NCT01748734

Brief Summary

The purpose of this study is to learn about treatment of depression in people who have any type of cancer. Cognitive therapy (CT) helps improve depressive symptoms by targeting patient's thoughts and behaviors. People who are depressed tend to have more negative or pessimistic thoughts. CT helps people evaluate the accuracy of their thoughts. By encouraging patients to develop more balanced views, symptoms of depression begin to improve

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2012

Completed
Last Updated

June 4, 2015

Status Verified

June 1, 2015

Enrollment Period

Same day

First QC Date

December 10, 2012

Last Update Submit

June 2, 2015

Conditions

Depression

Keywords

Depression

Outcome Measures

Primary Outcomes (3)

  • Psychiatric diagnoses, using the Structured Clinical Interview for the DSM-IV (SCID)

    Only modules for mood disorders, anxiety disorders, and substance use disorders will be used. The Global Assessment of Functioning (GAF) Scale will be included as part of the SCID interview. The Longitudinal Interview Follow-Up Evaluation (LIFE) will be used to assess psychosocial, diagnostic, and treatment information. Alpha level will be set at 0.05, beta at 0.20. 95% confidence intervals will be obtained for all outcome measures.

    Up to 12 months

  • Hamilton Rating Scale for Depression (HRSC) as a measure of depressive symptom severity

    The modified 17-item HRSD interview codes both responses and behavior. Complete remission of depressive symptoms is indicated by scores of 7 or less, partial remission by scores 8-12, and no remission by scores of 13 or greater. Alpha level will be set at 0.05, beta at 0.20. 95% confidence intervals will be obtained for all outcome measures.

    Up to 12 months

  • Beck Depression Inventory - 2nd Edition (BDI-II) used to assess the severity of symptoms of depression

    The BDI-II is a 21-item self-report instrument. Respondents describe their feelings during the past week by rating each item on a scale from 0-3. Thus, possible scores are 0 (minimal depression) to 63 (high depression). Complete remission is indicated by scores of 9 or less, partial remission by scores of 10-16, and no remission by scores of 17 or greater. Alpha level will be set at 0.05, beta at 0.20. 95% confidence intervals will be obtained for all outcome measures.

    Up to 12 months

Secondary Outcomes (5)

  • Stress, as measured by the life events scale and the cancer-related Impact of Events Scale (IES)

    Up to 12 months

  • Distress, as measured by the Profile of Mood States (POMS), Center for Epidemiological Studies Depression Scale (CES-D) Iowa short form, and the Beck Hopelessness Scale (HS)

    Up to 12 months

  • Quality of life, as measured by Medical Outcomes Study Short Form, Meaning in Life Scale (MiL), Satisfaction with Life Scale (SWLS), Fatigue Symptom Inventory-Revised (FSI), Brief Pain Questionnaire (BPQ), and Charlson Comorbidity Index (CCI)

    Up to 12 months

  • Social relationships, as measured by a single item from the Dyadic Adjustment Scale (DAS), a short form of the Sexual Experience Scale, and the Perceived Social Support From Friends (PSS-Fr) and Family (PSS-Fa)

    Up to 12 months

  • Therapy process & therapy mediators measured by Working Alliance Inventory (WAI), Expectations for Therapy, Attributional Style, COPE, Implicit Self-Relevant Beliefs Assessment (ISRBA), Ways of Responding (WOR), & Evaluation of Topics of the Intervention

    Up to 12 months

Study Arms (1)

Supportive care (cognitive behavioral therapy)

EXPERIMENTAL

Cognitive behavioral therapy comprising progressive muscle relaxation training, behavioral activation, seeking information as a coping strategy, enhancing social support, cognitive reappraisal, assertive communication, changing depressive core beliefs, goal setting and planning for maintenance, and maintenance over 1 hour once weekly sessions for 12-20 weeks, biweekly sessions for 4-6 weeks, and monthly sessions for 2-3 months for a total of 16-26 sessions.

Procedure: quality-of-life assessmentOther: questionnaire administrationOther: counseling interventionBehavioral: behavioral intervention

Interventions

quality-of-life assessmentPROCEDURE

Ancillary studies

Also known as: quality of life assessment
Supportive care (cognitive behavioral therapy)
questionnaire administrationOTHER

Ancillary studies

Supportive care (cognitive behavioral therapy)
counseling interventionOTHER

Undergo cognitive behavioral therapy

Also known as: counseling and communications studies
Supportive care (cognitive behavioral therapy)
behavioral interventionBEHAVIORAL

Undergo cognitive behavioral therapy

Also known as: Behavior Conditioning Therapy, Behavior Therapy, Behavioral Modification, Behavioral Therapy, Behavioral Treatment
Supportive care (cognitive behavioral therapy)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Prior diagnosis of invasive cancer, any site, any stage, any time since diagnosis; history of non malignant (basal cell) or low malignant potential (e.g., in situ cervix) cancers do not meet this criterion
  • Diagnosis of major depressive disorder (MDD), according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria (American Psychiatric Association, 2000)
  • Able and willing to give informed consent

You may not qualify if:

  • History of bipolar affective disorder or psychosis
  • Current axis I disorder (e.g. obsessive-compulsive disorder, specific phobia) other than MDD if it constitutes the predominant aspect of the clinical presentation and if it requires treatment other than that being offered
  • History of substance dependence in the past six months
  • Subnormal intellectual potential (intelligence quotient \[IQ\] below 80)
  • Current suicide risk sufficient to preclude treatment on an outpatient basis
  • Progressive neurological or related conditions/diagnoses
  • Non-ambulatory
  • Life expectancy less than 60 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Links

MeSH Terms

Conditions

Depression

Interventions

CounselingBehavior Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPsychotherapy

Study Officials

  • Barbara Andersen, Ph.D.

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 10, 2012

First Posted

December 12, 2012

Study Start

March 1, 2011

Primary Completion

March 1, 2011

Last Updated

June 4, 2015

Record last verified: 2015-06

Locations

US(1)