Internet Psychotherapy for Bipolar Disorder in Primary Care

NCT02448108 | Completed

• 2 other identifiers: 00085129000R34MH107541
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Quick Inventory of Depressive Symptoms

  up to 12 weeks

• Internal State Scale

  up to 12 weeks

• Short Form-12

  up to 12 weeks

• Functional Assessment Short Test

  up to 12 weeks

Study Arms (3)

i-IPSRT

EXPERIMENTAL

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

i-IPSRT + CH

EXPERIMENTAL

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

CC (Controlled Condition)

OTHER

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

i-IPSRT BEHAVIORAL

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

i-IPSRT; i-IPSRT + CH

Written Psychoeducation OTHER

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

CC (Controlled Condition)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Northwestern University: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Holly A Swartz, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 13, 2015
• First Posted: May 19, 2015
• Study Start: March 1, 2017
• Primary Completion: April 30, 2019
• Study Completion: September 30, 2019
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

US (1)