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DepressionPhase 1/2NCT00257400

Comparison of Two Psychotherapy Treatments for Depressed Women With a History of Sexual Abuse

A Phase 1/2 study testing Interpersonal Psychotherapy (IPT) and Individual Psychotherapy in people with Depression, run by University of Rochester 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 compare the effectiveness of individual versus interpersonal psychotherapy in treating depressed women with a history of sexual abuse. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Depression
What is being tested?
Interpersonal Psychotherapy (IPT) and Individual Psychotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteUnited States
Study dates
May 2003to Aug 2007
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Meets DSM-IV criteria for unipolar major depressive disorder
  • History of childhood sexual abuse before the age of 18
  • Seeking outpatient psychotherapy treatment in a community mental health center

Who cannot join

  • Meets DSM-IV criteria for major depression with psychotic features, bipolar disorder, schizophrenia, or mental retardation
  • Active alcohol or substance abuse within 3 months of study entry date

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Rochester Medical Center

    Rochester, New York, 14642

Other trials in United States

About this study

Official title: Interpersonal Psychotherapy for Depressed Women With Sexual Abuse Histories

This study will compare the effectiveness of individual versus interpersonal psychotherapy in treating depressed women with a history of sexual abuse.

Read the detailed description

Depression is a common but serious mental disorder that affects millions of people each year. Depression can severely impact people's lives, causing them to often feel sad and hopeless, as well as affecting people's sleep patterns, concentration, and energy levels. Women with a history of abuse are at an increased risk for developing symptoms of depression. However, treatments such as interpersonal psychotherapy and individual psychotherapy have been known to reduce symptoms of depression. This study will compare the effectiveness of individual and interpersonal psychotherapy in improving depressive symptoms and daily functioning in depressed women with a history of sexual abuse.

Participants in this study will undergo a two-part screening interview at the Strong Adult Ambulatory Clinic. This screening will include both written questionnaires and face-to-face interviews regarding any experiences of sexual or physical abuse; suicidal thoughts; family relationships; and current attitudes, thoughts, or feelings. Participants who meet all criteria will then be randomly assigned to receive one of two treatments: interpersonal psychotherapy or individual psychotherapy, which is considered usual care. All treatment sessions will be held at the Strong Adult Ambulatory Clinic. Participants assigned to receive interpersonal psychotherapy will attend weekly 50-minute sessions with a therapist. Interpersonal psychotherapy will focus on current interpersonal stressors in daily life, such as difficulties in close relationships or at work. Treatment will also help participants examine the relationship between their mood changes and interpersonal problems. Participants assigned to receive individual psychotherapy will undergo cognitive-behavioral therapy, supportive counseling, or a combination of the two. Participants will work with their therapists to decide upon a treatment plan designed to help changes in mood and other difficulties in daily life. The number and length of treatment sessions for this group will be determined on an individual basis. For all participants, evaluations consisting of questionnaires similar to those from the initial screening will be completed at mid-treatment, post-treatment, and 3 months after treatment.

Conditions
Depression
Being tested
Interpersonal Psychotherapy (IPT), Individual Psychotherapy
Keywords
major depressive disorder, psychotherapy, childhood sexual abuse, trauma
Medical subject headings
Depression, Depressive Disorder, Major, Wounds and Injuries

What participants receive

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

  • Interpersonal Psychotherapy (IPT)Behavioural

    Interpersonal Psychotherapy

  • Individual PsychotherapyBehavioural

    Individual Psychotherapy

Study groups in NCT00257400
Study groupRoleWhat they receive
Interpersonal Psychotherapy (IPT)ExperimentalInterpersonal Psychotherapy
Receives: Behavioral: Interpersonal Psychotherapy (IPT)
Individual PsychotherapyActive comparatorIndividual Psychotherapy
Receives: Behavioral: Individual Psychotherapy

What is being measured

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

  1. Hamilton Rating Scale for Depression

    Measured: Measured at pre-treatment and Weeks 10, 24, and 36

  2. Beck Depression Inventory

    Measured: Measured at pre-treatment and Weeks 10, 24, and 36

  3. Structured Clinical Interview for DSM-IV Diagnoses

    Measured: Measured at pre-treatment and Weeks 10, 24, and 36

Secondary outcomes (3)

  1. Social Adjustment Scale

    Measured: Measured at pre-treatment and Weeks 10, 24, and 36

  2. Medical Outcomes Survey

    Measured: Measured at pre-treatment and Weeks 10, 24, and 36

  3. Post Traumatic Stress Disorder (PTSD) Symptom Scale

    Measured: Measured at pre-treatment and Weeks 10, 24, and 36

Timeline

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

  1. First posted22 Nov 2005 (estimated)
  2. Study startMay 2003
  3. Primary completionAug 2007
  4. Study completionAug 2007

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
Parallel groups
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00257400
Sponsor's protocol ID
K23MH064528
Other IDs
K23MH064528, DSIR 8K-RTAT
Status last verified
Dec 2013
First submitted
21 Nov 2005
Last updated
3 Jan 2014
Results posted
No
Data monitoring committee
No

Publications

  • Talbot NL, Conwell Y, O'Hara MW, Stuart S, Ward EA, Gamble SA, Watts A, Tu X. Interpersonal psychotherapy for depressed women with sexual abuse histories: a pilot study in a community mental health center. J Nerv Ment Dis. 2005 Dec;193(12):847-50. doi: 10.1097/01.nmd.0000188987.07734.22.

    PubMed 16319710

  • Talbot NL, Chaudron LH, Ward EA, Duberstein PR, Conwell Y, O'Hara MW, Tu X, Lu N, He H, Stuart S. A randomized effectiveness trial of interpersonal psychotherapy for depressed women with sexual abuse histories. Psychiatr Serv. 2011 Apr;62(4):374-80. doi: 10.1176/ps.62.4.pss6204_0374.

    PubMed 21459988

  • Smith PN, Gamble SA, Cort NA, Ward EA, He H, Talbot NL. Attachment and alliance in the treatment of depressed, sexually abused women. Depress Anxiety. 2012 Feb;29(2):123-30. doi: 10.1002/da.20913. Epub 2011 Nov 7.

    PubMed 22065593

  • Smith PN, Gamble SA, Cort NA, Ward EA, Conwell Y, Talbot NL. The relationships of attachment style and social maladjustment to death ideation in depressed women with a history of childhood sexual abuse. J Clin Psychol. 2012 Jan;68(1):78-87. doi: 10.1002/jclp.20852. Epub 2011 Nov 28.

    PubMed 22125120

  • Cankaya B, Talbot NL, Ward EA, Duberstein PR. Parental sexual abuse and suicidal behaviour among women with major depressive disorder. Can J Psychiatry. 2012 Jan;57(1):45-51. doi: 10.1177/070674371205700108.

    PubMed 22296967

  • You S, Talbot NL, He H, Conner KR. Emotions and suicidal ideation among depressed women with childhood sexual abuse histories. Suicide Life Threat Behav. 2012 Jun;42(3):244-54. doi: 10.1111/j.1943-278X.2012.00086.x. Epub 2012 Mar 12.

    PubMed 22409700

  • Cort NA, Gamble SA, Smith PN, Chaudron LH, Lu N, He H, Talbot NL. Predictors of treatment outcomes among depressed women with childhood sexual abuse histories. Depress Anxiety. 2012 Jun;29(6):479-86. doi: 10.1002/da.21942. Epub 2012 May 8.

    PubMed 22570264

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Interpersonal Psychotherapy (IPT) and Individual Psychotherapy in people with Depression, run by University of Rochester 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 2 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 Jan 2014. 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?

Hamilton Rating Scale for Depression (time frame: Measured at pre-treatment and Weeks 10, 24, and 36). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00257400, which also lists 7 linked publications.

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 Jan 2014.

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