Clinical trial NCT00985686: E-Mental Health Adolescent Depression Program (LEAP)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: e-mental health
Adolescent mental health
Spirituality
Lead sponsor: Canadian Institute of Natural and Integrative Medicine
Sponsor class: OTHER
Collaborators: name: Alberta Centre for Child, Family & Community Research
name: Alberta Health Services, Calgary
name: Mount Royal University
name: SickKids Foundation
name: University of Calgary
First posted: 2009-09-28
Enrollment: 63
Sex: ALL
Minimum age (years): 13
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Children's Depression Rating Scale Revised (CDRS-R)
timeFrame: At 8 week intervals over a 24 week period
measure: Hamilton Depression Rating Scale (HAMD)
timeFrame: At 8 week intervals over a 24 week period
Secondary outcomes:
measure: Piers-Harris Children's Self-Concept Scale - Second Edition (Piers Harris 2)
timeFrame: At 8 week intervals over a 24 week period
measure: Six Factor Self-Concept Scale
timeFrame: At 8 week intervals over a 24 week period
measure: Profile of Mood States (POMS)
timeFrame: At 8 week intervals over a 24 week period
measure: Spiritual Well-Being Scale (SWBS)
timeFrame: At 8 week intervals over a 24 week period
measure: Spiritual Involvement and Belief Scale (SIBS)
timeFrame: At 8 week intervals over a 24 week period
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Canadian Institute of Natural and Integrative Medicine (CINIM)
state: Alberta
Study officials:
affiliation: Canadian Institute of Natural and Integrative Medicine
name: John Toews, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Canadian Institute of Natural and Integrative Medicine
name: Badri Rickhi, MB MD FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Jordan Cohen, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Mount Royal College
name: Dawne Clark, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Spiritual Directions
name: John Griffith, BA MDiv
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Hude Quan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alberta Health services
name: Janet Chafe, MSW, RSW
role: PRINCIPAL_INVESTIGATOR
affiliation: Alberta Health services
name: Sabine Moritz, Bsc MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Canadian Institute of Natural and Integrative Medicine
name: Patti Paccagnan, RN, BN, ACC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rickhi B, Kania-Richmond A, Moritz S, Cohen J, Paccagnan P, Dennis C, Liu M, Malhotra S, Steele P, Toews J. Evaluation of a spirituality informed e-mental health tool as an intervention for major depressive disorder in adolescents and young adults - a randomized controlled pilot trial. BMC Complement Altern Med. 2015 Dec 24;15:450. doi: 10.1186/s12906-015-0968-x.