Triple Chronotherapy in Adolescents

NCT03679962 | Completed

• 1 other identifier: 18.26
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Study Purpose This study is a randomized controlled trial examining the effectiveness of TCT in the acute treatment of depression and suicidality in adolescents compared to usual treatment care, which includes individual and group therapy, and medication adjustments. All potential participants will be identified at admission to the Psychiatric Youth Inpatient Unit of Billings Clinic and invited to participate. The length of participation is 2 months. Study Design The primary research question of this RCT is whether adjunctive TCT in depressed adolescents is more effective in the management of depression symptoms and in reducing suicidal ideation at two months follow-up, than those adolescents who are receiving usual care. A total of three aims are proposed. Hypothesis: Adjunctive TCT is more effective in the management of depression symptoms and in reducing suicidal ideation at two month follow-up than those adolescents who are receiving usual care. The first aim is to track the trajectories of depression symptoms, suicidal ideation, and insomnia severity in participants receiving TCT and in those receiving treatment as usual over 4 days of initial treatment, thereby answering the question of whether adjunctive TCT can effectively reduce the severity of depression, insomnia and suicidal ideation. The second aim is to examine whether TCT is more effective than usual care in sustaining treatment effects to the end of study period (2 months follow-up), therefore answering the question whether the effectiveness of the 4-day intervention of adjunctive TCT arm is sustainable up to the end of a two-month follow-up. Hypothesis: TCT is more effective than usual care in sustaining treatment effects to the end of the study period than usual care. The third aim is to assess the link to the clinical outcomes (change in depression symptoms, suicidal ideation, insomnia severity, and disease-associated quality of life) and patient satisfaction with the treatment. Hypothesis: Clinical outcomes (depression symptoms, suicidal ideation, insomnia, and disease-related quality of life) and patient satisfaction are more effective than usual care alone.

Conditions

Depressive Disorder, Major; Bipolar Depression; Suicidal Ideation

Keywords

Bright Light Therapy; Sleep Deprivation; Adolescent; Depression; Suicidal Ideation

Outcome Measures

Primary Outcomes (2)

• Patient Health Questionnaire -Adolescent version (PHQ-A)

  Measuring the change score of pre-post PHQ-A; a score of 5-9 indicates mild depression with watchful waiting and repeat test, 10-14 indicates moderate depression that should be followed up with due consideration as to counseling and/or pharmacotherapy, 15-19 signifies moderately severe depression what requires initiation of pharmacotherapy and/or psychotherapy, and a score of 20-27 is interpreted as severe depression with immediate initiation of pharmacotherapy and referral to a mental health specialist for psychotherapy and collaborative management.

  PHQ-A the day prior to total sleep deprivation, and then again over the next 3 consecutive days.

• Columbia Suicide Severity Rating Scale

  Measuring the change score of pre-post C-SSRS; 5 potential questions- yes/no questions indicating suicidal behavior and ideation; optimum score = 0.

  Daily throughout the treatment (Days 0-4)

Secondary Outcomes (2)

• Patient Health Questionnaire-Adolescent version (PHQ-A)

  PHQ-A the day prior to total sleep deprivation, and then again over the next 3 consecutive days, at 1-month and at 2-month

• Youth Quality of life Questionnaire

  Day 0 and repeat measure at 30 days

Study Arms (2)

Triple Chronotherapy

EXPERIMENTAL

Four-day intervention, with 24-hour total sleep deprivation, 3-days of sleep phase advancement and daily bright light therapy.

Behavioral: Triple Chronotherapy

Treatment as Usual

ACTIVE COMPARATOR

Normal inpatient care, including pharmacotherapy, psychotherapy, milieu therapy and social work interventions

Behavioral: Treatment as Usual

Interventions

Triple Chronotherapy BEHAVIORAL

Day 0: One night of total sleep deprivation. The first 24 hours are spent with 1:1 nursing care for provision of comfort measures to stimulate wakefulness and to encourage completion of the intervention. Day 1-4: Sleep phase advancement Day 1: Sleep from 6 PM to 1 AM Day 2: Sleep from 8 PM to 3 AM Day 3: Sleep from 10 PM and 5 AM Day 4: Awaken at 5 AM; discharge following light therapy On days 1-4 patients will receive bright light therapy at 7am to 7:30am using a 10,000 Verilux light box. At discharge patients will be given a light box, strongly advised to continue the maintenance sleep schedule and bright light therapy at 7am daily for 30 minutes. Patients will be scheduled for follow-up appointments at 1-week, 1-month and 2-month following discharge.

Triple Chronotherapy

Treatment as Usual BEHAVIORAL

Normal inpatient care, including pharmacotherapy, psychotherapy, milieu therapy and social work interventions

Treatment as Usual

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patient must be 12-17 years of age
• Must verbalize motivation for treatment
• Must provide informed assent; parent or guardian must provide consent
• Must be diagnosed with moderate to severe unipolar or bipolar depression. Severity of depression is determined using the Patient Health Questionnaire-9 (PHQ-9 modified for Adolescents \[PHQ-A\]). A score of 10 or more indicates moderate-severe depression

You may not qualify if:

• Active psychosis
• Manic state
• Younger than 12 years of age or older than 17 years of age
• Seizure disorder
• Pregnancy
• Lack of assent and consent
• Previous TCT treatment

Sponsors & Collaborators

• Billings Clinic: lead

Study Sites (1)

Billings Clinic

Billings, Montana, 59101, United States

Location

Related Publications (14)

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  PMID: 27376998 BACKGROUND

• Gulliver A, Griffiths KM, Christensen H. Perceived barriers and facilitators to mental health help-seeking in young people: a systematic review. BMC Psychiatry. 2010 Dec 30;10:113. doi: 10.1186/1471-244X-10-113.

  PMID: 21192795 BACKGROUND

• Abdallah CG, Adams TG, Kelmendi B, Esterlis I, Sanacora G, Krystal JH. KETAMINE'S MECHANISM OF ACTION: A PATH TO RAPID-ACTING ANTIDEPRESSANTS. Depress Anxiety. 2016 Aug;33(8):689-97. doi: 10.1002/da.22501. Epub 2016 Apr 6.

  PMID: 27062302 BACKGROUND

• Cao B, Luo Q, Fu Y, Du L, Qiu T, Yang X, Chen X, Chen Q, Soares JC, Cho RY, Zhang XY, Qiu H. Predicting individual responses to the electroconvulsive therapy with hippocampal subfield volumes in major depression disorder. Sci Rep. 2018 Apr 3;8(1):5434. doi: 10.1038/s41598-018-23685-9.

  PMID: 29615675 BACKGROUND

• Kayser S, Bewernick BH, Wagner S, Schlaepfer TE. Clinical Predictors of Response to Magnetic Seizure Therapy in Depression: A Preliminary Report. J ECT. 2019 Mar;35(1):48-52. doi: 10.1097/YCT.0000000000000495.

  PMID: 29613946 BACKGROUND

• Pflug B, Tolle R. Disturbance of the 24-hour rhythm in endogenous depression and the treatment of endogenous depression by sleep deprivation. Int Pharmacopsychiatry. 1971;6(3):187-96. doi: 10.1159/000468269. No abstract available.

  PMID: 4950570 BACKGROUND

• Nussbaumer B, Kaminski-Hartenthaler A, Forneris CA, Morgan LC, Sonis JH, Gaynes BN, Greenblatt A, Wipplinger J, Lux LJ, Winkler D, Van Noord MG, Hofmann J, Gartlehner G. Light therapy for preventing seasonal affective disorder. Cochrane Database Syst Rev. 2015 Nov 8;(11):CD011269. doi: 10.1002/14651858.CD011269.pub2.

  PMID: 26558494 BACKGROUND

• Tuunainen A, Kripke DF, Endo T. Light therapy for non-seasonal depression. Cochrane Database Syst Rev. 2004;2004(2):CD004050. doi: 10.1002/14651858.CD004050.pub2.

  PMID: 15106233 BACKGROUND

• Al-Karawi D, Jubair L. Bright light therapy for nonseasonal depression: Meta-analysis of clinical trials. J Affect Disord. 2016 Jul 1;198:64-71. doi: 10.1016/j.jad.2016.03.016. Epub 2016 Mar 15.

  PMID: 27011361 BACKGROUND

• Benedetti F, Riccaboni R, Locatelli C, Poletti S, Dallaspezia S, Colombo C. Rapid treatment response of suicidal symptoms to lithium, sleep deprivation, and light therapy (chronotherapeutics) in drug-resistant bipolar depression. J Clin Psychiatry. 2014 Feb;75(2):133-40. doi: 10.4088/JCP.13m08455.

  PMID: 24345382 BACKGROUND

• Martiny K, Refsgaard E, Lund V, Lunde M, Sorensen L, Thougaard B, Lindberg L, Bech P. A 9-week randomized trial comparing a chronotherapeutic intervention (wake and light therapy) to exercise in major depressive disorder patients treated with duloxetine. J Clin Psychiatry. 2012 Sep;73(9):1234-42. doi: 10.4088/JCP.11m07625.

  PMID: 23059149 BACKGROUND

• Martiny K, Refsgaard E, Lund V, Lunde M, Thougaard B, Lindberg L, Bech P. Maintained superiority of chronotherapeutics vs. exercise in a 20-week randomized follow-up trial in major depression. Acta Psychiatr Scand. 2015 Jun;131(6):446-57. doi: 10.1111/acps.12402. Epub 2015 Feb 17.

  PMID: 25689725 BACKGROUND

• Gest S, Legenbauer T, Bogen S, Schulz C, Pniewski B, Holtmann M. Chronotherapeutics: an alternative treatment of juvenile depression. Med Hypotheses. 2014 Mar;82(3):346-9. doi: 10.1016/j.mehy.2014.01.002. Epub 2014 Jan 15.

  PMID: 24468576 BACKGROUND

• Gest S, Holtmann M, Bogen S, Schulz C, Pniewski B, Legenbauer T. Chronotherapeutic treatments for depression in youth. Eur Child Adolesc Psychiatry. 2016 Feb;25(2):151-61. doi: 10.1007/s00787-015-0720-6. Epub 2015 May 17.

  PMID: 25982568 BACKGROUND

Related Links

• National Institute of Mental Health. Mental Health Information. 2015

MeSH Terms

Conditions

Depressive Disorder, Major; Bipolar Disorder; Suicidal Ideation; Sleep Deprivation; Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Bipolar and Related Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mariela Herrera, MD

  Billings Clinic

  PRINCIPAL INVESTIGATOR

• Laurie Riemann, BSN

  Billings Clinic

  STUDY DIRECTOR

• Jamie Besel, MSN

  Billings Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: September 21, 2018
• Study Start: January 25, 2019
• Primary Completion: March 13, 2023
• Study Completion: March 14, 2023
• Last Updated: August 16, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)