Therapy for Caregiver Depression
(CARES Trial)
Recruiting in Palo Alto (17 mi)
SF
Overseen byStephen F Smagula, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Pittsburgh
Disqualifiers: Dementia, Deadly illness, Substance use, others
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it mentions that participants should have no or stable medication for depression. This suggests that if you are on depression medication, it should be stable and not recently changed.
What data supports the effectiveness of the treatment for caregiver depression?
Research shows that chronotherapy, which includes adjusting sleep schedules and exposure to light, can help reduce depressive symptoms. Studies have found that these methods are effective in treating depression, especially when combined with other therapies, and can improve recovery and reduce hospital stays.12345
Is the therapy for caregiver depression safe for humans?
How does this treatment for caregiver depression differ from other treatments?
This treatment is unique because it involves chronotherapy, which uses strategies like controlling light exposure and adjusting sleep patterns to influence the body's biological clock. Unlike traditional treatments that may focus on medication, this approach targets the timing of environmental cues to improve mood and reduce depressive symptoms.12389
Research Team
SF
Stephen F Smagula, PhD
Principal Investigator
University of Pittsburgh
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.
Provide unpaid care to a co-residing patient with a dementia diagnosis
See 2 more
Exclusion Criteria
Deadly illness or plans to leave the study area
Probable dementia diagnosis
Current active substance use disorder
See 2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants engage in the SAMM protocol or a supportive control condition to increase morning activity engagement over a 6-week period
6 weeks
Weekly follow-ups
Follow-up
Participants are monitored for changes in depression, anxiety, and other health measures
6 months
Treatment Details
Interventions
- Activity Strategy-based Session with Therapist (Behavioural Intervention)
- Advance sleep-wake time (Behavioural Intervention)
- Attention-based Session with Therapist (Behavioural Intervention)
- Morning Action Plan Execution (Behavioural Intervention)
Trial OverviewThe 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.
Participant Groups
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 Pittsburgh
Lead Sponsor
Trials
1820
Patients Recruited
16,360,000+
National Institute of Mental Health (NIMH)
Collaborator
Trials
3007
Patients Recruited
2,852,000+
Findings from Research
Chronotherapy, which includes strategies like light therapy and sleep deprivation, has been shown to effectively reduce depressive symptoms and improve recovery in patients with depression and bipolar disorder.
Recent research indicates that combining chronotherapeutic interventions with pharmacological treatments can enhance efficacy, leading to shorter hospital stays and fewer changes in medication prescriptions.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
The effect of chronotherapy on depressive symptoms. Evidence-based practice.Khalifeh, AH.[2018]
A modified triple chronotherapy protocol involving partial sleep deprivation and light therapy significantly reduced depression levels in 35 hospitalized patients with moderately severe non-seasonal depressive disorder over a 6-day treatment period.
While both white and orange light treatments were effective, white light showed some advantages in improving mood and energy during sessions, indicating that light spectrum and intensity may influence treatment outcomes.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
A 6-day combined wake and light therapy trial for unipolar depression.Danilenko, KV., Lebedinskaia, MY., Gadetskaia, EV., et al.[2020]
The circadian reinforcement therapy (CRT) significantly reduced depression levels and improved sleep quality in patients after discharge from inpatient care, compared to treatment-as-usual (TAU), with a notable reduction in Hamilton Depression Rating Scale scores (P=.04).
Participants in the CRT group experienced better evening mood, improved sleep quality, earlier sleep onset, and longer sleep duration, along with lower day-to-day variability in mood and sleep parameters, indicating a more stable circadian rhythm.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Circadian Reinforcement Therapy in Combination With Electronic Self-Monitoring to Facilitate a Safe Postdischarge Period for Patients With Major Depression: Randomized Controlled Trial.Aggestrup, AS., Svendsen, SD., Præstegaard, A., et al.[2023]
Chronotherapeutics, which involves manipulating sleep-wake cycles and light exposure, has shown promising antidepressant effects, particularly in challenging cases like bipolar depression, where traditional antidepressants often fail.
Recent research has clarified the mechanisms behind chronotherapeutics, linking its efficacy to changes in neurotransmitter systems and the biological clock, suggesting it can be effectively integrated into standard psychiatric treatment.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Antidepressant chronotherapeutics for bipolar depression.Benedetti, F.[2023]
In a study of 194 bipolar depressed patients, over 60% responded positively to a treatment combining total sleep deprivation and light therapy (TSD + LT), indicating its potential efficacy for depression.
The study found that chronotype, or whether a person is a 'morning' or 'evening' type, significantly influenced treatment response, with evening-type patients showing higher rates of improvement.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Chronotype influences response to antidepressant chronotherapeutics in bipolar patients.Dallaspezia, S., Suzuki, M., Clara, L., et al.[2019]
In a study involving five patients with endogenous depression, a phase-advance procedure that shifted their daily schedules by 5 hours led to improvements in their depressive symptoms over a 2-week period following one night of partial sleep deprivation.
All patients showed improvement after partial sleep deprivation, and four out of five maintained remission during the phase-advance process, suggesting that adjusting circadian rhythms may have therapeutic benefits for depression.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Antidepressant effects of the sleep/wake cycle phase advance. Preliminary report.Souêtre, E., Salvati, E., Pringuey, D., et al.[2019]
The immune system plays a significant role in the development of depression and its associated sleep disturbances, suggesting that immune responses may disrupt both neurobiological and chronobiological processes.
Antidepressants and chronotherapeutic treatments may improve circadian rhythms and sleep patterns by modulating immune responses, indicating a potential bi-directional relationship between the immune system and circadian biology in depression.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Neuroimmunomodulation in unipolar depression: a focus on chronobiology and chronotherapeutics.Eyre, H., Baune, BT.[2021]
The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) significantly improved depression response rates (35.0% vs. 8.8% for treatment as usual) in adults with serious mental illness, indicating its efficacy as a nonpharmacologic treatment.
Improvements in insomnia symptoms were strongly correlated with reductions in depression symptoms, particularly in younger adults, suggesting that enhancing sleep quality may be a key mechanism for TranS-C's effectiveness.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
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.Smagula, SF., Gasperetti, CE., Buysse, DJ., et al.[2023]
A pilot study involving 20 participants demonstrated that adherence to a light-exposure schedule significantly reduced the severity of jet lag symptoms, suggesting that automated online treatments can be effective.
The study highlights the potential of Internet-based interventions for managing conditions like jet lag, although it also raises concerns about the lack of professional supervision in such automated treatments.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
An automated treatment for jet lag delivered through the internet.Lieberman, DZ.[2018]
References
The effect of chronotherapy on depressive symptoms. Evidence-based practice. [2018]
A 6-day combined wake and light therapy trial for unipolar depression. [2020]
Circadian Reinforcement Therapy in Combination With Electronic Self-Monitoring to Facilitate a Safe Postdischarge Period for Patients With Major Depression: Randomized Controlled Trial. [2023]
Antidepressant chronotherapeutics for bipolar depression. [2023]
Chronotype influences response to antidepressant chronotherapeutics in bipolar patients. [2019]
Antidepressant effects of the sleep/wake cycle phase advance. Preliminary report. [2019]
Neuroimmunomodulation in unipolar depression: a focus on chronobiology and chronotherapeutics. [2021]
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]
An automated treatment for jet lag delivered through the internet. [2018]