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DepressionPhase 1/2NCT00353223

Interpersonal Psychotherapy for Depression in People With Heart Failure

A Phase 1/2 study testing Interpersonal and behavioral psychotherapy in people with Depression and Heart Failure, Congestive, run by University of Iowa at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the effectiveness of interpersonal psychotherapy and behavioral activation techniques in treating depression in people with congestive heart failure. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Depression, Heart Failure, Congestive
What is being tested?
Interpersonal and behavioral psychotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteUnited States
Study dates
Jul 2006to Jun 2010
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Current heart failure
  • Current minor or major depression
  • Score of 14 or higher on the Beck Depression Inventory-II

Who cannot join

  • Score of less than 24 on the Mini-Mental State Exam

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Iowa

    Iowa City, Iowa, 52242

Other trials in United States

About this study

Official title: Interpersonal Psychotherapy for Depression in Patients With Heart Failure

This study will evaluate the effectiveness of interpersonal psychotherapy and behavioral activation techniques in treating depression in people with congestive heart failure.

Read the detailed description

This study aims to develop an intervention based on interpersonal psychotherapy (IPT) and behavioral activation (BA) techniques to treat depression in people with congestive heart failure. By addressing how participants' loss of functioning has changed their personal relationships, the psychotherapy will help participants to discuss how they are coping with their illness and loss of functioning. It will also help participants with heart failure to develop new recreational activities in keeping with their new level of functioning. The study will first develop the methods for the intervention and then pilot the study in a small randomized, controlled trial.

Access to care has been a major barrier to treatment in prior psychosocial studies in cardiac patients. Because many people with advanced heart failure are homebound, the treatment in this study will be administered primarily by telephone, which will greatly enhance dissemination of the intervention. The treatment techniques developed will be applicable to a range of homebound patients and frail elderly, not just patients with heart failure. The long-term goal of the study is to develop pragmatic interventions to reduce depression in people coping with irreversible functional decline.

Specific Aim #1 - Treatment Standardization: The purpose of this phase will be to develop an intervention that addresses the emotional and behavioral consequences of heart failure by 1) integrating IPT and BA techniques to address both interpersonal and functional issues related to disability, 2) applying IPT theory of "role transition" and "grief and loss" to coping with functional decline, 3) applying BA interventions to maximize functioning in patients with severe impairment due to medical illness, 4) developing the techniques needed to implement both IPT and BA successfully over the telephone, 5) developing the methods to implement an appropriate attention control (AC) group, 6) generating complementary visual materials for patients to enhance understanding of the therapeutic model, and 7) evaluating a range of functional assessments to be used as alternative outcomes. Two therapists will conduct the treatment by telephone with 15 depressed heart failure patients. Participants' baseline 17-item Hamilton Rating Scale for Depression (HRSD) total score will be compared with the HRSD total score from Weeks 6 and 12.

Specific Aim #2 - Treatment Evaluation: The purpose of this phase will be to pilot the new treatment in a randomized, controlled trial of people suffering major or minor depression. This phase will include the application of therapist training techniques, assessment of treatment fidelity, and selection of optimal outcome, adherence, process, and treatment quality measures. Participants will be randomly assigned to receive IPT or an attention control condition (AC). Both groups will attend 12 sessions, 9 of which will be 30-minute to 1-hour sessions over the phone. The remaining 3 will be in-home visits lasting 1 to 2 hours. The IPT group will receive IPT designed for people with heart failure. The AC group will not receive therapy. Instead, a clinician will ask them questions about their depression and heart failure. Depressive symptoms will be measured for all participants using the HRSD at baseline and Weeks 6 and 12.

Specific Aim #3 - Treatment Feasibility: In both the standardization and evaluation phases, specific treatment feasibility issues will be addressed. The main feasibility issue will be the acceptability and effectiveness of a telephone administered intervention with severely impaired older people. In addition, recruitment and retention issues will be addressed in all stages of treatment development. The main outcome of this aim will be adequate recruitment sources, including adequate representation of minorities, to conduct a large scale R01 intervention.

Being tested
Interpersonal and behavioral psychotherapy, Attention control (AC) condition
Keywords
Heart Failure, Functional Impairment, Health-Related Quality of Life, Telemedicine
Medical subject headings
Depression, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interpersonal and behavioral psychotherapyBehavioural

    Participants will receive a combined intervention of interpersonal and behavioral psychotherapy designed for people with heart failure. Participants will attend 12 sessions, 9 of which will be 30-minute to 1-hour sessions over the phone. The remaining 3 will be in-home visits, lasting 1 to 2 hours. The psychotherapy sessions will allow participants to discuss how they are coping with their illness and loss of functioning. They will also aim to help participants with heart failure to develop new recreational activities in keeping with their new level of functioning.

  • Attention control (AC) conditionBehavioural

    The AC group will not receive therapy. Instead, a clinician will ask them questions about their depression and heart failure. Participants will attend 12 sessions, 9 of which will be 30-minute to 1-hour sessions over the phone. The remaining 3 will be in-home visits, lasting 1 to 2 hours.

Study groups in NCT00353223
Study groupRoleWhat they receive
AExperimentalParticipants will receive combined interpersonal and behavioral psychotherapy aimed at reducing depression in patients with heart failure.
Receives: Behavioral: Interpersonal and behavioral psychotherapy
BActive comparatorParticipants will receive the attention control condition.
Receives: Behavioral: Attention control (AC) condition

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Score on the 17-item HRSD

    Measured: Measured at Week 12

Secondary outcomes (4)
  1. Health-related quality of life

    Measured: Measured at Week 12

  2. Interpersonal functioning

    Measured: Measured at Week 12

  3. Behavioral activation

    Measured: Measured at Week 12

  4. Self care of heart failure

    Measured: Measured at Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2006 (estimated)
  2. Study startJul 2006
  3. Primary completionJun 2010
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00353223
Sponsor's protocol ID
R34MH073566
Other IDs
R34MH073566, DATR A4-GPS
Status last verified
May 2013
First submitted
14 Jul 2006
Last updated
3 Jun 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Interpersonal and behavioral psychotherapy in people with Depression and Heart Failure, Congestive, run by University of Iowa at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Score on the 17-item HRSD (time frame: Measured at Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2013.

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