Trial Outcomes & Findings for Telephone Administered Psychotherapy for the Treatment of Depression for Veterans in Rural Areas (NCT NCT00223652)

Results Overview

Evaluators administered the Hamilton Depression Rating Scale(Ham-D). Veterans were assessed at baseline,12 weeks, 20 weeks(posttreatment), and 6-month follow-up using the Ham-D. Self-reported depression was measured using the Hamilton Depression Rating Scale(Ham-D). Data across the three time points (baseline, Week 12, Week 20) were analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome Ham-D. Ham-D ranges from 0-52, higher values indicate more severe depression. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

85 participants

Primary outcome timeframe

Baseline, 12 weeks, 20 weeks

Results posted on

2015-04-24

Participant Flow

Participant milestones

Participant milestones
Measure	Telephone-administered Cognitive-Behavioral Therapy Telephone cognitive behavioral therapy Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains.	Treatment as Usual Treatment as usual control.
T-CBT 12 Weeks, TAU 20 Weeks STARTED	41	44
T-CBT 12 Weeks, TAU 20 Weeks COMPLETED	40	41
T-CBT 12 Weeks, TAU 20 Weeks NOT COMPLETED	1	3
T-CBT 20 Weeks, TAU 20 Weeks STARTED	40	41
T-CBT 20 Weeks, TAU 20 Weeks COMPLETED	40	41
T-CBT 20 Weeks, TAU 20 Weeks NOT COMPLETED	0	0
T-CBT and TAU 6 Month Follow-up STARTED	40	41
T-CBT and TAU 6 Month Follow-up COMPLETED	39	37
T-CBT and TAU 6 Month Follow-up NOT COMPLETED	1	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Telephone Administered Psychotherapy for the Treatment of Depression for Veterans in Rural Areas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Telephone-administered Cognitive-Behavioral Therapy n=41 Participants Telephone cognitive behavioral therapy Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains.	Treatment as Usual n=44 Participants Treatment as usual control.	Total n=85 Participants Total of all reporting groups
Age, Continuous	56.83 years STANDARD_DEVIATION 10.81 • n=5 Participants	54.98 years STANDARD_DEVIATION 10.42 • n=7 Participants	55.9 years STANDARD_DEVIATION 10.59 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	39 Participants n=7 Participants	77 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants	34 Participants n=7 Participants	67 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants	44 participants n=7 Participants	85 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 12 weeks, 20 weeks

Evaluators administered the Hamilton Depression Rating Scale(Ham-D). Veterans were assessed at baseline,12 weeks, 20 weeks(posttreatment), and 6-month follow-up using the Ham-D. Self-reported depression was measured using the Hamilton Depression Rating Scale(Ham-D). Data across the three time points (baseline, Week 12, Week 20) were analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome Ham-D. Ham-D ranges from 0-52, higher values indicate more severe depression. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression.

Outcome measures

Outcome measures
Measure	Telephone-administered Cognitive-Behavioral Therapy n=41 Participants Telephone cognitive behavioral therapy Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains.	Treatment as Usual n=44 Participants Treatment as usual control.
Change in Severity of Depression Using Hamilton Depression Rating Scale Baseline, n = 41, n = 44, respectively	20.83 units on a scale Standard Deviation 3.96	19.23 units on a scale Standard Deviation 3.72
Change in Severity of Depression Using Hamilton Depression Rating Scale Week 12, n = 40, n = 41 respectively	16.71 units on a scale Standard Deviation 6.42	17.27 units on a scale Standard Deviation 5.29
Change in Severity of Depression Using Hamilton Depression Rating Scale Week 20, n = 40, n =41, respectively	15.43 units on a scale Standard Deviation 5.51	17.00 units on a scale Standard Deviation 5.68

PRIMARY outcome

Timeframe: Baseline, Week 12, Week 20

Self-reported depression was measured using the Patient Health Questionnaire-9 (PHQ-9). Data across the three time points (baseline, Week 12, Week 20) were analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome PHQ-9. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression, respectively. PHQ-9 score ranges from 0-27, higher values indicate more severe depression.

Outcome measures

Outcome measures
Measure	Telephone-administered Cognitive-Behavioral Therapy n=41 Participants Telephone cognitive behavioral therapy Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains.	Treatment as Usual n=44 Participants Treatment as usual control.
Change in Severity of Depression Using the Patient Health Questionnaire-9 Baseline, n = 41, n = 44, respectively	17.12 units on a scale Standard Deviation 5.10	17.39 units on a scale Standard Deviation 4.79
Change in Severity of Depression Using the Patient Health Questionnaire-9 Week 12, n = 40, n = 41, respectively	12.19 units on a scale Standard Deviation 5.96	14.35 units on a scale Standard Deviation 6.05
Change in Severity of Depression Using the Patient Health Questionnaire-9 Week 20, n = 40, n = 41, respectively	11.15 units on a scale Standard Deviation 6.46	12.90 units on a scale Standard Deviation 5.28

PRIMARY outcome

Timeframe: Baseline to week 12, and week 20

Veterans meeting criteria for major depressive disorder were randomized to receive 16 session of T-CBT over 20 weeks or treatment as usual through the CBOC. Generalized estimating equations models with exchangeable working correlation structure was used for the binary outcome (MDE). A veteran was required to meet diagnostic criteria for severe psychiatric disorder(e.g., psychotic, bipolar, or dementia disorder; post-traumatic stress disorder \[PTSD\] patients were not excluded). DSM-IV diagnosis was assessed using the full Mini International Neuropsychiatric Interview at baseline, whereas the major depressive episode(MDE) module was administered at follow-up.

Outcome measures

Outcome measures
Measure	Telephone-administered Cognitive-Behavioral Therapy n=41 Participants Telephone cognitive behavioral therapy Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains.	Treatment as Usual n=44 Participants Treatment as usual control.
Number of Participants Meeting Criteria for Major Depressive Disorder number of particpants with MDE at Baseline	41 participants	44 participants
Number of Participants Meeting Criteria for Major Depressive Disorder number of particpants with MDE Week 12	20 participants	29 participants
Number of Participants Meeting Criteria for Major Depressive Disorder number of particpants with MDE Week 20	19 participants	23 participants

SECONDARY outcome

Timeframe: 6 month follow-up (week 44)

Evaluators administered the Hamilton Depression Rating Scale(Ham-D). Veterans were assessed at baseline,12 weeks, 20 weeks(post treatment), and 6-month follow-up using the Ham-D.Data was analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome Ham-D. Ham-D ranges from 0-52, higher values indicate more severe depression. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression.

Outcome measures

Outcome measures
Measure	Telephone-administered Cognitive-Behavioral Therapy n=39 Participants Telephone cognitive behavioral therapy Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains.	Treatment as Usual n=37 Participants Treatment as usual control.
Maintenance of Treatment Effect	13.62 units on a scale Standard Deviation 6.36	14.81 units on a scale Standard Deviation 5.01

SECONDARY outcome

Timeframe: 6-month post treatment follow-up

6-month post treatment follow-up on outcome measure of the Patient Health Questionnaire-9 (PHQ-9). Data was analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome PHQ-9. PHQ-9 score ranges from 0-27, higher values indicate more severe depression. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression, respectively.

Outcome measures

Outcome measures
Measure	Telephone-administered Cognitive-Behavioral Therapy n=39 Participants Telephone cognitive behavioral therapy Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains.	Treatment as Usual n=37 Participants Treatment as usual control.
Maintenance of Treatment Effect	11.25 units on a scale Standard Deviation 6.67	12.26 units on a scale Standard Deviation 5.63

SECONDARY outcome

Timeframe: 6-month follow up at week 44 post treatment

Veterans meeting criteria for major depressive disorder were randomized to receive 16 session of T-CBT over 20 weeks or treatment as usual through the CBOC. Generalized estimating equations models with exchangeable working correlation structure was used for the binary outcome (MDE). A veteran was required to meet diagnostic criteria for severe psychiatric disorder(e.g., psychotic, bipolar, or dementia disorder; post-traumatic stress disorder \[PTSD\] patients were not excluded). DSM-IV diagnosis was assessed using the full Mini International Neuropsychiatric Interview at baseline, whereas the major depressive episode(MDE) module was administered at follow-up.

Outcome measures

Outcome measures
Measure	Telephone-administered Cognitive-Behavioral Therapy n=39 Participants Telephone cognitive behavioral therapy Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains.	Treatment as Usual n=37 Participants Treatment as usual control.
Number of Participants Meeting Criteria for Major Depression Disorder at 6 Month Follow-up	16 participants	18 participants

Adverse Events

Telephone-administered Cognitive-Behavioral Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment as Usual

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

David C. Mohr

Northwestern University

Phone: 312- 503-1403

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place