AnxietyPhase 3NCT00152763
Psychological Support for Patients With an Implantable Cardioverter Defibrillator
A Phase 3 study testing Cognitive Behaviour Therapy (CBT) and Usual Cardiac Care (UCC) in people with Anxiety and Depression, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
About 30% of patients survive a cardiac arrest, and the majority of these receive an implantable cardioverter defibrillator (ICD) for prevention of sudden cardiac death (SCD). While ICD therapy offers survival benefit over drug therapy, there remain significant quality of life (QL) issues. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Cognitive Behaviour Therapy (CBT) and Usual Cardiac Care (UCC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2003to Nov 2007
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients from either Toronto General hospital or St. Michael's Hospital who have coronary heart disease,
- Receiving their first ICD implant for secondary prevention of SCD or for primary prevention of SCD and their underlying heart disease was hypertrophic cardiomyopathy.
Who cannot join
- Not able to read or understand English;
- Evidence of psychosis, dementia or cognitive impairment as documented in the patients' hospital records;
- Receiving an ICD for primary prevention of ICD.
Trial locations and contacts
1 site in 1 country.
About this study
About 30% of patients survive a cardiac arrest, and the majority of these receive an implantable cardioverter defibrillator (ICD) for prevention of sudden cardiac death (SCD). While ICD therapy offers survival benefit over drug therapy, there remain significant quality of life (QL) issues. About 50% of patients experience chronic anxiety about receiving an ICD shock. Anxiety and depression in turn appear to predispose to more arrhythmias necessitating ICD therapy. The aims of the current study are:
- to evaluate a 8-session psychosocial intervention to help patients cope effectively with receiving an ICD for secondary prevention of SCD,
- to determine if baseline measures of depression and anxiety predict ICD therapies (i.e., anti-tachycardia pace terminations and shocks); and
- to explore if the psychosocial intervention results in less need for appropriate ICD therapies.
Read the detailed description
About 30% of patients survive a cardiac arrest, and the majority of these receive an implantable cardioverter defibrillator (ICD) for prevention of sudden cardiac death (SCD). While ICD therapy offers survival benefit over drug therapy, there remain significant quality of life (QL) issues. About 50% of patients experience chronic anxiety about receiving an ICD shock. Anxiety and depression in turn appear to predispose to more arrhythmias necessitating ICD therapy. The aims of the current study are:
- to evaluate a 8-session psychosocial intervention to help patients cope effectively with receiving an ICD for secondary prevention of SCD,
- to determine if baseline measures of depression and anxiety predict ICD therapies (i.e., anti-tachycardia pace terminations and shocks); and
- to explore if the psychosocial intervention results in less need for appropriate ICD therapies.
This study will randomize 218 ICD patients to receive either usual cardiac care (n=109) OR usual cardiac care plus CBT (n=109). Participants are recruited from two hospitals in Toronto that perform ICD implants (St. Michael's Hospital and the Toronto General Hospital). Counselling follows a CBT manual and involves both face-to-face sessions and telephone sessions. The telephone is employed as a means to deliver therapy as at least half of our ICD subjects reside outside of Toronto and all patients are prohibited from driving an automobile for the first six months following ICD implant. Outcome is assessed 6 and 12-months following the date of randomization and include measures of psychological function and quality of life. Secondary outcome is frequency of ICD therapies over follow-up (i.e., anti-tachycardia pacing terminations and DC shocks).
Inclusion Criteria:
- Patients from either Toronto General hospital or St. Michael's Hospital who have coronary heart disease,
- Receiving their first ICD implant for secondary prevention of SCD or primary prevention of SCD if their underlying heart disease was hypertrophic cardiomyopathy.
Exclusion Criteria:
- Not able to read or understand English;
- Evidence of psychosis, dementia or cognitive impairment as documented in the patients' hospital records;
- Receiving an ICD for primary prevention of ICD.
- Conditions
- Anxiety, Depression
- Being tested
- Cognitive Behaviour Therapy (CBT), Usual Cardiac Care (UCC)
- Keywords
- health anxiety
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behaviour Therapy (CBT)Behavioural
Cognitive behavior therapy tailored to psychological adaptation to an ICD, included 8 telephone counselling sessions, plus psycho-educational booklet and a therapist manual.
Usual Cardiac Care (UCC)Other
Usual cardiac care (UCC) was defined as whatever the respective ICD treatment sites routinely offer their patients. All patients received standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavior Therapy - males | Experimental | Eight telephone sessions of cognitive behavior therapy tailored to psychological adaptation to an ICD, plus a psycho-educational booklet for participants and a therapist manual. This arm included the males. Receives: Behavioral: Cognitive Behaviour Therapy (CBT) |
| Cognitive Behavior Therapy - females | Experimental | Eight telephone sessions of cognitive behavior therapy tailored to psychological adaptation to an ICD, plus a psycho-educational booklet for participants and a therapist manual. This arm included the females. Receives: Behavioral: Cognitive Behaviour Therapy (CBT) |
| Usual Cardiac Care - Males | Active comparator | The UCC was defined as whatever the respective ICD treatment sites routinely offer their patients. All patients received standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed. This arm was just for males randomized. Receives: Other: Usual Cardiac Care (UCC) |
| Usual Cardiac Care - females | Active comparator | The UCC was defined as whatever the respective ICD treatment sites routinely offer their patients. All patients received standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed. This arm was for females randomized. Receives: Other: Usual Cardiac Care (UCC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale - Depression Scale at Baseline
Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.
Measured: Baseline
Hospital Anxiety and Depression Scale - Depression Scale at 6-months Follow-up
Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.
Measured: Six-months follow-up
Hospital Anxiety and Depression Scale - Depression Scale at 12-months Follow-up
Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.
Measured: Twelve-months follow-up
Hospital Anxiety and Depression Scale - Anxiety Scale at Baseline
Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.
Measured: Baseline
Hospital Anxiety and Depression Scale - Anxiety Scale at 6-months Follow-up
Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.
Measured: Six-months follow-up
Hospital Anxiety and Depression Scale - Anxiety Scale at 12-months Follow-up
Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.
Measured: Twelve-months follow-up
Impact of Events Scale-Revised - Total Score at Baseline
Psychometric measure of post traumatic stress disorder symptoms, scores range from 0 to 4. A score threshold of 1.4 has been found to diagnostic of post traumatic stress disorder in war veterans. Higher scores represent greater total post traumatic stress disorder symptoms.
Measured: Baseline
Impact of Events Scale-Revised - Total Score at 6-months Follow-up
Psychometric measure of post traumatic stress disorder symptoms, scores range from 0 to 4. A score threshold of 1.4 has been found to diagnostic of post traumatic stress disorder in war veterans. Higher scores represent greater total post traumatic stress disorder symptoms.
Measured: Six-months follow-up
Impact of Events Scale-Revised - Total Score at 12-months Follow-up
Psychometric measure of post traumatic stress disorder symptoms, scores range from 0 to 4. A score threshold of 1.4 has been found to diagnostic of post traumatic stress disorder in war veterans. Higher scores represent greater total post traumatic stress disorder symptoms.
Measured: Twelve-months follow-up
Impact of Events Scale-Revised - Intrusiveness Scale at Baseline
Psychometric measure of post traumatic stress disorder intrusiveness symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder intrusiveness symptoms.
Measured: Baseline
Impact of Events Scale-Revised - Intrusiveness Scale at 6-months Follow-up
Psychometric measure of post traumatic stress disorder intrusiveness symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder intrusiveness symptoms.
Measured: Six-months follow-up
Impact of Events Scale-Revised - Intrusiveness Scale at 12-months Follow-up
Psychometric measure of post traumatic stress disorder intrusiveness symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder intrusiveness symptoms.
Measured: Twelve-months follow-up
Impact of Events Scale-Revised - Avoidance Scale at Baseline
Psychometric assessment of post traumatic stress disorder avoidance symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder avoidance symptoms.
Measured: Baseline
Impact of Events Scale-Revised - Avoidance Scale at 6-months Follow-up
Psychometric assessment of post traumatic stress disorder avoidance symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder avoidance symptoms.
Measured: Six-months follow-up
Impact of Events Scale-Revised - Avoidance Scale at 12-months Follow-up
Psychometric assessment of post traumatic stress disorder avoidance symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder avoidance symptoms.
Measured: Twelve-months follow-up
Impact of Event Scale-Revised Hyperarousal Scale at Baseline
Psychometric measure of post traumatic stress disorder hyper-arousal symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder hyperarousal symptoms.
Measured: Baseline
Impact of Event Scale-Revised Hyperarousal Scale at 6-months Follow-up
Psychometric measure of post traumatic stress disorder hyper-arousal symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder hyperarousal symptoms.
Measured: Six-months follow-up
Impact of Event Scale-Revised Hyperarousal Scale at 12-months Follow-up
Psychometric measure of post traumatic stress disorder hyper-arousal symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder hyperarousal symptoms.
Measured: Twelve-months follow-up
Crown-Crisp Experiential Index - Phobic Anxiety Scale at Baseline
Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.
Measured: Baseline
Crown-Crisp Experiential Index - Phobic Anxiety Scale at 6-months Follow-up
Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.
Measured: Six-months follow-up
Crown-Crisp Experiential Index - Phobic Anxiety Scale at 12-months Follow-up
Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.
Measured: Twelve-months follow-up
Secondary outcomes (7)
SF-36 Mental Component Summary Scale at Baseline
Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.
Measured: Baseline
SF-36 Mental Component Summary Scale at 6-months Follow-up
Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.
Measured: Six-months follow-up
SF-36 Mental Component Summary Scale at 12-months Follow-up
Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.
Measured: Twelve-months follow-up
SF-36 Physical Component Summary Score at Baseline
Quality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health.
Measured: Baseline
SF-36 Physical Component Summary Score at 6-months Follow-up
Quality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health.
Measured: Six-months follow-up
SF-36 Physical Component Summary Score at 12-months Follow-up
Quality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health.
Measured: Twelve-months follow-up
Percentage of Participants Who Received ICD Therapies
Percentage of participants who received ICD shocks or anti-tachycardia therapies, data extracted from participants ICD devices over follow-up.
Measured: 12-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startOct 2003
- Primary completionSep 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Jane Irvine, D.Phil., Principal investigator, University Health Network, Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152763
- Sponsor's protocol ID
- NA 5170
- Other IDs
- Grant number NA 5170
- Status last verified
- Jan 2011
- First submitted
- 7 Sep 2005
- Last updated
- 28 Jan 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Irvine, J. Stanley, J., Ong, L., Cribbie, R., Ritvo, P., Katz, J., Dorian, P., O'Donnell, S., Harris, L., Cameron, D., Hill, A., Newman, D., Johnson, S. N., Bilanovic, A. Sears, S F. Acceptability of a Cognitive Behavior Therapy Intervention to Implantable Cardioverter Defibrillator Recipients, Journal of Cognitive Psychotherapy, 2010; 24(4) (November), 243-264.
Ford J, Rosman L, Wuensch K, Irvine J, Sears SF. Cognitive-Behavioral Treatment of Posttraumatic Stress in Patients With Implantable Cardioverter Defibrillators: Results From a Randomized Controlled Trial. J Trauma Stress. 2016 Aug;29(4):388-92. doi: 10.1002/jts.22111. Epub 2016 Jul 14.
PubMed 27415850Irvine J, Firestone J, Ong L, Cribbie R, Dorian P, Harris L, Ritvo P, Katz J, Newman D, Cameron D, Johnson S, Bilanovic A, Hill A, O'Donnell S, Sears S Jr. A randomized controlled trial of cognitive behavior therapy tailored to psychological adaptation to an implantable cardioverter defibrillator. Psychosom Med. 2011 Apr;73(3):226-33. doi: 10.1097/PSY.0b013e31820afc63. Epub 2011 Feb 14.
PubMed 21321256
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Support for Patients With an Implantable Cardioverter Defibrillator
- ClinicalTrials.gov ID
- NCT00152763
- Acronym / sponsor ID
- NA 5170
- Conditions
- Anxiety, Depression
- Keywords
- health anxiety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- Sep 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 9 Sep 2005 (estimated)
- Results
- Posted 28 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
About 30% of patients survive a cardiac arrest, and the majority of these receive an implantable cardioverter defibrillator (ICD) for prevention of sudden cardiac death (SCD). While ICD therapy offers survival benefit over drug therapy, there remain significant quality of life (QL) issues. About 50% of patients experience chronic anxiety about receiving an ICD shock. Anxiety and depression in turn appear to predispose to more arrhythmias necessitating ICD therapy. The aims of the current study are:
- to evaluate a 8-session psychosocial intervention to help patients cope effectively with receiving an ICD for secondary prevention of SCD,
- to determine if baseline measures of depression and anxiety predict ICD therapies (i.e., anti-tachycardia pace terminations and shocks); and
- to explore if the psychosocial intervention results in less need for appropriate ICD therapies.
Detailed description
About 30% of patients survive a cardiac arrest, and the majority of these receive an implantable cardioverter defibrillator (ICD) for prevention of sudden cardiac death (SCD). While ICD therapy offers survival benefit over drug therapy, there remain significant quality of life (QL) issues. About 50% of patients experience chronic anxiety about receiving an ICD shock. Anxiety and depression in turn appear to predispose to more arrhythmias necessitating ICD therapy. The aims of the current study are:
- to evaluate a 8-session psychosocial intervention to help patients cope effectively with receiving an ICD for secondary prevention of SCD,
- to determine if baseline measures of depression and anxiety predict ICD therapies (i.e., anti-tachycardia pace terminations and shocks); and
- to explore if the psychosocial intervention results in less need for appropriate ICD therapies.
This study will randomize 218 ICD patients to receive either usual cardiac care (n=109) OR usual cardiac care plus CBT (n=109). Participants are recruited from two hospitals in Toronto that perform ICD implants (St. Michael's Hospital and the Toronto General Hospital). Counselling follows a CBT manual and involves both face-to-face sessions and telephone sessions. The telephone is employed as a means to deliver therapy as at least half of our ICD subjects reside outside of Toronto and all patients are prohibited from driving an automobile for the first six months following ICD implant. Outcome is assessed 6 and 12-months following the date of randomization and include measures of psychological function and quality of life. Secondary outcome is frequency of ICD therapies over follow-up (i.e., anti-tachycardia pacing terminations and DC shocks).
Inclusion Criteria:
- Patients from either Toronto General hospital or St. Michael's Hospital who have coronary heart disease,
- Receiving their first ICD implant for secondary prevention of SCD or primary prevention of SCD if their underlying heart disease was hypertrophic cardiomyopathy.
Exclusion Criteria:
- Not able to read or understand English;
- Evidence of psychosis, dementia or cognitive impairment as documented in the patients' hospital records;
- Receiving an ICD for primary prevention of ICD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavior Therapy - males | Experimental | Behavioral: Cognitive Behaviour Therapy (CBT)Eight telephone sessions of cognitive behavior therapy tailored to psychological adaptation to an ICD, plus a psycho-educational booklet for participants and a therapist manual. This arm included the males. |
| Cognitive Behavior Therapy - females | Experimental | Behavioral: Cognitive Behaviour Therapy (CBT)Eight telephone sessions of cognitive behavior therapy tailored to psychological adaptation to an ICD, plus a psycho-educational booklet for participants and a therapist manual. This arm included the females. |
| Usual Cardiac Care - Males | Active comparator | Other: Usual Cardiac Care (UCC)The UCC was defined as whatever the respective ICD treatment sites routinely offer their patients. All patients received standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed. This arm was just for males randomized. |
| Usual Cardiac Care - females | Active comparator | Other: Usual Cardiac Care (UCC)The UCC was defined as whatever the respective ICD treatment sites routinely offer their patients. All patients received standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed. This arm was for females randomized. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients from either Toronto General hospital or St. Michael's Hospital who have coronary heart disease,
- Receiving their first ICD implant for secondary prevention of SCD or for primary prevention of SCD and their underlying heart disease was hypertrophic cardiomyopathy.
Key exclusion criteria (3 listed)
- Not able to read or understand English;
- Evidence of psychosis, dementia or cognitive impairment as documented in the patients' hospital records;
- Receiving an ICD for primary prevention of ICD.
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 |
|---|---|---|
| Cognitive Behaviour Therapy (CBT)Cognitive behavior therapy tailored to psychological adaptation to an ICD, included 8 telephone counselling sessions, plus psycho-educational booklet and a therapist manual. | Behavioural | Cognitive Behavior Therapy - females, Cognitive Behavior Therapy - males |
| Usual Cardiac Care (UCC)Usual cardiac care (UCC) was defined as whatever the respective ICD treatment sites routinely offer their patients. All patients received standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed. | Other | Usual Cardiac Care - Males, Usual Cardiac Care - females |
Primary outcome
Hospital Anxiety and Depression Scale - Depression Scale at Baseline
Time frame: Baseline
Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.
Hospital Anxiety and Depression Scale - Depression Scale at 6-months Follow-up
Time frame: Six-months follow-up
Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.
Hospital Anxiety and Depression Scale - Depression Scale at 12-months Follow-up
Time frame: Twelve-months follow-up
Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.
Hospital Anxiety and Depression Scale - Anxiety Scale at Baseline
Time frame: Baseline
Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.
Hospital Anxiety and Depression Scale - Anxiety Scale at 6-months Follow-up
Time frame: Six-months follow-up
Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.
Hospital Anxiety and Depression Scale - Anxiety Scale at 12-months Follow-up
Time frame: Twelve-months follow-up
Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.
Impact of Events Scale-Revised - Total Score at Baseline
Time frame: Baseline
Psychometric measure of post traumatic stress disorder symptoms, scores range from 0 to 4. A score threshold of 1.4 has been found to diagnostic of post traumatic stress disorder in war veterans. Higher scores represent greater total post traumatic stress disorder symptoms.
Impact of Events Scale-Revised - Total Score at 6-months Follow-up
Time frame: Six-months follow-up
Psychometric measure of post traumatic stress disorder symptoms, scores range from 0 to 4. A score threshold of 1.4 has been found to diagnostic of post traumatic stress disorder in war veterans. Higher scores represent greater total post traumatic stress disorder symptoms.
Impact of Events Scale-Revised - Total Score at 12-months Follow-up
Time frame: Twelve-months follow-up
Psychometric measure of post traumatic stress disorder symptoms, scores range from 0 to 4. A score threshold of 1.4 has been found to diagnostic of post traumatic stress disorder in war veterans. Higher scores represent greater total post traumatic stress disorder symptoms.
Impact of Events Scale-Revised - Intrusiveness Scale at Baseline
Time frame: Baseline
Psychometric measure of post traumatic stress disorder intrusiveness symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder intrusiveness symptoms.
Impact of Events Scale-Revised - Intrusiveness Scale at 6-months Follow-up
Time frame: Six-months follow-up
Psychometric measure of post traumatic stress disorder intrusiveness symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder intrusiveness symptoms.
Impact of Events Scale-Revised - Intrusiveness Scale at 12-months Follow-up
Time frame: Twelve-months follow-up
Psychometric measure of post traumatic stress disorder intrusiveness symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder intrusiveness symptoms.
Impact of Events Scale-Revised - Avoidance Scale at Baseline
Time frame: Baseline
Psychometric assessment of post traumatic stress disorder avoidance symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder avoidance symptoms.
Impact of Events Scale-Revised - Avoidance Scale at 6-months Follow-up
Time frame: Six-months follow-up
Psychometric assessment of post traumatic stress disorder avoidance symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder avoidance symptoms.
Impact of Events Scale-Revised - Avoidance Scale at 12-months Follow-up
Time frame: Twelve-months follow-up
Psychometric assessment of post traumatic stress disorder avoidance symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder avoidance symptoms.
Impact of Event Scale-Revised Hyperarousal Scale at Baseline
Time frame: Baseline
Psychometric measure of post traumatic stress disorder hyper-arousal symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder hyperarousal symptoms.
Impact of Event Scale-Revised Hyperarousal Scale at 6-months Follow-up
Time frame: Six-months follow-up
Psychometric measure of post traumatic stress disorder hyper-arousal symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder hyperarousal symptoms.
Impact of Event Scale-Revised Hyperarousal Scale at 12-months Follow-up
Time frame: Twelve-months follow-up
Psychometric measure of post traumatic stress disorder hyper-arousal symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder hyperarousal symptoms.
Crown-Crisp Experiential Index - Phobic Anxiety Scale at Baseline
Time frame: Baseline
Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.
Crown-Crisp Experiential Index - Phobic Anxiety Scale at 6-months Follow-up
Time frame: Six-months follow-up
Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.
Crown-Crisp Experiential Index - Phobic Anxiety Scale at 12-months Follow-up
Time frame: Twelve-months follow-up
Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.
7 secondary outcomes
SF-36 Mental Component Summary Scale at Baseline
Time frame: Baseline
SF-36 Mental Component Summary Scale at 6-months Follow-up
Time frame: Six-months follow-up
SF-36 Mental Component Summary Scale at 12-months Follow-up
Time frame: Twelve-months follow-up
SF-36 Physical Component Summary Score at Baseline
Time frame: Baseline
SF-36 Physical Component Summary Score at 6-months Follow-up
Time frame: Six-months follow-up
SF-36 Physical Component Summary Score at 12-months Follow-up
Time frame: Twelve-months follow-up
Percentage of Participants Who Received ICD Therapies
Time frame: 12-months follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundIrvine, J. Stanley, J., Ong, L., Cribbie, R., Ritvo, P., Katz, J., Dorian, P., O'Donnell, S., Harris, L., Cameron, D., Hill, A., Newman, D., Johnson, S. N., Bilanovic, A. Sears, S F. Acceptability of a Cognitive Behavior Therapy Intervention to Implantable Cardioverter Defibrillator Recipients, Journal of Cognitive Psychotherapy, 2010; 24(4) (November), 243-264.
- Derived from this study: PubMed 27415850Ford J, Rosman L, Wuensch K, Irvine J, Sears SF. Cognitive-Behavioral Treatment of Posttraumatic Stress in Patients With Implantable Cardioverter Defibrillators: Results From a Randomized Controlled Trial. J Trauma Stress. 2016 Aug;29(4):388-92. doi: 10.1002/jts.22111. Epub 2016 Jul 14.
- Derived from this study: PubMed 21321256Irvine J, Firestone J, Ong L, Cribbie R, Dorian P, Harris L, Ritvo P, Katz J, Newman D, Cameron D, Johnson S, Bilanovic A, Hill A, O'Donnell S, Sears S Jr. A randomized controlled trial of cognitive behavior therapy tailored to psychological adaptation to an implantable cardioverter defibrillator. Psychosom Med. 2011 Apr;73(3):226-33. doi: 10.1097/PSY.0b013e31820afc63. Epub 2011 Feb 14.
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
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.
Jane Irvine, D.Phil. principal investigator
University Health Network, Toronto 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 3 study testing Cognitive Behaviour Therapy (CBT) and Usual Cardiac Care (UCC) in people with Anxiety and Depression, run by University Health Network, Toronto at 1 site in Canada.
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 2 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 28 Jan 2011. 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 Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hospital Anxiety and Depression Scale - Depression Scale at Baseline (time frame: Baseline). The study lists 21 primary outcomes in all. 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 NCT00152763, which also lists 3 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 28 Jan 2011.