Psychological Support for Patients With an Implantable Cardioverter Defibrillator

NCT00152763 | Completed Phase 3 Results

• 2 other identifiers: NA 5170Grant number NA 5170
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 1

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. 1.to evaluate a 8-session psychosocial intervention to help patients cope effectively with receiving an ICD for secondary prevention of SCD,
2. 2.to determine if baseline measures of depression and anxiety predict ICD therapies (i.e., anti-tachycardia pace terminations and shocks); and
3. 3.to explore if the psychosocial intervention results in less need for appropriate ICD therapies.

Conditions

Anxiety; Depression

Keywords

health anxiety

Outcome Measures

Primary Outcomes (21)

• 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.

  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

Secondary Outcomes (7)

• SF-36 Mental Component Summary Scale at Baseline

  Baseline

• SF-36 Mental Component Summary Scale at 6-months Follow-up

  Six-months follow-up

• SF-36 Mental Component Summary Scale at 12-months Follow-up

  Twelve-months follow-up

• SF-36 Physical Component Summary Score at Baseline

  Baseline

• SF-36 Physical Component Summary Score at 6-months Follow-up

  Six-months follow-up

Study Arms (4)

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.

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.

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.

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.

Other: Usual Cardiac Care (UCC)

Interventions

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.

Cognitive Behavior Therapy - females; Cognitive Behavior Therapy - males

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.

Usual Cardiac Care - Males; Usual Cardiac Care - females

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (3)

• 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.

  BACKGROUND

• 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.

  PMID: 27415850 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.

  PMID: 21321256 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Jane Irvine
• Organization: University Health Network, Toronto General Hospital

jirvine@yorku.ca

(416) 736-5115

Study Officials

• Jane Irvine, D.Phil.

  University Health Network, Toronto General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 9, 2005
• Study Start: October 1, 2003
• Primary Completion: September 1, 2007
• Study Completion: November 1, 2007
• Last Updated: January 28, 2011
• Results First Posted: January 28, 2011

Record last verified: 2011-01

Locations

CA (1)