NCT01230047

Brief Summary

This is a quasi-experimental evaluation of psychoeducational course focusing on mindfulness and lifestyle changes for depression and anxiety; clients in active treatment group are compared to those in a treatment-as-usual wait-list control group. The primary hypothesis is that the psychoeducational course will result in lower levels of depression and anxiety as compared to the wait-listed treatment-as-usual comparison group.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Oct 2010

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2010

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 28, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 28, 2010

Status Verified

October 1, 2010

Enrollment Period

3 months

First QC Date

October 19, 2010

Last Update Submit

October 27, 2010

Conditions

Keywords

depressionanxietypsychoeducationself-helppsychosocial

Outcome Measures

Primary Outcomes (1)

  • Beck Depression Inventory (BDI)

    Depression will be assessed by comparing BDI scores on day one with BDI scores at twelve weeks (four weeks after conclusion of the psychoeducational course). The primary study hypothesis is that the psychoeducational course group will have a greater reduction in BDI scores when compared to the treatment-as-usual wait-listed comparison group.

    BDI administered at 12 weeks

Secondary Outcomes (19)

  • Beck Anxiety Inventory (BAI)

    BAI administered at 8 weeks

  • Beck Anxiety Inventory (BAI)

    BAI administered at 12 weeks

  • Beck Anxiety Inventory (BAI)

    BAI administered at 24 weeks

  • Beck Anxiety Inventory (BAI)

    BAI administered at 60 weeks

  • Beck Depression Inventory (BDI)

    BDI administered at 8 weeks

  • +14 more secondary outcomes

Study Arms (2)

Psychoeducational Course

EXPERIMENTAL

In this arm, clients receive the psychoeducational course.

Behavioral: Psychoeducational course

Treatment-as-usual/Waiting list

NO INTERVENTION

Clients assigned to this condition will receive treatment-as-usual (TAU) and be placed on a waiting list.

Interventions

Psychoeducational course on mindfulness and lifestyle interventions for depression and anxiety

Also known as: Psychoeducational, therapeutic, psychosocial, self-help
Psychoeducational Course

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants self-report as having depression or anxiety
  • Adults (age 18 or above)
  • Clients willing to participate in an 8-week psychoeducational course

You may not qualify if:

  • A diagnosis of a psychotic disorder
  • Unwilling to participate in 8-week psychoeducational course

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Utah Youth Village

Salt Lake City, Utah, 84121, United States

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersDepressive Disorder, Major

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersDepressive DisorderMood Disorders

Study Officials

  • Jeffrey R Lacasse, PhD

    Arizona State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 19, 2010

First Posted

October 28, 2010

Study Start

October 1, 2010

Primary Completion

January 1, 2011

Study Completion

October 1, 2011

Last Updated

October 28, 2010

Record last verified: 2010-10

Locations