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Internet Psychotherapy for Bipolar Disorder in Primary Care

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ClinicalTrials.gov Identifier: NCT02448108
Recruitment Status : Recruiting
First Posted : May 19, 2015
Last Update Posted : December 13, 2017
Sponsor:
Collaborators:
Northwestern University
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Holly Swartz, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Behavioral: i-IPSRT Other: Written Psychoeducation Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Internet Psychotherapy for Treating Bipolar Disorder in Primary Care
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Arm Intervention/treatment
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

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.

Other Name: i-IPSRT + CH
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

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.

Other Name: i-IPSRT + CH
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
Written material about the importance of social rhythm regularity to mood stability in bipolar disorder



Primary Outcome Measures :
  1. Client-Satisfaction Questionnaire [ Time Frame: Up to Week 12 ]
    measure of client satisfaction

  2. Adherence to intervention ( number of log-ins) [ Time Frame: Up to 12 weeks ]
    Adherence as measured by number of log-ins

  3. Social Rhythm Metric (measure of lifestyle regularity) [ Time Frame: Up to 12 weeks ]
    measure of lifestyle regularity

  4. Supportive Accountability Questionnaire [ Time Frame: Up to Week 12 ]
    assesses level of perceived accountability to another person for treatment participation


Secondary Outcome Measures :
  1. Quick Inventory of Depressive Symptoms [ Time Frame: up to 12 weeks ]
    measure of depressive symptoms

  2. Internal State Scale [ Time Frame: up to 12 weeks ]
    measure of mood symptoms

  3. Short Form-12 [ Time Frame: up to 12 weeks ]
    measure of overall health status

  4. Functional Assessment Short Test [ Time Frame: up to 12 weeks ]
    assessment of impairment in functioning

  5. PROMIS-Sleep Disturbance [ Time Frame: up to 12 weeks ]
    measure of sleep problems



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02448108


Contacts
Contact: Crystal R Spotts, M.Ed. 412-246-5764 spottscr@upmc.edu
Contact: Holly A Swartz, MD 412-246-5588 swartzha@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Crystal Spotts    412-246-5764    spottscr@upmc.edu   
Contact: Holly Swartz, MD       swartzha@upmc.edu   
Sponsors and Collaborators
University of Pittsburgh
Northwestern University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Holly A Swartz, MD University of Pittsburgh

Responsible Party: Holly Swartz, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02448108     History of Changes
Other Study ID Numbers: 00085129000
R34MH107541 ( U.S. NIH Grant/Contract )
First Posted: May 19, 2015    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders