Therapy for Caregiver Depression

(CARES Trial)

Overseen By Sara Sellars, MA

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to assist caregivers experiencing depression or stress. Participants will either follow a morning activity plan or attend supportive sessions to discuss their stress. The goal is to determine which method better improves mood, morning energy, and brain connections related to depression. Caregivers who provide at least 15 hours of weekly care for someone with dementia and struggle with morning routines may be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative support methods for caregivers.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the treatments in the "Therapy for Caregiver Depression" trial have been safe and promising in past studies.

For the Activity Strategy-based Session with a Therapist, research found that engaging in more positive activities generally improves well-being and is well-received. Participants found these activities helpful in reducing stress and depression.

Regarding the Advance Sleep-Wake Time strategy, previous studies on changing sleep schedules have been conducted safely, especially with guidance on light exposure and melatonin use. These changes are common in managing sleep issues and are considered safe.

The Attention-based Session with a Therapist employs safe methods, focusing on active listening and support, which have effectively reduced depression symptoms. Providing a safe and understanding space for caregivers to share their experiences is a key part of this approach.

Lastly, the Morning Action Plan Execution involves planning and tracking morning activities, which caregivers have found very helpful. Past research shows that these activities help reduce caregiver stress without causing harm.

Overall, these strategies have been tested and found to be safe, making them promising options for participants considering this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Therapy for Caregiver Depression trial because it explores new ways to tackle depression in caregivers, focusing on morning activity engagement and supportive conversations. Unlike traditional treatments like medication or cognitive-behavioral therapy, this approach emphasizes practical lifestyle changes and emotional support. The SAMM Protocol encourages caregivers to proactively plan and execute morning activities, potentially boosting mood and energy levels. Meanwhile, the supportive control condition highlights the power of active listening and empathy, offering caregivers a safe space to express their challenges. This trial could uncover valuable insights into how simple, non-pharmaceutical interventions can effectively support mental health.

What evidence suggests that this trial's treatments could be effective for caregiver depression?

Research has shown that activity-based strategies, which participants may experience through the SAMM protocol, can help reduce symptoms of depression. Studies have found that caregivers engaging in planned activities often feel less stressed and depressed. This method involves establishing a routine for morning activities, which has been linked to better mental health.

For sleep, another strategy under study involves adjusting sleep patterns to align with the body's natural clock, known as chronotherapy. Research suggests that this adjustment can improve mood and energy, particularly for those with sleep problems and depression. Overall, both strategies have shown promise in managing depression symptoms and enhancing well-being. ^{3 6 7 8 9}

Who Is on the Research Team?

Stephen F Smagula, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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

I am currently undergoing Cognitive Behavioral Therapy for mood or sleep issues.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8857284/

Therapist Adaptations to Evidence-based Practices and ... Coders classified therapist-described adaptations into five types: 1) Modifying Presentation, 2) Integrating, 3) Extending, 4) Reducing, and 5) Generalizing.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11076375/

Routine Outcome Monitoring and Clinical Feedback in ... Results showed that if therapists followed the recommended treatment strategy for the first ten sessions, better outcomes resulted by an effect size of about ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0272735823000995

The use of Acceptance and Commitment Therapy (ACT) in ... ACT has been found to be effective in improving psychological flexibility and treatment outcomes in hundreds of randomized controlled trials (RCTs; ACBS, 2019; ...

4. digitalcommons.usu.edu digitalcommons.usu.edu/cgi/viewcontent.cgi?article=8988&context=etd

Are Effort and Helpfulness Ratings of Session Activities ... Caregiving interventions are most successful in reducing stress, depressive symptoms, and overall caregiver burden when they incorporate multiple treatment.

5. marketplace.va.gov marketplace.va.gov/innovations/tailored-activity-program

The Tailored Activity Program-VA (TAP-VA) TAP-VA is designed for Veterans with dementia and their caregivers. TAP-VA decreases dementia-related behavioral symptoms and caregiver burden.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2882847/

Behavioral activation interventions for well-being: A meta- ... This study reports on a meta-analysis of randomized controlled studies to examine the effect of BA on well-being.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10683951/

Characterizing measurement-based care implementation ... This study examined therapists' sharing and discussion of MBC in treatment sessions. Thirty therapists were randomly assigned to the MBC condition.

8. tandfonline.com tandfonline.com/doi/full/10.1080/10522158.2024.2420922?src=

Caregiver engagement and treatment response in child ... This study was a qualitative analysis of indicators of caregiver engagement found to impact child response to trauma therapy.

9. scholarworks.indianapolis.iu.edu scholarworks.indianapolis.iu.edu/bitstreams/b743fc5e-00a5-43ee-8e41-89e0a6b3f16b/download

Community-based service providers' experiences with ... Study participants noted several strategies to ensure successful delivery of activities, including monitoring PWD energy levels, involving informal caregivers, ...