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Internet Psychotherapy for Bipolar Disorder in Primary Care

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
i-IPSRT
Written Psychoeducation
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Pittsburgh Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

i-IPSRT

i-IPSRT + CH

CC (Controlled Condition)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Client-Satisfaction Questionnaire
measure of client satisfaction
Social Rhythm Metric (measure of lifestyle regularity)
measure of lifestyle regularity
Supportive Accountability Questionnaire
assesses level of perceived accountability to another person for treatment participation

Secondary Outcome Measures

Quick Inventory of Depressive Symptoms
measure of depressive symptoms
Internal State Scale
measure of mood symptoms
Short Form-12
measure of overall health status
Functional Assessment Short Test
assessment of impairment in functioning

Full Information

First Posted
May 13, 2015
Last Updated
January 3, 2020
Sponsor
University of Pittsburgh
Collaborators
Northwestern University, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02448108
Brief Title
Internet Psychotherapy for Bipolar Disorder in Primary Care
Official Title
Internet Psychotherapy for Treating Bipolar Disorder in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Northwestern University, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
i-IPSRT
Arm Type
Experimental
Arm Description
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.
Arm Title
i-IPSRT + CH
Arm Type
Experimental
Arm Description
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.
Arm Title
CC (Controlled Condition)
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
i-IPSRT
Other Intervention Name(s)
i-IPSRT + CH
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Written Psychoeducation
Intervention Description
Written material about the importance of social rhythm regularity to mood stability in bipolar disorder
Primary Outcome Measure Information:
Title
Client-Satisfaction Questionnaire
Description
measure of client satisfaction
Time Frame
Up to Week 12
Title
Social Rhythm Metric (measure of lifestyle regularity)
Description
measure of lifestyle regularity
Time Frame
Up to 12 weeks
Title
Supportive Accountability Questionnaire
Description
assesses level of perceived accountability to another person for treatment participation
Time Frame
Up to Week 12
Secondary Outcome Measure Information:
Title
Quick Inventory of Depressive Symptoms
Description
measure of depressive symptoms
Time Frame
up to 12 weeks
Title
Internal State Scale
Description
measure of mood symptoms
Time Frame
up to 12 weeks
Title
Short Form-12
Description
measure of overall health status
Time Frame
up to 12 weeks
Title
Functional Assessment Short Test
Description
assessment of impairment in functioning
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holly A Swartz, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

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Internet Psychotherapy for Bipolar Disorder in Primary Care

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