DepressionLEAPNCT00985686

E-Mental Health Adolescent Depression Program (LEAP)

A study testing LEAP Project in people with Depression, run by Patricia Steele at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 13 to 24 years
Conditions the study is for: Depression
What is being tested?: LEAP Project
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: 1 siteCanada
Study dates: Jan 2010to Sep 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 13 to 24 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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)

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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 locations and contacts

1 site in 1 country.

Canada1 site

Canadian Institute of Natural and Integrative Medicine (CINIM)
Calgary, Alberta, T2M 3T1

Other trials in Canada

About this study

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

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:

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

Read the 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
Being tested: LEAP Project
Keywords: e-mental health, Adolescent mental health, Spirituality
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LEAP ProjectOther
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 groups in NCT00985686
Study group	Role	What they receive
Study Arm	Experimental	Arm where participants began the LEAP Project intervention upon recruitment for an 8 week period. Receives: 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). Receives: Other: LEAP Project

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: At 8 week intervals over a 24 week period

Secondary outcomes (5)

Piers-Harris Children's Self-Concept Scale - Second Edition (Piers Harris 2)
Measure of self-concept in 13 to 18 year olds. The scale can be completed in 10-15 minutes and includes 60 items covering six subscales: physical appearance and attributes, intellectual and school status, happiness and satisfaction, freedom from anxiety, behavioural adjustment and popularity.
Measured: At 8 week intervals over a 24 week period
Six Factor Self-Concept Scale
Measure of self concept in 19 to 24 year olds. The Six-Factor Self-Concept Scale is a multidimensional measure of adult self-concept that was designed to have broad applicability across life settings, roles, and activities. The scale consist of 115 items and assess six factors including likability, morality, task accomplishment, giftedness, power and vulnerability.
Measured: At 8 week intervals over a 24 week period
Profile of Mood States (POMS)
Measure of psychological well-being in 19 to 24 year olds. The POMS has the format of an adjective check list and consists of 65 items. It provides a total score of mood disturbance and six factor based subscale scores.
Measured: At 8 week intervals over a 24 week period
Spiritual Well-Being Scale (SWBS)
Measure of level spiritual well-being in 13-18 year olds. The self administered 10-item version was used.
Measured: At 8 week intervals over a 24 week period
Spiritual Involvement and Belief Scale (SIBS)
Measure of spiritual well-being in 19 to 24 year olds. The instrument is self-administered and contains 26 items in a Likert-type format.
Measured: At 8 week intervals over a 24 week period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Sep 2012

First posted28 Sep 2009 (estimated)
Study startJan 2010
Primary completionSep 2012
Study completionSep 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00985686
Sponsor's protocol ID: 22549
Other IDs: Ethics ID 22549
Acronym: LEAP
Status last verified: Jul 2015
First submitted: 24 Sep 2009
Last updated: 29 Jul 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 26702639

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00985686
Acronym / sponsor ID: LEAP / 22549
Conditions: Depression
Keywords: e-mental health, Adolescent mental health, Spirituality
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: Patricia SteeleUniversity, hospital or other
Collaborators: Alberta Centre for Child, Family & Community Research, Alberta Health Services, Calgary, Mount Royal University, SickKids Foundation, University of Calgary
Study start: Jan 2010
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 28 Sep 2009 (estimated)
Results: Posted 6 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Study Arm	Experimental	Other: LEAP ProjectArm where participants began the LEAP Project intervention upon recruitment for an 8 week period.
Waitlist Arm	Active comparator	Other: LEAP ProjectArm 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).

Who may qualify

Ages: 13 to 24 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LEAP ProjectIn 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.	Other	Study Arm, Waitlist Arm

Primary outcome

Children's Depression Rating Scale Revised (CDRS-R)
Time frame: At 8 week intervals over a 24 week period
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.
Hamilton Depression Rating Scale (HAMD)
Time frame: At 8 week intervals over a 24 week period
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.

5 secondary outcomes

Piers-Harris Children's Self-Concept Scale - Second Edition (Piers Harris 2)
Time frame: At 8 week intervals over a 24 week period
Six Factor Self-Concept Scale
Time frame: At 8 week intervals over a 24 week period
Profile of Mood States (POMS)
Time frame: At 8 week intervals over a 24 week period
Spiritual Well-Being Scale (SWBS)
Time frame: At 8 week intervals over a 24 week period
Spiritual Involvement and Belief Scale (SIBS)
Time frame: At 8 week intervals over a 24 week period

Results and safety

Results posted to the registry on 6 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study Arm, Younger Subgroup	18	17
Study Arm, Older Subgroup	16	15
Waitlist Arm, Younger Subgroup	13	13
Waitlist Arm, Older Subgroup	16	14

Primary outcome: Children's Depression Rating Scale Revised (CDRS-R)

Time frame: At 8 week intervals over a 24 week period. Mean (Standard Error). Unit: units on a scale

Measure	Younger Subgroup (13-18 Years of Age) n = 31
Study Arm - Baseline (n=18)	57.18 (1.87)
Waitlist Arm - Baseline (n=13)	61.67 (2.21)
Study Arm - Week 8 (n=18)	44.94 (2.86)
Waitlist Arm - Week 8 (n=13)	58.93 (3.37)
Study Arm - Week 16 (n=18)	36.54 (2.77)
Waitlist Arm - Week 16 (n=13)	44.97 (3.26)
Study Arm - Week 24 (n=17)	34.37 (3.22)
Waitlist Arm - Week 24 (n=13)	42.28 (3.79)

Primary outcome: Hamilton Depression Rating Scale (HAMD)

Time frame: At 8 week intervals over a 24 week period. Mean (Standard Error). Unit: units on a scale

Measure	Older Subgroup (19-24 Years of Age) n = 31
Study Arm - Baseline (n=15)	22.14 (0.65)
Waitlist Arm - Baseline (n=16)	20.90 (0.65)
Study Arm - Week 8 (n=15)	14.07 (1.13)
Waitlist Arm - Week 8 (n=16)	17.79 (1.12)
Study Arm - Week 16 (n=15)	11.40 (1.39)
Waitlist Arm - Week 16 (n=16)	9.91 (1.39)
Study Arm - Week 24 (n=15)	8.81 (1.4)
Waitlist Arm - Week 24 (n=14)	8.49 (1.40)

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study Arm, Younger Subgroup	0 of 18 (0%)	0 of 18 (0%)	Not reported
Study Arm, Older Subgroup	0 of 15 (0%)	0 of 15 (0%)	Not reported
Waitlist Arm, Younger Subgroup	0 of 13 (0%)	0 of 13 (0%)	Not reported
Waitlist Arm, Older Subgroup	0 of 16 (0%)	0 of 16 (0%)	Not reported

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26702639Rickhi 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.
Canadian Institute of Natural and Integrative Medicine (CINIM)Link provided by the sponsor.
The LEAP ProjectLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Toews, MD, FRCPC principal investigator

Canadian Institute of Natural and Integrative Medicine

Badri Rickhi, MB MD FRCPC principal investigator

Canadian Institute of Natural and Integrative Medicine

Jordan Cohen, MD, FRCPC principal investigator

University of Calgary

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing LEAP Project in people with Depression, run by Patricia Steele at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Children's Depression Rating Scale Revised (CDRS-R) (time frame: At 8 week intervals over a 24 week period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00985686, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2015; AzTrials last refreshed its copy on 27 Oct 2026.