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

October 27, 2010 updated by: Arizona State University

Evaluation of a Psychoeducational Intervention Teaching Mindfulness and Lifestyle Interventions for Clinical Depression and Anxiety (A Pilot Study)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84121
        • Utah Youth Village

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Psychoeducational Course
In this arm, clients receive the psychoeducational course.
Behavioral: Psychoeducational course
Psychoeducational course on mindfulness and lifestyle interventions for depression and anxiety
Other Names:
  • Psychoeducational, therapeutic, psychosocial, self-help
No Intervention: Treatment-as-usual/Waiting list
Clients assigned to this condition will receive treatment-as-usual (TAU) and be placed on a waiting list.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory (BDI)
Time Frame: 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.
BDI administered at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Anxiety Inventory (BAI)
Time Frame: BAI administered at 8 weeks
BAI administered at 8 weeks
Beck Anxiety Inventory (BAI)
Time Frame: BAI administered at 12 weeks
BAI administered at 12 weeks
Beck Anxiety Inventory (BAI)
Time Frame: BAI administered at 24 weeks
BAI administered at 24 weeks
Beck Anxiety Inventory (BAI)
Time Frame: BAI administered at 60 weeks
BAI administered at 60 weeks
Beck Depression Inventory (BDI)
Time Frame: BDI administered at 8 weeks
BDI administered at 8 weeks
Beck Depression Inventory (BDI)
Time Frame: BDI administered at 24 weeks
BDI administered at 24 weeks
Beck Depression Inventory (BDI)
Time Frame: BDI administered at 60 weeks
BDI administered at 60 weeks
Beck Anxiety Inventory (BAI)
Time Frame: BAI administered at Day 1 of Study
BAI administered at Day 1 of Study
Beck Depression Inventory (BDI)
Time Frame: BDI administered at Day 1 of Study
BDI administered at Day 1 of Study
Client Medication Use
Time Frame: Measured on Day 1 of Study
Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication.
Measured on Day 1 of Study
Client Medication Use
Time Frame: Measured at 8 weeks
Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication.
Measured at 8 weeks
Client Medication Use
Time Frame: Measured at 12 weeks
Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication.
Measured at 12 weeks
Client Medication Use
Time Frame: Measured at 24 weeks
Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication.
Measured at 24 weeks
Client Medication Use
Time Frame: Measured at 60 weeks
Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication.
Measured at 60 weeks
Client Currently Seeing Therapist
Time Frame: Measured on Day 1 of study
Clients are given a survey which includes a question asking if they are currently seeing a clinician for psychotherapy.
Measured on Day 1 of study
Client Currently Seeing Therapist
Time Frame: Measured at week 8
Clients are given a survey which includes a question asking if they are currently seeing a clinician for psychotherapy.
Measured at week 8
Client Currently Seeing Therapist
Time Frame: Measured at week 12
Clients are given a survey which includes a question asking if they are currently seeing a clinician for psychotherapy.
Measured at week 12
Client Currently Seeing Therapist
Time Frame: Measured at week 24
Clients are given a survey which includes a question asking if they are currently seeing a clinician for psychotherapy.
Measured at week 24
Client Currently Seeing Therapist
Time Frame: Measured at week 60
Clients are given a survey which includes a question asking if they are currently seeing a clinician for psychotherapy.
Measured at week 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arizona State University

Investigators

  • Principal Investigator: Jeffrey R Lacasse, PhD, Arizona State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

January 1, 2011

Study Completion (Anticipated)

October 1, 2011

Study Registration Dates

First Submitted

October 19, 2010

First Submitted That Met QC Criteria

October 27, 2010

First Posted (Estimate)

October 28, 2010

Study Record Updates

Last Update Posted (Estimate)

October 28, 2010

Last Update Submitted That Met QC Criteria

October 27, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Psychoeducational course

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe