CClinicalTrials.gg
CompletedNCT02448108Updated Jan 7, 2020

Internet Psychotherapy for Bipolar Disorder in Primary Care

An interventional study of i-IPSRT and Written Psychoeducation in Bipolar Disorder, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-01-07.

Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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). 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.

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Conditions studied

  • Bipolar Disorder

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03

In context

Bipolar Disorder

1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.

This study's enrollment of 47 is below the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.

Browse Bipolar Disorder studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
47 participants (actual)

Study arms

  • Experimental
    i-IPSRT

    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.

    Behavioral: i-IPSRT

  • Experimental
    i-IPSRT + CH

    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.

    Behavioral: i-IPSRT

  • Other
    CC (Controlled Condition)

    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.

    Other: Written Psychoeducation

Interventions

  • Behaviorali-IPSRT

    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.

    Also known as: i-IPSRT + CH

  • OtherWritten Psychoeducation

    Written material about the importance of social rhythm regularity to mood stability in bipolar disorder

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What researchers measure

Primary outcomes

  1. Client-Satisfaction Questionnaire

    measure of client satisfaction

    Time frame: Up to Week 12

  2. Social Rhythm Metric (measure of lifestyle regularity)

    measure of lifestyle regularity

    Time frame: Up to 12 weeks

  3. Supportive Accountability Questionnaire

    assesses level of perceived accountability to another person for treatment participation

    Time frame: Up to Week 12

Secondary outcomes

  1. Quick Inventory of Depressive Symptoms

    measure of depressive symptoms

    Time frame: up to 12 weeks

  2. Internal State Scale

    measure of mood symptoms

    Time frame: up to 12 weeks

  3. Short Form-12

    measure of overall health status

    Time frame: up to 12 weeks

  4. Functional Assessment Short Test

    assessment of impairment in functioning

    Time frame: up to 12 weeks

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Study locations

1 site
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania 15213, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02448108
Lead sponsor
University of Pittsburgh
Collaborators
Northwestern University, National Institute of Mental Health (NIMH)
Responsible party
Holly Swartz (Professor, University of Pittsburgh) — Principal investigator
First posted
May 19, 2015
Start date
Mar 1, 2017
Primary completion
Apr 30, 2019
Completion
Sep 30, 2019
Last update
Jan 7, 2020

Study contacts

Holly A Swartz, MD
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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