress, negative emotion, or caregiver burden in this population is being actively studied; no trial results are posted as of now. | Effectiveness for reducing emotional distress or improving caregiver quality of life is under investigation; no results available yet. | Published reviews consistently report small to moderate improvements in caregiver stress, depressive symptoms, and coping, though effect sizes and durability may be modest. Evidence is stronger for psychoeducation and multi-component programs. |
| Important limitations | Long-term effectiveness and adoption outside a research setting are not yet established. Caregivers need smartphone access and English literacy. The effects in caregivers with major psychiatric or cognitive disorders are unknown. | No published long-term outcome data in this population. Participants must have smartphone access and cannot have significant sensory or cognitive impairments. No evidence yet regarding use in caregivers actively receiving cognitive reappraisal therapy. | Many digital programs show modest or short-term benefits. Engagement varies and some users experience technology access barriers or prefer in-person support. Not all interventions are tailored for the specific emotional regulation needs targeted by this trial. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (remote or in-person) to assess eligibility and consent
Duration - 1 day
Participants receive a brief, approximately 10-minute structured cognitive emotion regulation training via videoconference, learning either psychological distancing, reinterpretation, or no regulation control strategies.
1 training visit via videoconference
Duration - 7 days
Participants engage in 7 days of daily smartphone-based cognitive emotion regulation training with ongoing ecological momentary assessments of positive and negative affect and daily stress. Physiological data such as heart rate variability are collected remotely.
Daily smartphone-based training and assessments for 7 days
Duration - 3 months
Participants complete follow-up assessments of psychological and physiological outcomes at 2 weeks, 4 weeks, and 3 months after training to evaluate intervention effects and mechanisms.
4 follow-up visits (remote or in-person) at Day 7, Day 14, Day 28, and Month 3
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
Have more questions? Get in touch with our team for quick support
Matthias Berking, David Ebert, Pim Cuijpers...
https://pubmed.ncbi.nlm.nih.gov/23712210/L M M Boots, M E de Vugt, R J M van Knippenberg...
https://pubmed.ncbi.nlm.nih.gov/23963684/Kyler M Godwin, Whitney L Mills, Jane A Anderson...
https://pubmed.ncbi.nlm.nih.gov/23528881/Richard Schulz
https://pubmed.ncbi.nlm.nih.gov/31031074/Bryan T Denny, Kevin N Ochsner
https://pubmed.ncbi.nlm.nih.gov/24364856/Bryan T Denny
https://pubmed.ncbi.nlm.nih.gov/31961188/Matthias Berking, Peggilee Wupperman, Alexander Reichardt...
https://pubmed.ncbi.nlm.nih.gov/18835479/Paul Brewster, Lisa Barnes, Mary Haan...
https://pubmed.ncbi.nlm.nih.gov/30240574/Bryan Denny
Lead Sponsor
National Institute on Aging (NIA)
Collaborating Sponsor