Clinical trial NCT01947647: Transdiagnostic Psychotherapy for Veterans With Mood and Anxiety Disorders
Official title: Transdiagnostic Psychotherapy for Veterans With Mood and Anxiety Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Persistent Depressive Disorder
Posttraumatic Stress Disorder
Panic Disorder
Social Phobia
Specific Phobia
Generalized Anxiety Disorder
Obsessive Compulsive Disorder
Keywords: behavior therapy
Randomized Controlled Trials
Depressive Disorder
Anxiety Disorders
comorbidity
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2013-09-20
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cognitive behavioral therapy (CBT) is a brief, efficient, and effective psychotherapy for individuals with depressive and anxiety disorders. However, CBT is largely underutilized within Veteran Affairs Medical Centers (VAMCs) due to the cost and burden of trainings necessary to deliver the large number of CBT protocols. Transdiagnostic CBT, in contrast, is specifically designed to address numerous distinct disorders within a single protocol. This transdiagnostic approach has the potential to dramatically improve the accessibility of CBT within VAMCs and therefore improve clinical outcomes of Veterans. The proposed research seeks to evaluate the efficacy of a transdiagnostic CBT by assessing clinical outcomes and quality of life in VAMC patients with depressive and anxiety disorders throughout the course of treatment and in comparison to an existing evidence-based psychotherapy, behavioral activation treatment.

Detailed description: Objective To evaluate the transdiagnostic CBT in a randomized clinical trial (RCT) of VAMC patients with depressive/anxiety disorders by investigating its preliminary efficacy in reducing symptomatology, comorbidity, and improving quality of life compared to behavioral activation therapy (BAT) (psychotherapy control condition). Patient satisfaction and predictors of feasibility (attendance and dropout) also will be assessed.

Recruitment Strategy VAMC patients will be recruited through the Primary Care - Mental Health Integration program and CBT Clinic at the Ralph H. Johnson (RHJ) VAMC. Within these programs, all VAMC patients reporting symptoms of depression and anxiety meet with a mental health staff member to complete a diagnostic interview and self-report measures as part of their standard clinical practices. If VAMC patients endorse symptoms consistent with a depressive/anxiety disorder, the patient's interest in participating in research will be assessed and, if agreeable to research, patients will be put in contact with research staff (same day meeting and/or follow-up phone to schedule research assessment). A research assessment will be completed with the project staff to first complete consent documentation and then assess inclusion/exclusion criteria (with a targeted sample of 96 VAMC patients; \> 72 completers), including a semi-structured clinical interview and self-report questionnaires focused on the psychiatric symptoms and quality of life. Participants who meet diagnostic criteria for the targeted disorders will be randomized into a study condition, and will be assigned to a project therapist. Because most VAMC patients who meet study criteria likely will present with multiple depressive/anxiety disorders, principal diagnosis, or the most impairing of the diagnosable disorders, will be used to select patients for participation. To balance diagnoses across the two conditions, a stratified random assignment based on principal diagnosis will be used for the most common principal diagnoses (MDD, PTSD, and PD).

Procedures Eligible VAMC patients will be randomized into one of two treatment conditions: transdiagnostic CBT or BAT. Both treatment conditions will include 12-16 weekly 50-minute individual psychotherapy sessions. The total number of sessions will vary slightly depending on participant needs and progress during therapy, as is common in most CBT approaches to psychotherapy (and will serve as a covariate in the outcome analyses). The general format of sessions will involve: 1) brief check-in; 2) review of materials from previous sessions; 3) review of homework assignments; 4) overview of new materials and in-session exercises; and 5) assignment of homework for next session. Attendance and homework completion will be recorded.

Randomization Procedures Participants will be randomly assigned (1:1) to one of the two study arms (n = 59 per arm) using a permuted block randomization procedure. Randomization will be stratified by principal diagnostic group and block size will be varied to minimize the likelihood of unmasking. After determining eligibility and completing consent and baseline assessment materials, enrolled participants will be assigned to treatment groups by the Project Research Assistant using a computer generated randomization scheme. Once a participant is randomized and attends the first session, they will be included in the intent-to-treat analysis. Randomization will occur at the participant level.

Transdiagnostic CBT Treatment Condition As noted above in the Preliminary Studies section, a transdiagnostic CBT protocol was developed and revised through two demonstration studies and one focus group. The resulting protocol involves several primary components, including psychoeducation on the symptoms of depression and anxiety (session 1), assessment of motivation and setup of treatment plans (session 2), exposure therapy (sessions 3-15), and relapse prevention (final session). In addition to these primary components, optional modules are included to supplement exposure therapy later in treatment to address secondary symptoms (e.g., anger, sleep, hypervigilance, drinking to cope). The goal of these modules is to allow providers to tailor treatment to specific symptoms that may be present in any single or set of diagnoses that may be reducing the effects from the primary exposure approach. Session will be weekly for 45-60 minutes with homework assignments to be completed between sessions.

BAT Control Condition To provide an evidence-based comparison for the transdiagnostic CBT condition, a second group of participants will receive manualized BAT. BAT is based on early behavioral models that suggest that decreases in positively reinforcing healthy behaviors are associated with the development of negative affect. In general, BAT involves teaching patients to monitor their mood and daily activities with the goal of increasing pleasant, reinforcing activities and reducing unpleasant events. BA is a brief treatment, can be administered in either individual or group formats, and has demonstrated reliable effectiveness across a wide range of university, community, civilian and Veteran clinical samples with depression. BAT also has been shown to be effective in the treatment of PTSD and other related depressive/anxiety disorders in Veterans. In the present study, the BAT condition will be manualized, following an existing protocol in the literature. BAT will be structurally equivalent to the transdiagnostic CBT with the same session length (45-60 minutes), frequency of sessions (weekly), duration of treatment (12-16 sessions), and amount of homework.

Eligibility criteria: Inclusion Criteria:

Inclusion criteria involve:

* participants must be clearly competent to provide informed consent for research participation;
* participants must meet DSM diagnostic criteria for a principal diagnosis of a depressive/anxiety disorder (Panic Disorder, PTSD, Social Anxiety Disorder, Obsessive-Compulsive Disorder (OCD), Generalized Anxiety Disorder (GAD), specific phobia, major depressive disorder, or persistent depressive disorder); and
* participants must be 18 - 80 years old.

Exclusion Criteria:

Exclusion criteria involve:

* recent history (\< 2 months) of psychiatric hospitalization or a suicide attempt as documented in their medical record,
* current diagnosis of substance dependence or abuse on the structured clinical interview,
* acute, severe illness or medical condition that likely will require hospitalization and/or otherwise interfere with study procedures as documented in their medical record (e.g., active chemotherapy/radiation treatment for cancer, kidney dialysis, oxygen therapy for chronic obstructive pulmonary disease),
* recent start of new psychiatric medication (\< 4 weeks),
* diagnosis of traumatic brain injury (TBI) in their medical record and/or endorsement of screener questionnaire regarding the symptoms of TBI modified from the Post-Deployment Health Assessment employed by the Department of Defense, or
* diagnosis of schizophrenia, psychotic symptoms, personality disorder, and/or bipolar disorder. VAMC patients excluded due to these factors will be reconsidered for participation once the condition related to their exclusion is resolved or stabilized. Together, these inclusion/exclusion criteria should allow the vast majority of interested VAMC patients with depressive/anxiety disorders to be eligible to participate. Ineligible VAMC patients will be referred for non-study-related treatments within mental health at the RHJ VAMC.

Primary outcomes:
measure: DASS-Depression
timeFrame: baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)
measure: DASS-Anxiety
timeFrame: baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)
measure: DASS-Stress
timeFrame: baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)
measure: STICSA-Cognitive
timeFrame: baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)
measure: STICSA-Somatic
timeFrame: baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)
measure: IIRS
timeFrame: baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center, Charleston, SC
state: South Carolina
Study officials:
affiliation: Ralph H. Johnson VA Medical Center, Charleston, SC
name: Daniel F Gros, PhD MA BS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coyne AE, Gros DF. Comorbidity as a moderator of the differential efficacy of transdiagnostic behavior therapy and behavioral activation for affective disorders. Psychother Res. 2022 Sep;32(7):886-897. doi: 10.1080/10503307.2021.2022236. Epub 2022 Jan 7.
citation: Shapiro MO, Gros DF. Acceptability of a transdiagnostic behavior therapy in veterans with affective disorders. Psychol Serv. 2021 Nov;18(4):643-650. doi: 10.1037/ser0000490. Epub 2020 Jul 16.
citation: Gros DF, Oglesby ME, Wray JM. An Open Trial of Behavioral Activation in Veterans With Major Depressive Disorder or Posttraumatic Stress Disorder in Primary Care. Prim Care Companion CNS Disord. 2019 Oct 3;21(5):19m02468. doi: 10.4088/PCC.19m02468.