Major Depressive DisorderTBT-RCTNCT01947647
Transdiagnostic Psychotherapy for Veterans With Mood and Anxiety Disorders
A study testing Transdiagnostic Behavior Therapy and Behavioral Activation Therapy in people with Major Depressive Disorder and Persistent Depressive Disorder, run by VA Office of Research and Development at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Major Depressive Disorder, Persistent Depressive Disorder, Posttraumatic Stress Disorder
- What is being tested?
- Transdiagnostic Behavior Therapy and Behavioral Activation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2014to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5799
About this study
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.
Read the 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.
- Conditions
- Major Depressive Disorder, Persistent Depressive Disorder, Posttraumatic Stress Disorder, Panic Disorder, Social Phobia, Specific Phobia
- Being tested
- Transdiagnostic Behavior Therapy, Behavioral Activation Therapy
- Keywords
- behavior therapy, Randomized Controlled Trials, Depressive Disorder, Anxiety Disorders, comorbidity
- Medical subject headings
- Depressive Disorder, Major, Stress Disorders, Post-Traumatic, Panic Disorder, Phobia, Social, Phobia, Specific, Generalized Anxiety Disorder, Obsessive-Compulsive Disorder, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdiagnostic Behavior TherapyBehavioural
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 TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Behavioral Activation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study start17 Nov 2014
- Primary completion1 Jun 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Daniel F Gros, PhD MA BS, Principal investigator, Ralph H. Johnson VA Medical Center, Charleston, SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947647
- Sponsor's protocol ID
- MHBA-018-13S
- Other IDs
- CX000845
- Acronym
- TBT-RCT
- Status last verified
- Jul 2019
- First submitted
- 11 Sep 2013
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34996343Shapiro 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.
PubMed 32673037Gros 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.
PubMed 31600432
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdiagnostic Psychotherapy for Veterans With Mood and Anxiety Disorders
- ClinicalTrials.gov ID
- NCT01947647
- Acronym / sponsor ID
- TBT-RCT / MHBA-018-13S
- Conditions
- Major Depressive Disorder, Persistent Depressive Disorder, Posttraumatic Stress Disorder, Panic Disorder, Social Phobia, Specific Phobia
- Keywords
- behavior therapy, Randomized Controlled Trials, Depressive Disorder, Anxiety Disorders, comorbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 17 Nov 2014 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 20 Sep 2013 (estimated)
- Results
- Posted 28 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transdiagnostic Behavior Therapy | Experimental | Behavioral: Transdiagnostic Behavior TherapyA 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 | Active comparator | Behavioral: Behavioral Activation TherapyTo 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdiagnostic Behavior TherapyA 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. | Behavioural | Transdiagnostic Behavior Therapy |
| Behavioral Activation TherapyTo 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. | Behavioural | Behavioral Activation Therapy |
Primary outcome
DASS-Depression
Time frame: baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)
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).
DASS-Anxiety
Time frame: baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)
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).
DASS-Stress
Time frame: baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)
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).
STICSA-Cognitive
Time frame: baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)
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).
STICSA-Somatic
Time frame: baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)
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).
IIRS
Time frame: baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34996343Coyne 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.
- Derived from this study: PubMed 32673037Shapiro 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.
- Derived from this study: PubMed 31600432Gros 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel F Gros, PhD MA BS principal investigator
Ralph H. Johnson VA Medical Center, Charleston, SC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transdiagnostic Behavior Therapy and Behavioral Activation Therapy in people with Major Depressive Disorder and Persistent Depressive Disorder, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DASS-Depression (time frame: baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01947647, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.