Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Grant number NA 5170 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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:
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behaviour Therapy (CBT) | Behavioral | Cognitive behavior therapy tailored to psychological adaptation to an ICD, included 8 telephone counselling sessions, plus psycho-educational booklet and a therapist manual. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| SF-36 Mental Component Summary Scale at 6-months Follow-up |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jane Irvine, D.Phil. | University Health Network, Toronto General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 27415850 | Derived | 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. | |
| 21321256 |
Not provided
Not provided
Upon recruitment, participants completed baseline psychological assessment prior to being randomized to the experimental intervention arm (cognitive behaviour therapy) or usual care.
Recruitment commenced in October 2003 at Toronto General Hospital and St. Michael's Hospital in Toronto, Ontario, Canada and concluded in August 2006.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Usual Cardiac Care - Men | Cardiac care as usual for the hospital clinic which includesstandard 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. |
| FG001 | Cognitive Behaviour Therapy - Women | Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet |
| FG002 | Usual Cardiac Care - Women | Cardiac care as usual which includes 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. |
| FG003 | Cognitive Therapy Group - Men | Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Usual Cardiac Care - Men | Cardiac care as usual for the hospital clinic which includesstandard 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intention to treat analyses but data on participants who died over follow-up were omitted. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
Not provided
Death was the only adverse event collected.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Cardiac Care - Men | Cardiac care as usual for the hospital clinic which includesstandard 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deaths | General disorders |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jane Irvine | University Health Network, Toronto General Hospital | (416) 736-5115 | 22444 | jirvine@yorku.ca |
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Twelve-months follow-up |
Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.
| 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. | 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. | 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. | 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. | 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. | 12-months follow-up |
| Derived |
| Irvine 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. |
| Lost to Follow-up |
|
| BG001 | Cognitive Behaviour Therapy - Women | Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet |
| BG002 | Usual Cardiac Care - Women | Cardiac care as usual which includes 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. |
| BG003 | Cognitive Therapy Group - Men | Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Cognitive Behaviour Therapy - Women | Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet |
| OG002 | Usual Cardiac Care - Women | Cardiac care as usual which includes 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. |
| OG003 | Cognitive Therapy Group - Men | Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet. |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | 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. | Intention to treat analyses but data on participants who died over follow-up were omitted. | Posted | Mean | Standard Deviation | units on a scale | Six-months follow-up |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Six-months follow-up |
|
|
|
| Primary | 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. | Intention to treat analyses but data on participants who died over follow-up were omitted. | Posted | Mean | Standard Deviation | units on a scale | Twelve-months follow-up |
|
|
|
| Primary | 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. | Intention to treat analyses but data on participants who died over follow-up were omitted. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | 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. | Intention to treat analyses but data on participants who died over follow-up were omitted. | Posted | Mean | Standard Deviation | units on a scale | Six-months follow-up |
|
|
|
| Primary | 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. | Intention to treat analyses but data on participants who died over follow-up were omitted. | Posted | Mean | Standard Deviation | units on a scale | Twelve-months follow-up |
|
|
|
| Primary | 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. | Intention to treat analysis although data for participants who died over follow-up were omitted. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Twelve-months follow-up |
|
|
|
| Primary | 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. | Intention to treat analysis although data for participants who died over follow-up were omitted. | Posted | Mean | Standard Deviation | units on a scale | Six-months follow-up |
|
|
|
| Primary | 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. | Intention to treat analysis although data for participants who died over follow-up were omitted. | Posted | Mean | Standard Deviation | units on a scale | Twelve-months follow-up |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Six-months follow-up |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Twelve-months follow-up |
|
|
|
| Primary | 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. | Intention to treat analysis although data from participants who died were omitted from analysis | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | 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. | Intention to treat analysis although data from participants who died were omitted from analysis | Posted | Mean | Standard Deviation | units on a scale | Six-months follow-up |
|
|
|
| Primary | 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. | Intention to treat analysis although data from participants who died were omitted from analysis | Posted | Mean | Standard Deviation | units on a scale | Twelve-months follow-up |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Six-months follow-up |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Twelve-months follow-up |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Six-months follow-up |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Twelve-months follow-up |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Six-months follow-up |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Twelve-months follow-up |
|
|
|
| Secondary | 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. | Posted | Number | Percentage of participants | 12-months follow-up |
|
|
|
| 4 |
| 77 |
| 0 |
| 0 |
| EG001 | Cognitive Behaviour Therapy - Women | Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet | 1 | 19 | 0 | 0 |
| EG002 | Usual Cardiac Care - Women | Cardiac care as usual which includes 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. | 2 | 20 | 0 | 0 |
| EG003 | Cognitive Therapy Group - Men | Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet. | 1 | 77 | 0 | 0 |
Not provided
Not provided