CClinicalTrials.gg
Status unknownNCT01230047Updated Oct 28, 2010

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

An interventional study of Psychoeducational course in Depression, Anxiety and Major Depression, sponsored by Arizona State University. Status unknown at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2010-10-28.

Sponsored by Arizona State University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2010), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Depression
  • Anxiety
  • Major Depression

Keywords

  • depression
  • anxiety
  • psychoeducation
  • self-help
  • psychosocial
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's planned enrollment of 30 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Arizona State University is the lead sponsor of 234 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • A diagnosis of a psychotic disorder
  • Unwilling to participate in 8-week psychoeducational course
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Psychoeducational Course

    In this arm, clients receive the psychoeducational course.

    Behavioral: Psychoeducational course

  • 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.

Interventions

  • BehavioralPsychoeducational course

    Psychoeducational course on mindfulness and lifestyle interventions for depression and anxiety

    Also known as: Psychoeducational, therapeutic, psychosocial, self-help

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: BDI administered at 12 weeks

Secondary outcomes

  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

    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

  11. Client Medication Use

    Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication.

    Time frame: Measured at 8 weeks

  12. Client Medication Use

    Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication.

    Time frame: Measured at 12 weeks

  13. Client Medication Use

    Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication.

    Time frame: Measured at 24 weeks

  14. Client Medication Use

    Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication.

    Time frame: Measured at 60 weeks

  15. Client Currently Seeing Therapist

    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

  16. Client Currently Seeing Therapist

    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

  17. Client Currently Seeing Therapist

    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

  18. Client Currently Seeing Therapist

    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

  19. Client Currently Seeing Therapist

    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

07

Study locations

1 site
  • Utah Youth Village
    Salt Lake City, Utah 84121, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01230047
Lead sponsor
Arizona State University
First posted
Oct 28, 2010
Start date
Oct 2010
Primary completion
Jan 2011 (estimated)
Completion
Oct 2011 (estimated)
Last update
Oct 28, 2010

Study contacts

Jeffrey R Lacasse, PhD
principal investigator · Arizona State University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

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