Anxiety, Depression
Conditions
Keywords
health anxiety
Brief 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. 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: 1. to evaluate a 8-session psychosocial intervention to help patients cope effectively with receiving an ICD for secondary prevention of SCD, 2. to determine if baseline measures of depression and anxiety predict ICD therapies (i.e., anti-tachycardia pace terminations and shocks); and 3. 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: 1. to evaluate a 8-session psychosocial intervention to help patients cope effectively with receiving an ICD for secondary prevention of SCD, 2. to determine if baseline measures of depression and anxiety predict ICD therapies (i.e., anti-tachycardia pace terminations and shocks); and 3. 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.
Interventions
BEHAVIORALCognitive 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.
OTHERUsual 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.
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 for primary prevention of SCD and 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Crown-Crisp Experiential Index - Phobic Anxiety Scale at 12-months Follow-up | Twelve-months follow-up | Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms. |
| Impact of Events Scale-Revised - Avoidance Scale at 6-months Follow-up | 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 | 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 | 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 | 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 | 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 | 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 | Six-months follow-up | Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms. |
| Hospital Anxiety and Depression Scale - Depression Scale at Baseline | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SF-36 Mental Component Summary Scale at 6-months Follow-up | Six-months follow-up | Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health. |
| SF-36 Mental Component Summary Scale at 12-months Follow-up | Twelve-months follow-up | Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health. |
| SF-36 Physical Component Summary Score at Baseline | Baseline | Quality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health. |
| SF-36 Physical Component Summary Score at 6-months Follow-up | Six-months follow-up | Quality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health. |
| SF-36 Physical Component Summary Score at 12-months Follow-up | Twelve-months follow-up | Quality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health. |
| Percentage of Participants Who Received ICD Therapies | 12-months follow-up | Percentage of participants who received ICD shocks or anti-tachycardia therapies, data extracted from participants ICD devices over follow-up. |
| SF-36 Mental Component Summary Scale at Baseline | Baseline | Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health. |
Countries
Canada
Participant flow
Recruitment details
Recruitment commenced in October 2003 at Toronto General Hospital and St. Michael's Hospital in Toronto, Ontario, Canada and concluded in August 2006.
Pre-assignment details
Upon recruitment, participants completed baseline psychological assessment prior to being randomized to the experimental intervention arm (cognitive behaviour therapy) or usual care.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 77 |
| Cognitive Behaviour Therapy - Women Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet | 19 |
| 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. | 20 |
| Cognitive Therapy Group - Men Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet. | 77 |
| Total | 193 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 4 | 1 | 2 | 1 |
| Overall Study | Lost to Follow-up | 6 | 4 | 2 | 13 |
Baseline characteristics
| Characteristic | Usual Cardiac Care - Men | Cognitive Behaviour Therapy - Women | Usual Cardiac Care - Women | Cognitive Therapy Group - Men | Total |
|---|---|---|---|---|---|
| Age Continuous | 61.29 years STANDARD_DEVIATION 13.17 | 54.58 years STANDARD_DEVIATION 15.75 | 55.35 years STANDARD_DEVIATION 18.3 | 64.2 years STANDARD_DEVIATION 13.35 | 61.68 years STANDARD_DEVIATION 14.18 |
| Sex: Female, Male Female | 0 Participants | 19 Participants | 20 Participants | 0 Participants | 39 Participants |
| Sex: Female, Male Male | 77 Participants | 0 Participants | 0 Participants | 77 Participants | 154 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 4 / 77 | 1 / 19 | 2 / 20 | 1 / 77 |
Outcome results
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.
Time frame: Twelve-months follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Cardiac Care - Men | Crown-Crisp Experiential Index - Phobic Anxiety Scale at 12-months Follow-up | 0.98 units on a scale | Standard Deviation 0.4 |
| Cognitive Behaviour Therapy - Women | Crown-Crisp Experiential Index - Phobic Anxiety Scale at 12-months Follow-up | 1.13 units on a scale | Standard Deviation 0.35 |
| Usual Cardiac Care - Women | Crown-Crisp Experiential Index - Phobic Anxiety Scale at 12-months Follow-up | 1.07 units on a scale | Standard Deviation 0.4 |
| Cognitive Therapy Group - Men | Crown-Crisp Experiential Index - Phobic Anxiety Scale at 12-months Follow-up | 0.93 units on a scale | Standard Deviation 0.35 |
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.
Time frame: Six-months follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Cardiac Care - Men | Crown-Crisp Experiential Index - Phobic Anxiety Scale at 6-months Follow-up | 0.92 units on a scale | Standard Deviation 0.4 |
| Cognitive Behaviour Therapy - Women | Crown-Crisp Experiential Index - Phobic Anxiety Scale at 6-months Follow-up | 1.04 units on a scale | Standard Deviation 0.38 |
| Usual Cardiac Care - Women | Crown-Crisp Experiential Index - Phobic Anxiety Scale at 6-months Follow-up | 1.07 units on a scale | Standard Deviation 0.36 |
| Cognitive Therapy Group - Men | Crown-Crisp Experiential Index - Phobic Anxiety Scale at 6-months Follow-up | 0.84 units on a scale | Standard Deviation 0.35 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Cardiac Care - Men | Crown-Crisp Experiential Index - Phobic Anxiety Scale at Baseline | 0.98 units on a scale | Standard Deviation 0.39 |
| Cognitive Behaviour Therapy - Women | Crown-Crisp Experiential Index - Phobic Anxiety Scale at Baseline | 1.17 units on a scale | Standard Deviation 0.28 |
| Usual Cardiac Care - Women | Crown-Crisp Experiential Index - Phobic Anxiety Scale at Baseline | 1.23 units on a scale | Standard Deviation 0.41 |
| Cognitive Therapy Group - Men | Crown-Crisp Experiential Index - Phobic Anxiety Scale at Baseline | 0.83 units on a scale | Standard Deviation 0.33 |
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.
Time frame: Twelve-months follow-up
Population: Intention to treat analyses but data on participants who died over follow-up were omitted.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Cardiac Care - Men | Hospital Anxiety and Depression Scale - Anxiety Scale at 12-months Follow-up | 6.06 units on a scale | Standard Deviation 3.97 |
| Cognitive Behaviour Therapy - Women | Hospital Anxiety and Depression Scale - Anxiety Scale at 12-months Follow-up | 8.00 units on a scale | Standard Deviation 3.7 |
| Usual Cardiac Care - Women | Hospital Anxiety and Depression Scale - Anxiety Scale at 12-months Follow-up | 7.25 units on a scale | Standard Deviation 3.57 |
| Cognitive Therapy Group - Men | Hospital Anxiety and Depression Scale - Anxiety Scale at 12-months Follow-up | 4.43 units on a scale | Standard Deviation 3.77 |
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.
Time frame: Six-months follow-up
Population: Intention to treat analyses but data on participants who died over follow-up were omitted.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Cardiac Care - Men | Hospital Anxiety and Depression Scale - Anxiety Scale at 6-months Follow-up | 6.06 units on a scale | Standard Deviation 3.84 |
| Cognitive Behaviour Therapy - Women | Hospital Anxiety and Depression Scale - Anxiety Scale at 6-months Follow-up | 7.28 units on a scale | Standard Deviation 4.01 |
| Usual Cardiac Care - Women | Hospital Anxiety and Depression Scale - Anxiety Scale at 6-months Follow-up | 6.83 units on a scale | Standard Deviation 4.67 |
| Cognitive Therapy Group - Men | Hospital Anxiety and Depression Scale - Anxiety Scale at 6-months Follow-up | 4.69 units on a scale | Standard Deviation 3.92 |
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.
Time frame: Baseline
Population: Intention to treat analyses but data on participants who died over follow-up were omitted.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Cardiac Care - Men | Hospital Anxiety and Depression Scale - Anxiety Scale at Baseline | 6.53 units on a scale | Standard Deviation 4.26 |
| Cognitive Behaviour Therapy - Women | Hospital Anxiety and Depression Scale - Anxiety Scale at Baseline | 9.32 units on a scale | Standard Deviation 5.5 |
| Usual Cardiac Care - Women | Hospital Anxiety and Depression Scale - Anxiety Scale at Baseline | 7.70 units on a scale | Standard Deviation 3.85 |
| Cognitive Therapy Group - Men | Hospital Anxiety and Depression Scale - Anxiety Scale at Baseline | 4.80 units on a scale | Standard Deviation 3.93 |
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.
Time frame: Twelve-months follow-up
Population: Intention to treat analyses but data on participants who died over follow-up were omitted.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Cardiac Care - Men | Hospital Anxiety and Depression Scale - Depression Scale at 12-months Follow-up | 4.52 units on a scale | Standard Deviation 3.29 |
| Cognitive Behaviour Therapy - Women | Hospital Anxiety and Depression Scale - Depression Scale at 12-months Follow-up | 4.67 units on a scale | Standard Deviation 4.19 |
| Usual Cardiac Care - Women | Hospital Anxiety and Depression Scale - Depression Scale at 12-months Follow-up | 5.87 units on a scale | Standard Deviation 3.12 |
| Cognitive Therapy Group - Men | Hospital Anxiety and Depression Scale - Depression Scale at 12-months Follow-up | 4.15 units on a scale | Standard Deviation 3.36 |
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.
Time frame: Six-months follow-up
Population: Intention to treat analyses but data on participants who died over follow-up were omitted.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Cardiac Care - Men | Hospital Anxiety and Depression Scale - Depression Scale at 6-months Follow-up | 4.21 units on a scale | Standard Deviation 3.31 |
| Cognitive Behaviour Therapy - Women | Hospital Anxiety and Depression Scale - Depression Scale at 6-months Follow-up | 4.86 units on a scale | Standard Deviation 3.25 |
| Usual Cardiac Care - Women | Hospital Anxiety and Depression Scale - Depression Scale at 6-months Follow-up | 5.50 units on a scale | Standard Deviation 4.22 |
| Cognitive Therapy Group - Men | Hospital Anxiety and Depression Scale - Depression Scale at 6-months Follow-up | 3.82 units on a scale | Standard Deviation 3.39 |
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.
Time frame: Baseline
Population: Intention to treat analyses but data on participants who died over follow-up were omitted.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Cardiac Care - Men | Hospital Anxiety and Depression Scale - Depression Scale at Baseline | 4.70 units on a scale | Standard Deviation 3.41 |
| Cognitive Behaviour Therapy - Women | Hospital Anxiety and Depression Scale - Depression Scale at Baseline | 7.47 units on a scale | Standard Deviation 5.02 |
| Usual Cardiac Care - Women | Hospital Anxiety and Depression Scale - Depression Scale at Baseline | 5.35 units on a scale | Standard Deviation 3.82 |
| Cognitive Therapy Group - Men | Hospital Anxiety and Depression Scale - Depression Scale at Baseline | 4.12 units on a scale | Standard Deviation 4.01 |
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.
Time frame: Twelve-months follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Cardiac Care - Men | Impact of Event Scale-Revised Hyperarousal Scale at 12-months Follow-up | 0.64 units on a scale | Standard Deviation 0.73 |
| Cognitive Behaviour Therapy - Women | Impact of Event Scale-Revised Hyperarousal Scale at 12-months Follow-up | 0.57 units on a scale | Standard Deviation 0.54 |
| Usual Cardiac Care - Women | Impact of Event Scale-Revised Hyperarousal Scale at 12-months Follow-up | 0.67 units on a scale | Standard Deviation 0.7 |
| Cognitive Therapy Group - Men | Impact of Event Scale-Revised Hyperarousal Scale at 12-months Follow-up | 0.39 units on a scale | Standard Deviation 0.43 |
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.
Time frame: Six-months follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Cardiac Care - Men | Impact of Event Scale-Revised Hyperarousal Scale at 6-months Follow-up | 0.61 units on a scale | Standard Deviation 0.7 |
| Cognitive Behaviour Therapy - Women | Impact of Event Scale-Revised Hyperarousal Scale at 6-months Follow-up | 0.64 units on a scale | Standard Deviation 0.87 |
| Usual Cardiac Care - Women | Impact of Event Scale-Revised Hyperarousal Scale at 6-months Follow-up | 0.56 units on a scale | Standard Deviation 0.61 |
| Cognitive Therapy Group - Men | Impact of Event Scale-Revised Hyperarousal Scale at 6-months Follow-up | 0.52 units on a scale | Standard Deviation 0.7 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Cardiac Care - Men | Impact of Event Scale-Revised Hyperarousal Scale at Baseline | 0.78 units on a scale | Standard Deviation 0.86 |
| Cognitive Behaviour Therapy - Women | Impact of Event Scale-Revised Hyperarousal Scale at Baseline | 1.40 units on a scale | Standard Deviation 1.11 |
| Usual Cardiac Care - Women | Impact of Event Scale-Revised Hyperarousal Scale at Baseline | 1.07 units on a scale | Standard Deviation 0.98 |
| Cognitive Therapy Group - Men | Impact of Event Scale-Revised Hyperarousal Scale at Baseline | 0.64 units on a scale | Standard Deviation 0.67 |
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.
Time frame: Twelve-months follow-up
Population: Intention to treat analysis although data from participants who died were omitted from analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Cardiac Care - Men | Impact of Events Scale-Revised - Avoidance Scale at 12-months Follow-up | 0.82 units on a scale | Standard Deviation 0.74 |
| Cognitive Behaviour Therapy - Women | Impact of Events Scale-Revised - Avoidance Scale at 12-months Follow-up | 0.84 units on a scale | Standard Deviation 0.65 |
| Usual Cardiac Care - Women | Impact of Events Scale-Revised - Avoidance Scale at 12-months Follow-up | 0.98 units on a scale | Standard Deviation 0.86 |
| Cognitive Therapy Group - Men | Impact of Events Scale-Revised - Avoidance Scale at 12-months Follow-up | 0.57 units on a scale | Standard Deviation 0.66 |
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.
Time frame: Six-months follow-up
Population: Intention to treat analysis although data from participants who died were omitted from analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Cardiac Care - Men | Impact of Events Scale-Revised - Avoidance Scale at 6-months Follow-up | 0.86 units on a scale | Standard Deviation 0.64 |
| Cognitive Behaviour Therapy - Women | Impact of Events Scale-Revised - Avoidance Scale at 6-months Follow-up | 0.77 units on a scale | Standard Deviation 0.87 |
| Usual Cardiac Care - Women | Impact of Events Scale-Revised - Avoidance Scale at 6-months Follow-up | 0.74 units on a scale | Standard Deviation 0.71 |
| Cognitive Therapy Group - Men | Impact of Events Scale-Revised - Avoidance Scale at 6-months Follow-up | 0.55 units on a scale | Standard Deviation 0.64 |
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.
Time frame: Baseline
Population: Intention to treat analysis although data from participants who died were omitted from analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Cardiac Care - Men | Impact of Events Scale-Revised - Avoidance Scale at Baseline | 0.84 units on a scale | Standard Deviation 0.62 |
| Cognitive Behaviour Therapy - Women | Impact of Events Scale-Revised - Avoidance Scale at Baseline | 1.68 units on a scale | Standard Deviation 1.1 |
| Usual Cardiac Care - Women | Impact of Events Scale-Revised - Avoidance Scale at Baseline | 1.25 units on a scale | Standard Deviation 0.82 |
| Cognitive Therapy Group - Men | Impact of Events Scale-Revised - Avoidance Scale at Baseline | 0.64 units on a scale | Standard Deviation 0.58 |
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.
Time frame: Twelve-months follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Cardiac Care - Men | Impact of Events Scale-Revised - Intrusiveness Scale at 12-months Follow-up | 0.62 units on a scale | Standard Deviation 0.62 |
| Cognitive Behaviour Therapy - Women | Impact of Events Scale-Revised - Intrusiveness Scale at 12-months Follow-up | 0.64 units on a scale | Standard Deviation 0.6 |
| Usual Cardiac Care - Women | Impact of Events Scale-Revised - Intrusiveness Scale at 12-months Follow-up | 0.80 units on a scale | Standard Deviation 0.7 |
| Cognitive Therapy Group - Men | Impact of Events Scale-Revised - Intrusiveness Scale at 12-months Follow-up | 0.42 units on a scale | Standard Deviation 0.47 |
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.
Time frame: Six-months follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Cardiac Care - Men | Impact of Events Scale-Revised - Intrusiveness Scale at 6-months Follow-up | 0.61 units on a scale | Standard Deviation 0.52 |
| Cognitive Behaviour Therapy - Women | Impact of Events Scale-Revised - Intrusiveness Scale at 6-months Follow-up | 0.82 units on a scale | Standard Deviation 0.96 |
| Usual Cardiac Care - Women | Impact of Events Scale-Revised - Intrusiveness Scale at 6-months Follow-up | 0.73 units on a scale | Standard Deviation 0.73 |
| Cognitive Therapy Group - Men | Impact of Events Scale-Revised - Intrusiveness Scale at 6-months Follow-up | 0.56 units on a scale | Standard Deviation 0.73 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Cardiac Care - Men | Impact of Events Scale-Revised - Intrusiveness Scale at Baseline | 0.80 units on a scale | Standard Deviation 0.71 |
| Cognitive Behaviour Therapy - Women | Impact of Events Scale-Revised - Intrusiveness Scale at Baseline | 1.53 units on a scale | Standard Deviation 0.98 |
| Usual Cardiac Care - Women | Impact of Events Scale-Revised - Intrusiveness Scale at Baseline | 1.25 units on a scale | Standard Deviation 0.95 |
| Cognitive Therapy Group - Men | Impact of Events Scale-Revised - Intrusiveness Scale at Baseline | 0.61 units on a scale | Standard Deviation 0.64 |
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.
Time frame: Twelve-months follow-up
Population: Intention to treat analysis although data for participants who died over follow-up were omitted.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Cardiac Care - Men | Impact of Events Scale-Revised - Total Score at 12-months Follow-up | 0.70 units on a scale | Standard Deviation 0.64 |
| Cognitive Behaviour Therapy - Women | Impact of Events Scale-Revised - Total Score at 12-months Follow-up | 0.69 units on a scale | Standard Deviation 0.53 |
| Usual Cardiac Care - Women | Impact of Events Scale-Revised - Total Score at 12-months Follow-up | 0.82 units on a scale | Standard Deviation 0.69 |
| Cognitive Therapy Group - Men | Impact of Events Scale-Revised - Total Score at 12-months Follow-up | 0.46 units on a scale | Standard Deviation 0.47 |
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.
Time frame: Six-months follow-up
Population: Intention to treat analysis although data for participants who died over follow-up were omitted.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Cardiac Care - Men | Impact of Events Scale-Revised - Total Score at 6-months Follow-up | 0.70 units on a scale | Standard Deviation 0.52 |
| Cognitive Behaviour Therapy - Women | Impact of Events Scale-Revised - Total Score at 6-months Follow-up | 0.76 units on a scale | Standard Deviation 0.83 |
| Usual Cardiac Care - Women | Impact of Events Scale-Revised - Total Score at 6-months Follow-up | 0.68 units on a scale | Standard Deviation 0.64 |
| Cognitive Therapy Group - Men | Impact of Events Scale-Revised - Total Score at 6-months Follow-up | 0.54 units on a scale | Standard Deviation 0.62 |
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.
Time frame: Baseline
Population: Intention to treat analysis although data for participants who died over follow-up were omitted.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Cardiac Care - Men | Impact of Events Scale-Revised - Total Score at Baseline | 0.81 units on a scale | Standard Deviation 0.66 |
| Cognitive Behaviour Therapy - Women | Impact of Events Scale-Revised - Total Score at Baseline | 1.56 units on a scale | Standard Deviation 0.99 |
| Usual Cardiac Care - Women | Impact of Events Scale-Revised - Total Score at Baseline | 1.20 units on a scale | Standard Deviation 0.85 |
| Cognitive Therapy Group - Men | Impact of Events Scale-Revised - Total Score at Baseline | 0.63 units on a scale | Standard Deviation 0.51 |
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.
Time frame: 12-months follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Cardiac Care - Men | Percentage of Participants Who Received ICD Therapies | 30.5 Percentage of participants |
| Cognitive Behaviour Therapy - Women | Percentage of Participants Who Received ICD Therapies | 31.9 Percentage of participants |
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.
Time frame: Twelve-months follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Cardiac Care - Men | SF-36 Mental Component Summary Scale at 12-months Follow-up | 49.92 units on a scale | Standard Deviation 10.5 |
| Cognitive Behaviour Therapy - Women | SF-36 Mental Component Summary Scale at 12-months Follow-up | 46.26 units on a scale | Standard Deviation 14 |
| Usual Cardiac Care - Women | SF-36 Mental Component Summary Scale at 12-months Follow-up | 41.58 units on a scale | Standard Deviation 9.02 |
| Cognitive Therapy Group - Men | SF-36 Mental Component Summary Scale at 12-months Follow-up | 51.61 units on a scale | Standard Deviation 46.26 |
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.
Time frame: Six-months follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Cardiac Care - Men | SF-36 Mental Component Summary Scale at 6-months Follow-up | 48.73 units on a scale | Standard Deviation 10.34 |
| Cognitive Behaviour Therapy - Women | SF-36 Mental Component Summary Scale at 6-months Follow-up | 43.82 units on a scale | Standard Deviation 11.64 |
| Usual Cardiac Care - Women | SF-36 Mental Component Summary Scale at 6-months Follow-up | 45.67 units on a scale | Standard Deviation 10.84 |
| Cognitive Therapy Group - Men | SF-36 Mental Component Summary Scale at 6-months Follow-up | 51.32 units on a scale | Standard Deviation 10.99 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Cardiac Care - Men | SF-36 Mental Component Summary Scale at Baseline | 45.90 units on a scale | Standard Deviation 13.4 |
| Cognitive Behaviour Therapy - Women | SF-36 Mental Component Summary Scale at Baseline | 37.44 units on a scale | Standard Deviation 13.69 |
| Usual Cardiac Care - Women | SF-36 Mental Component Summary Scale at Baseline | 42.33 units on a scale | Standard Deviation 12.43 |
| Cognitive Therapy Group - Men | SF-36 Mental Component Summary Scale at Baseline | 49.84 units on a scale | Standard Deviation 10.56 |
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.
Time frame: Twelve-months follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Cardiac Care - Men | SF-36 Physical Component Summary Score at 12-months Follow-up | 42.65 units on a scale | Standard Deviation 10.33 |
| Cognitive Behaviour Therapy - Women | SF-36 Physical Component Summary Score at 12-months Follow-up | 42.70 units on a scale | Standard Deviation 10.44 |
| Usual Cardiac Care - Women | SF-36 Physical Component Summary Score at 12-months Follow-up | 42.82 units on a scale | Standard Deviation 14.53 |
| Cognitive Therapy Group - Men | SF-36 Physical Component Summary Score at 12-months Follow-up | 41.54 units on a scale | Standard Deviation 11.23 |
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.
Time frame: Six-months follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Cardiac Care - Men | SF-36 Physical Component Summary Score at 6-months Follow-up | 42.54 units on a scale | Standard Deviation 10.58 |
| Cognitive Behaviour Therapy - Women | SF-36 Physical Component Summary Score at 6-months Follow-up | 41.46 units on a scale | Standard Deviation 12.43 |
| Usual Cardiac Care - Women | SF-36 Physical Component Summary Score at 6-months Follow-up | 41.22 units on a scale | Standard Deviation 12.85 |
| Cognitive Therapy Group - Men | SF-36 Physical Component Summary Score at 6-months Follow-up | 42.69 units on a scale | Standard Deviation 10.06 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Cardiac Care - Men | SF-36 Physical Component Summary Score at Baseline | 39.19 units on a scale | Standard Deviation 10.46 |
| Cognitive Behaviour Therapy - Women | SF-36 Physical Component Summary Score at Baseline | 36.13 units on a scale | Standard Deviation 7.06 |
| Usual Cardiac Care - Women | SF-36 Physical Component Summary Score at Baseline | 37.60 units on a scale | Standard Deviation 11.81 |
| Cognitive Therapy Group - Men | SF-36 Physical Component Summary Score at Baseline | 38.85 units on a scale | Standard Deviation 10.15 |