Trial Outcomes & Findings for Telephone-Delivered Cognitive Behavior Therapy for Chronic Pain (NCT NCT00371267)

NCT ID: NCT00371267

Last Updated: 2014-11-06

Results Overview

Level of physical functioning in daily living, health-related quality of life Range: 0-100; higher score = higher functioning Score: Sum of weighted subscale scores

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

101 participants

Primary outcome timeframe

46 weeks

Results posted on

2014-11-06

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1 Telephone-delivered cognitive behavior therapy for pain management Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management	Arm 2 Telephone-delivered patient education regarding management of chronic pain Pain Education: Telephone-delivered education regarding chronic pain
Overall Study STARTED	48	50
Overall Study COMPLETED	39	32
Overall Study NOT COMPLETED	9	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Telephone-Delivered Cognitive Behavior Therapy for Chronic Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 n=48 Participants Telephone-delivered cognitive behavior therapy for pain management Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management	Arm 2 n=50 Participants Telephone-delivered patient education regarding management of chronic pain Pain Education: Telephone-delivered education regarding chronic pain	Total n=98 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 9 • n=93 Participants	69 years STANDARD_DEVIATION 10 • n=4 Participants	67.5 years STANDARD_DEVIATION 9.5 • n=27 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Sex: Female, Male Male	46 Participants n=93 Participants	48 Participants n=4 Participants	94 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=93 Participants	49 Participants n=4 Participants	96 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: 46 weeks

Population: Veterans with chronic pain

Level of physical functioning in daily living, health-related quality of life Range: 0-100; higher score = higher functioning Score: Sum of weighted subscale scores

Outcome measures

Outcome measures
Measure	Arm 1: Telephone CBT n=48 Participants Telephone-delivered cognitive behavior therapy for pain management Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management	Arm 2: Telephone Patient Education n=50 Participants Telephone-delivered patient education regarding management of chronic pain Pain Education: Telephone-delivered education regarding chronic pain
Short Form-12 Physical Health	44 units on a scale Standard Deviation 9	41 units on a scale Standard Deviation 9

PRIMARY outcome

Timeframe: 46 weeks

Population: Veterans with chronic pain

Daily functioning, quality of life Range: 0-100; higher scores = higher level of functioning Score: sum of weighted subscale scores

Outcome measures

Outcome measures
Measure	Arm 1: Telephone CBT n=48 Participants Telephone-delivered cognitive behavior therapy for pain management Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management	Arm 2: Telephone Patient Education n=50 Participants Telephone-delivered patient education regarding management of chronic pain Pain Education: Telephone-delivered education regarding chronic pain
Short Form-12 Mental Health	45 units on a scale Standard Deviation 9	46 units on a scale Standard Deviation 10

SECONDARY outcome

Timeframe: 46 weeks

Population: Veterans with chronic pain

Measure of symptoms of depression indicating severity of depression Total Score = sum of item scores Range: 0-63; higher scores = greater severity of depression

Outcome measures

Outcome measures
Measure	Arm 1: Telephone CBT n=48 Participants Telephone-delivered cognitive behavior therapy for pain management Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management	Arm 2: Telephone Patient Education n=50 Participants Telephone-delivered patient education regarding management of chronic pain Pain Education: Telephone-delivered education regarding chronic pain
Beck Depression Inventory (BDI)-2 Total Score	16 units on a scale Standard Deviation 11	17 units on a scale Standard Deviation 10

SECONDARY outcome

Timeframe: 46 weeks

Population: Veterans with chronic pain

Assessment of behavioral expression of pain Total Score = mean of item scores Range: 0-6; higher = more pain behavior

Outcome measures

Outcome measures
Measure	Arm 1: Telephone CBT n=48 Participants Telephone-delivered cognitive behavior therapy for pain management Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management	Arm 2: Telephone Patient Education n=50 Participants Telephone-delivered patient education regarding management of chronic pain Pain Education: Telephone-delivered education regarding chronic pain
Pain Behavior Checklist Total Score	2.3 units on a scale Standard Deviation 1.3	2.4 units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 46 weeks

Population: Veterans with chronic pain

Measure of rated pain intensity Score = mean Range: 0-5; higher scores = more intense pain

Outcome measures

Outcome measures
Measure	Arm 1: Telephone CBT n=48 Participants Telephone-delivered cognitive behavior therapy for pain management Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management	Arm 2: Telephone Patient Education n=50 Participants Telephone-delivered patient education regarding management of chronic pain Pain Education: Telephone-delivered education regarding chronic pain
Pain Intensity Rating	3.6 units on a scale Standard Deviation 1.3	3.4 units on a scale Standard Deviation 1.3

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2

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

Timothy P. Carmody, Ph.D.

San Francisco VA Medical Center

Phone: 415-221-4810

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place