Therapy for Caregiver Depression (CARES Trial)
Palo Alto (17 mi)Overseen byStephen F Smagula, PhD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: University of Pittsburgh
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests a program called SAMM, which helps caregivers of dementia patients plan and track morning activities. The goal is to reduce depression by getting them more active in the morning. Increased morning activity is expected to lower negative thinking and improve brain function related to mood.
What safety data exists for the treatment of caregiver depression using chronotherapy?The research indicates that chronotherapy, which includes strategies like sleep deprivation, light therapy, and sleep phase advance, has been studied for its efficacy and feasibility in treating depression. Studies have shown that these interventions can reduce hospitalization duration, improve recovery, and reduce changes in drug prescriptions. The antidepressant effects of phase-advance processes and circadian reinforcement therapy have been observed, suggesting potential benefits in managing depressive symptoms. However, specific safety data for caregiver depression is not detailed in the provided research, and further studies may be needed to fully understand the safety profile of these treatments in this specific context.13578
What data supports the idea that Therapy for Caregiver Depression is an effective treatment?The available research shows that Therapy for Caregiver Depression, which includes strategies like adjusting sleep schedules and exposure to light, is effective in reducing symptoms of depression. Studies have shown that these methods can shorten hospital stays and improve recovery. In particular, more than 60% of patients with bipolar depression responded positively to treatments involving sleep and light adjustments. This suggests that Therapy for Caregiver Depression can be a powerful tool, especially when traditional antidepressant drugs are less effective.45678
Is the treatment in the trial 'Therapy for Caregiver Depression' a promising treatment?Yes, the treatment is promising because it involves chronotherapy, which has been shown to help reduce depressive symptoms, shorten hospital stays, and improve recovery by using strategies like light therapy and sleep adjustments.25789
Do I have to stop taking my current medications for the trial?The trial requires that you have no or stable pharmacotherapy for depression, so you may need to stop or stabilize your current depression medications. The protocol does not specify about other medications.
Eligibility Criteria
This study is for individuals aged 60 or older who are unpaid caregivers to someone with dementia, feeling stressed, and have trouble getting going in the morning. They shouldn't be currently receiving cognitive therapy, have a substance use disorder, probable dementia themselves, or any condition that prevents MRI scans.Inclusion Criteria
My depression medication has not changed recently.
I am 60 years old or older.
Exclusion Criteria
I am currently undergoing Cognitive Behavioral Therapy for mood or sleep issues.
I cannot have an MRI due to safety or health reasons.
Treatment Details
The trial tests whether certain interventions like adjusting sleep-wake times and morning routines can help reduce depression symptoms and improve brain function related to mood in caregivers experiencing stress.
2Treatment groups
Experimental Treatment
Active Control
Group I: Active condition (SAMM Protocol)Experimental Treatment3 Interventions
The goal of the SAMM protocol is to increase morning activity engagement over a 6-week period. Participants in this condition will review their morning routine, and make a list of potential morning activities to add. They will choose one activity and develop a plan for doing it. Each day, participants are asked to track if they do the morning activity plan. If unsuccessful, at weekly follow-ups, participants are asked to refine their plan or make a new one.
Group II: Attention-matched supportive control conditionActive Control1 Intervention
Participants in this condition will receive sessions in the same number and duration as the SAMM experimental condition. Therapists will create a comfortable environment by demonstrating interest, empathy, and acceptance without judgment. Caregivers will be encouraged to talk about stressors they experience, providing an opportunity to voice and self-address their problems. In this control condition, therapists will not deliver any particular strategy except for active listening and referring to the educational materials.
Find a clinic near you
Research locations nearbySelect from list below to view details:
UPMC Western Behavioral HealthPittsburgh, PA
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Who is running the clinical trial?
University of PittsburghLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
Antidepressant effects of the sleep/wake cycle phase advance. Preliminary report. [2019]Five patients with endogenous depression were asked to participate in a phase-advance procedure consisting in advancing by 5 h the time schedule of the major external synchronizers such as light/dark, sleep/wake, meal time and social activity cycles. Clinical and biological parameters were observed throughout this 2-week process which followed one night of partial sleep deprivation. All patients improved with partial sleep deprivation and four of the five showed continuing remission during the phase-advance process. The antidepressant effects of the phase-advance process are discussed in light of different chronobiological models for depression.
An automated treatment for jet lag delivered through the internet. [2018]Seventy percent of persons who suffer from psychiatric illness do not receive treatment. Cost-effective, automated treatment can be delivered through the Internet but can be complicated by the lack of professional supervision. This open study piloted a fully automated, publicly available treatment for jet lag as a means of highlighting some of the issues involved in delivering treatment over the Internet. Twenty study participants rated the severity of their jet lag symptoms and their adherence to a light-exposure schedule calculated to accelerate adaptation to a new time zone. A significant negative correlation was observed between how closely participants followed the light-exposure schedules and the severity of their jet lag symptoms.
Neuroimmunomodulation in unipolar depression: a focus on chronobiology and chronotherapeutics. [2021]The rising burden of unipolar depression along with its often related sleep disturbances, as well as increasing rates of sleep restriction in modern society, make the search for an extended understanding of the aetiology and pathophysiology of depression necessary. Accumulating evidence suggests an important role for the immune system in mediating disrupted neurobiological and chronobiological processes in depression. This review aims to provide an overview of the neuroimmunomodulatory processes involved with depression and antidepressant treatments with a special focus on chronobiology, chronotherapeutics and the emerging field of immune-circadian bi-directional crosstalk. Increasing evidence suggests that chronobiological disruption can mediate immune changes in depression, and likewise, immune processes can mediate chronobiological disruption. This may suggest a bi-directional relationship in immune-circadian crosstalk. Furthermore, given the immunomodulatory effects of antidepressants and chronotherapeutics, as well as their associated beneficial effects on circadian disturbance, we--and others--suggest that these therapeutic agents may exert their chronobiotic effects partially via the neuroimmune system. Further research is required to better elucidate the mechanisms of immune involvement in the chronobiology of depression.
Antidepressant chronotherapeutics for bipolar depression. [2023]Chronotherapeutics refers to treatments based on the principles of circadian rhythm organization and sleep physiology, which control the exposure to environmental stimuli that act on biological rhythms, in order to achieve therapeutic effects in the treatment of psychiatric conditions. It includes manipulations of the sleep-wake cycle such as sleep deprivation and sleep phase advance, and controlled exposure to light and dark. The antidepressant effects of chronotherapeutics are evident in difficult-to-treat conditions such as bipolar depression, which has been associated with extremely low success rates of antidepressant drugs in naturalistic settings and with stable antidepressant response to chronotherapeutics in more than half of the patients. Recent advances in the study of the effects of chronotherapeutics on neurotransmitter systems, and on the biological clock machinery, allow us to pinpoint its mechanism of action and to transform it from a neglected or "orphan" treatment to a powerful clinical instrument in everyday psychiatric practice.
The effect of chronotherapy on depressive symptoms. Evidence-based practice. [2018]The global prevalence of depression is increasing, along with rates of depression-associated disability and mortality, rendering depressive disorders a major public health issue. Chronotherapy involves a variety of strategies that control exposure to environmental stimuli that influence the biological clock, such as sleep deprivation (SD) or wake therapy (WT), sleep phase advance (SPA), and light and dark therapy (LT, DT). The purpose of this Evidence-Based Practice (EBP) paper is to answer PICOT questions by a review the effectiveness of chronotherapeutics interventions on depressive symptoms with depression and the depressive episode in the course of bipolar disorder. Early studies suggested the effectiveness of LT, SD, and SPA, more recent research has revealed differences in the efficacy of single and combined interventions involving both chronotherapeutic and pharmacological components. This therapy reduced dura-tion of hospitalization, improvement recovery, and reduced for changes in drug prescriptions.
Chronotype influences response to antidepressant chronotherapeutics in bipolar patients. [2019]Patient diurnal mood fluctuation, sleep characteristics and factors affecting sleep homeostasis predict antidepressant response to the combination of total sleep deprivation and light therapy (TSD + LT). In order to study if chronotype could influence response to TSD+LT, we considered 194 bipolar depressed patients. Severity of depression was rated with Hamilton Depression Rating Scale; perceived mood levels were assessed by a self-administered 10-cm visual analogue scale and chronotype was assessed using the Mornigness-Eveningness Questionnaire. More than 60% of patients resulted responders to treatment with chronotype influencing the antidepressant response with evening type subjects showing higher response rates.
A 6-day combined wake and light therapy trial for unipolar depression. [2020]There are a dozen studies on double or triple chronotherapy in depression (sleep deprivation [wake therapy] + light therapy + sleep advance/stabilization). We investigated efficacy and feasibility of a modified triple chronotherapy protocol.
Circadian Reinforcement Therapy in Combination With Electronic Self-Monitoring to Facilitate a Safe Postdischarge Period for Patients With Major Depression: Randomized Controlled Trial. [2023]Patients with major depression exhibit circadian disturbance of sleep and mood, and when they are discharged from inpatient wards, this disturbance poses a risk of relapse. We developed a circadian reinforcement therapy (CRT) intervention to facilitate the transition from the inpatient ward to the home for these patients. CRT focuses on increasing the zeitgeber strength for the circadian clock through social contact, physical activity, diet, daylight exposure, and sleep timing.
Efficacy of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction for Depression Symptoms and Sleep-Wake Disruption in Older and Younger Adults: Secondary Age-Stratified Analysis of a Randomized Controlled Trial. [2023]Perform a secondary analysis examining the efficacy of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for depression symptom responses, and explore changes in potential target mechanisms.