Internet-based Adolescent Depression Treatment Program (LEAP Project)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Canadian Institute of Natural and Integrative Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Alberta Centre for Child, Family & Community Research
SickKids Foundation
AHS Cancer Control Alberta
University of Calgary
Information provided by:
Canadian Institute of Natural and Integrative Medicine
ClinicalTrials.gov Identifier:
NCT00985686
First received: September 24, 2009
Last updated: January 31, 2011
Last verified: January 2011
  Purpose

The purpose of this project is to explore the potential value and practicality of an innovative depression intervention for young people. More specifically, the objectives of this project are:

  1. to pilot the Internet-based Spirituality Program with depressed young people (age 13-24) in Calgary by:

    1. obtaining preliminary estimates on the impact of the program on depression severity, response rates and remission rates to guide sample size estimations for a full size randomized trial.
    2. evaluating if the suggested research methodology is feasible with respect to recruitment rate, patient burden and clinical implementation to guide design of a full size randomized trial.
  2. to gather feedback from depressed young people, their families and referral sources in the community (schools, family physicians, mental health outpatient services) on the perceived value of the program and on ways to eventually make it available as a community resource for others dealing with depression.

Condition Intervention Phase
Depression
Other: Internet-based spirituality teaching program
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Teen Mental Health: Pilot of an Internet-based Adolescent Depression Treatment Program

Resource links provided by NLM:


Further study details as provided by Canadian Institute of Natural and Integrative Medicine:

Primary Outcome Measures:
  • Depression Severity, Depression Response, and Depression Remission Rates using the Children's Depression Rating Scale Revised (CDRS-R)or the Hamilton Depression Rating Scale (HAM-D) [ Time Frame: Every 8 weeks throughout study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Self Rated Psychological Health (Using the Piers-Harris 2 or Six Factor Self Concept Scale) [ Time Frame: Every 8 weeks throughout the study ] [ Designated as safety issue: Yes ]
  • Psychological Well Being, for adult participants only (Profile of Mood States) [ Time Frame: Every 8 weeks throughout the study ] [ Designated as safety issue: Yes ]
  • Spirituality Level (Spiritual Well-Being Scale or the Spiritual Involvement and Beliefs Scale) [ Time Frame: Every 8 weeks throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: January 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Intervention Group Other: Internet-based spirituality teaching program
In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created an Internet-based Depression treatment program for young people(see Appendix for sample materials). It is a self-study, e-learning based program that is delivered over eight weeks requiring a weekly commitment of 2-3 hours. The program is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles that are presented in 8 modules.

Detailed Description:

Depression in adolescents and young adults is a prevalent illness in Canada and presents a high burden for those affected and their families. In Canada, depressive disorders are on the rise and their onset is occurring earlier in life. There is a growing body of evidence suggesting that spiritual wellness may play a role in depression recovery. Considering the limitations of available treatments for depression and the significant burden of the disease there is a need for new treatment options that are safe, effective, affordable and acceptable to young people. Our previous research gives strong support to the idea of using a spiritually based intervention for depression. To our knowledge, no research has been conducted on using spirituality as a self-study intervention in the management of depression in young adults. Over the last two years our team has created a spirituality-based intervention program for adolescent depression. The program could present an innovative and low cost treatment option for young patients with major depression.

  Eligibility

Ages Eligible for Study:   13 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 13-24 years of age
  • Meet DSM-IV criteria for unipolar major depression (mild-moderate severity based on Children's Depression Rating Scale-Revised or the Hamilton Depression Rating Scale),
  • Ability to comply with study intervention, provision of informed assent and parental consent 

Exclusion Criteria:

In order to avoid confounding through a change in the use of mood altering substances or therapies and through underlying medical conditions, patients will be excluded for any of the following reasons:

  • change in use of pharmacotherapeutic or herbal treatment for depression in the last three month OR during the first 2 months of trial participation (mild to moderately depressed patients who have not had a change in their treatment in the last three months will be eligible to participate if it is foreseeable that their current treatment will continue unchanged for the first 2 months of trial participation),
  • patients currently undergoing a specific psychotherapeutic treatment that has been shown to be effective for depression (such as Cognitive Behavioral Therapy (CBT) or Interpersonal Therapy (IPT)) or planning to start such therapy in the next two months
  • change in the use of medications that have mood altering effects in the last 3 months OR during the first 2 months of trial participation,
  • History of bipolar disorder, psychotic disorder or psychotic episodes, personality disorder, multiple suicide attempts; History of ADD/ADHD permitted if stabilized (no longer meets DSM-IV criteria for active ADD/ADHD) for at least 2 months; stabilized treated ADD/ADHD permitted if on regular long acting medication and agree to continue,
  • Uncontrolled medical conditions in the last 3 months (assessed by qualified physician),
  • High suicide risk,
  • DSM-IV diagnosis of substance dependence (except nicotine, caffeine) within past 12-months,
  • History of tx resistance to ≥ 2 antidepressant medications when treated for an adequate period with a therapeutic dose
  • Recent deaths in the family
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00985686

Contacts
Contact: Sabine Moritz, BSc MSc (403)-220-0022 ext 103 s.moritz@cinim.org
Contact: Study Coordinator (403)-220-0022 ext 222 leap@cinim.org

Locations
Canada, Alberta
Canadian Institute of Natural and Integrative Medicine (CINIM) Recruiting
Calgary, Alberta, Canada, T2M 3T1
Contact: Sabine Moritz, BSc MSc    (403)-220-0022 ext 103    s.moritz@cinim.org   
Contact: Study Coordinator    (403)-220-0022 ext 222    leap@cinim.org   
Sponsors and Collaborators
Canadian Institute of Natural and Integrative Medicine
Alberta Centre for Child, Family & Community Research
SickKids Foundation
AHS Cancer Control Alberta
University of Calgary
Investigators
Principal Investigator: John Toews, MD, FRCPC Canadian Institute of Natural and Integrative Medicine
Principal Investigator: Badri Rickhi, MB MD FRCPC Canadian Institute of Natural and Integrative Medicine
Principal Investigator: Jordan Cohen, MD, FRCPC University of Calgary
Principal Investigator: Patti Paccagnan, RN, BN Canadian Institute of Natural and Integrative Medicine
Principal Investigator: Dawne Clark, PhD Mount Royal College
Principal Investigator: John Griffith, BA MDiv Spiritual Directions
Principal Investigator: Hude Quan, PhD University of Calgary
Principal Investigator: Janet Chafe, MSW, RSW AHS Cancer Control Alberta
  More Information

Additional Information:
No publications provided

Responsible Party: Sabine Moritz, Canadian Institute of Natural and Integrative Medicine
ClinicalTrials.gov Identifier: NCT00985686     History of Changes
Other Study ID Numbers: 22549, Ethics ID 22549
Study First Received: September 24, 2009
Last Updated: January 31, 2011
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014