Brief CBT for Anxiety and Advanced Cancer

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Cancer; Depression; Cognitive Behavioral Therapy; Anxiety

Treatments: Behavioral: Brief Cognitive Behavioral Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00706290

CDR0000597438

2007P000368 (Other Identifier)

1R03CA128478-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

49 participants in 2 patient groups

Intervention - CBT

Experimental group

Description:

Participants randomized to the intervention group received cognitive behavioral therapy (CBT) for anxiety after completing a baseline assessment consisting of clinician administered psychiatric evaluations and a psychosocial self-report battery. After completing the CBT intervention, consisting of 6-7 sessions over the course of 2-3 months, participants completed a post-intervention assessment identical to the baseline.

Treatment:

Behavioral: Brief Cognitive Behavioral Therapy

Routine Care Control

No Intervention group

Description:

Participants randomized to the control condition completed a baseline assessment consisting of clinician administered psychiatric evaluations and a psychosocial self-report battery. They then received routine medical care. After 2 months and after completing the post clinical assessment identical to the baseline, they were offered the opportunity to receive the CBT intervention for free. This ensured that all participants ultimately received cognitive-behavioral therapy if desired, while permitting an examination of the effect size for the intervention compared to routine care.