Therapy for Caregiver Depression

(CARES Trial)

Overseen By Sara Albert

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Dementia, Deadly illness, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

120 Participants Needed

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. ^{1 2 3 4 5}

Is the therapy for caregiver depression safe for humans?

The therapy, which involves adjusting sleep and light exposure, has been studied for depression and generally appears safe. It focuses on changing sleep patterns and exposure to light, which are natural and non-invasive methods. ^{1 2 3 6 7}

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. ^{1 2 3 8 9}

Research Team

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

Exclusion Criteria

Deadly illness or plans to leave the study area

Probable dementia diagnosis

Current active substance use disorder

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
• Advance sleep-wake time
• Attention-based Session with Therapist
• Morning Action Plan Execution

Trial Overview 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.

Participant Groups

Group I: Active condition (SAMM Protocol) Experimental Treatment 3 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 condition Active Control 1 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.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

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

1. Saudi Arabia pubmed.ncbi.nlm.nih.gov

The effect of chronotherapy on depressive symptoms. Evidence-based practice. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

A 6-day combined wake and light therapy trial for unipolar depression. [2020]

3. Canada 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. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Antidepressant chronotherapeutics for bipolar depression. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Chronotype influences response to antidepressant chronotherapeutics in bipolar patients. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Antidepressant effects of the sleep/wake cycle phase advance. Preliminary report. [2019]

7. Austria pubmed.ncbi.nlm.nih.gov

Neuroimmunomodulation in unipolar depression: a focus on chronobiology and chronotherapeutics. [2021]

8. England 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

An automated treatment for jet lag delivered through the internet. [2018]