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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01230047
Recruitment Status : Unknown
Verified October 2010 by Arizona State University.
Recruitment status was:  Active, not recruiting
First Posted : October 28, 2010
Last Update Posted : October 28, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Depression Anxiety Major Depression Behavioral: Psychoeducational course Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Psychoeducational Intervention Teaching Mindfulness and Lifestyle Interventions for Clinical Depression and Anxiety (A Pilot Study)
Study Start Date : October 2010
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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 Name: 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.



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Beck Anxiety Inventory (BAI) [ Time Frame: BAI administered at 8 weeks ]
  2. Beck Anxiety Inventory (BAI) [ Time Frame: BAI administered at 12 weeks ]
  3. Beck Anxiety Inventory (BAI) [ Time Frame: BAI administered at 24 weeks ]
  4. Beck Anxiety Inventory (BAI) [ Time Frame: BAI administered at 60 weeks ]
  5. Beck Depression Inventory (BDI) [ Time Frame: BDI administered at 8 weeks ]
  6. Beck Depression Inventory (BDI) [ Time Frame: BDI administered at 24 weeks ]
  7. Beck Depression Inventory (BDI) [ Time Frame: BDI administered at 60 weeks ]
  8. Beck Anxiety Inventory (BAI) [ Time Frame: BAI administered at Day 1 of Study ]
  9. Beck Depression Inventory (BDI) [ Time Frame: BDI administered at Day 1 of Study ]
  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01230047


Locations
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United States, Utah
Utah Youth Village
Salt Lake City, Utah, United States, 84121
Sponsors and Collaborators
Arizona State University
Investigators
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Principal Investigator: Jeffrey R Lacasse, PhD Arizona State University
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Responsible Party: Jeffrey R. Lacasse, College of Public Programs, Arizona State University
ClinicalTrials.gov Identifier: NCT01230047    
Other Study ID Numbers: 1018
First Posted: October 28, 2010    Key Record Dates
Last Update Posted: October 28, 2010
Last Verified: October 2010
Keywords provided by Arizona State University:
depression
anxiety
psychoeducation
self-help
psychosocial
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders