E-Mental Health Adolescent Depression Program (LEAP)

NCT00985686 | Completed Results

• 2 other identifiers: 22549Ethics ID 22549
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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. 1.to pilot the Internet-based Spirituality Program with depressed young people (age 13-24) in Calgary by:
2. 2.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.
3. 3.obtaining preliminary estimates on response rates and remission rates to guide sample size estimations for a full size randomized trial.
4. 4.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.
5. 5.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.

Conditions

Depression

Keywords

e-mental health; Adolescent mental health; Spirituality

Outcome Measures

Primary Outcomes (2)

• Children's Depression Rating Scale Revised (CDRS-R)

  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.

  At 8 week intervals over a 24 week period

• Hamilton Depression Rating Scale (HAMD)

  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.

  At 8 week intervals over a 24 week period

Secondary Outcomes (5)

• Piers-Harris Children's Self-Concept Scale - Second Edition (Piers Harris 2)

  At 8 week intervals over a 24 week period

• Six Factor Self-Concept Scale

  At 8 week intervals over a 24 week period

• Profile of Mood States (POMS)

  At 8 week intervals over a 24 week period

• Spiritual Well-Being Scale (SWBS)

  At 8 week intervals over a 24 week period

• Spiritual Involvement and Belief Scale (SIBS)

  At 8 week intervals over a 24 week period

Study Arms (2)

Study Arm

EXPERIMENTAL

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

Other: LEAP Project

Waitlist Arm

ACTIVE COMPARATOR

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

Interventions

LEAP Project 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.

Study Arm; Waitlist Arm

Eligibility Criteria

• Age: 13 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Patricia Steele: lead
• Alberta Centre for Child, Family & Community Research: collaborator
• Alberta Health Services, Calgary: collaborator
• Mount Royal University: collaborator
• SickKids Foundation: collaborator
• University of Calgary: collaborator

Study Sites (1)

Canadian Institute of Natural and Integrative Medicine (CINIM)

Calgary, Alberta, T2M 3T1, Canada

Location

Related Publications (1)

• 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.

  PMID: 26702639 DERIVED

Related Links

• Canadian Institute of Natural and Integrative Medicine (CINIM)
• The LEAP Project

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Limitations and Caveats

Limitations Inconsistent followup by all study participants Overall generalizability is limited due to a predominantly female sample Self-selection of participants with an open attitude to spirituality No comparison to placebo or active treatment

Results Point of Contact

• Title: Dr. John Toews
• Organization: Canadian Institute of Natural and Integrative Medicine

j.toews@cinim.org

4032200022

Study Officials

• 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

  Alberta Health services

  PRINCIPAL INVESTIGATOR

• Sabine Moritz, Bsc MSc

  Alberta Health services

  PRINCIPAL INVESTIGATOR

• Patti Paccagnan, RN, BN, ACC

  Canadian Institute of Natural and Integrative Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Executive Director, CINIM

Study Record Dates

• First Submitted: September 24, 2009
• First Posted: September 28, 2009
• Study Start: January 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: July 29, 2015
• Results First Posted: March 6, 2015

Record last verified: 2015-07

Locations

CA (1)