Internet Psychotherapy for Bipolar Disorder in Primary Care

Study Overview
=================
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.

Official Title
-----------------
Internet Psychotherapy for Treating Bipolar Disorder in Primary Care

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Behavioral: i-IPSRT
* Other: Written Psychoeducation


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: i-IPSRT<br>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<br>* 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.<br>* Other names: i-IPSRT + CH;|
| Experimental: i-IPSRT + CH<br>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<br>* 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.<br>* Other names: i-IPSRT + CH;|
| Other: CC (Controlled Condition)<br>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<br>* Written material about the importance of social rhythm regularity to mood stability in bipolar disorder<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Client-Satisfaction Questionnaire | measure of client satisfaction | Up to Week 12 | 
| Social Rhythm Metric (measure of lifestyle regularity) | measure of lifestyle regularity | Up to 12 weeks | 
| Supportive Accountability Questionnaire | assesses level of perceived accountability to another person for treatment participation | Up to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick Inventory of Depressive Symptoms | measure of depressive symptoms | up to 12 weeks | 
| Internal State Scale | measure of mood symptoms | up to 12 weeks | 
| Short Form-12 | measure of overall health status | up to 12 weeks | 
| Functional Assessment Short Test | assessment of impairment in functioning | up to 12 weeks |