Trial Outcomes & Findings for Telephone Psychotherapy for Late-Life Generalized Anxiety Disorder (GAD) (NCT NCT01259596)
NCT ID: NCT01259596
Last Updated: 2018-08-29
Results Overview
self-reported severity and frequency of worry the scores range from 8 to 40, with higher scores representing higher severity of worry. Higher scores represent worse outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
141 participants
Primary outcome timeframe
baseline to week 13
Results posted on
2018-08-29
Participant Flow
Participant milestones
| Measure |
Cognitive-behavioral Therapy
Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention
psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
|
Nondirective Supportive Therapy
Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings
psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
71
|
|
Overall Study
COMPLETED
|
66
|
65
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Telephone Psychotherapy for Late-Life Generalized Anxiety Disorder (GAD)
Baseline characteristics by cohort
| Measure |
Cognitive-behavioral Therapy
n=70 Participants
Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention
psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
|
Nondirective Supportive Therapy
n=71 Participants
Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings
psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
29 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
70 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=5 Participants
|
71 participants
n=7 Participants
|
141 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to week 13self-reported severity and frequency of worry the scores range from 8 to 40, with higher scores representing higher severity of worry. Higher scores represent worse outcome.
Outcome measures
| Measure |
Cognitive-behavioral Therapy
n=65 Participants
Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention
psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
|
Nondirective Supportive Therapy
n=64 Participants
Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings
psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
|
|---|---|---|
|
Changes From Baseline in Penn State Worry Questionnaire (PSWQ-A) at Week 13
|
-9.44 units on a scale
Interval -11.02 to -7.86
|
-5.37 units on a scale
Interval -6.89 to -3.85
|
PRIMARY outcome
Timeframe: baseline to week 13interviewer-rated severity of anxiety symptoms; the scores range from 0 to 56, with higher scores representing higher severity of anxiety. Higher scores represent worse outcome.
Outcome measures
| Measure |
Cognitive-behavioral Therapy
n=64 Participants
Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention
psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
|
Nondirective Supportive Therapy
n=64 Participants
Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings
psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
|
|---|---|---|
|
Changes From Baseline in Hamilton Anxiety Rating Scale (HAM-A) at Week 13
|
-7.04 units on a scale
Interval -8.88 to -5.21
|
-5.53 units on a scale
Interval -7.28 to -3.77
|
SECONDARY outcome
Timeframe: baseline to week 13self report measure of depressive symptoms; scores range from 0 to 63, with a higher score representing higher levels of depressive symptoms Higher scores represent worse outcome.
Outcome measures
| Measure |
Cognitive-behavioral Therapy
n=64 Participants
Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention
psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
|
Nondirective Supportive Therapy
n=64 Participants
Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings
psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
|
|---|---|---|
|
Changes From Baseline in Beck Depression Inventory (BDI) at 13 Weeks
|
-10.77 units on a scale
Interval -12.73 to -8.81
|
-7.54 units on a scale
Interval -9.44 to -5.64
|
SECONDARY outcome
Timeframe: week 13self report measure of perceived difficulties with mobility and performing basic and advanced activities of daily living; the scale consists of 19 items; scores range from 19 to 114, with higher scores indicating more disability. Higher scores represent worse outcome.
Outcome measures
| Measure |
Cognitive-behavioral Therapy
n=65 Participants
Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention
psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
|
Nondirective Supportive Therapy
n=64 Participants
Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings
psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
|
|---|---|---|
|
Pepper Center Tool for Disability (PCT-D)
|
1.71 units on a scale
Interval 1.55 to 1.87
|
1.86 units on a scale
Interval 1.7 to 2.01
|
SECONDARY outcome
Timeframe: week 13physical and emotional health related quality of life; The SF-36 is a self-report measure of health-related quality of life (HRQL) consisting of 36 items that form 8 subscales: physical functioning, role limitations due to physical health problems, role limitations due to emotional health problems, social functioning, freedom from pain, energy, emotional well-being, and general health perceptions. These 8 subscales are also combined into two domains: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). All of these scales range from 0 (maximum impairment) to 100 (no impairment). A lower score represents worse outcome.
Outcome measures
| Measure |
Cognitive-behavioral Therapy
n=65 Participants
Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention
psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
|
Nondirective Supportive Therapy
n=64 Participants
Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings
psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
|
|---|---|---|
|
Short Form (36) Health Survey (SF-36) to Week 13
|
60.5 units on a scale
Interval 55.9 to 65.1
|
53.5 units on a scale
Interval 49.1 to 57.9
|
SECONDARY outcome
Timeframe: week 13self-report symptoms of insomnia; scores range from 0 to 28 with higher scores indicating greater symptoms of sleep disturbance; higher score represents worse outcomes
Outcome measures
| Measure |
Cognitive-behavioral Therapy
n=65 Participants
Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention
psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
|
Nondirective Supportive Therapy
n=64 Participants
Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings
psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
|
|---|---|---|
|
Insomnia Severity Index (ISI)
|
8.70 units on a scale
Interval 7.1 to 10.3
|
11.9 units on a scale
Interval 10.4 to 13.4
|
SECONDARY outcome
Timeframe: baseline to week 13Diagnostic and Statistical Manual of Mental Disorders, IV edition (DSM-IV0) symptoms of Generalized Anxiety Disorder; scores range from 0 to 24 with higher scores indicating greater symptoms of GAD; higher score represents worse outcome
Outcome measures
| Measure |
Cognitive-behavioral Therapy
n=65 Participants
Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention
psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
|
Nondirective Supportive Therapy
n=64 Participants
Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings
psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
|
|---|---|---|
|
Changes From Baseline in Generalized Anxiety Disorder-7 (GAD-7) to Week 13
|
-5.63 units on a scale
Interval -6.82 to -4.44
|
-3.27 units on a scale
Interval -4.4 to -2.14
|
Adverse Events
Cognitive-behavioral Therapy
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Nondirective Supportive Therapy
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cognitive-behavioral Therapy
n=70 participants at risk
Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention
psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
|
Nondirective Supportive Therapy
n=71 participants at risk
Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings
psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
|
|---|---|---|
|
Psychiatric disorders
serious adverse event
|
0.00%
0/70
|
0.00%
0/71
|
Other adverse events
| Measure |
Cognitive-behavioral Therapy
n=70 participants at risk
Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention
psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
|
Nondirective Supportive Therapy
n=71 participants at risk
Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings
psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
|
|---|---|---|
|
Psychiatric disorders
adverse event
|
5.7%
4/70 • Number of events 4
|
5.6%
4/71 • Number of events 4
|
Additional Information
Gretchen A. Brenes, Ph.D.
Wake Forest School of Medicine
Phone: 336-716-4551
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place