Bipolar DisorderITAPNCT04202393
Intervention for Comorbid Substance Use and Bipolar Disorders
A study testing Integrated Treatment Adherence Program (ITAP) and Safety Assessment and Follow-up Evaluation (SAFE) in people with Bipolar Disorder and Substance Use Disorders, run by Butler Hospital at 1 site in United States.
Trial summary
This trial aims to evaluate the effectiveness of a novel intervention for patients 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 (ITAP) 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
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2020to 31 Aug 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of a bipolar-spectrum disorder
- Diagnosis of a substance use disorder
- Taking at least one mood-stabilizing medication
Who cannot join
- Unable to speak and read English
- Younger than age 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RCT to Improve Post-Hospital Treatment Adherence for Comorbid Substance Use and Bipolar Disorders
This trial aims to evaluate the effectiveness of a novel intervention for patients 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.
- Conditions
- Bipolar Disorder, Substance Use Disorders
- Being tested
- Integrated Treatment Adherence Program (ITAP), Safety Assessment and Follow-up Evaluation (SAFE)
- Medical subject headings
- Bipolar Disorder, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Treatment Adherence Program (ITAP)Behavioural
Psychosocial support and treatment to improve treatment adherence, symptoms, and functioning.
Safety Assessment and Follow-up Evaluation (SAFE)Behavioural
Enhanced assessment and evaluation with clinician feedback.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Treatment Adherence Program (ITAP) | 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 (ITAP) |
| 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.
Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)
The Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C) assesses depressive symptom severity. Total scores range from 0 to 27 and higher scores indicated higher symptom severity.
Measured: 6 months
Clinician-Administered Rating Scale for Mania (CARS-M)
The Clinician-Administered Rating Scale for Mania (CARS-M) assesses mania symptom severity. Total scores range from 0 to 50 and higher scores indicated higher symptom severity.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start21 Oct 2020
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
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.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- 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
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Brandon Gaudiano, PhD, Principal investigator, Butler HospitalIvan Miller, PhD, Principal investigator, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202393
- Sponsor's protocol ID
- 1370188-2
- Other IDs
- R01MH122870
- Acronym
- ITAP
- Status last verified
- Nov 2025
- First submitted
- 16 Dec 2019
- Last updated
- 9 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upload to NIMH Data Archive
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT to Improve Post-Hospital Treatment Adherence for Comorbid Substance Use and Bipolar Disorders
- ClinicalTrials.gov ID
- NCT04202393
- Acronym / sponsor ID
- ITAP / 1370188-2
- Conditions
- Bipolar Disorder, Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 17 Dec 2019 (actual)
- Results
- Posted 13 Aug 2026
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 patients 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.
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 (ITAP) | Experimental | Behavioral: Integrated Treatment Adherence Program (ITAP)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 bipolar-spectrum disorder
- Diagnosis of a substance use disorder
- Taking at least one mood-stabilizing 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 (ITAP)Psychosocial support and treatment to improve treatment adherence, symptoms, and functioning. | Behavioural | Integrated Treatment Adherence Program (ITAP) |
| Safety Assessment and Follow-up Evaluation (SAFE)Enhanced assessment and evaluation with clinician feedback. | Behavioural | Safety Assessment and Follow-up Evaluation (SAFE) |
Primary outcome
Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)
Time frame: 6 months
The Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C) assesses depressive symptom severity. Total scores range from 0 to 27 and higher scores indicated higher symptom severity.
Clinician-Administered Rating Scale for Mania (CARS-M)
Time frame: 6 months
The Clinician-Administered Rating Scale for Mania (CARS-M) assesses mania symptom severity. Total scores range from 0 to 50 and higher scores indicated higher symptom severity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Upload to NIMH Data Archive
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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.
Brandon Gaudiano, PhD principal investigator
Butler Hospital
Ivan Miller, PhD principal investigator
Butler Hospital
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 (ITAP) and Safety Assessment and Follow-up Evaluation (SAFE) in people with Bipolar Disorder and Substance Use Disorders, run by Butler Hospital 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 9 Sep 2026. 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 13 Aug 2026). 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?
Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C) (time frame: 6 months). The study lists 2 primary outcomes in all. 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 9 Sep 2026; AzTrials last refreshed its copy on 30 Oct 2026.