E-Mental Health Adolescent Depression Program (LEAP)

Patricia Steele

Status: Completed

Conditions: Depression

Treatments: Other: LEAP Project

Study type: Interventional

Funder types: Other

Identifiers

NCT00985686

22549

Ethics ID 22549 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 13 to 24 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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63 participants in 2 patient groups

Study Arm

Experimental group

Description:

Arm where participants began the LEAP Project intervention upon recruitment for an 8 week period.

Treatment:

Other: LEAP Project

Waitlist Arm

Active Comparator group

Description:

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).

Treatment:

Other: LEAP Project