Clinical trial NCT02448108: Internet Psychotherapy for Bipolar Disorder in Primary Care
Official title: Internet Psychotherapy for Treating Bipolar Disorder in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: National Institute of Mental Health (NIMH)
First posted: 2015-05-19
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Client-Satisfaction Questionnaire
timeFrame: Up to Week 12
measure: Social Rhythm Metric (measure of lifestyle regularity)
timeFrame: Up to 12 weeks
measure: Supportive Accountability Questionnaire
timeFrame: Up to Week 12
Secondary outcomes:
measure: Quick Inventory of Depressive Symptoms
timeFrame: up to 12 weeks
measure: Internal State Scale
timeFrame: up to 12 weeks
measure: Short Form-12
timeFrame: up to 12 weeks
measure: Functional Assessment Short Test
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Holly A Swartz, MD
role: PRINCIPAL_INVESTIGATOR
References: