Transdiagnostic Psychotherapy for Veterans With Mood and Anxiety Disorders

NCT01947647 | Completed Results

• 2 other identifiers: MHBA-018-13SCX000845
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Transdiagnostic Behavior Therapy

EXPERIMENTAL

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

Behavioral Activation Therapy

ACTIVE COMPARATOR

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

Interventions

Transdiagnostic Behavior Therapy BEHAVIORAL

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.

Transdiagnostic Behavior Therapy

Behavioral Activation Therapy BEHAVIORAL

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 Activation Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

Location

Related Publications (3)

• 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.

  PMID: 34996343 DERIVED

• 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.

  PMID: 32673037 DERIVED

• 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.

  PMID: 31600432 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Stress Disorders, Post-Traumatic; Panic Disorder; Phobia, Social; Phobia, Specific; Generalized Anxiety Disorder; Obsessive-Compulsive Disorder; Depressive Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Phobic Disorders

Limitations and Caveats

higher than expected dropout rates

Results Point of Contact

• Title: Daniel Gros, PHD
• Organization: Ralph H. Johnson VAMC

daniel.gros@va.gov

843-789-7311

Study Officials

• Daniel F Gros, PhD MA BS

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2013
• First Posted: September 20, 2013
• Study Start: November 17, 2014
• Primary Completion: June 1, 2018
• Study Completion: December 31, 2018
• Last Updated: August 28, 2019
• Results First Posted: August 28, 2019

Record last verified: 2019-07

Locations

US (1)