Feasibility of Telehealth Problem-Solving Therapy for Depressed Homebound Older Adults

March 20, 2015 updated by: Namkee Choi, University of Texas at Austin

Telehealth Problem-Solving Therapy for Depressed Homebound Older Adults

This study will test the feasibility and effectiveness of therapy given via teleconferencing to depressed homebound older adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Older people with disabilities who cannot leave their homes are at increased risk of depression or depressive symptoms. Short-term psychotherapy, without medications, has been found effective for treating this population of people. Problem-solving therapy (PST) is a brief, structured, cognitive-behavioral therapy that teaches people problem-solving and coping skills to deal with negative life events and daily problems. Previous research demonstrated that PST is an effective treatment for depression when delivered to older adults in their homes. The cost of service for these in-home visits, however, can be prohibitive for many older adults and social service providers. One way to extend treatment to more older adults is to deliver PST via teleconferencing (tele-PST). This study will test the feasibility and effectiveness of tele-PST in treating depression in homebound older adults.

This study will have two phases. Phase 1 will examine the feasibility of delivering treatment via teleconference. Participants in this phase will receive six weekly sessions of tele-PST and then complete a 2-week follow-up visit in which their depression, disability, and resourcefulness will be assessed. Logistical and procedural problems and acceptability of the treatment to participants will be used to guide modifications or adaptations made to tele-PST before conducting a larger, randomized trial in Phase 2.

Participation in Phase 2 will last 6 weeks, with follow-up visits lasting until 24 weeks after the conclusion of treatment. Participants will be randomly assigned to one of three groups: tele-PST, in-person PST, and attention control. Participants in the tele-PST group will receive six weekly sessions of PST via teleconference, and participants in the in-person PST group will receive six weekly sessions of PST from a study therapist in person. Both these groups will also receive six monthly maintenance calls from their study therapist after the completion of treatment. Participants in the attention group will receive six weekly phone calls followed by six monthly phone calls to monitor their health. All participants in Phase 2 will complete assessments at 2, 12, and 24 weeks following their treatment. These assessments will measure the adequacy of recruitment, enrollment, and retention strategies; the compliance rates and service delivery costs of tele-PST and in-person PST; and participants' depression, disability, and resourcefulness.

Study Type

Interventional

Enrollment (Actual)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78712-0358
        • University of Texas at Austin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Non-Hispanic white, African American, or Hispanic
  • Homebound, as defined by receiving a home-delivered meals service or personal assistance and in-home support services because of disability
  • Moderate-to-severe depressive symptom severity, as defined by a score greater than or equal to 15 on the Hamilton Rating Scale for Depression (HAMD)
  • Has a home television set that can be used for problem-solving therapy (PST) sessions
  • Has a landline telephone

Exclusion Criteria:

  • High suicide risk, as defined by an intent or plan to attempt suicide within a month or indication of persistently moderate or severe suicidal ideation or behavior
  • Presence of dementia or executive dysfunction
  • Presence of bipolar disorder
  • Lifetime or current (within 12 months) psychotic symptoms or disorder
  • Presence of co-occurring alcohol or other addictive substance abuse, including benzodiazepines and opioids
  • Hearing or vision impairment that would interfere with PST participation
  • Inability to actively participate in PST sessions due to acute or severe medical illness or functional impairment, such as a bed-bound state
  • Current involvement in psychotherapy
  • Inability to speak English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Participants will receive problem-solving therapy (PST) delivered via teleconferencing (tele-PST).
Behavioral: Tele-Problem-Solving Therapy
Six sessions of tele-PST
ACTIVE_COMPARATOR: 2
Participants will receive problem-solving therapy (PST) delivered in-person.
Behavioral: In-Person PST
Six sessions of in person PST
PLACEBO_COMPARATOR: 3
Participants will receive monitoring phone calls.
Behavioral: Attention control
Six weekly telephone calls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
24-item Hamilton Rating Scale for Depression (HAMD)
Time Frame: Measured at 2, 12, and 24 weeks
Measured at 2, 12, and 24 weeks
12-item World Health Organization Disability Assessment Schedule (WHO-DAS-II)
Time Frame: Measured at 2, 12, and 24 weeks
Measured at 2, 12, and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas at Austin

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Namkee G. Choi, PhD, University of Texas at Austin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

May 13, 2009

First Submitted That Met QC Criteria

May 13, 2009

First Posted (ESTIMATE)

May 15, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 23, 2015

Last Update Submitted That Met QC Criteria

March 20, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R34MH083872 (NIH)
  • DATR A4-GPS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Tele-Problem-Solving Therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe