Brief CBT for Anxiety and Advanced Cancer
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| City: |
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Boston |
| State: |
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Massachusetts |
| Zip Code: |
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02114 |
| Conditions: |
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Anxiety - Depression - Unspecified Adult Solid Tumor, Protocol Specific - Cancer - Cognitive Behavioral Therapy |
| Purpose: |
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RATIONALE: Providing cognitive-behavioral therapy (CBT) may reduce anxiety and improve
quality of life of patients with advanced cancer.
PURPOSE: To examine the development and pilot testing of a brief cognitive-behavioral
therapy intervention to treat anxiety and improve quality of life in patients with advanced
cancer.
Hypothesis: Patients with anxiety associated with advanced cancer who receive CBT will
report significantly fewer anxiety symptoms compared to those in the comparison condition.
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| Study Summary: |
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OBJECTIVES:
- To develop and examine the feasibility and patient acceptability of administering a
manualized cognitive-behavioral intervention that improves quality of life by treating
anxiety in patients with advanced cancer.
- To estimate the effect size of a manualized cognitive-behavioral intervention to reduce
anxiety in patients with advanced cancer.
- To estimate the effect size for the secondary outcomes (i.e., depression and quality of
life) and to examine the extent to which specific variables (i.e., sex, age,
chemotherapy side effects, pain levels) are consistent with the conceptual model as
potential moderators of treatment effect.
OUTLINE: This is a pilot study followed by a randomized study. Patients are stratified
according to type of cancer.
- Pilot study: Patients complete qualitative interviews to explore ways that anxiety
impacts patients, to identify components of a cognitive-behavioral therapy intervention
that are most useful, and to determine the optimal method of delivery for the
intervention (e.g., number and timing of interventions, administration during
chemotherapy infusions when feasible). Based upon these results a full treatment manual
is written for use in the randomized study.
Patients are then randomized to 1 of 2 treatment arms.
- Arm I (cognitive-behavioral therapy): Patients undergo six-seven 90-minute treatment
sessions (over 2 months) based on the results of the pilot study. Modules include
psychoeducation and goal setting; relaxation training; cognitive restructuring; coping
with cancer fears; activity planning and pacing; and review, termination, and plan for
continued use of skills.
- Arm II (routine care): Patients receive routine medical care.
At the completion of treatment, all participants meet with a blinded independent assessor to
assess outcomes. Patients undergo psychiatric evaluation, including the Hamilton Anxiety
Rating Scale (HAM-A), the Montgomery Asberg Depression Rating Scale (MADRS), the Mini
International Neuropsychiatric Interview (MINI), and a psychosocial self-reported battery at
baseline and after 2-3 months.
After completing treatment, patients who underwent routine care (arm II) may undergo
cognitive-behavioral therapy as in arm I, if desired.
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| Criteria: |
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INCLUSION CRITERIA:
- Diagnosis of incurable solid tumor cancers
- At least four weeks post-diagnosis
- Current symptoms of anxiety and anxiety as principal psychiatric problem
- Patients with co-morbid depression are eligible as long as anxiety symptoms are
primary
- Concurrent pharmacotherapy for anxiety allowed
EXCLUSION CRITERIA:
- Delirium or dementia
- Active and untreated major psychiatric condition such as schizophrenia or bipolar
disorder, other psychotic disorders, or substance dependence
- Other inability to complete informed consent process or study procedures
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| NCT ID: |
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NCT00706290 |
| Primary Contact: |
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Principal Investigator
Joseph Greer, PhD
Massachusetts General Hospital
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| Backup Contact: |
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N/A |
| Location Contact: |
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Boston, Massachusetts 02114
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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