Brief CBT for Anxiety and Advanced Cancer

Depression Clinical Trial

Official title: Brief CBT for Anxiety and Advanced Cancer

Status Completed

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.

Clinical Trial 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. ;

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

• NCT number: NCT00706290
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Completed
• Phase: Phase 2
• Start date: April 2007
• Completion date: August 2010