Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder and Borderline Personality Disorder (PTSD-BPD)
Primary Purpose
Posttraumatic Stress Disorder, Borderline Personality Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Processing Therapy with Suicide Risk Management
Treatment as Usual with Suicide Rick Management
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Cognitive Processing Therapy, Suicide Risk Management, Suicide, Self-harm
Eligibility Criteria
Inclusion Criteria:
- Aged 18-65 years
- Must reside in the Bay Area
- Current DSM-5 diagnosis of PTSD and BPD
- Must be willing to be audio- or videorecorded for assessment and treatment sessions
Exclusion Criteria:
- Acute mania, acute psychosis, or intellectual disability
- Conditions requiring medical attention to a potentially life-threatening illness (e.g., severe anorexia nervosa)
- Severe impairments in written and aural comprehension
- EU individuals
Sites / Locations
- Palo Alto UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
CPT + SRM
TAU + SRM
Arm Description
Participants will be randomized to teletherapy sessions of Cognitive Processing Therapy + Suicide Risk Management for PTSD-BPD which will be administered twice weekly over 6 weeks, for a total of 12 sessions.
Participants will be randomized to teletherapy sessions with only Suicide Risk Management for PTSD-BPD which will be administered once a week for 6 weeks, for a total of 6 sessions.
Outcomes
Primary Outcome Measures
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
A 30-item clinician administered structured interview based on the DSM-5 PTSD criteria.
Borderline Symptom List 23 (BSL-23) [SELF-REPORT]
A self-report measure of borderline personality disorder (BPD) severity. The measure captures subjective ratings of the following symptoms: self-perception, affect regulation, self destruction, dysphoria, loneliness, intrusions, and hostility (Bohus et al., 2009).
Secondary Outcome Measures
Suicide Attempt Self-Injury Interview (SASII)
Assess characteristics of self-harm (i.e., suicide attempts and NSSI), including frequency, medical severity, intent to die, lethality, and precipitants of self-harm since the previous assessment.
Difficulties in Emotion Regulation Scale (DERS) [SELF-REPORT]
A self-report measure assessing various dimensions of emotion dysregulation (Gratz & Roemer, 2004).
Posttraumatic Cognitions Inventory (PTCI) [SELF-REPORT]
A 33-item scale assessing post-traumatic symptoms, reactions and appraisals. The measure possesses three subscales; negative cognitions related to the self, negative cognitions related to the world, and self-blame cognitions related to the traumatic event.
Beck's Depression Inventory-II (BDI-II) [SELF-REPORT]
A 21-item, self-report inventory that measures the severity of depression symptomatology. It corresponds closely to DSM-5 depression criteria and is found to be a more reliable measure of depression (Beck & Steer, 1988).
State-Trait Anxiety Inventory, Trait Version (STAI-T)
A measure that consists of 20 items for assessing trait anxiety and 20 for assessing state anxiety. It is used to diagnose anxiety and to help distinguish it from depressive syndromes.
State-Trait Anger Expression Inventory-II (STAXI-II) [SELF-REPORT]
A 57-item self-report measure that examines the expression, control, and experience of anger (Schamborg, Tully, & Browne, 2016).
Social Adjustment Scale - Self Report (SAS-SR) [SELF-REPORT]
A measure that consists of 54 items for assessing role performance in six areas of functioning, including work, social and leisure activities, relationships with extended family, role as a marital partner (if applicable), parental role (if applicable), and role within the family unit.
Trauma-Related Guilt Inventory (TRGI) [SELF-REPORT]
A 32-item self-report measure that is designed to measure guilt experienced as a result of a traumatic event. It is composed of three subscales including; guilt cognitions, distress and global guilt.
Suicidal Behaviors Questionnaire-Revised
Scores range from 3 to 18, with 18 being higher suicide risk.
Substance Use Inventory (SUI)
A brief measure with detailed questions regarding participants' use and primary route of different substances they used in the last seven days. The individuals' are also asked about the average dollar amount spent on each drug and in a single day. (Weiss, et al., 1995).
PTSD Checklist-5 (PCL-5) [SELF-REPORT]
A 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. It is used to help screen individuals for PTSD as well as monitor their symptom changes during and after treatment.
Acceptability of Intervention Measure (AIM)
A 4-item measure which asks therapists and patients about their perceived acceptability of the intervention on a 5-point Likert scale.
Treatment sessions attended
Feasibility as measured by number of treatment sessions
Rate of dropout
Feasibility as measured by rate of treatment dropout
Emotional Reactivity and Attentional Biases via Oddball task
Used as a behavioral measure of changes in emotional reactivity and attentional biases- our two propose mechanisms of change in CPT+SRM. The oddball task is computer-based task (Hayes, et al., 2009) designed to measure emotional reactivity and attentional biases. Participants will view a pseudorandom distribution of brief presentations of emotionally-salient distractors (negative images depicting mutilations, burn victims, attacks, sick individuals), neutral distractors (matched with negative images for luminance, presence of human figures, chromatic features), baseline standards (squares), and attention "targets" (circles) in an event-related design. Participants will be instructed to press the same button for all stimuli, but a different button for attention targets. Behavioral changes associated with emotional reactivity and attention bias will be assessed using response latency and accuracy scores for emotional and attention targets, respectively.
Mental Health Involvement Scale [SELF-REPORT]
A 9-item measure used to inquire about other ancillary services (e.g., group treatment, couples/family therapy) that participants are receiving throughout the study. This is a measure developed and used in prior research by the investigative team, but currently does not have published psychometric properties.
Measure of CPT+SRM Uptake [SELF-REPORT]
Measures uptake of the treatment using an adapted measure from LoSavio, et al. (2019). This brief survey will assess clinicians' ongoing use of CPT+SRM since their participation in the study (e.g., whether they continue to offer CPT+SRM, the number of clients they have offered CPT+SRM to, average number of sessions attended, etc.) and further inform whether our training methods and treatment will have a lasting impact on practice approaches in community settings. There are no psychometric data available for this questionnaire.
Unanticipated Problems Involving Risk to Subjects or Others (UPIRSO)
Safety of the treatment will be monitored via unanticipated problems involving risk to subjects or others (UPIRSO) that occur throughout treatment and the number of mental health hospitalizations.
The International Personality Disorder Exam (IPDE, BPD only)
A well-established diagnostic instrument used by the World Health Organization, will be used to identify the presence and severity of BPD. The IPDE also allows for a dimensional assessment of BPD.
The Structured Clinical Interview for the Diagnostic and Statistical Manual-5 (SCID-5)
Used to obtain other DSM-5 diagnoses.
The Lifetime Suicide Attempt Self-Injury Interview (L-SASII)
A semi-structured interview, will assess characteristics of self-harm (i.e., suicide attempts and NSSI), including frequency, medical severity, intent to die, lethality, and precipitants of self-harm.
A Demographic Form [SELF-REPORT]
Used in previous PTSD treatment studies will also be used to measure a range of demographic data.
Trauma-Related Shame Inventory (TRSI) [SELF-REPORT] Trauma-Related Shame Inventory (TRSI) [SELF-REPORT]: is a 24-item self-report measure that evaluates levels of shame in the context of one's trauma. --
A 24-item self-report measure that evaluates levels of shame in the context of one's trauma.
Patient Health Questionnaire - 9 (PHQ-9)
A 9-item self-report measure that evaluates severity of depression symptoms.
Generalized Anxiety Disorder - 7 (GAD7)
A 7-item self-report measure that evaluates severity of generalized anxiety symptoms.
WHO Disability Assessment Schedule (WHODAS) 2.0 (12-Item Version)
A 12-item self-report measure of disability across six domains (understanding and communicating, getting around, self-care, getting along with people, life activities, and participation in society).
DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure-Adult
A 23-item self-report measure of psychiatric symptoms that cut across diagnostic categories.
Full Information
NCT ID
NCT04230668
First Posted
January 9, 2020
Last Updated
February 3, 2023
Sponsor
Palo Alto University
Collaborators
Toronto Metropolitan University, York University, Stanford University, National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT04230668
Brief Title
Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder and Borderline Personality Disorder (PTSD-BPD)
Official Title
A Pilot Effectiveness Trial of Cognitive Processing Therapy Augmented With Suicide Risk Management for Individuals With Comorbid PTSD and BPD
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
September 10, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Palo Alto University
Collaborators
Toronto Metropolitan University, York University, Stanford University, National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Posttraumatic Stress Disorder (PTSD) with co-occurring Borderline Personality Disorder (BPD) (i.e., PTSD-BPD) is common (as high as 58%), debilitating, costly, and limited treatment options available for this population. PTSD-BPD is associated with even greater functional impairment and higher healthcare burden than either disorder alone. There are surprisingly few treatments available for this clinical profile, despite its association with major negative health outcomes, cost, and morbidity. There is a pressing need to innovate treatments that can effectively and efficiently treat PTSD-BPD. The existing treatments used for PTSD-BPD are lengthy, laborious, resource-intensive, and require complete cessation of suicidal behaviors prior to treatment. Furthermore, no integrated treatment has been innovated to deliver the active ingredients to efficiently affect the mechanisms underpinning this comorbidity. The investigators propose to examine an adapted version of a first-line PTSD intervention, Cognitive Processing Therapy, augmented with a Suicide Risk Management, i.e., (CPT+SRM) as a brief (12 sessions) and more parsimonious treatment alternative that strategically targets shared mechanisms underpinning PTSD and BPD. The purpose of this pilot study is to 1) collect initial feasibility, acceptability, and safety data on this adapted treatment, 2) conduct a pilot randomized clinical trial evaluating the efficacy of CPT+SRM versus Treatment as Usual (TAU) + SRM, and 3) evaluate two targets (i.e, improvements in emotional intensity and cognitive dysfunction) as mechanisms leading to change in our primary outcomes. Both treatment conditions will be administered via telehealth.
Potential benefits include reduction in participants' PTSD, BPD and other mental health symptoms. Additionally, this work could benefit the community by improving the treatment repertoire for PTSD-BPD. Potential risks include emotional distress, suicidality, and/or self-harm. Participants may experience discomfort and/or distress while discussing participants trauma(s) and mental health. These risks will be mitigated using a suicide risk management protocol which therapists in the assessment of risk and protective factors of suicide, followed by documentation for the decision-making around the management of risk.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Borderline Personality Disorder
Keywords
Cognitive Processing Therapy, Suicide Risk Management, Suicide, Self-harm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a two-phased study. Phase 1 of this investigation will consist of an initial case series in which the CPT+SRM manual will be developed along with fidelity measures. The finalized treatment manual will then be tested in Phase 2, a randomized-controlled trial comparing 12 individual sessions/6 weeks of CPT+SRM versus 6 weeks of TAU+SRM.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
33 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CPT + SRM
Arm Type
Experimental
Arm Description
Participants will be randomized to teletherapy sessions of Cognitive Processing Therapy + Suicide Risk Management for PTSD-BPD which will be administered twice weekly over 6 weeks, for a total of 12 sessions.
Arm Title
TAU + SRM
Arm Type
Experimental
Arm Description
Participants will be randomized to teletherapy sessions with only Suicide Risk Management for PTSD-BPD which will be administered once a week for 6 weeks, for a total of 6 sessions.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy with Suicide Risk Management
Intervention Description
CPT is an evidence-based treatment for PTSD. This first-line treatment for PTSD will be adapted and combined with SRM into 12 sessions, 60-90 minutes targeting both PTSD and BPD. Individuals assigned to this intervention will attend treatment sessions, and be asked to do treatment homework at home. The primary outcomes are PTSD and BPD severity.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual with Suicide Rick Management
Intervention Description
In the Suicide Risk Management only condition, participants will receive 6 weekly sessions over the course of six weeks focused on suicide stabilization and management. Each SRM session will be variable lengths, depending on the participants' suicide risk and can be up to 60 minutes.
Primary Outcome Measure Information:
Title
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Description
A 30-item clinician administered structured interview based on the DSM-5 PTSD criteria.
Time Frame
Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Title
Borderline Symptom List 23 (BSL-23) [SELF-REPORT]
Description
A self-report measure of borderline personality disorder (BPD) severity. The measure captures subjective ratings of the following symptoms: self-perception, affect regulation, self destruction, dysphoria, loneliness, intrusions, and hostility (Bohus et al., 2009).
Time Frame
Baseline, once a week while in treatment (for 6 weeks)
Secondary Outcome Measure Information:
Title
Suicide Attempt Self-Injury Interview (SASII)
Description
Assess characteristics of self-harm (i.e., suicide attempts and NSSI), including frequency, medical severity, intent to die, lethality, and precipitants of self-harm since the previous assessment.
Time Frame
3-weeks, Post-treatment/6-weeks, 3-month follow-up
Title
Difficulties in Emotion Regulation Scale (DERS) [SELF-REPORT]
Description
A self-report measure assessing various dimensions of emotion dysregulation (Gratz & Roemer, 2004).
Time Frame
Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Title
Posttraumatic Cognitions Inventory (PTCI) [SELF-REPORT]
Description
A 33-item scale assessing post-traumatic symptoms, reactions and appraisals. The measure possesses three subscales; negative cognitions related to the self, negative cognitions related to the world, and self-blame cognitions related to the traumatic event.
Time Frame
Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Title
Beck's Depression Inventory-II (BDI-II) [SELF-REPORT]
Description
A 21-item, self-report inventory that measures the severity of depression symptomatology. It corresponds closely to DSM-5 depression criteria and is found to be a more reliable measure of depression (Beck & Steer, 1988).
Time Frame
Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Title
State-Trait Anxiety Inventory, Trait Version (STAI-T)
Description
A measure that consists of 20 items for assessing trait anxiety and 20 for assessing state anxiety. It is used to diagnose anxiety and to help distinguish it from depressive syndromes.
Time Frame
Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Title
State-Trait Anger Expression Inventory-II (STAXI-II) [SELF-REPORT]
Description
A 57-item self-report measure that examines the expression, control, and experience of anger (Schamborg, Tully, & Browne, 2016).
Time Frame
Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Title
Social Adjustment Scale - Self Report (SAS-SR) [SELF-REPORT]
Description
A measure that consists of 54 items for assessing role performance in six areas of functioning, including work, social and leisure activities, relationships with extended family, role as a marital partner (if applicable), parental role (if applicable), and role within the family unit.
Time Frame
Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Title
Trauma-Related Guilt Inventory (TRGI) [SELF-REPORT]
Description
A 32-item self-report measure that is designed to measure guilt experienced as a result of a traumatic event. It is composed of three subscales including; guilt cognitions, distress and global guilt.
Time Frame
Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Title
Suicidal Behaviors Questionnaire-Revised
Description
Scores range from 3 to 18, with 18 being higher suicide risk.
Time Frame
Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Title
Substance Use Inventory (SUI)
Description
A brief measure with detailed questions regarding participants' use and primary route of different substances they used in the last seven days. The individuals' are also asked about the average dollar amount spent on each drug and in a single day. (Weiss, et al., 1995).
Time Frame
Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Title
PTSD Checklist-5 (PCL-5) [SELF-REPORT]
Description
A 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. It is used to help screen individuals for PTSD as well as monitor their symptom changes during and after treatment.
Time Frame
Baseline, once a week while in treatment (for 6 weeks)
Title
Acceptability of Intervention Measure (AIM)
Description
A 4-item measure which asks therapists and patients about their perceived acceptability of the intervention on a 5-point Likert scale.
Time Frame
Baseline and Post-treatment/6-weeks
Title
Treatment sessions attended
Description
Feasibility as measured by number of treatment sessions
Time Frame
Pre-post treatment (6 weeks)
Title
Rate of dropout
Description
Feasibility as measured by rate of treatment dropout
Time Frame
Pre-post treatment (6 weeks)
Title
Emotional Reactivity and Attentional Biases via Oddball task
Description
Used as a behavioral measure of changes in emotional reactivity and attentional biases- our two propose mechanisms of change in CPT+SRM. The oddball task is computer-based task (Hayes, et al., 2009) designed to measure emotional reactivity and attentional biases. Participants will view a pseudorandom distribution of brief presentations of emotionally-salient distractors (negative images depicting mutilations, burn victims, attacks, sick individuals), neutral distractors (matched with negative images for luminance, presence of human figures, chromatic features), baseline standards (squares), and attention "targets" (circles) in an event-related design. Participants will be instructed to press the same button for all stimuli, but a different button for attention targets. Behavioral changes associated with emotional reactivity and attention bias will be assessed using response latency and accuracy scores for emotional and attention targets, respectively.
Time Frame
Baseline, Post-treatment/6-weeks, 3-months follow-up
Title
Mental Health Involvement Scale [SELF-REPORT]
Description
A 9-item measure used to inquire about other ancillary services (e.g., group treatment, couples/family therapy) that participants are receiving throughout the study. This is a measure developed and used in prior research by the investigative team, but currently does not have published psychometric properties.
Time Frame
Post-treatment/6-weeks
Title
Measure of CPT+SRM Uptake [SELF-REPORT]
Description
Measures uptake of the treatment using an adapted measure from LoSavio, et al. (2019). This brief survey will assess clinicians' ongoing use of CPT+SRM since their participation in the study (e.g., whether they continue to offer CPT+SRM, the number of clients they have offered CPT+SRM to, average number of sessions attended, etc.) and further inform whether our training methods and treatment will have a lasting impact on practice approaches in community settings. There are no psychometric data available for this questionnaire.
Time Frame
9-months after concluding treatment with the last study participant
Title
Unanticipated Problems Involving Risk to Subjects or Others (UPIRSO)
Description
Safety of the treatment will be monitored via unanticipated problems involving risk to subjects or others (UPIRSO) that occur throughout treatment and the number of mental health hospitalizations.
Time Frame
Baseline, 3-weeks, Post-treatment/6-weeks
Title
The International Personality Disorder Exam (IPDE, BPD only)
Description
A well-established diagnostic instrument used by the World Health Organization, will be used to identify the presence and severity of BPD. The IPDE also allows for a dimensional assessment of BPD.
Time Frame
Baseline
Title
The Structured Clinical Interview for the Diagnostic and Statistical Manual-5 (SCID-5)
Description
Used to obtain other DSM-5 diagnoses.
Time Frame
Baseline
Title
The Lifetime Suicide Attempt Self-Injury Interview (L-SASII)
Description
A semi-structured interview, will assess characteristics of self-harm (i.e., suicide attempts and NSSI), including frequency, medical severity, intent to die, lethality, and precipitants of self-harm.
Time Frame
Baseline
Title
A Demographic Form [SELF-REPORT]
Description
Used in previous PTSD treatment studies will also be used to measure a range of demographic data.
Time Frame
Baseline
Title
Trauma-Related Shame Inventory (TRSI) [SELF-REPORT] Trauma-Related Shame Inventory (TRSI) [SELF-REPORT]: is a 24-item self-report measure that evaluates levels of shame in the context of one's trauma. --
Description
A 24-item self-report measure that evaluates levels of shame in the context of one's trauma.
Time Frame
Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Title
Patient Health Questionnaire - 9 (PHQ-9)
Description
A 9-item self-report measure that evaluates severity of depression symptoms.
Time Frame
Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Title
Generalized Anxiety Disorder - 7 (GAD7)
Description
A 7-item self-report measure that evaluates severity of generalized anxiety symptoms.
Time Frame
Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Title
WHO Disability Assessment Schedule (WHODAS) 2.0 (12-Item Version)
Description
A 12-item self-report measure of disability across six domains (understanding and communicating, getting around, self-care, getting along with people, life activities, and participation in society).
Time Frame
Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Title
DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure-Adult
Description
A 23-item self-report measure of psychiatric symptoms that cut across diagnostic categories.
Time Frame
Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18-65 years
Must reside in the Bay Area, CA
Current DSM-5 diagnosis of PTSD and BPD
Must be willing to be audio- or videorecorded for assessment and treatment sessions
Exclusion Criteria:
Acute mania, acute psychosis, or intellectual disability
Conditions requiring medical attention to a potentially life-threatening illness (e.g., severe anorexia nervosa)
Severe impairments in written and aural comprehension
EU individuals
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ariana Guenther, B.A.
Phone
650-485-1513
Email
bestlab@paloaltou.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janice R Kuo, PhD
Organizational Affiliation
Palo Alto University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Palo Alto University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ariana Guenther, B.A. (Hons)
Phone
650-485-1513
Email
bestlab@paloaltou.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Resick, P. A., Monson, C. M., & Chard, K. M. (2016). Cognitive processing therapy for PTSD: A comprehensive manual. New York, NY: Guilford Press.
Results Reference
background
Citation
Stanley, B., & Brown, G. (2012). Safety planning intervention: A brief intervention to mitigate suicide risk. Cognitive and Behavioural Practice, 19(2), 256-264.
Results Reference
background
Learn more about this trial
Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder and Borderline Personality Disorder (PTSD-BPD)
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