N/A
N=63
E-Mental Health Adolescent Depression Program (LEAP)
Depression
Bottom Line
View on ClinicalTrials.gov: NCT00985686 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Children's Depression Rating Scale Revised (CDRS-R) — 57.18; 61.67; 44.94; 58.93 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LEAP Project (Other)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- Patricia Steele
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Children's Depression Rating Scale Revised (CDRS-R) |
57.18; 61.67; 44.94; 58.93; 36.54; 44.97 | — |
| PRIMARY Hamilton Depression Rating Scale (HAMD) |
22.14; 20.90; 14.07; 17.79; 11.40; 9.91 | — |
| SECONDARY Piers-Harris Children's Self-Concept Scale - Second Edition (Piers Harris 2) |
— | — |
| SECONDARY Six Factor Self-Concept Scale |
— | — |
| SECONDARY Profile of Mood States (POMS) |
— | — |
| SECONDARY Spiritual Well-Being Scale (SWBS) |
— | — |
| SECONDARY Spiritual Involvement and Belief Scale (SIBS) |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00985686). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.