Long Term Depressed MoodPhase 3NCT00226863
Meditation and Hypnosis for Chronic Depressed Mood
A Phase 3 study testing meditation plus education, group psychotherapy with hypnosis plus education and education in people with Long Term Depressed Mood, run by Stanford University.
Trial summary
This study examined whether meditation or group psychotherapy including hypnosis plus education, compared to an educational control, would ameliorate long-term depressed mood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long Term Depressed Mood
- What is being tested?
- meditation plus education, group psychotherapy with hypnosis plus education and education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Currently meeting DSM-IV criteria for a chronic depressive disorder, with the requirement that depressive symptoms had to have lasted for at least 2 years without a remission of 2 months or more.
- Being 18 years of age or older.
- Being sufficiently proficient in English to be able to participate in group therapy.
- Being able to attend weekly meetings at Stanford.
Who cannot join
- Concurrent bipolar disorder or severe depressive disorder (this latter was determined in supervision for the SCID interviews).
- Presence or history of psychosis.
- A current primary diagnosis of panic disorder, generalized anxiety disorder, or PTSD.
- A current primary diagnosis of drug or alcohol dependency or abuse (within the last 3 months).
- Serious suicidal risk, as defined by:
- Current suicidality, i.e., beyond simple ideation (e.g., making threats or attempts; gathering means; has a plan); OR
Show all 10Show fewer
- Serious prior attempts (bodily harm; gathered means; hospitalization).
- Has a significant medical condition that could interfere with participation in meditation/yoga.
- Current participation in psychotherapy or a meditation group.
- Has started (or changed level or type of) prescribed antidepressant medication or St. John's Wort in the previous 3 months.
About this study
This study examined whether meditation or group psychotherapy including hypnosis plus education, compared to an educational control, would ameliorate long-term depressed mood.
- Conditions
- Long Term Depressed Mood
- Being tested
- meditation plus education, group psychotherapy with hypnosis plus education, education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meditation plus educationBehavioural
group psychotherapy with hypnosis plus educationBehavioural
educationBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long Term Depressed MoodStudies of the same condition, open and under way.
- More trials run by Stanford 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Investigators
- Lisa D. Butler, Ph.D., Study director, Stanford UniversityDavid Spiegel, M.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226863
- Sponsor's protocol ID
- 1HSA698
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 27 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meditation and Hypnosis for Chronic Depressed Mood
- ClinicalTrials.gov ID
- NCT00226863
- Acronym / sponsor ID
- 1HSA698
- Conditions
- Long Term Depressed Mood
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- First posted
- 27 Sep 2005 (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 study examined whether meditation or group psychotherapy including hypnosis plus education, compared to an educational control, would ameliorate long-term depressed mood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Currently meeting DSM-IV criteria for a chronic depressive disorder, with the requirement that depressive symptoms had to have lasted for at least 2 years without a remission of 2 months or more.
- Being 18 years of age or older.
- Being sufficiently proficient in English to be able to participate in group therapy.
- Being able to attend weekly meetings at Stanford.
Key exclusion criteria (10 listed)
- Concurrent bipolar disorder or severe depressive disorder (this latter was determined in supervision for the SCID interviews).
- Presence or history of psychosis.
- A current primary diagnosis of panic disorder, generalized anxiety disorder, or PTSD.
- A current primary diagnosis of drug or alcohol dependency or abuse (within the last 3 months).
- Serious suicidal risk, as defined by:
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 |
|---|---|---|
| meditation plus education | Behavioural | – |
| group psychotherapy with hypnosis plus education | Behavioural | – |
| education | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2005.
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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.
Lisa D. Butler, Ph.D. study director
Stanford University
David Spiegel, M.D. principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing meditation plus education, group psychotherapy with hypnosis plus education and education in people with Long Term Depressed Mood, run by Stanford University.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 27 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 27 Sep 2005.