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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depression, Anxiety, Major Depression

Intervention / Treatment
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* Behavioral: Psychoeducational course


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychoeducational Course<br>In this arm, clients receive the psychoeducational course. | Behavioral: Psychoeducational course<br>* Psychoeducational course on mindfulness and lifestyle interventions for depression and anxiety<br>* Other names: Psychoeducational, therapeutic, psychosocial, self-help;|
| No Intervention: Treatment-as-usual/Waiting list<br>Clients assigned to this condition will receive treatment-as-usual (TAU) and be placed on a waiting list. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication. | Measured on Day 1 of Study | 
| Client Medication Use | Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication. | Measured at 8 weeks | 
| Client Medication Use | Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication. | Measured at 12 weeks | 
| Client Medication Use | Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication. | Measured at 24 weeks | 
| Client Medication Use | Clients fill out a survey which includes a question asking if they are currently taking psychiatric medication. | Measured at 60 weeks | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, anxiety, psychoeducation, self-help, psychosocial