Multisite RCT of STEP-Home: A Transdiagnostic Skill-based Community Reintegration Workshop
| Status: | Recruiting |
|---|---|
| Conditions: | Anxiety, Chronic Pain, Depression, Neurology, Psychiatric, Psychiatric, Psychiatric, Psychiatric |
| Therapuetic Areas: | Musculoskeletal, Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/6/2019 |
| Start Date: | April 1, 2019 |
| End Date: | March 31, 2023 |
| Contact: | Catherine B Fortier, PhD |
| Email: | catherine.fortier@va.gov |
| Phone: | (857) 364-4361 |
In this proposal, the investigators extend their previous SPiRE feasibility and preliminary
effectiveness study to examine STEP-Home efficacy in a RCT design. This novel therapy will
target the specific needs of a broad range of underserved post-9/11 Veterans. It is designed
to foster reintegration by facilitating meaningful improvement in the functional skills most
central to community participation: emotional regulation (ER), problem solving (PS), and
attention functioning (AT). The skills trained in the STEP-Home workshop are novel in their
collective use and have not been systematically applied to a Veteran population prior to the
investigators' SPiRE study. STEP-Home will equip Veterans with skills to improve daily
function, reduce anger and irritability, and assist reintegration to civilian life through
return to work, family, and community, while simultaneously providing psychoeducation to
promote future engagement in VA care.
The innovative nature of the STEP-Home intervention is founded in the fact that it is: (a) an
adaptation of an established and efficacious intervention, now applied to post-9/11 Veterans;
(b) nonstigmatizing (not "therapy" but a "skills workshop" to boost acceptance, adherence and
retention); (c) transdiagnostic (open to all post-9/11 Veterans with self-reported
reintegration difficulties; Veterans often have multiple mental health diagnoses, but it is
not required for enrollment); (d) integrative (focus on the whole person rather than specific
and often stigmatizing mental and physical health conditions); (e) comprised of
Veteran-specific content to teach participants cognitive behavioral skills needed for
successful reintegration (which led to greater acceptability in feasibility study); (f)
targets anger and irritability, particularly during interactions with civilians; (g)
emphasizes psychoeducation (including other available treatment options for common mental
health conditions); and (h) challenges beliefs/barriers to mental health care to increase
openness to future treatment and greater mental health treatment utilization. Many Veterans
who participated in the development phases of this workshop have gone on to trauma or other
focused therapies, or taken on vocational (work/school/volunteer) roles after STEP-Home.
The investigators have demonstrated that the STEP-Home workshop is feasible and results in
pre-post change in core skill acquisition that the investigators demonstrated to be directly
associated with post-workshop improvement in reintegration status in their SPiRE study. Given
the many comorbidities of this cohort, the innovative treatment addresses multiple aspects of
mental health, cognitive, and emotional function simultaneously and bolsters reintegration in
a short-term group to maximize cost-effectiveness while maintaining quality of care.
effectiveness study to examine STEP-Home efficacy in a RCT design. This novel therapy will
target the specific needs of a broad range of underserved post-9/11 Veterans. It is designed
to foster reintegration by facilitating meaningful improvement in the functional skills most
central to community participation: emotional regulation (ER), problem solving (PS), and
attention functioning (AT). The skills trained in the STEP-Home workshop are novel in their
collective use and have not been systematically applied to a Veteran population prior to the
investigators' SPiRE study. STEP-Home will equip Veterans with skills to improve daily
function, reduce anger and irritability, and assist reintegration to civilian life through
return to work, family, and community, while simultaneously providing psychoeducation to
promote future engagement in VA care.
The innovative nature of the STEP-Home intervention is founded in the fact that it is: (a) an
adaptation of an established and efficacious intervention, now applied to post-9/11 Veterans;
(b) nonstigmatizing (not "therapy" but a "skills workshop" to boost acceptance, adherence and
retention); (c) transdiagnostic (open to all post-9/11 Veterans with self-reported
reintegration difficulties; Veterans often have multiple mental health diagnoses, but it is
not required for enrollment); (d) integrative (focus on the whole person rather than specific
and often stigmatizing mental and physical health conditions); (e) comprised of
Veteran-specific content to teach participants cognitive behavioral skills needed for
successful reintegration (which led to greater acceptability in feasibility study); (f)
targets anger and irritability, particularly during interactions with civilians; (g)
emphasizes psychoeducation (including other available treatment options for common mental
health conditions); and (h) challenges beliefs/barriers to mental health care to increase
openness to future treatment and greater mental health treatment utilization. Many Veterans
who participated in the development phases of this workshop have gone on to trauma or other
focused therapies, or taken on vocational (work/school/volunteer) roles after STEP-Home.
The investigators have demonstrated that the STEP-Home workshop is feasible and results in
pre-post change in core skill acquisition that the investigators demonstrated to be directly
associated with post-workshop improvement in reintegration status in their SPiRE study. Given
the many comorbidities of this cohort, the innovative treatment addresses multiple aspects of
mental health, cognitive, and emotional function simultaneously and bolsters reintegration in
a short-term group to maximize cost-effectiveness while maintaining quality of care.
Post-9/11 Veterans who served in OEF/OIF face many challenges as they re-enter civilian life
after structured military careers. Yet, underutilization and resistance to mental health
treatment remains a significant problem. Recent investigations of community reintegration
problems among returning Veterans found that half of combat Veterans who use Veterans
Administration (VA) services reported difficulty in readjusting to civilian life, including
difficulty in social functioning, productivity in work and school settings, community
involvement, and self-care domains. High rates of marital, family, and cohabitation discord
were reported, with 75% reporting a family conflict in the last week. At least one-third
reported divorce, dangerous driving and risky behaviors, increased substance use, and
impulsivity and anger control problems since deployment. Almost all Veterans expressed
interest in receiving services to help readjust to civilian life, and receiving reintegration
services at a VA facility was reported as the preferred way to receive help. Mental health
and anger problems are often cited as driving Veterans' difficulties readjusting to civilian
life. Anger is becoming more widely recognized for its involvement in the psychological
adjustment problems of post-9/11 Veterans. Research has shown that anger directly influences
treatment outcome. In fact, history of untreated PTSD and aggression have been demonstrated
to be pervasive among post-9/11 Veterans who die by suicide in the months before death.
Veterans with probable PTSD report more reintegration and anger problems, and greater
interest in services than Veterans without. Reintegration and anger problems continue for
years post-combat and may not resolve without intervention.
Research on TBI in post-9/11 Veterans underscores the need for programs that utilize an
interdisciplinary approach to reintegration. Programs designed to address challenges of
Veterans as they reintegrate in vocational environments, particularly integrative approaches,
are greatly needed. The STEP-Home intervention provides such a program. STEP-Home includes
focused cognitive and emotional regulation skills training and is informed by the most recent
research with returning Veterans and available programs focused on reintegration in VA and
military settings (e.g., Battlemind training).
Phase 1: Years 1 and 2 The investigators will initiate the study at the Boston VAMC and
develop Standard Operating Procedures for the addition of site 2 in Phase 2.
Phase 2: Years 3 and 4 The investigators will initiate the study at the second site, the
Houston VAMC, in Year 3. The investigators will apply in Year 2 for IRB approval to initiate
site 2.
Hypotheses & Aims
Primary Aim 1. Examine treatment effects of STEP-Home on primary outcomes relative to Present
Centered Group Therapy (PCGT):
Hypothesis 1A. Participants randomized into the STEP-Home intervention will show improvement
on reintegration, readjustment, and anger post-intervention (expressed by lower scores; less
difficulty).
Military to Civilian Questionnaire (M2CQ), Post-Deployment Readjustment Inventory (PDRI), and
State-Trait Anger Expression Inventory (STAXI-2) scores post-intervention (T4) < baseline
(T1)
Hypothesis 1B. Participants randomized into STEP-Home will show greater improvement in
primary outcomes as compared to PCGT.
Change scores baseline (T1) to post-intervention (T4) STEP-Home > PCGT change scores
Post-intervention (T4) primary outcome scores STEP-Home < PCGT primary outcome scores (T4)
Primary Aim 2. Examine maintenance of treatment effects on primary outcomes:
Hypothesis 2: Treatment effects will be maintained at follow up in both groups. Differential
treatment effect of STEP-Home over PCGT post-intervention (T4) will be maintained at follow
up (T5).
Exploratory Aim 1. Explore treatment effects of STEP-Home on measures of mental health,
functional and vocational status and cognitive secondary outcomes targeted indirectly in the
workshop.
Exploratory Hypothesis 1. Acquisition of core skills (problem solving, emotional regulation,
attention training) will mediate the effect of treatment on primary outcomes
post-intervention and at follow up.
The successful completion of the aims proposed has the potential to significantly improve
skills to foster civilian reintegration in post-9/11Veterans. Furthermore, the STEP-Home
SPiRE feasibility study demonstrated that the workshop also serves as a gateway for Veterans
who are hesitant to participate in traditional mental health treatments to promote openness
and engagement in additional, critically needed, VA services. Given the high rate of
treatment resistance in this cohort, developing acceptable interventions that promote
treatment engagement and retention, and open the door to future VA care, is necessary to
improve functional status and to reduce long-term healthcare costs of untreated mental health
illnesses.
after structured military careers. Yet, underutilization and resistance to mental health
treatment remains a significant problem. Recent investigations of community reintegration
problems among returning Veterans found that half of combat Veterans who use Veterans
Administration (VA) services reported difficulty in readjusting to civilian life, including
difficulty in social functioning, productivity in work and school settings, community
involvement, and self-care domains. High rates of marital, family, and cohabitation discord
were reported, with 75% reporting a family conflict in the last week. At least one-third
reported divorce, dangerous driving and risky behaviors, increased substance use, and
impulsivity and anger control problems since deployment. Almost all Veterans expressed
interest in receiving services to help readjust to civilian life, and receiving reintegration
services at a VA facility was reported as the preferred way to receive help. Mental health
and anger problems are often cited as driving Veterans' difficulties readjusting to civilian
life. Anger is becoming more widely recognized for its involvement in the psychological
adjustment problems of post-9/11 Veterans. Research has shown that anger directly influences
treatment outcome. In fact, history of untreated PTSD and aggression have been demonstrated
to be pervasive among post-9/11 Veterans who die by suicide in the months before death.
Veterans with probable PTSD report more reintegration and anger problems, and greater
interest in services than Veterans without. Reintegration and anger problems continue for
years post-combat and may not resolve without intervention.
Research on TBI in post-9/11 Veterans underscores the need for programs that utilize an
interdisciplinary approach to reintegration. Programs designed to address challenges of
Veterans as they reintegrate in vocational environments, particularly integrative approaches,
are greatly needed. The STEP-Home intervention provides such a program. STEP-Home includes
focused cognitive and emotional regulation skills training and is informed by the most recent
research with returning Veterans and available programs focused on reintegration in VA and
military settings (e.g., Battlemind training).
Phase 1: Years 1 and 2 The investigators will initiate the study at the Boston VAMC and
develop Standard Operating Procedures for the addition of site 2 in Phase 2.
Phase 2: Years 3 and 4 The investigators will initiate the study at the second site, the
Houston VAMC, in Year 3. The investigators will apply in Year 2 for IRB approval to initiate
site 2.
Hypotheses & Aims
Primary Aim 1. Examine treatment effects of STEP-Home on primary outcomes relative to Present
Centered Group Therapy (PCGT):
Hypothesis 1A. Participants randomized into the STEP-Home intervention will show improvement
on reintegration, readjustment, and anger post-intervention (expressed by lower scores; less
difficulty).
Military to Civilian Questionnaire (M2CQ), Post-Deployment Readjustment Inventory (PDRI), and
State-Trait Anger Expression Inventory (STAXI-2) scores post-intervention (T4) < baseline
(T1)
Hypothesis 1B. Participants randomized into STEP-Home will show greater improvement in
primary outcomes as compared to PCGT.
Change scores baseline (T1) to post-intervention (T4) STEP-Home > PCGT change scores
Post-intervention (T4) primary outcome scores STEP-Home < PCGT primary outcome scores (T4)
Primary Aim 2. Examine maintenance of treatment effects on primary outcomes:
Hypothesis 2: Treatment effects will be maintained at follow up in both groups. Differential
treatment effect of STEP-Home over PCGT post-intervention (T4) will be maintained at follow
up (T5).
Exploratory Aim 1. Explore treatment effects of STEP-Home on measures of mental health,
functional and vocational status and cognitive secondary outcomes targeted indirectly in the
workshop.
Exploratory Hypothesis 1. Acquisition of core skills (problem solving, emotional regulation,
attention training) will mediate the effect of treatment on primary outcomes
post-intervention and at follow up.
The successful completion of the aims proposed has the potential to significantly improve
skills to foster civilian reintegration in post-9/11Veterans. Furthermore, the STEP-Home
SPiRE feasibility study demonstrated that the workshop also serves as a gateway for Veterans
who are hesitant to participate in traditional mental health treatments to promote openness
and engagement in additional, critically needed, VA services. Given the high rate of
treatment resistance in this cohort, developing acceptable interventions that promote
treatment engagement and retention, and open the door to future VA care, is necessary to
improve functional status and to reduce long-term healthcare costs of untreated mental health
illnesses.
Inclusion Criteria:
- Post-9/11 Veterans who report some reintegration, readjustment, or anger difficulty
- i.e., Veterans who report "some difficulty" (Likert rating) on at least one of
the primary measures: M2CQ; PDRI; STAXI-2
- 18-65 years old (to avoid outcomes being affected by aging)
- English-speaking (sessions will be conducted in English)
- Agreeing to participate
- i.e., completion of ICF/HIPAA
Exclusion Criteria:
- schizophreniform disorder/active psychosis
- bipolar disorder
- active suicidality/homicidality requiring crisis intervention
- other severe psychiatric disorders prohibiting appropriate group participation
- neurological diagnosis prohibiting appropriate group participation (excluding TBI)
- current substance dependence
- current participation in any other form of active behavioral therapy at the time of
enrollment
- e.g., Cognitive Processing Therapy, cognitive rehabilitation for mTBI, or other
psychotherapy
We found this trial at
2
sites
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Boston, Massachusetts 02130
Principal Investigator: Catherine B Fortier, PhD
Phone: 857-364-4802
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