AnxietyPhase 2NCT00706290
Brief CBT for Anxiety and Advanced Cancer
A Phase 2 study testing Brief Cognitive Behavioral Therapy in people with Anxiety and Depression, run by Massachusetts General Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Depression, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- Brief Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Aug 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the detailed 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.
- Conditions
- Anxiety, Depression, Unspecified Adult Solid Tumor, Protocol Specific, Cancer, Cognitive Behavioral Therapy
- Being tested
- Brief Cognitive Behavioral Therapy
- Keywords
- anxiety, depression, quality of life, psychosocial effects of cancer and its treatment, advanced cancer, metastatic cancer, stage IV cancer, cognitive behavioral therapy
- Medical subject headings
- Anxiety Disorders, Depression, Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Cognitive Behavioral TherapyBehavioural
Also called Brief CBT, CBT
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention - CBT | Experimental | 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. Receives: Behavioral: Brief Cognitive Behavioral Therapy |
| Routine Care Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1) At enrollment pre-intervention. 2) Post intervention (2-3 months after enrollment)
Secondary outcomes (2)
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.
Measured: 1) At enrollment pre-intervention. 2) Post intervention (2-3 months after enrollment)
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.
Measured: 1) At enrollment pre-intervention. 2) Post intervention (2-3 months after enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2008 (estimated)
- Study startApr 2007
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Joseph A. Greer, Ph.D., Massachusetts General Hospital
- Investigators
- Joseph Greer, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706290
- Sponsor's protocol ID
- CDR0000597438
- Other IDs
- 1R03CA128478-01, 2007P000368
- Status last verified
- Jun 2014
- First submitted
- 26 Jun 2008
- Last updated
- 6 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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):1337-45. doi: 10.1634/theoncologist.2012-0041. Epub 2012 Jun 11.
PubMed 22688670Greer 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. doi: 10.1891/0889-8391.24.4.294.
PubMed 21234281
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief CBT for Anxiety and Advanced Cancer
- ClinicalTrials.gov ID
- NCT00706290
- Acronym / sponsor ID
- CDR0000597438
- Conditions
- Anxiety, Depression, Unspecified Adult Solid Tumor, Protocol Specific, Cancer, Cognitive Behavioral Therapy
- Keywords
- anxiety, depression, quality of life, psychosocial effects of cancer and its treatment, advanced cancer, metastatic cancer, stage IV cancer, cognitive behavioral therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 27 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention - CBT | Experimental | Behavioral: Brief Cognitive Behavioral TherapyParticipants 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. |
| Routine Care Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of incurable solid tumor cancers
- At least four weeks post-diagnosis
- Current symptoms of anxiety and anxiety as principal psychiatric problem
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Cognitive Behavioral TherapyAlso: Brief CBT, CBTThe 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. | Behavioural | Intervention - CBT |
Primary outcome
Anxiety symptoms as measured by the Hamilton Anxiety Rating Scale
Time frame: 1) At enrollment pre-intervention. 2) Post intervention (2-3 months after enrollment)
The Hamilton Anxiety Ratings Scale (HAM-A) consists of 14 items that provide an overall measure of global anxiety.
2 secondary outcomes
Depression as measured by the Montgomery Asberg Depression Rating Scale
Time frame: 1) At enrollment pre-intervention. 2) Post intervention (2-3 months after enrollment)
Quality of life as measured by the Functional Assessment of Scale Cancer Therapy (FACT-G)
Time frame: 1) At enrollment pre-intervention. 2) Post intervention (2-3 months after enrollment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2014.
- Results publication: PubMed 22688670Greer 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):1337-45. doi: 10.1634/theoncologist.2012-0041. Epub 2012 Jun 11.
- Results publication: PubMed 21234281Greer 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. doi: 10.1891/0889-8391.24.4.294.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Greer, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brief Cognitive Behavioral Therapy in people with Anxiety and Depression, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety symptoms as measured by the Hamilton Anxiety Rating Scale (time frame: 1) At enrollment pre-intervention. 2) Post intervention (2-3 months after enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00706290, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2014.