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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01230047
• Other study ID #: 1018
• Status: Active, not recruiting
• Phase: N/A
• First received: October 19, 2010
• Last updated: October 27, 2010
• Start date: October 2010
• Est. completion date: October 2011

Study information

• Verified date: October 2010
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: October 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Behavioral:
• Psychoeducational course
Psychoeducational course on mindfulness and lifestyle interventions for depression and anxiety

Locations

Country	Name	City	State
United States	Utah Youth Village	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	BDI administered at 12 weeks	No
Secondary	Beck Anxiety Inventory (BAI)		BAI administered at 8 weeks	No
Secondary	Beck Anxiety Inventory (BAI)		BAI administered at 12 weeks	No
Secondary	Beck Anxiety Inventory (BAI)		BAI administered at 24 weeks	No
Secondary	Beck Anxiety Inventory (BAI)		BAI administered at 60 weeks	No
Secondary	Beck Depression Inventory (BDI)		BDI administered at 8 weeks	No
Secondary	Beck Depression Inventory (BDI)		BDI administered at 24 weeks	No
Secondary	Beck Depression Inventory (BDI)		BDI administered at 60 weeks	No
Secondary	Beck Anxiety Inventory (BAI)		BAI administered at Day 1 of Study	No
Secondary	Beck Depression Inventory (BDI)		BDI administered at Day 1 of Study	No
Secondary	Client Medication Use	Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication.	Measured on Day 1 of Study	No
Secondary	Client Medication Use	Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication.	Measured at 8 weeks	No
Secondary	Client Medication Use	Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication.	Measured at 12 weeks	No
Secondary	Client Medication Use	Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication.	Measured at 24 weeks	No
Secondary	Client Medication Use	Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication.	Measured at 60 weeks	No
Secondary	Client Currently Seeing Therapist	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	No
Secondary	Client Currently Seeing Therapist	Clients are given a survey which includes a question asking if they are currently seeing a clinician for psychotherapy.	Measured at week 8	No
Secondary	Client Currently Seeing Therapist	Clients are given a survey which includes a question asking if they are currently seeing a clinician for psychotherapy.	Measured at week 12	No
Secondary	Client Currently Seeing Therapist	Clients are given a survey which includes a question asking if they are currently seeing a clinician for psychotherapy.	Measured at week 24	No
Secondary	Client Currently Seeing Therapist	Clients are given a survey which includes a question asking if they are currently seeing a clinician for psychotherapy.	Measured at week 60	No