E-Mental Health Adolescent Depression Program (LEAP) - Clinical Trial for Depression | NCT00985686

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

LEAP Project

About this trial

This is an interventional treatment trial for Depression focused on measuring e-mental health, Adolescent mental health, Spirituality

Eligibility Criteria

13 Years - 24 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

Canadian Institute of Natural and Integrative Medicine (CINIM)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study Arm

Waitlist Arm

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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.

Spiritual Well-Being Scale (SWBS)

Measure of level spiritual well-being in 13-18 year olds. The self administered 10-item version was used.

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.

Full Information

NCT ID

NCT00985686

First Posted

September 24, 2009

Last Updated

July 7, 2015

Sponsor

Patricia Steele

Collaborators

Alberta Centre for Child, Family & Community Research, Alberta Health Services, Calgary, Mount Royal University, SickKids Foundation, University of Calgary

1. Study Identification

Unique Protocol Identification Number

NCT00985686

Brief Title

E-Mental Health Adolescent Depression Program (LEAP)

Acronym

LEAP

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Patricia Steele

Collaborators

Alberta Centre for Child, Family & Community Research, Alberta Health Services, Calgary, Mount Royal University, SickKids Foundation, University of Calgary

4. Oversight

Data Monitoring Committee

No

5. Study Description

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: 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

Keywords

e-mental health, Adolescent mental health, Spirituality

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study Arm

Arm Type

Experimental

Arm Description

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

Arm Title

Waitlist Arm

Arm Type

Active Comparator

Arm 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).

Intervention Type

Other

Intervention Name(s)

LEAP Project

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

At 8 week intervals over a 24 week period

Title

Hamilton Depression Rating Scale (HAMD)

Description

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.

Time Frame

At 8 week intervals over a 24 week period

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

At 8 week intervals over a 24 week period

Title

Six Factor Self-Concept Scale

Description

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.

Time Frame

At 8 week intervals over a 24 week period

Title

Profile of Mood States (POMS)

Description

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.

Time Frame

At 8 week intervals over a 24 week period

Title

Spiritual Well-Being Scale (SWBS)

Description

Measure of level spiritual well-being in 13-18 year olds. The self administered 10-item version was used.

Time Frame

At 8 week intervals over a 24 week period

Title

Spiritual Involvement and Belief Scale (SIBS)

Description

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.

Time Frame

At 8 week intervals over a 24 week period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

24 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials: