An Interrupted Time-Series Pilot Trial of LGBTQ-Affirming Cognitive Processing Therapy for Interpersonal and Developmental Trauma

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Alabama at Birmingham

About this trial

We 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Cognitive Processing Therapy

    Behavioral

    n/a; this is the only intervention within the study

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Cognitive Processing TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PTSD Checklist for DSM-5

PCL-5

Time frame
Week -2, week -1, week 0, weeks 1-12, week 24, week 36
2

Social Functioning Questionnaire

SFQ; measure of functioning/impairment

Time frame
Week -2, week -1, week 0, weeks 1-12, week 24, week 36
3

Post-Traumatic Cognitions Inventory-9

PTCI-9; brief measure of beliefs about the self, others, and the world

Time frame
Week -2, week -1, week 0, weeks 1-12, week 24, week 36
4

Clinician-Administered PTSD Scale for DSM-5

CAPS-5; clinician-administered measure of post-traumatic stress disorder symptoms

Time frame
Weeks -2, 12

Secondary outcomes

1

Generalized Anxiety Disorder-7

GAD-7; measure of generalized anxiety symptoms

Time frame
Screening/week -2; week 12
2

Generalized Anxiety Disorder-2

GAD-2; brief measure of generalized anxiety symptoms

Time frame
Weeks 1-12, 24, and 36
3

Patient Health Questionnaire-9

PHQ-9; measure of depressive symptoms

Time frame
Screening/week -2; week 12
4

Patient Health Questionnaire-2

PHQ-2; brief measure of depressive symptoms

Time frame
Weeks 1-12, 24, and 36

Other outcomes

1

Credibility/Expectancy of Therapy

CEQ; measure of participant's expectations about the intervention

Time frame
Week -2
2

Agnew Relationship Measure-5

ARM-5; brief measure of therapeutic alliance

Time frame
Weeks 2-12

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: