Trial Outcomes & Findings for Transdiagnostic Psychotherapy for Veterans With Mood and Anxiety Disorders (NCT NCT01947647)

NCT ID: NCT01947647

Last Updated: 2019-08-28

Results Overview

The DASS-Depression (Lovibond and Lovibond, 1995) is a 7-item measure designed to assess dysphoric mood. Items are rated on a 4-point Likert scale, ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time), and summed to compute the total scale (range 0-21). Higher scores are indicative of greater symptom severity, with scores greater than 10 typically considered of clinical significance. Support for the factor structure, convergent and discriminant validity, and internal consistency of the DASS has been found in community (Lovibond and Lovibond, 1995).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 105 participants
• Primary outcome timeframe: baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)
• Results posted on: 2019-08-28

Participant Flow

105 participants were consented and completed the intake procedures. However, of the 105 total participants, 12 participants did not met eligibility for the treatment trial and were not randomized to a treatment condition.

Participant milestones

Measure	Transdiagnostic Behavior Therapy Transdiagnostic Behavior Therapy, a 12-week transdiagnostic psychotherapy for symptoms of depression and anxiety.	Behavioral Activation Behavioral Activation, a 12-week psychotherapy for depressive symptoms
Treatment Phase STARTED	46	47
Treatment Phase COMPLETED	29	21
Treatment Phase NOT COMPLETED	17	26
6-month Followup Phase STARTED	29	21
6-month Followup Phase COMPLETED	20	13
6-month Followup Phase NOT COMPLETED	9	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transdiagnostic Psychotherapy for Veterans With Mood and Anxiety Disorders

Baseline characteristics by cohort

Measure	Transdiagnostic Behavior Therapy n=46 Participants Transdiagnostic Behavior Therapy is a 12-week transdiagnostic psychotherapy for symptoms of depression and anxiety	Behavioral Activation n=47 Participants Behavioral Activation is a 12-week psychotherapy for symptoms of depression	Total n=93 Participants Total of all reporting groups
Age, Continuous	43.46 years STANDARD_DEVIATION 11.55 • n=5 Participants	42.60 years STANDARD_DEVIATION 12.91 • n=7 Participants	43.02 years STANDARD_DEVIATION 12.20 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	34 Participants n=7 Participants	71 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 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	25 Participants n=5 Participants	16 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	27 Participants n=7 Participants	44 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	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
DASS-Depression	10.30 units on a scale STANDARD_DEVIATION 6.11 • n=5 Participants	10.54 units on a scale STANDARD_DEVIATION 4.71 • n=7 Participants	10.42 units on a scale STANDARD_DEVIATION 5.41 • n=5 Participants
DASS-Anxiety	8.19 units on a scale STANDARD_DEVIATION 5.95 • n=5 Participants	6.57 units on a scale STANDARD_DEVIATION 4.59 • n=7 Participants	7.37 units on a scale STANDARD_DEVIATION 5.34 • n=5 Participants
DASS-Stress	11.27 units on a scale STANDARD_DEVIATION 5.27 • n=5 Participants	10.41 units on a scale STANDARD_DEVIATION 5.03 • n=7 Participants	10.84 units on a scale STANDARD_DEVIATION 5.14 • n=5 Participants
STICSA-Cognitive	25.62 units on a scale STANDARD_DEVIATION 7.58 • n=5 Participants	23.56 units on a scale STANDARD_DEVIATION 5.95 • n=7 Participants	24.57 units on a scale STANDARD_DEVIATION 6.84 • n=5 Participants
STICSA-Somatic	21.05 units on a scale STANDARD_DEVIATION 7.20 • n=5 Participants	19.18 units on a scale STANDARD_DEVIATION 5.55 • n=7 Participants	20.09 units on a scale STANDARD_DEVIATION 6.44 • n=5 Participants
IIRS	51.92 units on a scale STANDARD_DEVIATION 17.55 • n=5 Participants	52.47 units on a scale STANDARD_DEVIATION 16.64 • n=7 Participants	52.19 units on a scale STANDARD_DEVIATION 17.00 • n=5 Participants

PRIMARY outcome

Timeframe: baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)

Population: 43 participants dropped out of treatment

The DASS-Depression (Lovibond and Lovibond, 1995) is a 7-item measure designed to assess dysphoric mood. Items are rated on a 4-point Likert scale, ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time), and summed to compute the total scale (range 0-21). Higher scores are indicative of greater symptom severity, with scores greater than 10 typically considered of clinical significance. Support for the factor structure, convergent and discriminant validity, and internal consistency of the DASS has been found in community (Lovibond and Lovibond, 1995).

Outcome measures

Measure	Transdiagnostic Behavior Therapy n=29 Participants Transdiagnostic Behavior Therapy is a 12-week transdiagnostic psychotherapy for symptoms of depression and anxiety	Behavioral Activation n=21 Participants Behavioral Activation is a 12-week psychotherapy for symptoms of depression
DASS-Depression post-treatment	3.93 score on a scale Standard Deviation 4.83	5.91 score on a scale Standard Deviation 4.95
DASS-Depression follow-up	4.51 score on a scale Standard Deviation 5.10	6.01 score on a scale Standard Deviation 5.36

PRIMARY outcome

Timeframe: baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)

Population: 43 participants dropped out of treatment

The DASS-Anxiety (Lovibond and Lovibond, 1995) is a 7-item measure designed to assess symptoms of fear and autonomic arousal. Items are rated on a 4-point scale, ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time), and summed to compute the total scale (range 0-21). Higher scores are indicative of greater symptom severity, with scores greater than 10 typically considered of clinical significance. Support for the factor structure, convergent and discriminant validity, and internal consistency has been found in community (Lovibond and Lovibond, 1995).

Outcome measures

Measure	Transdiagnostic Behavior Therapy n=29 Participants Transdiagnostic Behavior Therapy is a 12-week transdiagnostic psychotherapy for symptoms of depression and anxiety	Behavioral Activation n=21 Participants Behavioral Activation is a 12-week psychotherapy for symptoms of depression
DASS-Anxiety post-treatment	4.05 score on a scale Standard Deviation 4.61	3.86 score on a scale Standard Deviation 3.73
DASS-Anxiety follow-up	4.14 score on a scale Standard Deviation 4.22	4.15 score on a scale Standard Deviation 2.82

PRIMARY outcome

Timeframe: baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)

Population: 43 participants dropped out of treatment

The DASS-Stress (Lovibond and Lovibond, 1995) is a 7-item measure designed to assess symptoms of tension and agitation. Items are rated on a 4-point Likert scale, ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time), and summed to compute the total scale (range 0-21). Higher scores are indicative of greater symptom severity, with scores greater than 10 typically considered of clinical significance. Support for the factor structure, convergent and discriminant validity, and internal consistency has been found in community (Lovibond and Lovibond, 1995).

Outcome measures

Measure	Transdiagnostic Behavior Therapy n=29 Participants Transdiagnostic Behavior Therapy is a 12-week transdiagnostic psychotherapy for symptoms of depression and anxiety	Behavioral Activation n=21 Participants Behavioral Activation is a 12-week psychotherapy for symptoms of depression
DASS-Stress post-treatment	5.94 score on a scale Standard Deviation 5.26	5.00 score on a scale Standard Deviation 4.25
DASS-Stress follow-up	6.29 score on a scale Standard Deviation 5.82	5.93 score on a scale Standard Deviation 4.09

PRIMARY outcome

Timeframe: baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)

Population: 43 participants dropped out of treatment

The STICSA-Cognitive (Ree et al., 2008) is a 11-item measure designed to assess trait cognitive anxiety. Items are rated on a 4-point scale, ranging from 1 (not at all) to 4 (very much so), with a total score range of 11-44. Higher scores are indicative of greater symptom severity, with scores above 23 considered of clinical significance. The cognitive scale have been supported by factor analysis and has been found to have high internal consistency (alphas > .87; Gros et al., 2007; 2010).

Outcome measures

Measure	Transdiagnostic Behavior Therapy n=29 Participants Transdiagnostic Behavior Therapy is a 12-week transdiagnostic psychotherapy for symptoms of depression and anxiety	Behavioral Activation n=21 Participants Behavioral Activation is a 12-week psychotherapy for symptoms of depression
STICSA-Cognitive post-treatment	18.10 score on a scale Standard Deviation 8.12	16.90 score on a scale Standard Deviation 5.26
STICSA-Cognitive follow-up	18.05 score on a scale Standard Deviation 8.59	17.85 score on a scale Standard Deviation 6.20

PRIMARY outcome

Timeframe: baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)

Population: 43 participants dropped out of treatment

The STICSA-Somatic (Ree et al., 2008) is a 10-item measure designed to assess trait somatic anxiety. Items are rated on a 4-point scale, ranging from 1 (not at all) to 4 (very much so), with a total score range of 10-40. Higher scores indicative of greater symptom severity, with scores above 18 considered of clinical significance. The somatic scale have been supported by factor analysis and has been found to have high internal consistency (alphas > .87; Gros et al., 2007; 2010).

Outcome measures

Measure	Transdiagnostic Behavior Therapy n=29 Participants Transdiagnostic Behavior Therapy is a 12-week transdiagnostic psychotherapy for symptoms of depression and anxiety	Behavioral Activation n=21 Participants Behavioral Activation is a 12-week psychotherapy for symptoms of depression
STICSA-Somatic post-treatment	16.57 score on a scale Standard Deviation 6.90	16 score on a scale Standard Deviation 4.59
STICSA-Somatic follow-up	16.81 score on a scale Standard Deviation 5.61	16.96 score on a scale Standard Deviation 4.17

PRIMARY outcome

Timeframe: baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)

Population: Patient assigned to psychotherapy triage appointment within the MHC CBT Clinic.

The IIRS (Devin et al., 1983) is a 13-item scale that assesses the extent to which a disease interferes with important domains of life. Each item is rated on a 7-point Likert scale, ranging from 1 (not very much) to 7 (very much), with a total score range of 13-91. Although norms are not available for all diagnoses given the transdiagnostic nature of the IIRS, higher scores are indicative of greater impairment. The IIRS has strong psychometric properties in the previous literature in participants with physical and/or emotional health concerns (Devins et al., 2001; Devins, 2010).

Outcome measures

Measure	Transdiagnostic Behavior Therapy n=29 Participants Transdiagnostic Behavior Therapy is a 12-week transdiagnostic psychotherapy for symptoms of depression and anxiety	Behavioral Activation n=21 Participants Behavioral Activation is a 12-week psychotherapy for symptoms of depression
IIRS post-treatment	33.13 score on a scale Standard Deviation 21.31	33.84 score on a scale Standard Deviation 18.08
IIRS follow-up	32.85 score on a scale Standard Deviation 20.41	29.77 score on a scale Standard Deviation 11.50

Adverse Events

Transdiagnostic Behavior Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Behavioral Activation

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

Daniel Gros, PHD

Ralph H. Johnson VAMC

Phone: 843-789-7311

Email: daniel.gros@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place