Overview

This trial is active, not recruiting.

Conditions depression, anxiety, major depression
Treatment psychoeducational course
Sponsor Arizona State University
Start date October 2010
End date January 2011
Trial size 30 participants
Trial identifier NCT01230047, 1018

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
In this arm, clients receive the psychoeducational course.
psychoeducational course Psychoeducational, therapeutic, psychosocial, self-help
Psychoeducational course on mindfulness and lifestyle interventions for depression and anxiety
(No Intervention)
Clients assigned to this condition will receive treatment-as-usual (TAU) and be placed on a waiting list.

Primary Outcomes

Measure
Beck Depression Inventory (BDI)
time frame: BDI administered at 12 weeks

Secondary Outcomes

Measure
Beck Anxiety Inventory (BAI)
time frame: BAI administered at 8 weeks
Beck Anxiety Inventory (BAI)
time frame: BAI administered at 12 weeks
Beck Anxiety Inventory (BAI)
time frame: BAI administered at 24 weeks
Beck Anxiety Inventory (BAI)
time frame: BAI administered at 60 weeks
Beck Depression Inventory (BDI)
time frame: BDI administered at 8 weeks
Beck Depression Inventory (BDI)
time frame: BDI administered at 24 weeks
Beck Depression Inventory (BDI)
time frame: BDI administered at 60 weeks
Beck Anxiety Inventory (BAI)
time frame: BAI administered at Day 1 of Study
Beck Depression Inventory (BDI)
time frame: BDI administered at Day 1 of Study
Client Medication Use
time frame: Measured on Day 1 of Study
Client Medication Use
time frame: Measured at 8 weeks
Client Medication Use
time frame: Measured at 12 weeks
Client Medication Use
time frame: Measured at 24 weeks
Client Medication Use
time frame: Measured at 60 weeks
Client Currently Seeing Therapist
time frame: Measured on Day 1 of study
Client Currently Seeing Therapist
time frame: Measured at week 8
Client Currently Seeing Therapist
time frame: Measured at week 12
Client Currently Seeing Therapist
time frame: Measured at week 24
Client Currently Seeing Therapist
time frame: Measured at week 60

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

Inclusion Criteria: - Participants self-report as having depression or anxiety - Adults (age 18 or above) - Clients willing to participate in an 8-week psychoeducational course Exclusion Criteria: - A diagnosis of a psychotic disorder - Unwilling to participate in 8-week psychoeducational course

Additional Information

Official title Evaluation of a Psychoeducational Intervention Teaching Mindfulness and Lifestyle Interventions for Clinical Depression and Anxiety (A Pilot Study)
Principal investigator Jeffrey R Lacasse, PhD
Description This study evaluates a psychoeducational intervention: Teaching mindfulness and lifestyle interventions to adult clients who self-report problems with depression and/or anxiety. The course is eight weeks long. Clients are assigned to either (1) receive the course (COU condition) from October- December 2010 or (2) placed on a waiting list and receive treatment-as-usual (TAU condition). Those in the TAU group will be offered the course in January 2011. Random assignment to COU or TAU conditions will be attempted although this may be relaxed due to institutional constraints. Participants are assessed on the Beck Depression Inventory (BDI) and Beck Anxiety Inventory (BAI) at the beginning of the course, on the last day of the course, at 1-month post-course, at 4-months post-course, and at 12-months post-course. Participants in the COU condition will be compared to those in TAU condition at the beginning of the course, on the last day of the course, and at 1-month post-course. Further evaluations (4 and 12 months post-course) will be pre-post evaluations without a comparison group.
Trial information was received from ClinicalTrials.gov and was last updated in October 2010.
Information provided to ClinicalTrials.gov by Arizona State University.