Post-traumatic Stress DisorderNCT05924399
PTSD Affect Labeling Study
A study testing Affect Labeling Training in people with Post-traumatic Stress Disorder and Post-Traumatic Stress Disorder, Chronic, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The overall goal of this study is to use fMRI and psychophysiological measures to investigate a novel strategy involving "Affect Labeling" for improving emotion regulation in PTSD that could lead to a new treatment regimen for PTSD. Our project has two specific aims. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-traumatic Stress Disorder, Post-Traumatic Stress Disorder, Chronic
- What is being tested?
- Affect Labeling Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2014to 9 Oct 2015
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All Ps must be veterans with deployment experience.
- Ps must meet DSM-IV criterion "A" for PTSD, which requires exposure to a traumatic event involving actual or threatened physical injury or death. This trauma must have occurred during military service, but may take a variety of forms (e.g., injury to self, witnessing death of another, etc.).
- Ps must be 18-45 years old (18-60 for non-fMRI Ps) since normal age-related structural and functional variations in participants above and below this age range could prevent accurate comparison of neural activity across participants.
- Ps must be English-speaking as translation of all study materials into other languages would be cost-prohibitive.
- Both male and female participants are allowed.
- Ps who will complete the fMRI must be right-handed in order to allow comparison of neural activity across participants.
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- Additional Inclusion Criterion for PTSD Participants (PTSDs): PTSDs must meet full DSM- IV criteria for PTSD with a trauma related to their military service, as assessed by the CAPS.
- Additional Inclusion Criterion for Healthy Control Participants (HCs): HCs must not meet DSM-IV criteria for current/lifetime PTSD or any other current Axis I disorders.
- Must be 18-45 years old
- Must be English-speaking
- Male or female participants are allowed
Who cannot join
- Ps must not have any metallic implants or other non-removable metal in the body (e.g., shrapnel, surgical staples or screws, etc.) as this would preclude them from undergoing any MRI scanning.
- Ps must not be claustrophobic in order to be able to complete all fMRI procedures.
- Ps must not be pregnant (as assessed by verbal report) as the research question is not pregnancy-related.
- Ps must not have any serious unstable medical illnesses.
- Ps must not have intellectual impairment, bipolar disorder, psychosis, delusional disorder, or suicidality.
- Ps must not have any organic brain damage, including a history of moderate to severe traumatic brain injury (TBI), as this would confound analyses comparing activations across subjects. A history of mild TBI is allowed.
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- Ps must not meet DSM-IV criteria for Substance Dependence within the last six months due to both the possibility of neural changes associated with the substance use, and issues of participant safety.
- Ps must not have made any recent modifications to psychotropic medication status (i.e., within the last 1 month for benzodiazepines and within the last 3 months for SSRI and SSNIs).
- Ps must not have recently initiated or made changes to any psychotherapy (within the last 3 months).
- Ps must not have had any chronic or repeated neglect/maltreatment, sexual abuse, physical abuse, emotional abuse, or domestic violence prior to the age of 7 (as assessed with the Early Trauma Inventory and CAPS), given evidence for adverse brain development and structural abnormalities in this subgroup of individuals.
- Ps must not be pregnant (as assessed by verbal report) as the research question is not pregnancy-related.
- Ps must not have any serious unstable medical illnesses.
- Ps must not have intellectual impairment, bipolar disorder, psychosis, delusional disorder, or suicidality.
- Ps must not meet DSM-IV criteria for Substance Dependence within the last six months due to issues of participant safety.
- Ps must not have made any recent modifications to psychotropic medication status (i.e., within the last 1 month for benzodiazepines and within the last 3 months for SSRI and SSNIs).
- Ps must not have recently initiated or made changes to any psychotherapy (within the last 3 months).
- Additional Exclusion Criterion for PTSD Participants (PTSDs):
- The investigators will exclude highly-dissociative individuals, defined as those who score 15 or higher on the Clinician Administered Dissociative States Scale (Bremner et al., 1998). While the majority (i.e., 70%) of individuals with PTSD are characterized by prefrontal under-regulation and limbic over-responding to trauma cues, research has also identified a subgroup of PTSD individuals, up to 30%, who are characterized as highly 'dissociative' and exhibit the opposite neural pattern to trauma cues, i.e., abnormally low and over-regulated amygdala responses (Lanius et al., 2010). The current proposal focuses on the former, larger group of less-dissociation-prone PTSD individuals with inhibitory deficits, as this appears to be the group for whom inhibitory enhancement may be particularly helpful. Accordingly, the investigators will exclude those with high levels of baseline dissociative symptomology in this first proof-of-concept study.
- Ps must not have been exposed to a DSM-IV defined traumatic event.
- Ps must not meet criteria for any current DSM-IV Axis I disorder and must not have intellectual impairment or current suicidality.
- Ps must not be pregnant (as assessed by verbal report) as the research question is not pregnancy-related.
- Ps must not have any serious unstable medical illnesses.
- Ps must not be currently receiving treatment for a psychiatric problem (including psychotherapy and psychotropic medication).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: Affect Labeling: A Promising New Approach for Mitigating PTSD
The overall goal of this study is to use fMRI and psychophysiological measures to investigate a novel strategy involving "Affect Labeling" for improving emotion regulation in PTSD that could lead to a new treatment regimen for PTSD.
Our project has two specific aims. First, the investigators aim to identify a novel neural target for possible PTSD intervention by verifying that RVLPFC-based inhibitory processing is impaired in PTSD. Second, the investigators will examine whether repeated practice with a simple cognitive-emotional task that requires inhibitory processing, namely, affect labeling, can strengthen the RVLPFC's ability to down-regulate emotional responses and physiological reactivity in PTSD and thereby form the basis of a novel treatment strategy to be developed in future studies. Secondary objectives are to examine the extent to which RVLPFC-based inhibitory impairments in PTSD are specific to trauma-relevant emotional processing (i.e., trauma-related distress) or extend to other types of inhibitory regulation in general, which would have implications for the future study of inhibitory-enhancement-based interventions for PTSD.
Read the detailed description
Previous research suggests that individuals with PTSD have impaired RVLPFC- based inhibitory regulation. Such deficits would appear to contribute to poor inhibitory regulation of emotional responses when faced with trauma-reminders, which represents a core pathological mechanism of PTSD.
However, no previous studies have directly examined RVLPFC-based inhibitory deficits of emotional responses in PTSD. Affect labeling is a simple process that involves linguistic processing of emotional responses, for example, verbally labeling current feelings as "anxious" or "angry", and is an established form of affective inhibitory regulation involving RVLPFC down-regulation of amygdala-based affective responses. Therefore, the investigators will test whether PTSD is associated with impaired RVLPFC-based emotional inhibitory processing compared to healthy control participants by performing fMRI scan while they use affect labeling to label their own emotional responses to emotionally-evocative images relevant to their trauma. The investigators will then test whether repeated practice with affect labeling will "repair" the impaired RVLPFC inhibitory control in PTSD, by strengthening the capacity of the RVLPFC to down-regulate amygdala responses. In support of this idea, the investigators have previously demonstrated that exposure therapy augmented with affect labeling was more effective in reducing fear responses than exposure alone in specific phobia (Kircanski et al., 2013). In the present study, following the initial baseline fMRI scan mentioned above, participants with PTSD will complete three weeks of affect labeling training and then undergo a second fMRI scan to again assess inhibitory regulation capacity.
The investigators hypothesize that, compared to healthy (without PTSD) subjects, participants with PTSD will exhibit less RVLPFC activity, more amygdala activity (i.e., less amygdala deactivation), as well as less inverse correlation between the RVLPFC and the amygdala at baseline, reflecting impaired inhibitory regulation. In addition, the investigators hypothesize that participants will exhibit increased physiological reactivity compared to healthy control subjects.
The investigators also hypothesize that affect labeling training will lead to increased inhibitory regulation success, which will be reflected by increased RVLPFC activity, decreased amygdala activity, increased inverse connectivity between RVLPFC and amygdala from pre to post training. The results from this initial effort will form the foundation for future studies examining affect labeling training as a bona fide treatment strategy for PTSD.
- Being tested
- Affect Labeling Training
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Affect Labeling TrainingBehavioural
(1) Participants will view combat-relevant images and then label the image or how they feel while viewing the image. (2) Participants will view facial expressions and then label the image. (3) Participants will view negative combat- irrelevant images (such as snakes or spiders) and then label the image or how they feel while viewing the image. (4) Participants will complete Go-NoGo trials similar to the fMRI Go-NoGo task described above. Participants will receive all four types of inhibitory training.
| Study group | Role | What they receive |
|---|---|---|
| Affect Labeling Training | Experimental | Participants complete a total of six training sessions, twice a week for three consecutive weeks. In each session, they spend 40 minutes completing computer-based inhibitory regulation training utilizing four strategies. Receives: Behavioral: Affect Labeling Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Affective Schedules - State & Trait Versions (PANAS)
The PANAS is a widely used measure comprising 20-items assessing activated forms of Positive Affect and Negative Affect using 5-point scales (1 = very slightly/not at all, 5 = extremely). Higher scores on each subscale (positive affect and negative affect) reflect higher levels of positive and negative affect, respectively.
Measured: Change from baseline to Post-AL Training (3 weeks from baseline)
Mood and Anxiety Symptom Questionnaire - Mini Version
The Mini-MASQ is a 26-item measure of mood and anxiety symptoms developed to evaluate predictions of the tripartite model of anxiety and depression. The MASQ has three subscales: (1) General Distress (GD: 8 items), (2) Anxious Arousal (AA: 10 items), and (3) Anhedonic Depression (AD: 8 items). Respondents indicate the extent to which they experienced each symptom during the past week from 1=not at all to 5=extremely.
Measured: Change from baseline to Post-AL Training (3 weeks from baseline)
Emotion Regulation Questionnaires (ERQ)
The ERQ is a 10-item measure designed to assess individual differences in the habitual use of two emotion regulation strategies: cognitive reappraisal and expressive suppression.
Measured: Change from baseline to Post-AL Training (3 weeks from baseline)
fMRI Inhibitory regulation of trauma-relevant emotion
The primary outcome variables for our key objectives will be neural activity obtained during the baseline fMRI scans for participants with PTSD (PTSDs) vs. healthy controls (HCs) as well as changes in neural activity from pre to post training for PTSDs.
Measured: Change from baseline to Post-AL Training (3 weeks from baseline)
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Clinician-reported PTSD symptom severity
Measured: Change from baseline to Post-AL Training (3 weeks from baseline)
Mindful Attention Awareness Scale (MAAS)
The trait MAAS is a 15-item scale designed to assess a core characteristic of mindfulness, namely, a receptive state of mind in which attention, informed by a sensitive awareness of what is occurring in the present, simply observes what is taking place.
Measured: Change from baseline to Post-AL Training (3 weeks from baseline)
PTSD Checklist for DSM-5 (PCL-5)
Self-reported PTSD symptom severity. The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD using a 5-point Likert scale of how much they were bothered by each symptom (0 = "not at all" to 4 = "extremely"). Scores are summed and higher scores represent greater self-reported PTSD symptoms. Scores range from 0-80.
Measured: Change from baseline to Post-AL Training (3 weeks from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start5 Aug 2014
- Primary completion9 Oct 2015
- Study completion9 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Defense Group, Inc., Defense Advanced Research Projects Agency
- Responsible party
- Principal investigator, Michelle Craske, University of California, Los Angeles
- Investigators
- Lisa J Burklund, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924399
- Sponsor's protocol ID
- W911NF-14-C-0056
- Status last verified
- Jun 2023
- First submitted
- 6 Jun 2023
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Burklund LJ, Davies CD, Niles A, Torre JB, Brown L, Vinograd M, Lieberman MD, Craske MG. Affect labeling: a promising new neuroscience-based approach to treating combat-related PTSD in veterans. Front Psychol. 2024 Jun 7;15:1270424. doi: 10.3389/fpsyg.2024.1270424. eCollection 2024.
PubMed 38911954
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affect Labeling: A Promising New Approach for Mitigating PTSD
- ClinicalTrials.gov ID
- NCT05924399
- Acronym / sponsor ID
- W911NF-14-C-0056
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Defense Group, Inc., Defense Advanced Research Projects Agency
- Study start
- 5 Aug 2014 (actual)
- Primary completion
- 9 Oct 2015 (actual)
- Study completion
- 9 Oct 2015 (actual)
- First posted
- 29 Jun 2023 (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 overall goal of this study is to use fMRI and psychophysiological measures to investigate a novel strategy involving "Affect Labeling" for improving emotion regulation in PTSD that could lead to a new treatment regimen for PTSD.
Our project has two specific aims. First, the investigators aim to identify a novel neural target for possible PTSD intervention by verifying that RVLPFC-based inhibitory processing is impaired in PTSD. Second, the investigators will examine whether repeated practice with a simple cognitive-emotional task that requires inhibitory processing, namely, affect labeling, can strengthen the RVLPFC's ability to down-regulate emotional responses and physiological reactivity in PTSD and thereby form the basis of a novel treatment strategy to be developed in future studies. Secondary objectives are to examine the extent to which RVLPFC-based inhibitory impairments in PTSD are specific to trauma-relevant emotional processing (i.e., trauma-related distress) or extend to other types of inhibitory regulation in general, which would have implications for the future study of inhibitory-enhancement-based interventions for PTSD.
Detailed description
Previous research suggests that individuals with PTSD have impaired RVLPFC- based inhibitory regulation. Such deficits would appear to contribute to poor inhibitory regulation of emotional responses when faced with trauma-reminders, which represents a core pathological mechanism of PTSD.
However, no previous studies have directly examined RVLPFC-based inhibitory deficits of emotional responses in PTSD. Affect labeling is a simple process that involves linguistic processing of emotional responses, for example, verbally labeling current feelings as "anxious" or "angry", and is an established form of affective inhibitory regulation involving RVLPFC down-regulation of amygdala-based affective responses. Therefore, the investigators will test whether PTSD is associated with impaired RVLPFC-based emotional inhibitory processing compared to healthy control participants by performing fMRI scan while they use affect labeling to label their own emotional responses to emotionally-evocative images relevant to their trauma. The investigators will then test whether repeated practice with affect labeling will "repair" the impaired RVLPFC inhibitory control in PTSD, by strengthening the capacity of the RVLPFC to down-regulate amygdala responses. In support of this idea, the investigators have previously demonstrated that exposure therapy augmented with affect labeling was more effective in reducing fear responses than exposure alone in specific phobia (Kircanski et al., 2013). In the present study, following the initial baseline fMRI scan mentioned above, participants with PTSD will complete three weeks of affect labeling training and then undergo a second fMRI scan to again assess inhibitory regulation capacity.
The investigators hypothesize that, compared to healthy (without PTSD) subjects, participants with PTSD will exhibit less RVLPFC activity, more amygdala activity (i.e., less amygdala deactivation), as well as less inverse correlation between the RVLPFC and the amygdala at baseline, reflecting impaired inhibitory regulation. In addition, the investigators hypothesize that participants will exhibit increased physiological reactivity compared to healthy control subjects.
The investigators also hypothesize that affect labeling training will lead to increased inhibitory regulation success, which will be reflected by increased RVLPFC activity, decreased amygdala activity, increased inverse connectivity between RVLPFC and amygdala from pre to post training. The results from this initial effort will form the foundation for future studies examining affect labeling training as a bona fide treatment strategy for PTSD.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Affect Labeling Training | Experimental | Behavioral: Affect Labeling TrainingParticipants complete a total of six training sessions, twice a week for three consecutive weeks. In each session, they spend 40 minutes completing computer-based inhibitory regulation training utilizing four strategies. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- All Ps must be veterans with deployment experience.
- Ps must meet DSM-IV criterion "A" for PTSD, which requires exposure to a traumatic event involving actual or threatened physical injury or death. This trauma must have occurred during military service, but may take a variety of forms (e.g., injury to self, witnessing death of another, etc.).
- Ps must be 18-45 years old (18-60 for non-fMRI Ps) since normal age-related structural and functional variations in participants above and below this age range could prevent accurate comparison of neural activity across participants.
- Ps must be English-speaking as translation of all study materials into other languages would be cost-prohibitive.
- Both male and female participants are allowed.
Key exclusion criteria (23 listed)
- Ps must not have any metallic implants or other non-removable metal in the body (e.g., shrapnel, surgical staples or screws, etc.) as this would preclude them from undergoing any MRI scanning.
- Ps must not be claustrophobic in order to be able to complete all fMRI procedures.
- Ps must not be pregnant (as assessed by verbal report) as the research question is not pregnancy-related.
- Ps must not have any serious unstable medical illnesses.
- Ps must not have intellectual impairment, bipolar disorder, psychosis, delusional disorder, or suicidality.
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 |
|---|---|---|
| Affect Labeling Training(1) Participants will view combat-relevant images and then label the image or how they feel while viewing the image. (2) Participants will view facial expressions and then label the image. (3) Participants will view negative combat- irrelevant images (such as snakes or spiders) and then label the image or how they feel while viewing the image. (4) Participants will complete Go-NoGo trials similar to the fMRI Go-NoGo task described above. Participants will receive all four types of inhibitory training. | Behavioural | Affect Labeling Training |
Primary outcome
Positive and Negative Affective Schedules - State & Trait Versions (PANAS)
Time frame: Change from baseline to Post-AL Training (3 weeks from baseline)
The PANAS is a widely used measure comprising 20-items assessing activated forms of Positive Affect and Negative Affect using 5-point scales (1 = very slightly/not at all, 5 = extremely). Higher scores on each subscale (positive affect and negative affect) reflect higher levels of positive and negative affect, respectively.
Mood and Anxiety Symptom Questionnaire - Mini Version
Time frame: Change from baseline to Post-AL Training (3 weeks from baseline)
The Mini-MASQ is a 26-item measure of mood and anxiety symptoms developed to evaluate predictions of the tripartite model of anxiety and depression. The MASQ has three subscales: (1) General Distress (GD: 8 items), (2) Anxious Arousal (AA: 10 items), and (3) Anhedonic Depression (AD: 8 items). Respondents indicate the extent to which they experienced each symptom during the past week from 1=not at all to 5=extremely.
Emotion Regulation Questionnaires (ERQ)
Time frame: Change from baseline to Post-AL Training (3 weeks from baseline)
The ERQ is a 10-item measure designed to assess individual differences in the habitual use of two emotion regulation strategies: cognitive reappraisal and expressive suppression.
fMRI Inhibitory regulation of trauma-relevant emotion
Time frame: Change from baseline to Post-AL Training (3 weeks from baseline)
The primary outcome variables for our key objectives will be neural activity obtained during the baseline fMRI scans for participants with PTSD (PTSDs) vs. healthy controls (HCs) as well as changes in neural activity from pre to post training for PTSDs.
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: Change from baseline to Post-AL Training (3 weeks from baseline)
Clinician-reported PTSD symptom severity
Mindful Attention Awareness Scale (MAAS)
Time frame: Change from baseline to Post-AL Training (3 weeks from baseline)
The trait MAAS is a 15-item scale designed to assess a core characteristic of mindfulness, namely, a receptive state of mind in which attention, informed by a sensitive awareness of what is occurring in the present, simply observes what is taking place.
PTSD Checklist for DSM-5 (PCL-5)
Time frame: Change from baseline to Post-AL Training (3 weeks from baseline)
Self-reported PTSD symptom severity. The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD using a 5-point Likert scale of how much they were bothered by each symptom (0 = "not at all" to 4 = "extremely"). Scores are summed and higher scores represent greater self-reported PTSD symptoms. Scores range from 0-80.
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 29 Jun 2023.
- Derived from this study: PubMed 38911954Burklund LJ, Davies CD, Niles A, Torre JB, Brown L, Vinograd M, Lieberman MD, Craske MG. Affect labeling: a promising new neuroscience-based approach to treating combat-related PTSD in veterans. Front Psychol. 2024 Jun 7;15:1270424. doi: 10.3389/fpsyg.2024.1270424. eCollection 2024.
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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 J Burklund, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Affect Labeling Training in people with Post-traumatic Stress Disorder and Post-Traumatic Stress Disorder, Chronic, run by University of California, Los Angeles 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 11 inclusion and 23 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 29 Jun 2023. 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?
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?
Positive and Negative Affective Schedules - State & Trait Versions (PANAS) (time frame: Change from baseline to Post-AL Training (3 weeks from baseline)). The study lists 7 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 NCT05924399, which also lists 1 linked publication.
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 29 Jun 2023.