Bipolar DisorderNCT02448108
Internet Psychotherapy for Bipolar Disorder in Primary Care
A study testing i-IPSRT and Written Psychoeducation in people with Bipolar Disorder, run by University of Pittsburgh at 1 site in United States.
Trial summary
The investigators will conduct a small pilot study to test the feasibility and acceptability of treating bipolar disorder (BP) in primary care with online psychotherapy delivered both with and without telephone, text, and email support from a clinical helper (CH). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- i-IPSRT and Written Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 30 Sep 2019
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older;
- meet DSM 5 criteria for bipolar disorder I, II or Other Specified Bipolar and Related Disorder;
- using the SCID 5;
- score > or = to 9 on Patient Health Questionnaire-9 or score > or = 155 on Internal State Scale;
- receiving care from a Primary Care Physician in a designated study site;
- access to broadband Internet connection and telephone; and
- ability to read and speak English.
Who cannot join
- Self-reported visual impairment that would prevent completion of study procedures;
- Psychotic disorder, substance use disorder or current manic episode, which would deem participation in the study either inappropriate or dangerous;
- currently receiving specialty mental health services for bipolar disorder from a psychiatrist or therapist;
- planning to leave Primary Care Practice within next 3 months; and
- active suicidal ideation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Internet Psychotherapy for Treating Bipolar Disorder in Primary Care
The investigators will conduct a small pilot study to test the feasibility and acceptability of treating bipolar disorder (BP) in primary care with online psychotherapy delivered both with and without telephone, text, and email support from a clinical helper (CH). The ultimate goal of this work is to provide preliminary data needed to design a larger scale effectiveness study of online psychotherapy for treating BP in primary care.
Read the detailed description
Over a third of individuals with bipolar spectrum disorders (BP) are treated exclusively in primary care settings, and yet, primary care providers (PCPs) are ill-equipped to manage this complex and disabling illness. Medications, which can be prescribed by PCPs, hasten recovery from illness and improve long-term course of illness for those with BP, but relapse and residual symptoms are common when individuals are treated with pharmacotherapy alone. Best practices treatment for BP includes adjunctive, BP-specific psychotherapy as a key element of effective care. And yet, evidence-based BP-specific psychotherapies that engage and modify targets specific to BP are typically unavailable in primary care settings. Online interventions have the potential to overcome barriers to accessing evidence-based psychosocial treatments for BP in primary care. In other settings and with other populations, effectiveness of online interventions improved when human support/coaching (clinical helpers; CH) via text, email, and telephone was added to the intervention. Interpersonal and Social Rhythm Therapy (IPSRT) is a BP-specific psychotherapy that uses a problem-solving approach to help individuals regularize their social rhythms in order to entrain underlying disturbances in circadian and sleep/wake regulation, factors that are increasingly recognized as playing important roles in the pathogenesis of BP. Its primary behavioral target is regularity of daily routines such as sleep/wake cycle and mealtimes. This construct is measured by the validated Social Rhythm Metric (SRM). The current project seeks to develop and conduct initial testing of an online version of IPSRT (i-IPSRT) for use in primary care. We will (1) evaluate the feasibility and acceptability of supported and unsupported online psychotherapy interventions for BP in primary care (i-IPSRT and i-IPSRT plus CH) compared to Control Condition (CC), (2) examine whether i-IPSRT and i-IPSRT + CH engages its primary behavioral target as measured by the SRM, and (3) explore the impact of i-IPSRT, i-IPSRT + CH, and CC on symptoms and functioning over 12 weeks. Information from this study will inform a larger trial to test the effectiveness of these approaches in primary care. The public health impact of developing an effective, technology-enabled approach to delivering evidenced-based psychotherapy that targets specific, modifiable, behaviors for BP in primary care settings is substantial, offering the potential to reduce illness burden and improve outcomes for individuals with this disabling disorder.
- Conditions
- Bipolar Disorder
- Being tested
- i-IPSRT, Written Psychoeducation
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-IPSRTBehavioural
Also called i-IPSRT + CH
internet IPSRT (a form of psychotherapy for individuals with bipolar disorder) will be offered via 12 specially-designed modules.
CH will have participated in a two day training about Bipolar Disorder and IPSRT.
Written PsychoeducationOther
Written material about the importance of social rhythm regularity to mood stability in bipolar disorder
| Study group | Role | What they receive |
|---|---|---|
| i-IPSRT | Experimental | Participants randomized to this arm will complete bi-weekly i-IPSRT modules over the course of 12 weeks and they will track their mood and SRM's via smartphones or computer. Receives: Behavioral: i-IPSRT |
| i-IPSRT + CH | Experimental | Participants randomized to this arm will complete bi-weekly i-IPSRT modules over the course of 12 weeks and they will track their mood and SRM's via smartphones or computer. Additionally, i-IPSRT support will be delivered by Clinical Helpers, who will reach out to participants in this arm via 5-10 minute weekly phone calls. Receives: Behavioral: i-IPSRT |
| CC (Controlled Condition) | Other | Participants randomized to this arm will receive brief written psychoeducational material that includes information about social rhythm regularity. This information will be either mailed or e-mailed to them. Receives: Other: Written Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Client-Satisfaction Questionnaire
measure of client satisfaction
Measured: Up to Week 12
Social Rhythm Metric (measure of lifestyle regularity)
measure of lifestyle regularity
Measured: Up to 12 weeks
Supportive Accountability Questionnaire
assesses level of perceived accountability to another person for treatment participation
Measured: Up to Week 12
Secondary outcomes (4)
Quick Inventory of Depressive Symptoms
measure of depressive symptoms
Measured: up to 12 weeks
Internal State Scale
measure of mood symptoms
Measured: up to 12 weeks
Short Form-12
measure of overall health status
Measured: up to 12 weeks
Functional Assessment Short Test
assessment of impairment in functioning
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study start1 Mar 2017
- Primary completion30 Apr 2019
- Study completion30 Sep 2019
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 University of PittsburghThe 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Holly Swartz, University of Pittsburgh
- Investigators
- Holly A Swartz, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448108
- Sponsor's protocol ID
- 00085129000
- Other IDs
- R34MH107541
- Status last verified
- Jan 2020
- First submitted
- 13 May 2015
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Psychotherapy for Treating Bipolar Disorder in Primary Care
- ClinicalTrials.gov ID
- NCT02448108
- Acronym / sponsor ID
- 00085129000
- Conditions
- Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Northwestern University, National Institute of Mental Health (NIMH)
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 19 May 2015 (estimated)
- 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.
The investigators will conduct a small pilot study to test the feasibility and acceptability of treating bipolar disorder (BP) in primary care with online psychotherapy delivered both with and without telephone, text, and email support from a clinical helper (CH). The ultimate goal of this work is to provide preliminary data needed to design a larger scale effectiveness study of online psychotherapy for treating BP in primary care.
Detailed description
Over a third of individuals with bipolar spectrum disorders (BP) are treated exclusively in primary care settings, and yet, primary care providers (PCPs) are ill-equipped to manage this complex and disabling illness. Medications, which can be prescribed by PCPs, hasten recovery from illness and improve long-term course of illness for those with BP, but relapse and residual symptoms are common when individuals are treated with pharmacotherapy alone. Best practices treatment for BP includes adjunctive, BP-specific psychotherapy as a key element of effective care. And yet, evidence-based BP-specific psychotherapies that engage and modify targets specific to BP are typically unavailable in primary care settings. Online interventions have the potential to overcome barriers to accessing evidence-based psychosocial treatments for BP in primary care. In other settings and with other populations, effectiveness of online interventions improved when human support/coaching (clinical helpers; CH) via text, email, and telephone was added to the intervention. Interpersonal and Social Rhythm Therapy (IPSRT) is a BP-specific psychotherapy that uses a problem-solving approach to help individuals regularize their social rhythms in order to entrain underlying disturbances in circadian and sleep/wake regulation, factors that are increasingly recognized as playing important roles in the pathogenesis of BP. Its primary behavioral target is regularity of daily routines such as sleep/wake cycle and mealtimes. This construct is measured by the validated Social Rhythm Metric (SRM). The current project seeks to develop and conduct initial testing of an online version of IPSRT (i-IPSRT) for use in primary care. We will (1) evaluate the feasibility and acceptability of supported and unsupported online psychotherapy interventions for BP in primary care (i-IPSRT and i-IPSRT plus CH) compared to Control Condition (CC), (2) examine whether i-IPSRT and i-IPSRT + CH engages its primary behavioral target as measured by the SRM, and (3) explore the impact of i-IPSRT, i-IPSRT + CH, and CC on symptoms and functioning over 12 weeks. Information from this study will inform a larger trial to test the effectiveness of these approaches in primary care. The public health impact of developing an effective, technology-enabled approach to delivering evidenced-based psychotherapy that targets specific, modifiable, behaviors for BP in primary care settings is substantial, offering the potential to reduce illness burden and improve outcomes for individuals with this disabling disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| i-IPSRT | Experimental | Behavioral: i-IPSRTParticipants randomized to this arm will complete bi-weekly i-IPSRT modules over the course of 12 weeks and they will track their mood and SRM's via smartphones or computer. |
| i-IPSRT + CH | Experimental | Behavioral: i-IPSRTParticipants randomized to this arm will complete bi-weekly i-IPSRT modules over the course of 12 weeks and they will track their mood and SRM's via smartphones or computer. Additionally, i-IPSRT support will be delivered by Clinical Helpers, who will reach out to participants in this arm via 5-10 minute weekly phone calls. |
| CC (Controlled Condition) | Other | Other: Written PsychoeducationParticipants randomized to this arm will receive brief written psychoeducational material that includes information about social rhythm regularity. This information will be either mailed or e-mailed to them. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years and older;
- meet DSM 5 criteria for bipolar disorder I, II or Other Specified Bipolar and Related Disorder;
- using the SCID 5;
- score > or = to 9 on Patient Health Questionnaire-9 or score > or = 155 on Internal State Scale;
- receiving care from a Primary Care Physician in a designated study site;
Key exclusion criteria (5 listed)
- Self-reported visual impairment that would prevent completion of study procedures;
- Psychotic disorder, substance use disorder or current manic episode, which would deem participation in the study either inappropriate or dangerous;
- currently receiving specialty mental health services for bipolar disorder from a psychiatrist or therapist;
- planning to leave Primary Care Practice within next 3 months; and
- active suicidal ideation.
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 |
|---|---|---|
| i-IPSRTAlso: i-IPSRT + CHinternet IPSRT (a form of psychotherapy for individuals with bipolar disorder) will be offered via 12 specially-designed modules. CH will have participated in a two day training about Bipolar Disorder and IPSRT. | Behavioural | i-IPSRT, i-IPSRT + CH |
| Written PsychoeducationWritten material about the importance of social rhythm regularity to mood stability in bipolar disorder | Other | CC (Controlled Condition) |
Primary outcome
Client-Satisfaction Questionnaire
Time frame: Up to Week 12
measure of client satisfaction
Social Rhythm Metric (measure of lifestyle regularity)
Time frame: Up to 12 weeks
measure of lifestyle regularity
Supportive Accountability Questionnaire
Time frame: Up to Week 12
assesses level of perceived accountability to another person for treatment participation
4 secondary outcomes
Quick Inventory of Depressive Symptoms
Time frame: up to 12 weeks
Internal State Scale
Time frame: up to 12 weeks
Short Form-12
Time frame: up to 12 weeks
Functional Assessment Short Test
Time frame: up to 12 weeks
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 7 Jan 2020.
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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.
Holly A Swartz, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing i-IPSRT and Written Psychoeducation in people with Bipolar Disorder, run by University of Pittsburgh 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 7 inclusion and 5 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 7 Jan 2020. 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?
Client-Satisfaction Questionnaire (time frame: Up to Week 12). The study lists 3 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 7 Jan 2020.