Bipolar DisorderNCT04127604
Post-Hospital Intervention for Veterans With Comorbid Bipolar and Substance Use Disorders
A study testing Integrated Treatment Adherence Program for Veterans (ITAP-VA) and Safety Assessment and Follow-up Evaluation (SAFE) in people with Bipolar Disorder and Substance Use Disorders, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This trial aims to evaluate the effectiveness of a novel intervention for Veterans with co-occurring bipolar and substance use disorders following a psychiatric hospitalization. Half of the participants will receive a specialized psychosocial intervention program, while the other half will receive an enhanced safety… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder, Substance Use Disorders
- What is being tested?
- Integrated Treatment Adherence Program for Veterans (ITAP-VA) and Safety Assessment and Follow-up Evaluation (SAFE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2020to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of a mood disorder
- Diagnosis of a substance use disorder (drug and/or alcohol)
- Taking at least one psychiatric medication
Who cannot join
- Unable to speak and read English
- Younger than age 18
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908-4734
About this study
This trial aims to evaluate the effectiveness of a novel intervention for Veterans with co-occurring bipolar and substance use disorders following a psychiatric hospitalization. Half of the participants will receive a specialized psychosocial intervention program, while the other half will receive an enhanced safety monitoring program, both provided in addition to their routine care.
Read the detailed description
This randomized controlled trial will evaluate the effectiveness of a psychosocial intervention designed to improve treatment adherence in Veterans with comorbid bipolar disorder and substance use disorders (BP-SUD) following a psychiatric hospitalization. Participants will be randomized to either the specialized psychosocial intervention or an enhanced safety monitoring program, both as adjuncts to VA treatment as usual. Veterans with BP-SUD will be recruited from the Providence VAMC inpatient psychiatric unit and assessed at baseline and at 3 (mid-treatment), 6 (post-treatment), and 9-month post-discharge.
- Conditions
- Bipolar Disorder, Substance Use Disorders
- Being tested
- Integrated Treatment Adherence Program for Veterans (ITAP-VA), Safety Assessment and Follow-up Evaluation (SAFE)
- Keywords
- Bipolar Disorder, Substance Use Disorders, Treatment Adherence, Veterans, Psychosocial intervention
- Medical subject headings
- Bipolar Disorder, Substance-Related Disorders, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Treatment Adherence Program for Veterans (ITAP-VA)Behavioural
Psychosocial support and treatment to improve treatment adherence, symptoms, and functioning.
Safety Assessment and Follow-up Evaluation (SAFE)Behavioural
Measurement-based care assessment and evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Treatment Adherence Program for Veterans (ITAP-VA) | Experimental | A combination of in-person and phone sessions along with significant other involvement over 6 months post-hospitalization. Receives: Behavioral: Integrated Treatment Adherence Program for Veterans (ITAP-VA) |
| Safety Assessment and Follow-up Evaluation (SAFE) | Active comparator | Enhanced symptom monitoring and safety evaluation over 6 months post-hospitalization. Receives: Behavioral: Safety Assessment and Follow-up Evaluation (SAFE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Adherence Rating Scale (BARS)
The Brief Adherence Rating Scale (BARS) assesses the percentage of missed medication doses over the past month. The total adherence score ranges from 0% to 100% and higher scores indicate greater adherence.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start2 Nov 2020
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar 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
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Providence VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Jane Metrik, PhD, Principal investigator, Providence VA Medical Center, Providence, RIBrandon A Gaudiano, PhD, Principal investigator, Providence VA Medical Center, Providence, RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127604
- Sponsor's protocol ID
- IIR 19-048
- Other IDs
- IRB-2019-027
- Status last verified
- Oct 2025
- First submitted
- 14 Oct 2019
- Last updated
- 22 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After all data have been collected and the results of the studies published, de-identified data will be made available to other qualified researchers on request. The request will be evaluated by the PI and the Co-Investigators to ensure that it meets reasonable standards of scientific integrity.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Hospital Intervention for Veterans With Comorbid Bipolar and Substance Use Disorders
- ClinicalTrials.gov ID
- NCT04127604
- Acronym / sponsor ID
- IIR 19-048
- Conditions
- Bipolar Disorder, Substance Use Disorders
- Keywords
- Bipolar Disorder, Substance Use Disorders, Treatment Adherence, Veterans, Psychosocial intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Providence VA Medical Center
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial aims to evaluate the effectiveness of a novel intervention for Veterans with co-occurring bipolar and substance use disorders following a psychiatric hospitalization. Half of the participants will receive a specialized psychosocial intervention program, while the other half will receive an enhanced safety monitoring program, both provided in addition to their routine care.
Detailed description
This randomized controlled trial will evaluate the effectiveness of a psychosocial intervention designed to improve treatment adherence in Veterans with comorbid bipolar disorder and substance use disorders (BP-SUD) following a psychiatric hospitalization. Participants will be randomized to either the specialized psychosocial intervention or an enhanced safety monitoring program, both as adjuncts to VA treatment as usual. Veterans with BP-SUD will be recruited from the Providence VAMC inpatient psychiatric unit and assessed at baseline and at 3 (mid-treatment), 6 (post-treatment), and 9-month post-discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Treatment Adherence Program for Veterans (ITAP-VA) | Experimental | Behavioral: Integrated Treatment Adherence Program for Veterans (ITAP-VA)A combination of in-person and phone sessions along with significant other involvement over 6 months post-hospitalization. |
| Safety Assessment and Follow-up Evaluation (SAFE) | Active comparator | Behavioral: Safety Assessment and Follow-up Evaluation (SAFE)Enhanced symptom monitoring and safety evaluation over 6 months post-hospitalization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of a mood disorder
- Diagnosis of a substance use disorder (drug and/or alcohol)
- Taking at least one psychiatric medication
Key exclusion criteria (2 listed)
- Unable to speak and read English
- Younger than age 18
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 |
|---|---|---|
| Integrated Treatment Adherence Program for Veterans (ITAP-VA)Psychosocial support and treatment to improve treatment adherence, symptoms, and functioning. | Behavioural | Integrated Treatment Adherence Program for Veterans (ITAP-VA) |
| Safety Assessment and Follow-up Evaluation (SAFE)Measurement-based care assessment and evaluation. | Behavioural | Safety Assessment and Follow-up Evaluation (SAFE) |
Primary outcome
Brief Adherence Rating Scale (BARS)
Time frame: 1 month
The Brief Adherence Rating Scale (BARS) assesses the percentage of missed medication doses over the past month. The total adherence score ranges from 0% to 100% and higher scores indicate greater adherence.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
- Individual participant dataSharing planned: Yes. After all data have been collected and the results of the studies published, de-identified data will be made available to other qualified researchers on request. The request will be evaluated by the PI and the Co-Investigators to ensure that it meets reasonable standards of scientific integrity.
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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.
Jane Metrik, PhD principal investigator
Providence VA Medical Center, Providence, RI
Brandon A Gaudiano, PhD principal investigator
Providence VA Medical Center, Providence, RI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Treatment Adherence Program for Veterans (ITAP-VA) and Safety Assessment and Follow-up Evaluation (SAFE) in people with Bipolar Disorder and Substance Use Disorders, 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 2 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 22 Oct 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Brief Adherence Rating Scale (BARS) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2025.