E-Mental Health Adolescent Depression Program (LEAP)

This study has been completed.
Sponsor:
Collaborators:
Alberta Centre for Child, Family & Community Research
AHS Cancer Control Alberta
Mount Royal University
SickKids Foundation
University of Calgary
Information provided by (Responsible Party):
Patricia Paccagnan, Canadian Institute of Natural and Integrative Medicine
ClinicalTrials.gov Identifier:
NCT00985686
First received: September 24, 2009
Last updated: February 19, 2015
Last verified: February 2015
  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 the primary outcome of depression severity, and secondary outcomes of spiritual well-being and self-concept.
    2. obtaining preliminary estimates on response rates and remission rates to guide sample size estimations for a full size randomized trial.
    3. 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
Depression
Other: LEAP Project

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: Evaluation of a Spirituality Informed E-mental Health Intervention (LEAP Project) for Major Depressive Disorder in Adolescents and Young Adults - A Randomized Controlled Pilot Trial

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Children's Depression Rating Scale Revised (CDRS-R) [ Time Frame: At 8 week intervals over a 24 week period ] [ Designated as safety issue: Yes ]
    Measure of depression severity in individuals 13 to 18 years of age. CDRS-R total raw scores includes the sum of 17 items, each item's scoring range is from 1 (no difficulties) to 5 (severe clinically significant difficulties) or 1 (no difficulties) to 7 (severe clinically significant difficulties), with a total possible raw score ranging from 17 to 113. To meet eligibility requirements, participants required a total raw score of 40 to 70.

  • Hamilton Depression Rating Scale (HAMD) [ Time Frame: At 8 week intervals over a 24 week period ] [ Designated as safety issue: Yes ]
    Measure of depression severity in individuals 19 to 24 years of age. HAMD total scores includes the sum of 17-items, with eight items scored on a range of 0 (absent) to 2 (marked or definite) and nine scored on a range of 0 (absent) to 4 (very severe). The level of depression was based on the following scoring ranges: 7 or under not depressed, 8-13 some depressive symptoms but no depressive disorder, 12-15 mild depression, 16-19 moderate depression, 20-24 moderately severe depression, and 25+ severe depression. To meet eligibility requirements, participants required a total score of 12-24.


Secondary Outcome Measures:
  • Piers-Harris Children's Self-Concept Scale - Second Edition (Piers Harris 2) [ Time Frame: At 8 week intervals over a 24 week period ] [ Designated as safety issue: No ]
    Measure of self-concept in 13 to 18 year olds. The scale can be completed in 10-15 minutes and includes 60 items covering six subscales: physical appearance and attributes, intellectual and school status, happiness and satisfaction, freedom from anxiety, behavioural adjustment and popularity.

  • Six Factor Self-Concept Scale [ Time Frame: At 8 week intervals over a 24 week period ] [ Designated as safety issue: No ]
    Measure of self concept in 19 to 24 year olds. The Six-Factor Self-Concept Scale is a multidimensional measure of adult self-concept that was designed to have broad applicability across life settings, roles, and activities. The scale consist of 115 items and assess six factors including likability, morality, task accomplishment, giftedness, power and vulnerability.

  • Profile of Mood States (POMS) [ Time Frame: At 8 week intervals over a 24 week period ] [ Designated as safety issue: No ]
    Measure of psychological well-being in 19 to 24 year olds. The POMS has the format of an adjective check list and consists of 65 items. It provides a total score of mood disturbance and six factor based subscale scores.

  • Spiritual Well-Being Scale (SWBS) [ Time Frame: At 8 week intervals over a 24 week period ] [ Designated as safety issue: No ]
    Measure of level spiritual well-being in 13-18 year olds. The self administered 10-item version was used.

  • Spiritual Involvement and Belief Scale (SIBS) [ Time Frame: At 8 week intervals over a 24 week period ] [ Designated as safety issue: No ]
    Measure of spiritual well-being in 19 to 24 year olds. The instrument is self-administered and contains 26 items in a Likert-type format.


Enrollment: 63
Study Start Date: January 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Arm
Arm where participants began the LEAP Project intervention upon recruitment for an 8 week period.
Other: LEAP Project
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 the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention 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.
Active Comparator: Waitlist Arm

Arm where participants received the LEAP Project intervention after an 8 week wait period.

At 8 weeks, the results from the wait-list arm (no intervention) were compared to the results of the study arm (intervention completed).

Other: LEAP Project
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 the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention 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.

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 management and 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-TR criteria for major depressive disorder (mild-moderate severity) based on the Children's Depression Rating Scale-Revised or the Hamilton Depression Rating Scale
  • ability to comply with study intervention, provision of informed assent and/or 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 pharma-therapeutic 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 psycho-therapeutic 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-TR 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-TR 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

Locations
Canada, Alberta
Canadian Institute of Natural and Integrative Medicine (CINIM)
Calgary, Alberta, Canada, T2M 3T1
Sponsors and Collaborators
Patricia Paccagnan
Alberta Centre for Child, Family & Community Research
AHS Cancer Control Alberta
Mount Royal University
SickKids Foundation
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: 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
Principal Investigator: Sabine Moritz, Bsc MSc AHS Cancer Control Alberta
Principal Investigator: Patti Paccagnan, RN, BN, ACC Canadian Institute of Natural and Integrative Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Patricia Paccagnan, Project Manager, CINIM, 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
Results First Received: January 14, 2015
Last Updated: February 19, 2015
Health Authority: Canada: Ethics Review Committee

Keywords provided by Canadian Institute of Natural and Integrative Medicine:
e-mental health
Adolescent mental health
Spirituality

Additional relevant MeSH terms:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 21, 2015