Sleep Mechanisms Of Regulating Emotions

Conditions

• Depression
• Insomnia

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Cognitive Behavioral Therapy for Insomnia — BEHAVIORAL
  CBT-I improves sleep through a combination of behavioral interventions (stimulus control (SC), sleep restriction (SR)), cognitive therapy (CT) as well as additional components such as mindfulness training and sleep hygiene education. SC is an intervention that re-establishes the connection between the bed/bedroom with sleep to help develop a more consistent sleep/wake pattern. SR leads to higher quality sleep by reducing excessive time spent in bed to the actual amount of sleep, thereby creating mild sleep deprivation and increasing the homeostatic sleep drive. Like CT for other disorders, CT for insomnia targets maladaptive thoughts and cognitions that may interfere with sleep.

Study Details

This project is the second phase of a two-phased project investigating the impact of a proven sleep intervention, Cognitive Behavioral Therapy for Insomnia (CBT-I) on engagement of the emotion regulation brain network as a putative mechanistic target.

Key Dates

Start date

Aug 12, 2024

Status verified

Apr 2026

Primary completion

Jun 30, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Immediate Treatment
  Participants randomized to the Immediate Treatment group will receive CBT-I treatment immediately after randomization.
• Other: Enhanced Sleep Hygiene
  Participants randomized to the Enhanced Sleep Hygiene (ESH) group will be offered the same CBT-I described above approximately 7 months after being randomized. We will also provide a list of referrals for treatment upon completion of their end of treatment visit (approx. week 11) should they choose to seek treatment sooner. In the interim, they will be provided with two sessions of sleep hygiene / sleep education and four additional meetings including monitoring of sleep and mood symptoms.

Primary Outcome Measure

Change in Emotion Regulation Network brain activation as assessed by functional magnetic resonance imaging [ Time Frame: Assessed at baseline (week 1) and end of treatment (week 13) ]

Central Contacts

• Kaela Mandler
  650-721-6089
  [email protected]
• Leah Harris
  [email protected]

Locations (1)

Find similar trials in Palo Alto, CA

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