DepressionNCT01230047
Mindfulness and Lifestyle Interventions for Depression and Anxiety: A Pilot Study
A study testing Psychoeducational course in people with Depression and Anxiety, run by Arizona State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Depression, Anxiety, Major Depression
- What is being tested?
- Psychoeducational course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants self-report as having depression or anxiety
- Adults (age 18 or above)
- Clients willing to participate in an 8-week psychoeducational course
Who cannot join
- A diagnosis of a psychotic disorder
- Unwilling to participate in 8-week psychoeducational course
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Psychoeducational Intervention Teaching Mindfulness and Lifestyle Interventions for Clinical Depression and Anxiety (A Pilot Study)
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.
- Conditions
- Depression, Anxiety, Major Depression
- Being tested
- Psychoeducational course
- Keywords
- depression, anxiety, psychoeducation, self-help, psychosocial
- Medical subject headings
- Depression, Anxiety Disorders, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational courseBehavioural
Also called Psychoeducational, therapeutic, psychosocial, self-help
Psychoeducational course on mindfulness and lifestyle interventions for depression and anxiety
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducational Course | Experimental | In this arm, clients receive the psychoeducational course. Receives: Behavioral: Psychoeducational course |
| Treatment-as-usual/Waiting list | No intervention | Clients assigned to this condition will receive treatment-as-usual (TAU) and be placed on a waiting list. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: BDI administered at 12 weeks
Secondary outcomes (19)
Beck Anxiety Inventory (BAI)
Measured: BAI administered at 8 weeks
Beck Anxiety Inventory (BAI)
Measured: BAI administered at 12 weeks
Beck Anxiety Inventory (BAI)
Measured: BAI administered at 24 weeks
Beck Anxiety Inventory (BAI)
Measured: BAI administered at 60 weeks
Beck Depression Inventory (BDI)
Measured: BDI administered at 8 weeks
Beck Depression Inventory (BDI)
Measured: BDI administered at 24 weeks
Beck Depression Inventory (BDI)
Measured: BDI administered at 60 weeks
Beck Anxiety Inventory (BAI)
Measured: BAI administered at Day 1 of Study
Beck Depression Inventory (BDI)
Measured: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: Measured at week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJan 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Investigators
- Jeffrey R Lacasse, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230047
- Sponsor's protocol ID
- 1018
- Status last verified
- Oct 2010
- First submitted
- 19 Oct 2010
- Last updated
- 28 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Psychoeducational Intervention Teaching Mindfulness and Lifestyle Interventions for Clinical Depression and Anxiety (A Pilot Study)
- ClinicalTrials.gov ID
- NCT01230047
- Acronym / sponsor ID
- 1018
- Conditions
- Depression, Anxiety, Major Depression
- Keywords
- depression, anxiety, psychoeducation, self-help, psychosocial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 28 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychoeducational Course | Experimental | Behavioral: Psychoeducational courseIn this arm, clients receive the psychoeducational course. |
| Treatment-as-usual/Waiting list | No intervention | –Clients assigned to this condition will receive treatment-as-usual (TAU) and be placed on a waiting list. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants self-report as having depression or anxiety
- Adults (age 18 or above)
- Clients willing to participate in an 8-week psychoeducational course
Key exclusion criteria (2 listed)
- A diagnosis of a psychotic disorder
- Unwilling to participate in 8-week psychoeducational course
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducational courseAlso: Psychoeducational, therapeutic, psychosocial, self-helpPsychoeducational course on mindfulness and lifestyle interventions for depression and anxiety | Behavioural | Psychoeducational Course |
Primary outcome
Beck Depression Inventory (BDI)
Time frame: 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.
19 secondary outcomes
Beck Anxiety Inventory (BAI)
Time frame: BAI administered at 8 weeks
Beck Anxiety Inventory (BAI)
Time frame: BAI administered at 12 weeks
Beck Anxiety Inventory (BAI)
Time frame: BAI administered at 24 weeks
Beck Anxiety Inventory (BAI)
Time frame: BAI administered at 60 weeks
Beck Depression Inventory (BDI)
Time frame: BDI administered at 8 weeks
Beck Depression Inventory (BDI)
Time frame: BDI administered at 24 weeks
Beck Depression Inventory (BDI)
Time frame: BDI administered at 60 weeks
Beck Anxiety Inventory (BAI)
Time frame: BAI administered at Day 1 of Study
Beck Depression Inventory (BDI)
Time frame: BDI administered at Day 1 of Study
Client Medication Use
Time frame: Measured on Day 1 of Study
Client Medication Use
Time frame: Measured at 8 weeks
Client Medication Use
Time frame: Measured at 12 weeks
Client Medication Use
Time frame: Measured at 24 weeks
Client Medication Use
Time frame: Measured at 60 weeks
Client Currently Seeing Therapist
Time frame: Measured on Day 1 of study
Client Currently Seeing Therapist
Time frame: Measured at week 8
Client Currently Seeing Therapist
Time frame: Measured at week 12
Client Currently Seeing Therapist
Time frame: Measured at week 24
Client Currently Seeing Therapist
Time frame: Measured at week 60
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey R Lacasse, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducational course in people with Depression and Anxiety, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory (BDI) (time frame: BDI administered at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2010.