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
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.