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Brief CBT for Anxiety and Advanced Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Anxiety, Depression, Unspecified Adult Solid Tumor, Protocol Specific, Cancer, Cognitive Behavioral Therapy

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Trial Information

Brief CBT for Anxiety and Advanced Cancer


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Anxiety symptoms as measured by the Hamilton Anxiety Rating Scale

Outcome Description:

The Hamilton Anxiety Ratings Scale (HAM-A) consists of 14 items that provide an overall measure of global anxiety.

Outcome Time Frame:

1) At enrollment pre-intervention. 2) Post intervention (2-3 months after enrollment)

Safety Issue:

No

Principal Investigator

Joseph Greer, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Partners Human Research Committee

Study ID:

CDR0000597438

NCT ID:

NCT00706290

Start Date:

April 2007

Completion Date:

August 2010

Related Keywords:

  • Anxiety
  • Depression
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Cancer
  • Cognitive Behavioral Therapy
  • anxiety
  • depression
  • quality of life
  • psychosocial effects of cancer and its treatment
  • advanced cancer
  • metastatic cancer
  • stage IV cancer
  • cognitive behavioral therapy
  • Anxiety Disorders
  • Depression
  • Depressive Disorder
  • Neoplasms

Name

Location
Massachusetts General Hospital Boston, Massachusetts  02114-2617