Clinical trial NCT01230047: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Anxiety
Major Depression
Keywords: depression
anxiety
psychoeducation
self-help
psychosocial
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2010-10-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Beck Depression Inventory (BDI)
timeFrame: BDI administered at 12 weeks
Secondary outcomes:
measure: Beck Anxiety Inventory (BAI)
timeFrame: BAI administered at 8 weeks
measure: Beck Anxiety Inventory (BAI)
timeFrame: BAI administered at 12 weeks
measure: Beck Anxiety Inventory (BAI)
timeFrame: BAI administered at 24 weeks
measure: Beck Anxiety Inventory (BAI)
timeFrame: BAI administered at 60 weeks
measure: Beck Depression Inventory (BDI)
timeFrame: BDI administered at 8 weeks
measure: Beck Depression Inventory (BDI)
timeFrame: BDI administered at 24 weeks
measure: Beck Depression Inventory (BDI)
timeFrame: BDI administered at 60 weeks
measure: Beck Anxiety Inventory (BAI)
timeFrame: BAI administered at Day 1 of Study
measure: Beck Depression Inventory (BDI)
timeFrame: BDI administered at Day 1 of Study
measure: Client Medication Use
timeFrame: Measured on Day 1 of Study
measure: Client Medication Use
timeFrame: Measured at 8 weeks
measure: Client Medication Use
timeFrame: Measured at 12 weeks
measure: Client Medication Use
timeFrame: Measured at 24 weeks
measure: Client Medication Use
timeFrame: Measured at 60 weeks
measure: Client Currently Seeing Therapist
timeFrame: Measured on Day 1 of study
measure: Client Currently Seeing Therapist
timeFrame: Measured at week 8
measure: Client Currently Seeing Therapist
timeFrame: Measured at week 12
measure: Client Currently Seeing Therapist
timeFrame: Measured at week 24
measure: Client Currently Seeing Therapist
timeFrame: Measured at week 60
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Utah Youth Village
state: Utah
Study officials:
affiliation: Arizona State University
name: Jeffrey R Lacasse, PhD
role: PRINCIPAL_INVESTIGATOR
References: