PsychotherapyNCT03114423
Eye Movement Desensitization and Reprocessing (EMDR) as a Treatment of Substance Use Disorders
A study testing EMDR-Therapy in people with Psychotherapy and Substance Use Disorders, run by Center of Integrative Addiction Research, Austria at 1 site in Austria.
Trial summary
The purpose of this clinical study is to examine the established, therapeutic EMDR intervention for patients with substance use disorders (SUD). The EMDR method is an integrative and structured therapeutic method which assumes that memories which have been dysfunctionally stored can lead to harmful behavior. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Psychotherapy, Substance Use Disorders
- What is being tested?
- EMDR-Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- 7 Apr 2017to Jul 2021
- 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 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- male
- SUD diagnosis
- age between 18 and 60 years
- patient must be stationary for at least six weeks
- patient must be full contractual capability
Who cannot join
- psychotic episode
- comorbid severe dissociative symptoms
- comorbid severe personality disorders
- organic conditional seizure disorders, and somatic disorders (e.g., severe cardiac arrhythmias).
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Grüner Kreis, Verein zur Rehabilitation und Integration suchtkranker Menschen
Johnsdorf, Styria, 8350
Human-Friedrich Unterrainer, PD DDr., 0043 699 18195 990, human.unterrainer@uni-graz.at
About this study
Official title: The Efficiency of Eye Movement Desensitization and Reprocessing (EMDR) for the Treatment of Substance Use Disorders: A Randomized Controlled Trial
The purpose of this clinical study is to examine the established, therapeutic EMDR intervention for patients with substance use disorders (SUD). The EMDR method is an integrative and structured therapeutic method which assumes that memories which have been dysfunctionally stored can lead to harmful behavior. The EMDR protocol used for this clinical trials has been specifically developed for patients with SUD - the results should be compared with traditional therapy. For the assessment of the EMDR treatment some questionnaires are given at several times.
Read the detailed description
Substance use disorders (SUD) have been prominently described on a neuronal level as a chronic and relapsing brain disorder, which is associated with changes in emotion, motivation and cognition. Furthermore on a behavioral level, SUD have been found to be linked to an increased amount of attachment and personality pathology. More in general, SUD treatment has been demonstrated to be a complex phenomenon, with high relapse rates of 30-50% after (successful) treatment.
As emotion regulation is associated with a vast amount of parameters of mental health and psychological well-being such as more satisfied employment, healthier relationships, better academic performance, and physical health, the long-term abuse of drugs on the other hand plays a detrimental role in patients' emotions and mind-sets. Research suggests that individuals who cannot regulate their emotions in an adequate way in everyday life, experience more mental turbulences or confusions. In turn this deficit might lead to substance abuse as one kind of dysfunctional method to regulate inner tensions.
Specifically, an increased amount of impulsivity has been named as being predictive for addictive diseases. Accordingly, impulsivity was observed as being linked to a poorer SUD treatment outcome, especially by promoting relapse, as the emotion regulation is hindered and damaged in SUD patients. Thus the increase of capacities to moderate emotional strain becomes an important factor for the treatment of SUD. Accordingly, many SUD treatment approaches have developed specific techniques in order to address the deficient emotion regulation system. Furthermore a history of traumatic experiences may be essential for the therapeutic work, because individuals with SUD often present a history of trauma with comorbid rates of up to 75%. Consequentely, various findings suggest that traumatic experiences represent a high risk factor for the development of SUD.
The method of Eye Movement Desensitization and Reprocessing (EMDR) is an integrative and well structured psychotherapeutic treatment which has received approval as an efficacious evidence-based approach for posttraumatic stress disorder (PTSD). EMDR, as a psychotherapeutic technique, accelerates the accessing and reprocessing of traumatic materials and supports the brain to release the nervous system from these traumatic experiences by means of normal handling of emotional information. Due to the fact that up to 40% of individuals with PTSD turn to substance abuse in their lifetime, EMDR is effective in the treatment of SUD especially in case of unsolved traumata, which are keeping up the vicious circle of SUD. Furthermore several studies suggest that EMDR is effective in addiction treatment by significantly reducing substance craving and thus also the rate of relapse, extending consecutive sobriety, as well as more than twice as many graduates in EMDR integrated programs. However, the evidence of the efficacy and effectiveness of EMDR on addiction treatment is still limited, because many findings are preliminary as being narratively or just case-study based or paying less attention to the role of emotions. Therefore, the purpose of this study is to further explore and determine the effectiveness of EMDR for the regulation of emotional processes in long-term addiction treatment.
This study is conceptualized as a randomized controlled trial with two groups: EMDR + TAU vs. TAU + sham intervention (TAU: Treatment As Usual; the sham intervention is a cognitive training). The groups are compared pre-treatment, post-treatment, and there are two follow-up points of assessment: one month after post-treatment and three months after post-treatment. There will be a total sample of 60 clinical SUD male participants, which will be investigated during their in-patient stay at a therapeutic community center (after an initial phase of acclimatization of six weeks). One half of the sample: 30 participants will receive EMDR + TAU (experimental group; EG), the other half receives TAU + sham intervention (control group; CG).
- Conditions
- Psychotherapy, Substance Use Disorders
- Being tested
- EMDR-Therapy, Sham Intervention
- Keywords
- EMDR, Psychotherapy, Substance Use Disorders, Eye Movement Desensitization and Reprocessing
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMDR-TherapyOther
The EMDR-protocol from Hase (2008) was used
Sham InterventionOther
For the training the COGPACK-program from Marker (2008) was used
| Study group | Role | What they receive |
|---|---|---|
| Treatment As Usual + Treatment with EMDR | Experimental | Not described Receives: Other: EMDR-Therapy |
| Treatment As Usual + Cognitive Training | Sham comparator | Not described Receives: Other: Sham Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotion Regulation Questionnaire (ERQ)
Emotion regulation is captured via 10 items on a 7-pint rating scale.
Measured: Change of baseline values in ERQ after three treatments; follow-up_1 four weeks and follow-up_2 12 weeks after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start7 Apr 2017
- Primary completionSep 2020 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for PsychotherapyStudies 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center of Integrative Addiction Research, Austria
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Graz
- Responsible party
- Sponsor
- Investigators
- Human-Friedrich Unterrainer, PD DDr., Principal investigator, Center of Integrative Addiction Research, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114423
- Sponsor's protocol ID
- EMDR_1
- Status last verified
- Aug 2019
- First submitted
- 11 Apr 2017
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abel, N. J., & O'Brien, J. M. (2010). EMDR Treatment of Comorbid PTSD and Alcohol Dependence: A Case Example. Journal of EMDR Practice and Research, 4(2), 50-59. http://doi.org/10.1891/1933-3196.4.2.50.
Abler, B., & Kessler, H. (2009). Emotion Regulation Questionnaire - Eine Deutschsprachige Fassung des ERQ von Gross und John. Diagnostica, 55(3), 144-152. http://doi.org/10.1026/0012-1924.55.3.144.
Aldao A, Nolen-Hoeksema S, Schweizer S. Emotion-regulation strategies across psychopathology: A meta-analytic review. Clin Psychol Rev. 2010 Mar;30(2):217-37. doi: 10.1016/j.cpr.2009.11.004. Epub 2009 Nov 20.
PubMed 20015584Ursano RJ, Bell C, Eth S, Friedman M, Norwood A, Pfefferbaum B, Pynoos JD, Zatzick DF, Benedek DM, McIntyre JS, Charles SC, Altshuler K, Cook I, Cross CD, Mellman L, Moench LA, Norquist G, Twemlow SW, Woods S, Yager J; Work Group on ASD and PTSD; Steering Committee on Practice Guidelines. Practice guideline for the treatment of patients with acute stress disorder and posttraumatic stress disorder. Am J Psychiatry. 2004 Nov;161(11 Suppl):3-31. No abstract available.
PubMed 15617511Brown, S. H., Gilman, S. G., Goodman, E. G., Adler-Tapia, R., & Freng, S. (2015). Integrated Trauma Treatment in Drug Court: Combining EMDR Therapy and Seeking Safety. Journal of EMDR Practice and Research, 9(3), 123-136. http://dx.doi.org/10.1891/1933-3196.9.3.123
Ersche KD, Sahakian BJ. The neuropsychology of amphetamine and opiate dependence: implications for treatment. Neuropsychol Rev. 2007 Sep;17(3):317-36. doi: 10.1007/s11065-007-9033-y. Epub 2007 Aug 10.
PubMed 17690986Flores, J. P., 2004. Addiction as an Attachment Disorder. Maryland: Jason Aronson Inc. Publishers. Franke, G. H. (2000). Brief Symptom Inventory (BSI). Göttingen: Beltz.
Hase, M., Schallmayer, S., & Sack, M. (2008). EMDR Reprocessing of the Addiction Memory: Pretreatment, Posttreatment, and 1-Month Follow-Up. Journal of EMDR Practice and Research, 2(3), 170-179. http://doi.org/10.1891/1933-3196.2.3.170.
Homer BD, Solomon TM, Moeller RW, Mascia A, DeRaleau L, Halkitis PN. Methamphetamine abuse and impairment of social functioning: a review of the underlying neurophysiological causes and behavioral implications. Psychol Bull. 2008 Mar;134(2):301-10. doi: 10.1037/0033-2909.134.2.301.
PubMed 18298273Jacobsen LK, Southwick SM, Kosten TR. Substance use disorders in patients with posttraumatic stress disorder: a review of the literature. Am J Psychiatry. 2001 Aug;158(8):1184-90. doi: 10.1176/appi.ajp.158.8.1184.
PubMed 11481147Klinitzke G, Romppel M, Hauser W, Brahler E, Glaesmer H. [The German Version of the Childhood Trauma Questionnaire (CTQ): psychometric characteristics in a representative sample of the general population]. Psychother Psychosom Med Psychol. 2012 Feb;62(2):47-51. doi: 10.1055/s-0031-1295495. Epub 2011 Dec 27. German.
PubMed 22203470Lee, C. W., Taylor, G., & Drummond, P. D. (2006). The active ingredient in EMDR: Is it traditional exposure or dual focus of attention? Clinical Psychology and Psychotherapy, 13(2), 97-107. http://doi.org/10.1002/cpp.479.
Loree AM, Lundahl LH, Ledgerwood DM. Impulsivity as a predictor of treatment outcome in substance use disorders: review and synthesis. Drug Alcohol Rev. 2015 Mar;34(2):119-34. doi: 10.1111/dar.12132. Epub 2014 Mar 31.
PubMed 24684591Marich J. Eye movement desensitization and reprocessing in addiction continuing care: a phenomenological study of women in recovery. Psychol Addict Behav. 2010 Sep;24(3):498-507. doi: 10.1037/a0018574.
PubMed 20853935Marissen MA, Franken IH, Blanken P, van den Brink W, Hendriks VM. Cue exposure therapy for the treatment of opiate addiction: results of a randomized controlled clinical trial. Psychother Psychosom. 2007;76(2):97-105. doi: 10.1159/000097968.
PubMed 17230050
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency of Eye Movement Desensitization and Reprocessing (EMDR) for the Treatment of Substance Use Disorders: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03114423
- Acronym / sponsor ID
- EMDR_1
- Conditions
- Psychotherapy, Substance Use Disorders
- Keywords
- EMDR, Psychotherapy, Substance Use Disorders, Eye Movement Desensitization and Reprocessing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Center of Integrative Addiction Research, AustriaUniversity, hospital or other
- Collaborators
- Medical University of Graz
- Study start
- 7 Apr 2017 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 14 Apr 2017 (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.
The purpose of this clinical study is to examine the established, therapeutic EMDR intervention for patients with substance use disorders (SUD). The EMDR method is an integrative and structured therapeutic method which assumes that memories which have been dysfunctionally stored can lead to harmful behavior. The EMDR protocol used for this clinical trials has been specifically developed for patients with SUD - the results should be compared with traditional therapy. For the assessment of the EMDR treatment some questionnaires are given at several times.
Detailed description
Substance use disorders (SUD) have been prominently described on a neuronal level as a chronic and relapsing brain disorder, which is associated with changes in emotion, motivation and cognition. Furthermore on a behavioral level, SUD have been found to be linked to an increased amount of attachment and personality pathology. More in general, SUD treatment has been demonstrated to be a complex phenomenon, with high relapse rates of 30-50% after (successful) treatment.
As emotion regulation is associated with a vast amount of parameters of mental health and psychological well-being such as more satisfied employment, healthier relationships, better academic performance, and physical health, the long-term abuse of drugs on the other hand plays a detrimental role in patients' emotions and mind-sets. Research suggests that individuals who cannot regulate their emotions in an adequate way in everyday life, experience more mental turbulences or confusions. In turn this deficit might lead to substance abuse as one kind of dysfunctional method to regulate inner tensions.
Specifically, an increased amount of impulsivity has been named as being predictive for addictive diseases. Accordingly, impulsivity was observed as being linked to a poorer SUD treatment outcome, especially by promoting relapse, as the emotion regulation is hindered and damaged in SUD patients. Thus the increase of capacities to moderate emotional strain becomes an important factor for the treatment of SUD. Accordingly, many SUD treatment approaches have developed specific techniques in order to address the deficient emotion regulation system. Furthermore a history of traumatic experiences may be essential for the therapeutic work, because individuals with SUD often present a history of trauma with comorbid rates of up to 75%. Consequentely, various findings suggest that traumatic experiences represent a high risk factor for the development of SUD.
The method of Eye Movement Desensitization and Reprocessing (EMDR) is an integrative and well structured psychotherapeutic treatment which has received approval as an efficacious evidence-based approach for posttraumatic stress disorder (PTSD). EMDR, as a psychotherapeutic technique, accelerates the accessing and reprocessing of traumatic materials and supports the brain to release the nervous system from these traumatic experiences by means of normal handling of emotional information. Due to the fact that up to 40% of individuals with PTSD turn to substance abuse in their lifetime, EMDR is effective in the treatment of SUD especially in case of unsolved traumata, which are keeping up the vicious circle of SUD. Furthermore several studies suggest that EMDR is effective in addiction treatment by significantly reducing substance craving and thus also the rate of relapse, extending consecutive sobriety, as well as more than twice as many graduates in EMDR integrated programs. However, the evidence of the efficacy and effectiveness of EMDR on addiction treatment is still limited, because many findings are preliminary as being narratively or just case-study based or paying less attention to the role of emotions. Therefore, the purpose of this study is to further explore and determine the effectiveness of EMDR for the regulation of emotional processes in long-term addiction treatment.
This study is conceptualized as a randomized controlled trial with two groups: EMDR + TAU vs. TAU + sham intervention (TAU: Treatment As Usual; the sham intervention is a cognitive training). The groups are compared pre-treatment, post-treatment, and there are two follow-up points of assessment: one month after post-treatment and three months after post-treatment. There will be a total sample of 60 clinical SUD male participants, which will be investigated during their in-patient stay at a therapeutic community center (after an initial phase of acclimatization of six weeks). One half of the sample: 30 participants will receive EMDR + TAU (experimental group; EG), the other half receives TAU + sham intervention (control group; CG).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual + Treatment with EMDR | Experimental | Other: EMDR-Therapy |
| Treatment As Usual + Cognitive Training | Sham comparator | Other: Sham Intervention |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- male
- SUD diagnosis
- age between 18 and 60 years
- patient must be stationary for at least six weeks
- patient must be full contractual capability
Key exclusion criteria (4 listed)
- psychotic episode
- comorbid severe dissociative symptoms
- comorbid severe personality disorders
- organic conditional seizure disorders, and somatic disorders (e.g., severe cardiac arrhythmias).
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 |
|---|---|---|
| EMDR-TherapyThe EMDR-protocol from Hase (2008) was used | Other | Treatment As Usual + Treatment with EMDR |
| Sham InterventionFor the training the COGPACK-program from Marker (2008) was used | Other | Treatment As Usual + Cognitive Training |
Primary outcome
Emotion Regulation Questionnaire (ERQ)
Time frame: Change of baseline values in ERQ after three treatments; follow-up_1 four weeks and follow-up_2 12 weeks after treatment.
Emotion regulation is captured via 10 items on a 7-pint rating scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- BackgroundAbel, N. J., & O'Brien, J. M. (2010). EMDR Treatment of Comorbid PTSD and Alcohol Dependence: A Case Example. Journal of EMDR Practice and Research, 4(2), 50-59. http://doi.org/10.1891/1933-3196.4.2.50.
- BackgroundAbler, B., & Kessler, H. (2009). Emotion Regulation Questionnaire - Eine Deutschsprachige Fassung des ERQ von Gross und John. Diagnostica, 55(3), 144-152. http://doi.org/10.1026/0012-1924.55.3.144.
- Background: PubMed 20015584Aldao A, Nolen-Hoeksema S, Schweizer S. Emotion-regulation strategies across psychopathology: A meta-analytic review. Clin Psychol Rev. 2010 Mar;30(2):217-37. doi: 10.1016/j.cpr.2009.11.004. Epub 2009 Nov 20.
- Background: PubMed 15617511Ursano RJ, Bell C, Eth S, Friedman M, Norwood A, Pfefferbaum B, Pynoos JD, Zatzick DF, Benedek DM, McIntyre JS, Charles SC, Altshuler K, Cook I, Cross CD, Mellman L, Moench LA, Norquist G, Twemlow SW, Woods S, Yager J; Work Group on ASD and PTSD; Steering Committee on Practice Guidelines. Practice guideline for the treatment of patients with acute stress disorder and posttraumatic stress disorder. Am J Psychiatry. 2004 Nov;161(11 Suppl):3-31. No abstract available.
- BackgroundBrown, S. H., Gilman, S. G., Goodman, E. G., Adler-Tapia, R., & Freng, S. (2015). Integrated Trauma Treatment in Drug Court: Combining EMDR Therapy and Seeking Safety. Journal of EMDR Practice and Research, 9(3), 123-136. http://dx.doi.org/10.1891/1933-3196.9.3.123
- Background: PubMed 17690986Ersche KD, Sahakian BJ. The neuropsychology of amphetamine and opiate dependence: implications for treatment. Neuropsychol Rev. 2007 Sep;17(3):317-36. doi: 10.1007/s11065-007-9033-y. Epub 2007 Aug 10.
- BackgroundFlores, J. P., 2004. Addiction as an Attachment Disorder. Maryland: Jason Aronson Inc. Publishers. Franke, G. H. (2000). Brief Symptom Inventory (BSI). Göttingen: Beltz.
- BackgroundHase, M., Schallmayer, S., & Sack, M. (2008). EMDR Reprocessing of the Addiction Memory: Pretreatment, Posttreatment, and 1-Month Follow-Up. Journal of EMDR Practice and Research, 2(3), 170-179. http://doi.org/10.1891/1933-3196.2.3.170.
- Background: PubMed 18298273Homer BD, Solomon TM, Moeller RW, Mascia A, DeRaleau L, Halkitis PN. Methamphetamine abuse and impairment of social functioning: a review of the underlying neurophysiological causes and behavioral implications. Psychol Bull. 2008 Mar;134(2):301-10. doi: 10.1037/0033-2909.134.2.301.
- Background: PubMed 11481147Jacobsen LK, Southwick SM, Kosten TR. Substance use disorders in patients with posttraumatic stress disorder: a review of the literature. Am J Psychiatry. 2001 Aug;158(8):1184-90. doi: 10.1176/appi.ajp.158.8.1184.
- Background: PubMed 22203470Klinitzke G, Romppel M, Hauser W, Brahler E, Glaesmer H. [The German Version of the Childhood Trauma Questionnaire (CTQ): psychometric characteristics in a representative sample of the general population]. Psychother Psychosom Med Psychol. 2012 Feb;62(2):47-51. doi: 10.1055/s-0031-1295495. Epub 2011 Dec 27. German.
- BackgroundLee, C. W., Taylor, G., & Drummond, P. D. (2006). The active ingredient in EMDR: Is it traditional exposure or dual focus of attention? Clinical Psychology and Psychotherapy, 13(2), 97-107. http://doi.org/10.1002/cpp.479.
- Individual participant dataSharing planned: No
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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.
Human-Friedrich Unterrainer, PD DDr. principal investigator
Center of Integrative Addiction Research, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMDR-Therapy in people with Psychotherapy and Substance Use Disorders, run by Center of Integrative Addiction Research, Austria at 1 site in Austria.
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 5 inclusion and 4 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 5 Aug 2019. 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 Austria. 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. Some participants in this study may receive a placebo. 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?
Contact Rene Pilz, MSc MBA (004331638581479, rene.pilz@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotion Regulation Questionnaire (ERQ) (time frame: Change of baseline values in ERQ after three treatments; follow-up_1 four weeks and follow-up_2 12 weeks after treatment.). 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 NCT03114423, which also lists 28 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 5 Aug 2019.