Post-Traumatic Stress Disorder, ChronicNCT07863817
An Interrupted Time-Series Pilot Trial of LGBTQ-Affirming Cognitive Processing Therapy for Interpersonal and Developmental Trauma
A study testing Cognitive Processing Therapy in people with Post-Traumatic Stress Disorder, Chronic and Depressed Mood, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The researchers are testing a single-group cognitive-behavioral intervention for treating traumatic stress related to interpersonal and developmental trauma in LGBTQ adults. This study requires in-person participation weekly at the UAB campus in Birmingham, AL. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Post-Traumatic Stress Disorder, Chronic, Depressed Mood, Depressive and Anxiety Disorders
- What is being tested?
- Cognitive Processing Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LGBTQ+-identifying
- PCL-5 score ≥ 30 (clinically significant PTSD symptoms) OR verifiable PTSD diagnosis based on CAPS interview
- 18 years or older
- Documented interpersonal or developmental trauma (e.g., a history of childhood physical, emotional, or sexual abuse; sexual assault; or intimate partner violence)
- English-speaking
Who cannot join
- Prior 12-month history of non substance-induced psychosis or mania
- Non-suicidal self-injury within three months prior to screening
- Suicide attempt within 12 months prior to screening
- Illicit substance use within 7 days prior to screening
- Active diagnosis of anorexia nervosa or bulimia nervosa
- Active plan for suicide within one month prior to screening
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Drew Whittington, MS, MA contact
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Nicholas Borgogna, PhD, (205) 934-3850, borgogna@uab.edu
About this study
The researchers are testing a single-group cognitive-behavioral intervention for treating traumatic stress related to interpersonal and developmental trauma in LGBTQ adults. This study requires in-person participation weekly at the UAB campus in Birmingham, AL.
Read the detailed description
The researchers are using an interrupted time-series design with multiple baseline measurements to assess the effectiveness of a 12-session LGBTQ-affirming cognitive processing therapy (CPT) intervention for post-traumatic stress and associated outcomes related to interpersonal (e.g., sexual assault, intimate partner violence) and developmental (e.g., child physical/sexual/emotional abuse/neglect).
- Conditions
- Post-Traumatic Stress Disorder, Chronic, Depressed Mood, Depressive and Anxiety Disorders, Anxiety, Depression - Major Depressive Disorder
- Being tested
- Cognitive Processing Therapy
- Keywords
- cognitive processing therapy, LGBTQ
- Medical subject headings
- Stress Disorders, Post-Traumatic, Consciousness Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Processing TherapyBehavioural
n/a; this is the only intervention within the study
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Processing Therapy | Experimental | Standard, manualized 12-session cognitive processing therapy Receives: Behavioral: Cognitive Processing Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summed Score on PTSD Checklist for DSM-5
PCL-5
Measured: Week -2, week -1, week 0, weeks 1-12, week 24, week 36
Mean Score on Social Functioning Questionnaire
SFQ; measure of functioning/impairment
Measured: Week -2, week -1, week 0, weeks 1-12, week 24, week 36
Mean Score on Post-Traumatic Cognitions Inventory-9
PTCI-9; brief measure of beliefs about the self, others, and the world
Measured: Week -2, week -1, week 0, weeks 1-12, week 24, week 36
Summed Score on Clinician-Administered PTSD Scale for DSM-5
CAPS-5; clinician-administered measure of post-traumatic stress disorder symptoms
Measured: Weeks -2, 12
Mean Score on Post-Traumatic Growth Inventory-10
PTGI-10
Measured: Weeks -2, 12
Secondary outcomes (10)
Summed Score on Generalized Anxiety Disorder-7
GAD-7; measure of generalized anxiety symptoms
Measured: Screening/week -2; week 12
Summed Score on Generalized Anxiety Disorder-2
GAD-2; brief measure of generalized anxiety symptoms
Measured: Weeks 1-12, 24, and 36
Summed Score on Patient Health Questionnaire-9
PHQ-9; measure of depressive symptoms
Measured: Screening/week -2; week 12
Summed Score on Patient Health Questionnaire-2
PHQ-2; brief measure of depressive symptoms
Measured: Weeks 1-12, 24, and 36
Mean Score on Inventory of Interpersonal Problems-32
IIP-32; measure of interpersonal problems
Measured: Weeks -2, 12, 24, 36
Mean Score on Experiences in Close Relationships-Short Form
ECR-SF; brief measure of attachment anxiety and avoidance
Measured: Weeks -2, 12
Mean Score on Experiential Avoidance Rating Scale
EARS; brief measure of experiential avoidance
Measured: Week -2, weeks 1-12
Mean Score on Cognitive Fusion Questionnaire
CFQ; brief measure of cognitive fusion
Measured: Week -2, Weeks 1-12
Mean Score Difficulty in Emotion Regulation Scale-16
DERS-16
Measured: Weeks -2, 12
Mean Score on Therapeutic Reactance Scale
TRS
Measured: Weeks -2, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress Disorder, ChronicStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interrupted time-series model with three pre-intervention baseline assessment points.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas C. Borgogna, University of Alabama at Birmingham
- Investigators
- Nicholas C Borgogna, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863817
- Sponsor's protocol ID
- STUDY00000286
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final deidentified dataset will be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interrupted Time-Series Pilot Trial of LGBTQ-Affirming Cognitive Processing Therapy for Interpersonal and Developmental Trauma
- ClinicalTrials.gov ID
- NCT07863817
- Acronym / sponsor ID
- STUDY00000286
- Conditions
- Post-Traumatic Stress Disorder, Chronic, Depressed Mood, Depressive and Anxiety Disorders, Anxiety, Depression - Major Depressive Disorder
- Keywords
- cognitive processing therapy, LGBTQ
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 7 Oct 2026 (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 researchers are testing a single-group cognitive-behavioral intervention for treating traumatic stress related to interpersonal and developmental trauma in LGBTQ adults. This study requires in-person participation weekly at the UAB campus in Birmingham, AL.
Detailed description
The researchers are using an interrupted time-series design with multiple baseline measurements to assess the effectiveness of a 12-session LGBTQ-affirming cognitive processing therapy (CPT) intervention for post-traumatic stress and associated outcomes related to interpersonal (e.g., sexual assault, intimate partner violence) and developmental (e.g., child physical/sexual/emotional abuse/neglect).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interrupted time-series model with three pre-intervention baseline assessment points.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Processing Therapy | Experimental | Behavioral: Cognitive Processing TherapyStandard, manualized 12-session cognitive processing therapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- LGBTQ+-identifying
- PCL-5 score ≥ 30 (clinically significant PTSD symptoms) OR verifiable PTSD diagnosis based on CAPS interview
- 18 years or older
- Documented interpersonal or developmental trauma (e.g., a history of childhood physical, emotional, or sexual abuse; sexual assault; or intimate partner violence)
- English-speaking
Key exclusion criteria (6 listed)
- Prior 12-month history of non substance-induced psychosis or mania
- Non-suicidal self-injury within three months prior to screening
- Suicide attempt within 12 months prior to screening
- Illicit substance use within 7 days prior to screening
- Active diagnosis of anorexia nervosa or bulimia nervosa
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 |
|---|---|---|
| Cognitive Processing Therapyn/a; this is the only intervention within the study | Behavioural | Cognitive Processing Therapy |
Primary outcome
Summed Score on PTSD Checklist for DSM-5
Time frame: Week -2, week -1, week 0, weeks 1-12, week 24, week 36
PCL-5
Mean Score on Social Functioning Questionnaire
Time frame: Week -2, week -1, week 0, weeks 1-12, week 24, week 36
SFQ; measure of functioning/impairment
Mean Score on Post-Traumatic Cognitions Inventory-9
Time frame: Week -2, week -1, week 0, weeks 1-12, week 24, week 36
PTCI-9; brief measure of beliefs about the self, others, and the world
Summed Score on Clinician-Administered PTSD Scale for DSM-5
Time frame: Weeks -2, 12
CAPS-5; clinician-administered measure of post-traumatic stress disorder symptoms
Mean Score on Post-Traumatic Growth Inventory-10
Time frame: Weeks -2, 12
PTGI-10
10 secondary outcomes
Summed Score on Generalized Anxiety Disorder-7
Time frame: Screening/week -2; week 12
Summed Score on Generalized Anxiety Disorder-2
Time frame: Weeks 1-12, 24, and 36
Summed Score on Patient Health Questionnaire-9
Time frame: Screening/week -2; week 12
Summed Score on Patient Health Questionnaire-2
Time frame: Weeks 1-12, 24, and 36
Mean Score on Inventory of Interpersonal Problems-32
Time frame: Weeks -2, 12, 24, 36
Mean Score on Experiences in Close Relationships-Short Form
Time frame: Weeks -2, 12
Mean Score on Experiential Avoidance Rating Scale
Time frame: Week -2, weeks 1-12
Mean Score on Cognitive Fusion Questionnaire
Time frame: Week -2, Weeks 1-12
Mean Score Difficulty in Emotion Regulation Scale-16
Time frame: Weeks -2, 12
Mean Score on Therapeutic Reactance Scale
Time frame: Weeks -2, 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Yes. Final deidentified dataset will be shared upon request.
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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.
Drew Whittington, MS, MA contact
Nicholas C Borgogna, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Processing Therapy in people with Post-Traumatic Stress Disorder, Chronic and Depressed Mood, run by University of Alabama at Birmingham 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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 15 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicholas C Borgogna, PhD ((205) 934-3850, borgogna@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Summed Score on PTSD Checklist for DSM-5 (time frame: Week -2, week -1, week 0, weeks 1-12, week 24, week 36). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2026.