E-Mental Health Adolescent Depression Program (LEAP)

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00985686

Acronym

LEAP

Enrollment

Registered

2009-09-28

Start date

2010-01-31

Completion date

2012-09-30

Last updated

2015-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

e-mental health, Adolescent mental health, Spirituality

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.

Interventions

OTHERLEAP 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

13 Years to 24 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Children's Depression Rating Scale Revised (CDRS-R)	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)	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.

Secondary

Measure	Time frame	Description
Profile of Mood States (POMS)	At 8 week intervals over a 24 week period	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.
Piers-Harris Children's Self-Concept Scale - Second Edition (Piers Harris 2)	At 8 week intervals over a 24 week period	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.
Spiritual Involvement and Belief Scale (SIBS)	At 8 week intervals over a 24 week period	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.
Spiritual Well-Being Scale (SWBS)	At 8 week intervals over a 24 week period	Measure of level spiritual well-being in 13-18 year olds. The self administered 10-item version was used.
Six Factor Self-Concept Scale	At 8 week intervals over a 24 week period	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.

Countries

Canada

Participant flow

Participants by arm

Arm	Count
Study Arm, Younger Subgroup Subgroup of participants 13-18 years of age randomized into the study arm.	18
Study Arm, Older Subgroup Subgroup of participants 19-24 years of age randomized into the study arm.	15
Waitlist Arm, Younger Subgroup Subgroup of participants 13-18 years of age randomized into the waitlist arm.	13
Waitlist Arm, Older Subgroup Subgroup of participants 19-24 years of age randomized into the waitlist arm.	16
Total	62

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Lost to Follow-up	1	1	0	2

Baseline characteristics

Characteristic	Total	Waitlist Arm, Older Subgroup	Waitlist Arm, Younger Subgroup	Study Arm, Older Subgroup	Study Arm, Younger Subgroup
Age, Continuous	18.1 years	20.9 years	15.2 years	21.0 years	15.3 years
Education High School	28 participants	0 participants	13 participants	0 participants	15 participants
Education Not in School	9 participants	2 participants	0 participants	5 participants	2 participants
Education Post Secondary Institution	25 participants	14 participants	0 participants	10 participants	1 participants
Living situation Alone	2 participants	1 participants	0 participants	1 participants	0 participants
Living situation One parent	17 participants	3 participants	3 participants	3 participants	8 participants
Living situation Other	7 participants	2 participants	2 participants	0 participants	3 participants
Living situation Partner	1 participants	0 participants	0 participants	1 participants	0 participants
Living situation Roommate	2 participants	0 participants	0 participants	2 participants	0 participants
Living situation With both parents	33 participants	10 participants	8 participants	8 participants	7 participants
Region of Enrollment Canada	62 participants	16 participants	13 participants	15 participants	18 participants
Religions denomination indicated No	32 participants	8 participants	8 participants	9 participants	7 participants
Religions denomination indicated Yes	30 participants	8 participants	5 participants	6 participants	11 participants
Sex: Female, Male Female	44 Participants	10 Participants	12 Participants	8 Participants	14 Participants
Sex: Female, Male Male	18 Participants	6 Participants	1 Participants	7 Participants	4 Participants
Use of other treatments during intervention phase Anti-depressants and Counselling	2 participants	1 participants	1 participants	0 participants	0 participants
Use of other treatments during intervention phase Anti-depressants only	10 participants	1 participants	2 participants	4 participants	3 participants
Use of other treatments during intervention phase Counselling only	16 participants	4 participants	3 participants	5 participants	4 participants
Use of other treatments during intervention phase None	34 participants	10 participants	7 participants	6 participants	11 participants
Work situation Not Working	36 participants	6 participants	10 participants	7 participants	13 participants
Work situation Working	26 participants	10 participants	3 participants	8 participants	5 participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	0 / 18	0 / 15	0 / 13	0 / 16
serious Total, serious adverse events	0 / 18	0 / 15	0 / 13	0 / 16

Outcome results

Primary

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.