Mindfulness and Lifestyle Interventions for Depression and Anxiety: A Pilot Study
Primary Purpose
Depression, Anxiety, Major Depression
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychoeducational course
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring depression, anxiety, psychoeducation, self-help, psychosocial
Eligibility 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
Sites / Locations
- Utah Youth Village
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Psychoeducational Course
Treatment-as-usual/Waiting list
Arm Description
In this arm, clients receive the psychoeducational course.
Clients assigned to this condition will receive treatment-as-usual (TAU) and be placed on a waiting list.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Beck Anxiety Inventory (BAI)
Beck Anxiety Inventory (BAI)
Beck Anxiety Inventory (BAI)
Beck Anxiety Inventory (BAI)
Beck Depression Inventory (BDI)
Beck Depression Inventory (BDI)
Beck Depression Inventory (BDI)
Beck Anxiety Inventory (BAI)
Beck Depression Inventory (BDI)
Client Medication Use
Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication.
Client Medication Use
Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication.
Client Medication Use
Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication.
Client Medication Use
Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication.
Client Medication Use
Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication.
Client Currently Seeing Therapist
Clients are given a survey which includes a question asking if they are currently seeing a clinician for psychotherapy.
Client Currently Seeing Therapist
Clients are given a survey which includes a question asking if they are currently seeing a clinician for psychotherapy.
Client Currently Seeing Therapist
Clients are given a survey which includes a question asking if they are currently seeing a clinician for psychotherapy.
Client Currently Seeing Therapist
Clients are given a survey which includes a question asking if they are currently seeing a clinician for psychotherapy.
Client Currently Seeing Therapist
Clients are given a survey which includes a question asking if they are currently seeing a clinician for psychotherapy.
Full Information
NCT ID
NCT01230047
First Posted
October 19, 2010
Last Updated
October 27, 2010
Sponsor
Arizona State University
1. Study Identification
Unique Protocol Identification Number
NCT01230047
Brief Title
Mindfulness and Lifestyle Interventions for Depression and Anxiety: A Pilot Study
Official Title
Evaluation of a Psychoeducational Intervention Teaching Mindfulness and Lifestyle Interventions for Clinical Depression and Anxiety (A Pilot Study)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
January 2011 (Anticipated)
Study Completion Date
October 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Arizona State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Major Depression
Keywords
depression, anxiety, psychoeducation, self-help, psychosocial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Psychoeducational Course
Arm Type
Experimental
Arm Description
In this arm, clients receive the psychoeducational course.
Arm Title
Treatment-as-usual/Waiting list
Arm Type
No Intervention
Arm Description
Clients assigned to this condition will receive treatment-as-usual (TAU) and be placed on a waiting list.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducational course
Other Intervention Name(s)
Psychoeducational, therapeutic, psychosocial, self-help
Intervention Description
Psychoeducational course on mindfulness and lifestyle interventions for depression and anxiety
Primary Outcome Measure Information:
Title
Beck Depression Inventory (BDI)
Description
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.
Time Frame
BDI administered at 12 weeks
Secondary Outcome Measure Information:
Title
Beck Anxiety Inventory (BAI)
Time Frame
BAI administered at 8 weeks
Title
Beck Anxiety Inventory (BAI)
Time Frame
BAI administered at 12 weeks
Title
Beck Anxiety Inventory (BAI)
Time Frame
BAI administered at 24 weeks
Title
Beck Anxiety Inventory (BAI)
Time Frame
BAI administered at 60 weeks
Title
Beck Depression Inventory (BDI)
Time Frame
BDI administered at 8 weeks
Title
Beck Depression Inventory (BDI)
Time Frame
BDI administered at 24 weeks
Title
Beck Depression Inventory (BDI)
Time Frame
BDI administered at 60 weeks
Title
Beck Anxiety Inventory (BAI)
Time Frame
BAI administered at Day 1 of Study
Title
Beck Depression Inventory (BDI)
Time Frame
BDI administered at Day 1 of Study
Title
Client Medication Use
Description
Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication.
Time Frame
Measured on Day 1 of Study
Title
Client Medication Use
Description
Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication.
Time Frame
Measured at 8 weeks
Title
Client Medication Use
Description
Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication.
Time Frame
Measured at 12 weeks
Title
Client Medication Use
Description
Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication.
Time Frame
Measured at 24 weeks
Title
Client Medication Use
Description
Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication.
Time Frame
Measured at 60 weeks
Title
Client Currently Seeing Therapist
Description
Clients are given a survey which includes a question asking if they are currently seeing a clinician for psychotherapy.
Time Frame
Measured on Day 1 of study
Title
Client Currently Seeing Therapist
Description
Clients are given a survey which includes a question asking if they are currently seeing a clinician for psychotherapy.
Time Frame
Measured at week 8
Title
Client Currently Seeing Therapist
Description
Clients are given a survey which includes a question asking if they are currently seeing a clinician for psychotherapy.
Time Frame
Measured at week 12
Title
Client Currently Seeing Therapist
Description
Clients are given a survey which includes a question asking if they are currently seeing a clinician for psychotherapy.
Time Frame
Measured at week 24
Title
Client Currently Seeing Therapist
Description
Clients are given a survey which includes a question asking if they are currently seeing a clinician for psychotherapy.
Time Frame
Measured at week 60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey R Lacasse, PhD
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Utah Youth Village
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Mindfulness and Lifestyle Interventions for Depression and Anxiety: A Pilot Study
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