An interventional study of Transdiagnostic Behavior Therapy (TBT) and Treatment as Usual-Problem Solving Therapy (TAU-PST) in Adjustment Disorders and Mental Disorder, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment
Adjustment Disorder (AjD) is the most common mental health condition diagnosed in Active Duty personnel, and is diagnosed following an extreme stress event such as traumatic loss of a comrade, serious accident or injury, or other intense stress event. Despite its high prevalence, no evidence based treatment for AjD has been subjected to randomized controlled trials. This study seeks to build on the research team's pilot work across several disorders study to benefit service members and Veterans with AjD, a highly prevalent but frequently inadequately treated condition.
The investigators will compare the effects of Transdiagnostic Behavior Therapy (TBT) vs treatment as usual which is Moving Forward Problem Solving Therapy (TAU-PST) on AjD symptom outcomes. The investigators hypothesize that TBT will result in greater overall symptom reduction compared to TAU-PST.
Adjustment Disorder (AjD) is the most common mental health condition diagnosed in Active Duty personnel, and is diagnosed following an extreme stress event such as traumatic loss of a comrade, serious accident or injury, or other intense stress event. Despite its high prevalence, no evidence based treatment for AjD has been subjected to randomized controlled trials.
Currently, the VA suggests a problem solving cognitive behavioral therapy, but this recommendation is not based on replicated, randomized controlled trials. Transdiagnostic Behavior Therapy (TBT), is based on key 'active components' of existing evidence based treatments such as Prolonged Exposure and Behavioral Activation, has been designed by this research team to be easily trained and inexpensively disseminated, and has been evaluated in a series of pilots with anxiety and depression disorders that, importantly, represent the key symptom classes of adjustment disorder.
Thus, the rationale for the proposed trial is that the research team has done preliminary efficacy testing of an easily exportable intervention that has impact on the key symptoms of adjustment disorder, and the standard of evidence demands replicated, randomized controlled trials to determine if initial signals of positive effect are sustained.
The study will use a 2 group repeated measures randomized controlled design to evaluate effectiveness of TBT for AjD compared to treatment as usual (TAU-PST). Participants will be randomly assigned in equal numbers (n = 75; N = 150) to one of two treatment arms: (1) TBT or (2) TAU-PST. Participants assigned to TBT will receive 6, 30-45-minute, manualized, individual therapy sessions. Participants assigned to TAU-PST will receive 6, 30-45-minute sessions of Problem-Solving Therapy. Dependent measures will include Department of Defense (DoD) specified common data elements and specific measures of AjD, PTSD, anxiety, depression, and functioning collected by blinded assessors at baseline, post-treatment, 3-month, and 6-month follow-up.
63 studies on the registry are indexed under Adjustment Disorders; 13 are open to participants now.
This study's planned enrollment of 150 is above the median of 100 across 52 interventional studies indexed under Adjustment Disorders.
Browse Adjustment Disorders studies →The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive 6, 30-45-minute, manualized, individual therapy sessions.
Behavioral: Transdiagnostic Behavior Therapy (TBT)
Participants will receive 6, 30-45-minute, manualized, individual therapy sessions.
Behavioral: Treatment as Usual-Problem Solving Therapy (TAU-PST)
TBT manualized treatment incorporates daily exposure exercises from up to four categories of avoidance that are most characteristic of the emotional disorders (i.e., situational, interoceptive, imaginal, and positive emotional).
PST is an evidence- based psychotherapy implemented in VA Primary Care - Mental Health Integration (PC-MHI), with hundreds of VA providers trained in the intervention nationally. The primary aim of PST is to improve a patient's ability to cope with stressful events by adopting an adaptive perspective to stressors and using goal-focused, problem-solving behaviors to manage the problems associated with the stressors.
Also known as: Moving Forward Problem Solving Therapy
Adjustment Disorder New Module Self Report
The Adjustment Disorder New Module (ADNM) is a 20-item self-report measure of AjD that first asks participants to select from a list of past year stressors and to identify which was the most prominent or distressing. The second section comprises 20 items, which form six subscales in accordance with International Classification of Diseases 11th Revision (ICD-11) criteria relating to pre-occupation, failure to adapt, avoidance, depressive mood, anxiety, and impulse disturbance (Lorenz et al., 2016). Participants rate on a 4-point Likert scale how often they have experienced particular symptoms during the past two weeks, and overall symptom severity is calculated as a sum of all item scores. Total score ranges from 20-80, with a higher score indicating a higher risk of developing adjustment disorder.
Time frame: Baseline
Adjustment Disorder New Module Self Report
The ADNM is a 20-item self-report measure of AjD that first asks participants to select from a list of past year stressors and to identify which was the most prominent or distressing. The second section comprises 20 items, which form six subscales in accordance with ICD-11 criteria relating to pre-occupation, failure to adapt, avoidance, depressive mood, anxiety, and impulse disturbance (Lorenz et al., 2016). Participants rate on a 4-point Likert scale how often they have experienced particular symptoms during the past two weeks, and overall symptom severity is calculated as a sum of all item scores. Total score ranges from 20-80, with a higher score indicating a higher risk of developing adjustment disorder.
Time frame: 1 week post treatment
Adjustment Disorder New Module Self Report
The ADNM is a 20-item self-report measure of AjD that first asks participants to select from a list of past year stressors and to identify which was the most prominent or distressing. The second section comprises 20 items, which form six subscales in accordance with ICD-11 criteria relating to pre-occupation, failure to adapt, avoidance, depressive mood, anxiety, and impulse disturbance (Lorenz et al., 2016). Participants rate on a 4-point Likert scale how often they have experienced particular symptoms during the past two weeks, and overall symptom severity is calculated as a sum of all item scores. Total score ranges from 20-80, with a higher score indicating a higher risk of developing adjustment disorder.
Time frame: 3 months post treatment
Adjustment Disorder New Module Self Report
The ADNM is a 20-item self-report measure of AjD that first asks participants to select from a list of past year stressors and to identify which was the most prominent or distressing. The second section comprises 20 items, which form six subscales in accordance with ICD-11 criteria relating to pre-occupation, failure to adapt, avoidance, depressive mood, anxiety, and impulse disturbance (Lorenz et al., 2016). Participants rate on a 4-point Likert scale how often they have experienced particular symptoms during the past two weeks, and overall symptom severity is calculated as a sum of all item scores. Total score ranges from 20-80, with a higher score indicating a higher risk of developing adjustment disorder.
Time frame: 6 months post treatment
Generalized Anxiety Disorder Questionnaire - 7
The Generalized Anxiety Disorder Questionnaire (GAD-7; Spitzer et al., 2006) consists of seven items measuring worry and anxiety symptoms. Each item is scored on a four-point Likert scale (0-3) with total scores ranging from 0 to 21 with higher scores reflecting greater anxiety severity.of Mental Disorders, Fifth Edition (DSM-5) (PCL-5) (Weathers et al., 2013) is structured to correspond to the DSM-5 PTSD criteria. The 20-items are scored on a 0-4 Likert scale for each symptom corresponding to "Not at all" to "Extremely". Total score ranges from 0 to 80, with a higher score indicating greater PTSD symptom severity.
Time frame: Baseline
Generalized Anxiety Disorder Questionnaire - 7
The Generalized Anxiety Disorder Questionnaire (GAD-7; Spitzer et al., 2006) consists of seven items measuring worry and anxiety symptoms. Each item is scored on a four-point Likert scale (0-3) with total scores ranging from 0 to 21 with higher scores reflecting greater anxiety severity.of Mental Disorders, Fifth Edition (DSM-5) (PCL-5) (Weathers et al., 2013) is structured to correspond to the DSM-5 PTSD criteria. The 20-items are scored on a 0-4 Likert scale for each symptom corresponding to "Not at all" to "Extremely". Total score ranges from 0 to 80, with a higher score indicating greater PTSD symptom severity.
Time frame: 1 week post treatment
Generalized Anxiety Disorder Questionnaire - 7
The Generalized Anxiety Disorder Questionnaire (GAD-7; Spitzer et al., 2006) consists of seven items measuring worry and anxiety symptoms. Each item is scored on a four-point Likert scale (0-3) with total scores ranging from 0 to 21 with higher scores reflecting greater anxiety severity.of Mental Disorders, Fifth Edition (DSM-5) (PCL-5) (Weathers et al., 2013) is structured to correspond to the DSM-5 PTSD criteria. The 20-items are scored on a 0-4 Likert scale for each symptom corresponding to "Not at all" to "Extremely". Total score ranges from 0 to 80, with a higher score indicating greater PTSD symptom severity.
Time frame: 3 months post treatment
Generalized Anxiety Disorder Questionnaire - 7
The Generalized Anxiety Disorder Questionnaire (GAD-7; Spitzer et al., 2006) consists of seven items measuring worry and anxiety symptoms. Each item is scored on a four-point Likert scale (0-3) with total scores ranging from 0 to 21 with higher scores reflecting greater anxiety severity.of Mental Disorders, Fifth Edition (DSM-5) (PCL-5) (Weathers et al., 2013) is structured to correspond to the DSM-5 PTSD criteria. The 20-items are scored on a 0-4 Likert scale for each symptom corresponding to "Not at all" to "Extremely". Total score ranges from 0 to 80, with a higher score indicating greater PTSD symptom severity.
Time frame: 6 months post treatment
Patient Health Questionnaire-9
The Patient Health Questionnaire-9 (PHQ-9) (Kroenke et al., 2001) is a widely used, well-validated measure of depression severity with high internal consistency (alpha .83 to .92; Cameron et al, 2008) and is correlated strongly with other depression measures. Its nine items assess affective and somatic symptoms and correspond to diagnostic criteria for major depressive disorder (MDD). This measure will also be collected every other week during treatment. Total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression).
Time frame: Baseline
Patient Health Questionnaire-9
The PHQ-9 (Kroenke et al., 2001) is a widely used, well-validated measure of depression severity with high internal consistency (alpha .83 to .92; Cameron et al, 2008) and is correlated strongly with other depression measures. Its nine items assess affective and somatic symptoms and correspond to diagnostic criteria for MDD. This measure will also be collected every other week during treatment. Total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression).
Time frame: 1 week post treatment
Patient Health Questionnaire-9
The PHQ-9 (Kroenke et al., 2001) is a widely used, well-validated measure of depression severity with high internal consistency (alpha .83 to .92; Cameron et al, 2008) and is correlated strongly with other depression measures. Its nine items assess affective and somatic symptoms and correspond to diagnostic criteria for MDD. This measure will also be collected every other week during treatment. Total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression).
Time frame: 3 months post treatment
Patient Health Questionnaire-9
The PHQ-9 (Kroenke et al., 2001) is a widely used, well-validated measure of depression severity with high internal consistency (alpha .83 to .92; Cameron et al, 2008) and is correlated strongly with other depression measures. Its nine items assess affective and somatic symptoms and correspond to diagnostic criteria for MDD. This measure will also be collected every other week during treatment. Total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression).
Time frame: 6 months post treatment
Insomnia Severity Index
The Insomnia Severity Index (ISI) self-report measure captures a respondent's perception of his or her current insomnia. The ISI includes seven items that assess severity of sleep onset, sleep maintenance, and early morning awakening problems; sleep dissatisfaction; interference of sleep difficulties with daytime functioning; noticeability of sleep problems by others; and distress caused by the sleep difficulties. Each item is rated on a 4-point Likert scale and the total score ranges from 0 to 28. A higher score suggests more severe insomnia.
Time frame: Baseline
Insomnia Severity Index
The ISI self-report measure captures a respondent's perception of his or her current insomnia. The ISI includes seven items that assess severity of sleep onset, sleep maintenance, and early morning awakening problems; sleep dissatisfaction; interference of sleep difficulties with daytime functioning; noticeability of sleep problems by others; and distress caused by the sleep difficulties. Each item is rated on a 4-point Likert scale and the total score ranges from 0 to 28. A higher score suggests more severe insomnia.
Time frame: 1 week post treatment
Insomnia Severity Index
The ISI self-report measure captures a respondent's perception of his or her current insomnia. The ISI includes seven items that assess severity of sleep onset, sleep maintenance, and early morning awakening problems; sleep dissatisfaction; interference of sleep difficulties with daytime functioning; noticeability of sleep problems by others; and distress caused by the sleep difficulties. Each item is rated on a 4-point Likert scale and the total score ranges from 0 to 28. A higher score suggests more severe insomnia.
Time frame: 3 months post treatment
Insomnia Severity Index
The ISI self-report measure captures a respondent's perception of his or her current insomnia. The ISI includes seven items that assess severity of sleep onset, sleep maintenance, and early morning awakening problems; sleep dissatisfaction; interference of sleep difficulties with daytime functioning; noticeability of sleep problems by others; and distress caused by the sleep difficulties. Each item is rated on a 4-point Likert scale and the total score ranges from 0 to 28. A higher score suggests more severe insomnia.
Time frame: 6 months post treatment
Medical Outcome Study Short Form-36 Health Survey
The Short Form-36 (SF-36) (Ware \& Sherbourne, 1992) is a 36-item questionnaire that measures health status, social support, and functioning over the past four weeks. Total score ranges from 0 to 100, with a higher score indicating better health status.
Time frame: Baseline
Medical Outcome Study Short Form-36 Health Survey
The SF-36 (Ware \& Sherbourne, 1992) is a 36-item questionnaire that measures health status, social support, and functioning over the past four weeks. Total score ranges from 0 to 100, with a higher score indicating better health status.
Time frame: 1 week post treatment
Medical Outcome Study Short Form-36 Health Survey
The SF-36 (Ware \& Sherbourne, 1992) is a 36-item questionnaire that measures health status, social support, and functioning over the past four weeks. Total score ranges from 0 to 100, with a higher score indicating better health status.
Time frame: 3 months post treatment
Medical Outcome Study Short Form-36 Health Survey
The SF-36 (Ware \& Sherbourne, 1992) is a 36-item questionnaire that measures health status, social support, and functioning over the past four weeks. Total score ranges from 0 to 100, with a higher score indicating better health status.
Time frame: 6 months post treatment
Dose Received
Number of treatment sessions completed.
Time frame: 14 weeks after treatment starts
Plan to share: No
Started Oct 2024 (actual). Primary completion is estimated for Jul 2028, 45 months after the start.
Of 25 interventional studies with no phase under Adjustment Disorders, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 38. This study's planned 45 months is above that.
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