Posttraumatic Stress Disorder Clinical Trial
Official title:
Examining the Effectiveness of STAIR as an Alternative to DBT for Patients With Emotion Dysregulation and PTSD
Verified date | May 2022 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will examine the impact of Skills Training in Affective and Interpersonal Regulation (STAIR) group, using self-report measures, on Posttraumatic Stress Disorder (PTSD), emotional dysregulation, borderline personality disorder symptoms, global psychopathology, and access to quality mental health care. Aims include assessing the feasibility of STAIR, reducing patients' trauma and emotion dysregulation symptoms, examining whether STAIR may be used as an alternative to DBT for patients on the DBT, and improving patient satisfaction and clinic efficiency
Status | Enrolling by invitation |
Enrollment | 30 |
Est. completion date | June 15, 2025 |
Est. primary completion date | June 15, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Be 18 years or older. - Have a DSM-5 diagnosis and/or symptoms for which DBT is an indicated treatment - Meet DSM-5 criteria for a diagnosis of posttraumatic stress disorder (PTSD) - Meet criteria at a subclinical level for BPD (a minimum of three symptoms) - Must be able to make group commitments for attendance, safety, and sobriety during group Exclusion Criteria: - If currently receiving individual therapy that follows the DBT protocol or is an evidence-based trauma-focused therapy - If the STAIR therapy group is determined to be clinically contraindicated |
Country | Name | City | State |
---|---|---|---|
United States | Stanford University | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
Cloitre M, Koenen KC, Cohen LR, Han H. Skills training in affective and interpersonal regulation followed by exposure: a phase-based treatment for PTSD related to childhood abuse. J Consult Clin Psychol. 2002 Oct;70(5):1067-74. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants who complete the STAIR intervention | This number will include those who attend the 12 weeks of STAIR with no more than three missed sessions | Week 12 | |
Primary | Total score of patient treatment satisfaction ratings | Calculate the total score for each participant on the Client Satisfaction Questionnaire-8, and find the average of those scores. Scores are summed across items. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction. | Week 12 | |
Primary | Frequency of participant attendance | Calculate the number of patients who attended each week of the STAIR treatment. | Week 1 through Week 12 | |
Primary | Change in emotion regulation total score from baseline to Week 12 | Problems with emotion regulation will be assessed using the Difficulty in Emotion Regulation Scale. Total score ranges from 36 to 180. Higher scores indicate greater problems with emotion regulation. | Baseline to Week 12 | |
Primary | Change in the severity of posttraumatic stress disorder symptom total score from baseline to Week 12 | The severity of posttraumatic stress disorder symptoms is measured using the PCL-5. Items are rated using a 5-point likert scale ranging from 0 "not at all" to 4 "extremely." All 20 items are summed to obtain a total score (0 to 80), higher scores indicate higher severity of PTSD symptoms. | Baseline to Week 12 | |
Primary | Change in Borderline symptom severity total score from baseline to Week 12 | Using the Borderline Evaluation of Severity Scale comprising of 15 items using a likert scale rated from 5 "Almost Always" to 1 "Almost Never." There are three subscales that comprise this measure: (1) Thoughts and Emotions (2) Behaviors-Negative and (3) Behaviors-Positive. The total for each subscale is determined to score the BEST. The scores of subscales A and B are then added together and the total from subscale C is subtracted. A correction factor of 15 is added to yield the final score which can range from 12 (best) to 72 (worst). | Baseline and Week 12 | |
Primary | Change in Borderline Symptom List-23 total score from baseline to Week 12 | This measure assesses feelings and experiences commonly endorsed by patients with BPD. The 23-item scale utilizes a 5-point Likert scale ranging from 0 = "not at all" to 4 = "very strong." The BSL-23 is scored by summing up the scores for all of the items. Total score ranges from 0 to 92, with higher scores reflecting more severe borderline personality symptoms. | Baseline and Week 12 | |
Primary | Change in current symptoms of psychopathology and psychological distress total score from baseline to Week 12 | The Symptom Checklist-90-Revised is a 90-item multidimensional self-report symptom measure that assesses current symptoms of psychopathology and psychological distress. The items were scored on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). It assesses nine symptom dimensions (somatization, obsessive compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism). Global measures are provided to summarize overall distress, and these include the Global Severity Index, Positive Symptom Distress Index, and Positive Symptom Total. Raw scores are calculated by dividing the sum of scores for a specific dimension by the number of items in the dimension. Global severity index is calculated by summing the scores of the nine dimensions and additional items, then dividing by the total number of responses. Total score ranges from 0 to 360. Higher scores indicate worsening of disease. | Baseline and Week 12 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03384706 -
A Comparison of CPT Versus ART Versus WL
|
N/A | |
Completed |
NCT03418129 -
Neuromodulatory Treatments for Pain Management in TBI
|
N/A | |
Completed |
NCT03129204 -
Sensation Awareness Focused Training for Spouses
|
N/A | |
Recruiting |
NCT05651295 -
A Precision Medicine Approach to Target Engagement for Emotion Regulation
|
N/A | |
Completed |
NCT05113277 -
Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention
|
N/A | |
Recruiting |
NCT05327504 -
Written Exposure Therapy for Veterans With SUD and PTSD
|
N/A | |
Recruiting |
NCT05843695 -
Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety
|
N/A | |
Active, not recruiting |
NCT05530642 -
An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel
|
N/A | |
Completed |
NCT00644423 -
Omega-3 Fatty Acids and Post Traumatic Stress Disorder (PTSD)
|
N/A | |
Completed |
NCT02989987 -
NET for SGBV Survivors in Eastern DR Congo
|
N/A | |
Completed |
NCT02320799 -
Randomized Controlled Trial of Interpersonal Psychotherapy for Depression and PTSD Among HIV+ Women in Kenya
|
N/A | |
Recruiting |
NCT02293291 -
Thermal Clinic Treatment in Gulf War Illness
|
Phase 1/Phase 2 | |
Completed |
NCT02242136 -
Treatment of Posttraumatic Stress Disorder and Aggressive Behavior in Soldiers and Ex-combatants
|
N/A | |
Completed |
NCT02720497 -
The Efficacy of 90-Minute Versus 60-Minute Sessions of Prolonged Exposure for PTSD
|
N/A | |
Completed |
NCT01911585 -
Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure
|
N/A | |
Terminated |
NCT01408641 -
Topiramate for Alcohol Use in Posttraumatic Stress Disorder
|
N/A | |
Completed |
NCT01693978 -
Contingency Outcomes in Prolonged Exposure
|
N/A | |
Completed |
NCT01469754 -
Longitudinal Survey Analysis in Lymphoma Survivors
|
N/A | |
Completed |
NCT02362477 -
Telemental Health and Cognitive Processing Therapy for Female Veterans With Military-related PTSD
|
Phase 3 | |
Terminated |
NCT01239173 -
Emotional Memory Reactivation in Posttraumatic Stress Disorder
|
Phase 3 |