PTSDAMWELLNCT04859686
Acupuncture and Mindfulness Based Stress Reduction for Wellness
A study testing Mindfulness-Based Stress Reduction and Acupuncture Treatment in people with PTSD, run by Uniformed Services University of the Health Sciences.
Trial summary
AMWELL is a randomized, waitlist-controlled, pilot study to evaluate the comparative efficacy of Mindfulness Based Stress Reduction (MBSR) and Acupuncture (AT) to Wait-List Control (WL) in adult female survivors of childhood sexual abuse (CSA) experiencing symptoms of psychological distress. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- PTSD
- What is being tested?
- Mindfulness-Based Stress Reduction and Acupuncture Treatment
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2008to 30 Oct 2010
- 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female survivors of childhood sexual assault reported in a clinical interview (e.g., age at which the abuse began and continued, frequency and duration, and the perpetrator)
- At least 21 years old
- Ability to read and write in English
- Under the care of a licensed psychotherapist or physician for study duration
- Clinical approval for acupuncture or MBSD
- Ability to attend 80% of the sessions
Show all 9Show fewer
- Willingness to practice skills 20-30 minutes per day, six days a week
- If taking psychotropic medication, on a stable dose for 30 days prior to baseline
- A score of 0.5 or greater on the Brief Symptom Inventory (BSI)
Who cannot join
- Any major illness or psychiatric disorder
- Symptom severity as evidenced by a CGI-S score of 6 or 7
- Current suicidal ideation
- Active alcoholism or drug dependency
- Current enrollment in another clinical trial
- Major surgery scheduled
- Plans to move from the area during the 12-week study period
- Current pregnancy, plans to become pregnant, or no means of birth control
About this study
Official title: Acupuncture and Meditation for Wellness (AMWELL)
AMWELL is a randomized, waitlist-controlled, pilot study to evaluate the comparative efficacy of Mindfulness Based Stress Reduction (MBSR) and Acupuncture (AT) to Wait-List Control (WL) in adult female survivors of childhood sexual abuse (CSA) experiencing symptoms of psychological distress.
Read the detailed description
Female CSA survivors at least 21 years old were recruited from newspaper ads, radio programs, study websites and various public announcements in the Baltimore, Md and surrounding area between September, 2008 to October, 2009.
- Conditions
- PTSD
- Being tested
- Mindfulness-Based Stress Reduction, Acupuncture Treatment
- Keywords
- PTSD, Depression, Acupuncture, Mindfulness-based stress reduction, Child abuse survivors
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress ReductionBehavioural
Also called MBSR
The MBSR program included weekly 2.5-hour sessions in a group format over eight weeks, plus a 1-day retreat. Formal practices included several types of meditation, such as mindful breathing, sitting meditation, walking meditation, gentle hatha yoga, body scan, and mindful awareness. Participants were asked to practice at home for 20 minutes daily, six days a week.
Acupuncture TreatmentProcedure or surgery
Participants received two treatments per week over eight weeks, 35-40 minutes each.
At each treatment, participants were treated with 10 body and two ear points: seven major points on either the front or back of the body. The treatment position alternated between sessions, such that the first session was on the back, with the next session on the front, unless a physical limitation prevented alternation.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants underwent intervention. Receives: Behavioral: Mindfulness-Based Stress Reduction; Procedure: Acupuncture Treatment |
| Waitlist | No intervention | Participants received no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist 4 (PCL-IV) Score
PCL-IV is a self-report measure of 17 DSM-IV symptoms of PTSD. A total symptom severity score (range = 17-85) was obtained by summing the scores from each of the 17 items that have response options ranging from 1 "Not at all" to 5 "Extremely. Higher scores indicate worse symptoms of PTSD. Participants were evaluated by a study coordinator at a baseline visit, at 4 weeks for a mid-treatment measure, at 8 weeks for a posttreatment measure, and at 12 weeks for a one month follow-up assessment. Effects of the intervention were assessed using repeated measures, mixed model analysis of mean scores for each of the outcomes at baseline, 4, 8, and 12 weeks. The magnitude of treatment effect was calculated by Cohen's d for each treatment defined as the baseline to 8 week or 12 week change in mean score divided by the standard deviation of the change in scores.
Measured: Week 4, 8 and 12
Beck Depression Inventory (BDI-II) Score
The 21-item BDI-II is a widely-used, standardized, validated self-reporting measure of depressive symptom severity. It addresses affective, behavioral, biological, cognitive, and motivational symptoms of depression. Participants rated statements from 0 to 3 to indicate the level which best described the severity of the symptoms experienced. The ratings were summed to a total score, with ranges of 4-9 indicating "normal," 10-18 "mild," 9-29 "moderate to severe," and ≥ 30 indicating "severe." Scores range from 0 - 40. Higher scores indicate worse depressive symptoms. Effects of the intervention were assessed using repeated measures, mixed model analysis of mean scores for each of the outcomes at baseline, 4, 8, and 12 weeks. The magnitude of treatment effect was calculated by Cohen's d for each treatment defined as the baseline to 8 week or 12 week change in mean score divided by the standard deviation of the change in scores.
Measured: Week, 4, 8 and 12
Secondary outcomes (2)
Pittsburgh Sleep Quality Index (PSQI Score
The PSQI is a 19-item self-reported inventory providing measures of daytime dysfunction, sleep latency, duration, disturbance, quality, and efficiency, which are arranged into seven component scores. Each item is rated 0 (best) to 3 (worst); the component sums are added together, ranging from 0 (worst) to 21 (best), providing a global PSQI score. Higher scores indicate worse sleep quality.
Measured: Week 4, 8 and 12
The Mindfulness Attention Awareness Scale (MAAS) Score
The 15-item self-report MAAS measures mindfulness as open or receptive awareness and attention to the present. The questions ask about daily experiences (e.g., I snack without being aware that I'm eating.), with answers being measured on a Likert-scale of 1 (almost always) to 6 (almost never). Scores range from 15 - 90. Higher scores reflect higher levels of mindfulness.
Measured: Week 4, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Sep 2008
- Primary completion1 Oct 2009
- Study completion30 Oct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (49)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uniformed Services University of the Health Sciences
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Brian Berman, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859686
- Sponsor's protocol ID
- HP-00043308
- Acronym
- AMWELL
- Status last verified
- Apr 2021
- First submitted
- 23 Oct 2020
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Afifi TO, Taillieu T, Zamorski MA, Turner S, Cheung K, Sareen J. Association of Child Abuse Exposure With Suicidal Ideation, Suicide Plans, and Suicide Attempts in Military Personnel and the General Population in Canada. JAMA Psychiatry. 2016 Mar;73(3):229-38. doi: 10.1001/jamapsychiatry.2015.2732.
PubMed 26817953American Psychological Association. (2017). Clinical Practice Guideline for the Treatment of Posttraumatic Stress Disorder. Available at: http://www.apa.org/ptsd-guideline/treatments/index.aspx. Washington DC; Author.
Bedard-Gilligan M, Jaeger J, Echiverri-Cohen A, Zoellner LA. Individual differences in trauma disclosure. J Behav Ther Exp Psychiatry. 2012 Jun;43(2):716-23. doi: 10.1016/j.jbtep.2011.10.005. Epub 2011 Oct 29.
PubMed 22080869Beck, A. T., Steer, R. A., & Brown, G. K. (1996). Beck Depression Inventory. San Antonio, TX: The Psychological Corporation.
Belgrade, M., & Smith, S. (2013). Acupuncture and alternative treatments for painful diabetic neuropathy. Painful Diabetic Polyneuropathy, 83-93.
Brown WJ, Dewey D, Bunnell BE, Boyd SJ, Wilkerson AK, Mitchell MA, Bruce SE. A Critical Review of Negative Affect and the Application of CBT for PTSD. Trauma Violence Abuse. 2018 Apr;19(2):176-194. doi: 10.1177/1524838016650188. Epub 2016 Jun 14.
PubMed 27301345Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
PubMed 12703651Brown, K. W., & Ryan, R. M. (2006). The Mindfulness Attention Awareness Scale (MAAS). Acceptance and Commitment Therapy. Measures Package, 82.
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Chen LP, Murad MH, Paras ML, Colbenson KM, Sattler AL, Goranson EN, Elamin MB, Seime RJ, Shinozaki G, Prokop LJ, Zirakzadeh A. Sexual abuse and lifetime diagnosis of psychiatric disorders: systematic review and meta-analysis. Mayo Clin Proc. 2010 Jul;85(7):618-29. doi: 10.4065/mcp.2009.0583. Epub 2010 May 10.
PubMed 20458101Creswell JD. Mindfulness Interventions. Annu Rev Psychol. 2017 Jan 3;68:491-516. doi: 10.1146/annurev-psych-042716-051139. Epub 2016 Sep 28.
PubMed 27687118Derogatis, L. R., & Spencer, P. M. (1993). Brief Symptom Inventory: BSI. Upper Saddle River, NJ: Pearson.
Diagnostic and Statistical Manual of Mental Disorders, (2013). American Psychiatric Publishing.
Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.
PubMed 15621359Earley MD, Chesney MA, Frye J, Greene PA, Berman B, Kimbrough E. Mindfulness intervention for child abuse survivors: a 2.5-year follow-up. J Clin Psychol. 2014 Oct;70(10):933-41. doi: 10.1002/jclp.22102. Epub 2014 May 20.
PubMed 24844944
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture and Meditation for Wellness (AMWELL)
- ClinicalTrials.gov ID
- NCT04859686
- Acronym / sponsor ID
- AMWELL / HP-00043308
- Conditions
- PTSD
- Keywords
- PTSD, Depression, Acupuncture, Mindfulness-based stress reduction, Child abuse survivors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Uniformed Services University of the Health SciencesUS federal agency
- Study start
- 1 Sep 2008 (actual)
- Primary completion
- 1 Oct 2009 (actual)
- Study completion
- 30 Oct 2010 (actual)
- First posted
- 26 Apr 2021 (actual)
- 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.
AMWELL is a randomized, waitlist-controlled, pilot study to evaluate the comparative efficacy of Mindfulness Based Stress Reduction (MBSR) and Acupuncture (AT) to Wait-List Control (WL) in adult female survivors of childhood sexual abuse (CSA) experiencing symptoms of psychological distress.
Detailed description
Female CSA survivors at least 21 years old were recruited from newspaper ads, radio programs, study websites and various public announcements in the Baltimore, Md and surrounding area between September, 2008 to October, 2009.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Mindfulness-Based Stress Reduction, Procedure: Acupuncture TreatmentParticipants underwent intervention. |
| Waitlist | No intervention | –Participants received no intervention. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female survivors of childhood sexual assault reported in a clinical interview (e.g., age at which the abuse began and continued, frequency and duration, and the perpetrator)
- At least 21 years old
- Ability to read and write in English
- Under the care of a licensed psychotherapist or physician for study duration
- Clinical approval for acupuncture or MBSD
Key exclusion criteria (8 listed)
- Any major illness or psychiatric disorder
- Symptom severity as evidenced by a CGI-S score of 6 or 7
- Current suicidal ideation
- Active alcoholism or drug dependency
- Current enrollment in another clinical trial
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 |
|---|---|---|
| Mindfulness-Based Stress ReductionAlso: MBSRThe MBSR program included weekly 2.5-hour sessions in a group format over eight weeks, plus a 1-day retreat. Formal practices included several types of meditation, such as mindful breathing, sitting meditation, walking meditation, gentle hatha yoga, body scan, and mindful awareness. Participants were asked to practice at home for 20 minutes daily, six days a week. | Behavioural | Treatment |
| Acupuncture TreatmentParticipants received two treatments per week over eight weeks, 35-40 minutes each. At each treatment, participants were treated with 10 body and two ear points: seven major points on either the front or back of the body. The treatment position alternated between sessions, such that the first session was on the back, with the next session on the front, unless a physical limitation prevented alternation. | Procedure or surgery | Treatment |
Primary outcome
PTSD Checklist 4 (PCL-IV) Score
Time frame: Week 4, 8 and 12
PCL-IV is a self-report measure of 17 DSM-IV symptoms of PTSD. A total symptom severity score (range = 17-85) was obtained by summing the scores from each of the 17 items that have response options ranging from 1 "Not at all" to 5 "Extremely. Higher scores indicate worse symptoms of PTSD. Participants were evaluated by a study coordinator at a baseline visit, at 4 weeks for a mid-treatment measure, at 8 weeks for a posttreatment measure, and at 12 weeks for a one month follow-up assessment. Effects of the intervention were assessed using repeated measures, mixed model analysis of mean scores for each of the outcomes at baseline, 4, 8, and 12 weeks. The magnitude of treatment effect was calculated by Cohen's d for each treatment defined as the baseline to 8 week or 12 week change in mean score divided by the standard deviation of the change in scores.
Beck Depression Inventory (BDI-II) Score
Time frame: Week, 4, 8 and 12
The 21-item BDI-II is a widely-used, standardized, validated self-reporting measure of depressive symptom severity. It addresses affective, behavioral, biological, cognitive, and motivational symptoms of depression. Participants rated statements from 0 to 3 to indicate the level which best described the severity of the symptoms experienced. The ratings were summed to a total score, with ranges of 4-9 indicating "normal," 10-18 "mild," 9-29 "moderate to severe," and ≥ 30 indicating "severe." Scores range from 0 - 40. Higher scores indicate worse depressive symptoms. Effects of the intervention were assessed using repeated measures, mixed model analysis of mean scores for each of the outcomes at baseline, 4, 8, and 12 weeks. The magnitude of treatment effect was calculated by Cohen's d for each treatment defined as the baseline to 8 week or 12 week change in mean score divided by the standard deviation of the change in scores.
2 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI Score
Time frame: Week 4, 8 and 12
The Mindfulness Attention Awareness Scale (MAAS) Score
Time frame: Week 4, 8 and 12
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 8 Jul 2021.
- Background: PubMed 26817953Afifi TO, Taillieu T, Zamorski MA, Turner S, Cheung K, Sareen J. Association of Child Abuse Exposure With Suicidal Ideation, Suicide Plans, and Suicide Attempts in Military Personnel and the General Population in Canada. JAMA Psychiatry. 2016 Mar;73(3):229-38. doi: 10.1001/jamapsychiatry.2015.2732.
- BackgroundAmerican Psychological Association. (2017). Clinical Practice Guideline for the Treatment of Posttraumatic Stress Disorder. Available at: http://www.apa.org/ptsd-guideline/treatments/index.aspx. Washington DC; Author.
- Background: PubMed 22080869Bedard-Gilligan M, Jaeger J, Echiverri-Cohen A, Zoellner LA. Individual differences in trauma disclosure. J Behav Ther Exp Psychiatry. 2012 Jun;43(2):716-23. doi: 10.1016/j.jbtep.2011.10.005. Epub 2011 Oct 29.
- BackgroundBeck, A. T., Steer, R. A., & Brown, G. K. (1996). Beck Depression Inventory. San Antonio, TX: The Psychological Corporation.
- BackgroundBelgrade, M., & Smith, S. (2013). Acupuncture and alternative treatments for painful diabetic neuropathy. Painful Diabetic Polyneuropathy, 83-93.
- Background: PubMed 27301345Brown WJ, Dewey D, Bunnell BE, Boyd SJ, Wilkerson AK, Mitchell MA, Bruce SE. A Critical Review of Negative Affect and the Application of CBT for PTSD. Trauma Violence Abuse. 2018 Apr;19(2):176-194. doi: 10.1177/1524838016650188. Epub 2016 Jun 14.
- Background: PubMed 12703651Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
- BackgroundBrown, K. W., & Ryan, R. M. (2006). The Mindfulness Attention Awareness Scale (MAAS). Acceptance and Commitment Therapy. Measures Package, 82.
- Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Background: PubMed 20458101Chen LP, Murad MH, Paras ML, Colbenson KM, Sattler AL, Goranson EN, Elamin MB, Seime RJ, Shinozaki G, Prokop LJ, Zirakzadeh A. Sexual abuse and lifetime diagnosis of psychiatric disorders: systematic review and meta-analysis. Mayo Clin Proc. 2010 Jul;85(7):618-29. doi: 10.4065/mcp.2009.0583. Epub 2010 May 10.
- Background: PubMed 27687118Creswell JD. Mindfulness Interventions. Annu Rev Psychol. 2017 Jan 3;68:491-516. doi: 10.1146/annurev-psych-042716-051139. Epub 2016 Sep 28.
- BackgroundDerogatis, L. R., & Spencer, P. M. (1993). Brief Symptom Inventory: BSI. Upper Saddle River, NJ: Pearson.
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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.
Brian Berman, MD principal investigator
University of Maryland, Baltimore
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction and Acupuncture Treatment in people with PTSD, run by Uniformed Services University of the Health Sciences.
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 9 inclusion and 8 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 8 Jul 2021. 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.
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.
What does the primary outcome measure?
PTSD Checklist 4 (PCL-IV) Score (time frame: Week 4, 8 and 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04859686, which also lists 49 linked publications.
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 8 Jul 2021.