Mindfulness and Lifestyle Interventions for Depression and Anxiety: A Pilot Study

Not Applicable

• Conditions: Depression; Anxiety; Major Depression
• Interventions: Behavioral: Psychoeducational course

• Registration Number: NCT01230047
• Lead Sponsor: Arizona State University

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.

Detailed 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.

Study Timeline

• Status Verified: 2010-10
• Study Start: 2010-10
• Study First Submitted: 2010-10-19
• Study First Submitted QC: 2010-10-27
• Last Update Submitted: 2010-10-27
• Study First Posted: 2010-10-28
• Last Update Posted: 2010-10-28
• Primary Completion: 2011-01
• Study Completion: 2011-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychoeducational Course	Psychoeducational course	In this arm, clients receive the psychoeducational course.

Primary Outcome Measures

Name	Time	Method
Beck Depression Inventory (BDI)	BDI administered at 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Beck Anxiety Inventory (BAI)	BAI administered at Day 1 of Study
Beck Depression Inventory (BDI)	BDI administered at Day 1 of Study
Client Medication Use	Measured at 60 weeks	Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication.
Client Currently Seeing Therapist	Measured at week 60	Clients are given a survey which includes a question asking if they are currently seeing a clinician for psychotherapy.

Trial Locations

Locations (1)

Utah Youth Village; 🇺🇸 Salt Lake City, Utah, United States