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

Sponsor

Arizona State University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01230047

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Anxiety Major Depression	Behavioral: Psychoeducational course	N/A

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Oct 1, 2010

Anticipated Primary Completion Date :

Jan 1, 2011

Anticipated Study Completion Date :

Oct 1, 2011

Arms and Interventions

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 Names: 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.

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 Names:

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.

Outcome Measures

Primary Outcome Measures

Beck Depression Inventory (BDI) [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

Beck Anxiety Inventory (BAI) [BAI administered at 8 weeks]
Beck Anxiety Inventory (BAI) [BAI administered at 12 weeks]
Beck Anxiety Inventory (BAI) [BAI administered at 24 weeks]
Beck Anxiety Inventory (BAI) [BAI administered at 60 weeks]
Beck Depression Inventory (BDI) [BDI administered at 8 weeks]
Beck Depression Inventory (BDI) [BDI administered at 24 weeks]
Beck Depression Inventory (BDI) [BDI administered at 60 weeks]
Beck Anxiety Inventory (BAI) [BAI administered at Day 1 of Study]
Beck Depression Inventory (BDI) [BDI administered at Day 1 of Study]
Client Medication Use [Measured on Day 1 of Study]
Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication.
Client Medication Use [Measured at 8 weeks]
Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication.
Client Medication Use [Measured at 12 weeks]
Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication.
Client Medication Use [Measured at 24 weeks]
Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication.
Client Medication Use [Measured at 60 weeks]
Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication.
Client Currently Seeing Therapist [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.
Client Currently Seeing Therapist [Measured at week 8]
Clients are given a survey which includes a question asking if they are currently seeing a clinician for psychotherapy.
Client Currently Seeing Therapist [Measured at week 12]
Clients are given a survey which includes a question asking if they are currently seeing a clinician for psychotherapy.
Client Currently Seeing Therapist [Measured at week 24]
Clients are given a survey which includes a question asking if they are currently seeing a clinician for psychotherapy.
Client Currently Seeing Therapist [Measured at week 60]
Clients are given a survey which includes a question asking if they are currently seeing a clinician for psychotherapy.