Transdiagnostic Psychotherapy for Veterans With Mood and Anxiety Disorders

Major Depressive Disorder Clinical Trial

— TBT-RCT  

Official title:

Transdiagnostic Psychotherapy for Veterans With Mood and Anxiety Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01947647
• Other study ID #: MHBA-018-13S
• Secondary ID: CX000845
• Status: Completed
• Phase: N/A
• Start date: November 17, 2014
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 31, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Generalized Anxiety Disorder
• Major Depressive Disorder
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder
• Panic Disorder
• Persistent Depressive Disorder
• Phobia, Social
• Phobic Disorders
• Posttraumatic Stress Disorder
• Social Phobia
• Specific Phobia
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• Transdiagnostic Behavior Therapy
A new transdiagnostic CBT protocol for the depressive/anxiety disorders 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.
• Behavioral Activation Therapy
To provide an evidence-based comparison for the transdiagnostic CBT condition, a second group of participants will receive manualized BAT. 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. 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.

Locations

Country	Name	City	State
United States	Ralph H. Johnson VA Medical Center, Charleston, SC	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DASS-Depression	The DASS-Depression (Lovibond and Lovibond, 1995) is a 7-item measure designed to assess dysphoric mood. Items are rated on a 4-point Likert scale, ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time), and summed to compute the total scale (range 0-21). Higher scores are indicative of greater symptom severity, with scores greater than 10 typically considered of clinical significance. Support for the factor structure, convergent and discriminant validity, and internal consistency of the DASS has been found in community (Lovibond and Lovibond, 1995).	baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)
Primary	DASS-Anxiety	The DASS-Anxiety (Lovibond and Lovibond, 1995) is a 7-item measure designed to assess symptoms of fear and autonomic arousal. Items are rated on a 4-point scale, ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time), and summed to compute the total scale (range 0-21). Higher scores are indicative of greater symptom severity, with scores greater than 10 typically considered of clinical significance. Support for the factor structure, convergent and discriminant validity, and internal consistency has been found in community (Lovibond and Lovibond, 1995).	baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)
Primary	DASS-Stress	The DASS-Stress (Lovibond and Lovibond, 1995) is a 7-item measure designed to assess symptoms of tension and agitation. Items are rated on a 4-point Likert scale, ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time), and summed to compute the total scale (range 0-21). Higher scores are indicative of greater symptom severity, with scores greater than 10 typically considered of clinical significance. Support for the factor structure, convergent and discriminant validity, and internal consistency has been found in community (Lovibond and Lovibond, 1995).	baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)
Primary	STICSA-Cognitive	The STICSA-Cognitive (Ree et al., 2008) is a 11-item measure designed to assess trait cognitive anxiety. Items are rated on a 4-point scale, ranging from 1 (not at all) to 4 (very much so), with a total score range of 11-44. Higher scores are indicative of greater symptom severity, with scores above 23 considered of clinical significance. The cognitive scale have been supported by factor analysis and has been found to have high internal consistency (alphas > .87; Gros et al., 2007; 2010).	baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)
Primary	STICSA-Somatic	The STICSA-Somatic (Ree et al., 2008) is a 10-item measure designed to assess trait somatic anxiety. Items are rated on a 4-point scale, ranging from 1 (not at all) to 4 (very much so), with a total score range of 10-40. Higher scores indicative of greater symptom severity, with scores above 18 considered of clinical significance. The somatic scale have been supported by factor analysis and has been found to have high internal consistency (alphas > .87; Gros et al., 2007; 2010).	baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)
Primary	IIRS	The IIRS (Devin et al., 1983) is a 13-item scale that assesses the extent to which a disease interferes with important domains of life. Each item is rated on a 7-point Likert scale, ranging from 1 (not very much) to 7 (very much), with a total score range of 13-91. Although norms are not available for all diagnoses given the transdiagnostic nature of the IIRS, higher scores are indicative of greater impairment. The IIRS has strong psychometric properties in the previous literature in participants with physical and/or emotional health concerns (Devins et al., 2001; Devins, 2010).	baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)