E-Mental Health Adolescent Depression Program (LEAP)

NCT ID: NCT00985686

Last Updated: 2015-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-09-30

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Study Arm

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

Group Type: EXPERIMENTAL

LEAP Project

Intervention Type: OTHER

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.

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).

Group Type: ACTIVE_COMPARATOR

LEAP Project

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alberta Centre for Child, Family & Community Research

OTHER

Sponsor Role: collaborator

Alberta Health Services, Calgary

OTHER

Sponsor Role: collaborator

Mount Royal University

OTHER

Sponsor Role: collaborator

SickKids Foundation

OTHER

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: collaborator

Patricia Steele

OTHER

Sponsor Role: lead

Responsible Party

Patricia Steele

Executive Director, CINIM

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

John Toews, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Canadian Institute of Natural and Integrative Medicine

Badri Rickhi, MB MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

Canadian Institute of Natural and Integrative Medicine

Jordan Cohen, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Dawne Clark, PhD

Role: PRINCIPAL_INVESTIGATOR

Mount Royal College

John Griffith, BA MDiv

Role: PRINCIPAL_INVESTIGATOR

Spiritual Directions

Hude Quan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Janet Chafe, MSW, RSW

Role: PRINCIPAL_INVESTIGATOR

Alberta Health services

Sabine Moritz, Bsc MSc

Role: PRINCIPAL_INVESTIGATOR

Alberta Health services

Patti Paccagnan, RN, BN, ACC

Role: PRINCIPAL_INVESTIGATOR

Canadian Institute of Natural and Integrative Medicine

Locations

Canadian Institute of Natural and Integrative Medicine (CINIM)

Calgary, Alberta, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 26702639 (View on PubMed)

Related Links

http://www.cinim.org

Canadian Institute of Natural and Integrative Medicine (CINIM)

http://www.leapproject.com

The LEAP Project

Other Identifiers

Ethics ID 22549

Identifier Type: OTHER

Identifier Source: secondary_id

22549

Identifier Type: -

Identifier Source: org_study_id