Trial Outcomes & Findings for Improving Quality of Life for Veterans Undergoing Interferon Treatment (NCT NCT00117559)

Results Overview

Beck Depression Inventory - measures depression. Range for Total score = 0 to 63 Higher scores are indicative of increased depression The Beck Depression Inventory (BDI; Beck \& Steer, 1988) is a widely used 21-item self-report instrument designed to assess depressive mood and symptoms. Each item is rated on a 4-point scale ranging from 0 to 3, with higher scores reflecting greater severity of depressive symptoms for the past two weeks. A sample item is "I do not feel sad." The BDI has demonstrated reliability (split-half reliability coefficient of .93) and validity (correlations with clinician ratings of depression range from .62 to .75; Beck, Steer, \& Garbing, 1988). Cronbach's alpha was high for the present sample at both time points (a = .91 and .90).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

19 participants

Primary outcome timeframe

8 weeks

Results posted on

2014-12-11

Participant Flow

Participant milestones

Participant milestones
Measure	TEL-CBT Telehealth, problem solving based treatment Telehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks	Treatment as Usual Control group
Overall Study STARTED	9	10
Overall Study COMPLETED	8	9
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Quality of Life for Veterans Undergoing Interferon Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TEL-CBT n=9 Participants Telehealth, problem solving based treatment Telehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks	Treatment as Usual n=10 Participants Control group	Total n=19 Participants Total of all reporting groups
Age, Continuous	53.78 years STANDARD_DEVIATION 4.35 • n=5 Participants	54.50 years STANDARD_DEVIATION 6.38 • n=7 Participants	54.16 years STANDARD_DEVIATION 5.38 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	10 participants n=7 Participants	19 participants n=5 Participants
BDI	12.93 units on a scale STANDARD_DEVIATION 8.17 • n=5 Participants	12.29 units on a scale STANDARD_DEVIATION 10.10 • n=7 Participants	12.61 units on a scale STANDARD_DEVIATION 9.14 • n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Beck Depression Inventory - measures depression. Range for Total score = 0 to 63 Higher scores are indicative of increased depression The Beck Depression Inventory (BDI; Beck \& Steer, 1988) is a widely used 21-item self-report instrument designed to assess depressive mood and symptoms. Each item is rated on a 4-point scale ranging from 0 to 3, with higher scores reflecting greater severity of depressive symptoms for the past two weeks. A sample item is "I do not feel sad." The BDI has demonstrated reliability (split-half reliability coefficient of .93) and validity (correlations with clinician ratings of depression range from .62 to .75; Beck, Steer, \& Garbing, 1988). Cronbach's alpha was high for the present sample at both time points (a = .91 and .90).

Outcome measures

Outcome measures
Measure	TEL-CBT n=8 Participants Telehealth, problem solving based treatment Telehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks	Treatment as Usual n=9 Participants Control group
BDI Pre-Treatment	12.93 units on a scale Standard Deviation 8.17	12.29 units on a scale Standard Deviation 10.10
BDI Post-Treatment	10.45 units on a scale Standard Deviation 6.03	16.67 units on a scale Standard Deviation 9.80

Adverse Events

TEL-CBT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment as Ususal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amy Silberbogen, Ph.D.

VA Boston Healthcare System

Phone: 857-364-4797

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place