Brief CBT for Anxiety and Advanced Cancer

Depression Clinical Trial

Official title:

Brief CBT for Anxiety and Advanced Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00706290
• Other study ID #: CDR0000597438
• Secondary ID: 1R03CA128478-012
• Status: Completed
• Phase: Phase 2
• First received: June 26, 2008
• Last updated: June 5, 2014
• Start date: April 2007
• Est. completion date: August 2010

Study information

• Verified date: June 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Partners Human Research CommitteeUnited States: National Cancer Institute
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Cancer
• Cognitive Behavioral Therapy
• Depression
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Behavioral:
• Brief Cognitive Behavioral Therapy
The cognitive-behavioral intervention consists of 6-7 sessions lasting 60-90 minutes each focused on psycho-education; relaxation training; cognitive-restructuring and coping with cancer fears; and activity planning and pacing. Sessions are delivered by a licensed clinical psychologist or trained psychology fellow or graduate student.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Greer JA, Park ER, Prigerson HG, Safren SA. Tailoring Cognitive-Behavioral Therapy to Treat Anxiety Comorbid with Advanced Cancer. J Cogn Psychother. 2010 Jan 1;24(4):294-313. — View Citation

Greer JA, Traeger L, Bemis H, Solis J, Hendriksen ES, Park ER, Pirl WF, Temel JS, Prigerson HG, Safren SA. A pilot randomized controlled trial of brief cognitive-behavioral therapy for anxiety in patients with terminal cancer. Oncologist. 2012;17(10):1337 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety symptoms as measured by the Hamilton Anxiety Rating Scale	The Hamilton Anxiety Ratings Scale (HAM-A) consists of 14 items that provide an overall measure of global anxiety.	1) At enrollment pre-intervention. 2) Post intervention (2-3 months after enrollment)	No
Secondary	Depression as measured by the Montgomery Asberg Depression Rating Scale	The Montgomery Asberg Depression Rating Scale (MADRS) is an empirically derived 10-item interview that measures depression symptoms.	1) At enrollment pre-intervention. 2) Post intervention (2-3 months after enrollment)	No
Secondary	Quality of life as measured by the Functional Assessment of Scale Cancer Therapy (FACT-G)	Consisting of 28 items, the FACT-G has four subscales assessing physical, functional, emotional, and social well-being during the past 7 days. Higher scores on the total score and each subscale indicate better quality of life.	1) At enrollment pre-intervention. 2) Post intervention (2-3 months after enrollment)	No