Transdiagnostic Psychotherapy for Veterans With Mood and Anxiety Disorders (TBT-RCT)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01947647
First received: September 11, 2013
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Major Depressive Disorder
Dysthymic Disorder
Posttraumatic Stress Disorder
Panic Disorder
Social Phobia
Specific Phobia
Generalized Anxiety Disorder
Obsessive Compulsive Disorder
Behavioral: Transdiagnostic Behavior Therapy
Behavioral: Behavioral Activation Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transdiagnostic Psychotherapy for Veterans With Mood and Anxiety Disorders

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Change in Albany Panic and Phobia Questionnaire [ Time Frame: baseline, immediate post-treatment, 6-month follow-up ] [ Designated as safety issue: No ]
    The APPQ is a 27-item self-report measure that assesses agoraphobia, social anxiety, and interoceptive avoidance. Each subscale has been shown to have good internal consistency ( s > .85) and temporal stability (rs > .87).


Secondary Outcome Measures:
  • Anxiety Disorder Interview Schedule-5 [ Time Frame: baseline, immediate post-treatment, 6-month follow-up ] [ Designated as safety issue: No ]
    The ADIS-5 is a well-established, semi-structured interview designed to assess a wide range of Axis I disorders. The ADIS-5 assesses current and past diagnoses with DSM diagnostic criteria, severity scores, and lists of feared and avoided situations for the anxiety disorders. The ADIS has demonstrated excellent inter-rater reliability and validity of depressive/anxiety disorder diagnoses.

  • Depression Anxiety Stress Scales 21-Item Version [ Time Frame: baseline, immediate post-treatment, 6-month follow-up ] [ Designated as safety issue: No ]
    The DASS is a 21-item measure with three subscales designed to assess dysphoric mood, fear and autonomic arousal, and tension and agitation. The factor structure, reliability, and validity of the subscales have been supported in the literature. The DASS scales also have demonstrated excellent convergence with similar measures of depression and anxiety and high internal consistency (? > .85).

  • Illness Intrusiveness Ratings Scale [ Time Frame: baseline, immediate post-treatment, 6-month follow-up ] [ Designated as safety issue: No ]
    The IIRS is a 13-item questionnaire that assesses the extent to which a disease interferes with important domains of life, including health, diet, work, and several others. Each item is rated on a 7-point Likert scale, ranging from 1 to 7, and summed to compute the scale score. The IIRS has been shown to have high internal consistency in the previous literature and present study (a = .88).

  • Satisfaction with Therapy and Therapist Scale - Revised [ Time Frame: immediate post-treatment, 6-month follow-up ] [ Designated as safety issue: No ]
    The STTS-R assesses patients� level of satisfaction with their therapeutic experiences. The STTS-R contains 12 items that represent two subscales: satisfaction with therapy and satisfaction with therapist. The measure has been investigated in a large sample of patients receiving group CBT for depressive/anxiety disorders. The two subscales have demonstrated excellent internal consistency (?s > .88) and high positive correlations with indicators of successful treatment outcome.

  • State-Trait Inventory for Cognitive and Somatic Anxiety - Trait Version [ Time Frame: baseline, immediate post-treatment, 6-month follow-up ] [ Designated as safety issue: No ]
    The STICSA-Trait is a 21-item measure that assesses trait cognitive and somatic anxiety. The cognitive and somatic subscales have been supported in the literature and both subscales have high internal consistency (as > .87). In addition, the STICSA-Trait scale was found to remain stable over repeated administrations during several stress manipulations (rs > .65).


Estimated Enrollment: 96
Study Start Date: September 2014
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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: 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.
Active Comparator: 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.
Behavioral: 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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 (PD, PTSD, SOC, OCD, GAD, specific phobia, MDD, or DD); 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01947647

Contacts
Contact: Daniel F Gros, PhD MA BS (843) 789-6225 daniel.gros@va.gov

Locations
United States, South Carolina
Ralph H. Johnson VA Medical Center, Charleston, SC Not yet recruiting
Charleston, South Carolina, United States, 29401-5799
Contact: Daniel F Gros, PhD MA BS    843-789-6225    daniel.gros@va.gov   
Principal Investigator: Daniel F Gros, PhD MA BS         
Sponsors and Collaborators
Investigators
Principal Investigator: Daniel F Gros, PhD MA BS Ralph H. Johnson VA Medical Center, Charleston, SC
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01947647     History of Changes
Other Study ID Numbers: MHBA-018-13S, CX000845
Study First Received: September 11, 2013
Last Updated: August 4, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
behavior therapy
Randomized Controlled Trials
Depressive Disorder
Anxiety Disorders
comorbidity

Additional relevant MeSH terms:
Phobic Disorders
Anxiety Disorders
Depressive Disorder, Major
Depressive Disorder
Stress Disorders, Traumatic
Depression
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Stress Disorders, Post-Traumatic
Panic Disorder
Disease
Dysthymic Disorder
Mental Disorders
Mood Disorders
Behavioral Symptoms
Personality Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014