Cognitive Therapy in Reducing Depression in Patients With Cancer

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

quality-of-life assessment

questionnaire administration

counseling intervention

behavioral intervention

About this trial

This is an interventional supportive care trial for Depression focused on measuring Depression

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Ohio State University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (cognitive behavioral therapy)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT01748734

First Posted

December 10, 2012

Last Updated

June 2, 2015

Sponsor

Ohio State University Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT01748734

Brief Title

Cognitive Therapy in Reducing Depression in Patients With Cancer

Official Title

An Examination of Cognitive Therapy for Depression in Cancer Patients.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ohio State University Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

Detailed Description

PRIMARY OBJECTIVES: I. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

Keywords

Depression

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Supportive care (cognitive behavioral therapy)

Arm Type

Experimental

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

quality-of-life assessment

Other Intervention Name(s)

quality of life assessment

Intervention Description

Ancillary studies

Intervention Type

Other

Intervention Name(s)

questionnaire administration

Intervention Description

Ancillary studies

Intervention Type

Other

Intervention Name(s)

counseling intervention

Other Intervention Name(s)

counseling and communications studies

Intervention Description

Undergo cognitive behavioral therapy

Intervention Type

Behavioral

Intervention Name(s)

behavioral intervention

Other Intervention Name(s)

Behavior Conditioning Therapy, Behavior Therapy, Behavioral Modification, Behavioral Therapy, Behavioral Treatment

Intervention Description

Undergo cognitive behavioral therapy

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Up to 12 months

Title

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

Description

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.

Time Frame

Up to 12 months

Title

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

Description

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.

Time Frame

Up to 12 months

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Up to 12 months

Title

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)

Description

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.

Time Frame

Up to 12 months

Title

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)

Description

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.

Time Frame

Up to 12 months

Title

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)

Description

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.

Time Frame

Up to 12 months

Title

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

Description

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.

Time Frame

Up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Barbara Andersen, Ph.D.

Organizational Affiliation

Ohio State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ohio State University Medical Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

12. IPD Sharing Statement

Links:

URL

http://cancer.osu.edu

Description

Jamesline

Depression

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial