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DepressionPhase 2NCT01748734

Cognitive Therapy in Reducing Depression in Patients With Cancer

A Phase 2 study testing quality-of-life assessment, questionnaire administration and counseling intervention in people with Depression, run by Ohio State University Comprehensive Cancer Center 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

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Depression
What is being tested?
quality-of-life assessment, questionnaire administration and counseling intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
Mar 2011to Mar 2011
Phase
Phase 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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: An Examination of Cognitive Therapy for Depression in Cancer Patients.

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

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the efficacy of biobehavioral/cognitive therapy for cancer patients/survivors with major depression.

II. Test for the covariation between reduction in depressive symptoms and improvements in quality of life.

OUTLINE:

Patients undergo 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.

After completion of study treatment, patients are followed up at 3, 6, and 12 months.

Conditions
Depression
Being tested
quality-of-life assessment, questionnaire administration, counseling intervention, behavioral intervention
Keywords
Depression
Medical subject headings
Depression

What participants receive

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

  • quality-of-life assessmentProcedure or surgery

    Also called quality of life assessment

    Ancillary studies

  • questionnaire administrationOther

    Ancillary studies

  • counseling interventionOther

    Also called counseling and communications studies

    Undergo cognitive behavioral therapy

  • behavioral interventionBehavioural

    Also called Behavior Conditioning Therapy, Behavior Therapy, Behavioral Modification, Behavioral Therapy

    Undergo cognitive behavioral therapy

Study groups in NCT01748734
Study groupRoleWhat they receive
Supportive care (cognitive behavioral therapy)ExperimentalCognitive 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.
Receives: Procedure: quality-of-life assessment; Other: questionnaire administration; Other: counseling intervention; Behavioral: behavioral intervention

What is being measured

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

  1. 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.

    Measured: Up to 12 months

  2. 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.

    Measured: Up to 12 months

  3. 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.

    Measured: Up to 12 months

Secondary outcomes (5)

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

    Life events scale, patients indicate experience of any of 5 stressful life events during the previous year and rate how emotionally upsetting the event was. Scores calculated for presence of each event (0-1), total number of events (0-5), and sum of the distress ratings (0-15). The IES is a 22-item self report questionnaire to assess reactions to cancer diagnosis and treatment. It measures frequency of intrusive thoughts, avoidant thoughts/behaviors, and hyperarousal during the previous week using a 4-point Likert scale. Items summed for total scores ranging from 0-75.

    Measured: Up to 12 months

  2. 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)

    POMS is a 65-item self report inventory yielding a total mood disturbance scale and 6 mood subscales on a 5-point Likert scale. Total score is sum of subscale scores and ranges from -32 to 200. CES-D is an 11-item form rated on a 3-point Likert scale. All items are summed with total scores ranging from 0 to 22. HS is a 20-item true-false form with scores ranging from 0 to 20. Alpha level will be set at 0.05, beta at 0.20. 95% confidence intervals will be obtained for all outcome measures.

    Measured: Up to 12 months

  3. 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)

    Medical Outcomes Study Short Form is 36-item scale with 8 subscales with scores ranging 0-100. MiL is 21-item scale with 4 dimensions; subscale scores range from 1 to 6 and summary scores range from 3 to 17. SWLS is a 5-item scale measured on a 7-point scale for total scores ranging from 5 to 35. FSI is a 14-item measure with scores ranging from 0 to 70. BPI has scales with ratings from 0 to 10. CCI has total scores ranging from 0 to 37 (age unadjusted) or 0 to 43 (age adjusted). Alpha level will be set at 0.05, beta at 0.20. 95% confidence intervals will be obtained for all outcome measures.

    Measured: Up to 12 months

  4. 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)

    DAS subscale for Affectional Expression used, rates overall relationship happiness from 0-6. Short form of the Sexual Experience Scale includes 3 items rated on a 9-point frequency scale. PSS-Fr and PSS-Fa are two 20-item instruments with total scores ranging from 0 to 20 for both scales. Alpha level will be set at 0.05, beta at 0.20. 95% confidence intervals will be obtained for all outcome measures.

    Measured: Up to 12 months

  5. 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

    WAI short assesses trust, confidence, and understanding and commitment to completing homework. Expectations for Therapy assesses expectations with regards to efficacy, type, and response. Attributional Style measures optimism. Brief COPE is a 28-item scale with 14 subscales; score ranges are 0 to 6. ISRBA is a computer-based assessment measuring valence of implicit self-relevant beliefs. WOR scale measures compensatory skills thought to be acquired in cognitive therapy for depression. Evaluation of Topics of the Intervention is an 11-item scale rating each component on a 4-point Likert scale.

    Measured: Up to 12 months

Timeline

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

  1. First posted12 Dec 2012 (estimated)
  2. Study startMar 2011
  3. Primary completionMar 2011

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 2
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01748734
Sponsor's protocol ID
OSU-07043
Other IDs
NCI-2012-00738
Status last verified
Jun 2015
First submitted
10 Dec 2012
Last updated
4 Jun 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing quality-of-life assessment, questionnaire administration and counseling intervention in people with Depression, run by Ohio State University Comprehensive Cancer Center 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 8 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 4 Jun 2015. 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 phase mean?

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?

Psychiatric diagnoses, using the Structured Clinical Interview for the DSM-IV (SCID) (time frame: Up to 12 months). 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 NCT01748734.

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 4 Jun 2015.

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