Behavioral Activation for PTSD/Depression Treatment in OIF/OEF Veterans

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00805532
• Collaborator: (none)
• Enrollment: 81
• Locations: 2
• Arms: 2
• Duration (Months): 50
• Patients Per Site: 40.5
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

The present study is a randomized, controlled trial that compares Behavioral Activation (BA) to Treatment As Usual (TAU) in PTSD Specialty clinics, as early psychotherapeutic interventions for OIF/OEF veterans with posttraumatic stress disorder (PTSD).

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder; Depression	Behavioral: Behavioral Activation treatment; Other: Treatment as Usual	N/A

Detailed Description

A sizable proportion of soldiers involved in the Iraq and Afghanistan conflicts are experiencing mental health and adjustment problems on their return, including posttraumatic stress disorder and depression (Hoge et al., 2004). Both PTSD and depression can be chronic and debilitating disorders, associated with impairments in social, occupational, and physical functioning, as well as high health care utilization (Katon, Unutzer, & Simon, 2004; Stein et al., 2005).

Although empirically supported treatments exist for established PTSD and depression, much less is known about effective early interventions for these conditions. Exploration of early intervention options is necessary, particularly in the case of the new veteran population, as such interventions could address social, occupational and physical impairments before they become too intractable. Also, successful early interventions could curtail high health care utilization dramatically across time. The development of such early interventions for PTSD and depression must also take into account any specifications of accessibility and acceptability that are particular to the OIF/OEF veteran population.

The present study is a randomized, controlled trial that compares Behavioral Activation (BA), to Treatment As Usual (TAU) as early interventions for OIF/OEF veterans with posttraumatic stress disorder (PTSD). Participants will be recruited largely from the primary health care setting (to increase acceptability and accessibility to the veteran population). Both BA and TAU treatment groups will be administered by psychotherapists who specialize in the treatment of PTSD. Both groups will be assessed at pre-, mid- and post-treatment time points to determine change over time, health care utilization and treatment satisfaction. This is a dual-site study that will be carried out at both the Portland VA Medical Center (PVAMC) and the VA Puget Sound Health Care Center (VA PSHCS) and coordinated at the PVAMC.

Study Design

• Study Type: Interventional
• Actual Enrollment: 81 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Behavioral Activation for PTSD, Depression Treatment in OIF/OEF Veterans
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Behavioral Activation Behavioral Activation (BA), modified to be delivered in 6-8, 60 minute sessions to address PTSD-related problems.	Behavioral: Behavioral Activation treatment; Behavioral Activation (BA) is a present-focused psychotherapy based on behavioral theory and principles of change, that aims to re-engage individuals with meaningful and pleasurable life activities by targeting and problem-solving patterns of avoidance. It is well-established as a treatment for depression and has been modified for the current study to address PTSD-related problems.; Other Names: BA
Active Comparator: Treatment as Usual Treatment As Usual for PTSD (TAU) within VA PTSD specialty clinics. Actual clinical practice varies between sites and between providers within sites, as is typical of the VA health care system.	Other: Treatment as Usual; Usual Care for PTSD (UC)-that is provided in the VA PTSD Specialty clinics. Actual clinical practice varies between sites and between providers within sites, as is typical of the VA health care system. Subjects assigned to Usual Care will be permitted to receive medical intervention (i.e., pharmacotherapy) and any additional psychotherapy deemed appropriate by the provider. They will also be offered a minimum of 6 sessions of individual therapy.; Other Names: TAU

Outcome Measures

Primary Outcome Measures

1. Clinician Administered PTSD Scale (CAPS-IV) [Pre-treatment, post-treatment (12 weeks after 1st therapy session), and 3-month follow-up (24 weeks after first therapy session)]

   The CAPS is a clinician-administered scale and is considered the "gold standard" for assessing the presence of PTSD. Items are ranked on Likert scales according to both frequency (0=never to 4=daily or almost every day) and intensity (0=none to 4=extreme) of symptoms, yielding an overall severity score by summing frequency and intensity ratings (range 0 to 136, with higher scores reflecting greater symptomatology). Scale scores corresponding to the 3 subcategories of PTSD symptoms (intrusive symptoms, avoidance symptoms, and hyperarousal symptoms) can be similarly obtained (scores range from 0-40, 0-56, 0-40 for the 3 subscales, respectively). Internal consistency, interrater reliability, and validity of this measure are strong and well-documented.

Secondary Outcome Measures

1. Posttraumatic Stress Disorder Checklist-Military Version (PCL-M) [Pre-treatment, post-treatment (12 weeks after first therapy appointment), 3-month follow-up (24 weeks after first therapy appointment)]

   The PCL-M is a 17 item self-report scale that assesses the presence of DSM-IV PTSD symptoms. Items are rated on a 5-point Likert scale (1= not at all to 5=extremely) according to how much the symptom bothered the respondent over the past month. Scores range from 17-85 with higher scores representing greater symptom severity.

2. Beck Depression Inventory-II (BDI-II) [Pre-treatment, post-treatment (12 weeks after first therapy appointment), 3-month follow-up (24 weeks after first therapy appointment)]

   The Beck Depression Inventory-II (BDI-II) (Beck, Steer, & Brown, 1996) is a 21-item measure of subjective levels of depression. Items are rated on Likert-scales from 0-3 (individual descriptions are provided for each number ranging from the absence of the symptom to the severe manifestation of the symptom). Scores can range from 0-63 with higher scores representing higher levels of depression. This widely used measure of depression is commonly included in outcome studies in order to determine treatment effects on severity of depressive symptoms and has excellent psychometric properties.

3. Sheehan Disability Scale (SDS) [Pre-treatment, post-treatment (12 weeks after first psychotherapy session), 3-month follow-up (24 weeks after first psychotherapy appointment)]

   The Sheehan Disability Scale (SDS) (Sheehan, 2000) is a three item self-rated scale of impairment that is widely used in psychopharmacology studies (allowing comparison with these studies). The items ask the respondent to rate (on a Likert scale of 0-10, unimpaired to highly impaired) to what extent their symptoms interfere with their functioning in the areas of: work, social, and family life; a summary score can be obtained by summing the three items (range 0-30, unimpaired to highly impaired). The scale's reliability and concurrent validity have been demonstrated in individuals with anxiety disorders and depression.

4. Behavioral Activation Scale (BAS) [Pre-treatment, post-treatment (12 weeks after 1st therapy appointment), 3-month follow-up (24 weeks after first therapy appointment)]

   The BAS is a 25-item self-report measure that assesses overall degree of behavioral activation as well as indicators of inactivation across three subscales: avoidance/rumination, work/school impairment, and social impairment. Items are rated on 7-point Likert scales (0=not at all to 6=completely). The total BAS score reflects overall level of activation with high scores reflecting higher activation (range 0 - 150).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Ability to comply with assessment and therapy schedule.

• Ability to comply with study regulations.

• English fluency.

• Must meet diagnostic criteria for PTSD (related to trauma experienced during military service). PTSD will be assessed using the Clinician-Administered PTSD Scale for DSM-IV (CAPS; Blake, Weathers, Nagy, Kaloupek, Charney & Keane, 2003).

Exclusion Criteria:

• Bipolar disorder.

• Psychotic disorders.

• Substance dependence. Because these conditions warrant alternative treatments. Bipolar, psychotic and substance dependence disorders will be assessed using the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I; First, Spitzer, Gibbon & Williams, 2002).

• Report active and imminent suicidal intent. If imminent suicidality is present, this would suggest that a treatment specifically targeting this intent is indicated. Suicidal intent will be assessed using The Brief Assessment for Suicidal Ideation or Behavior that was designed for this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Medical Center, Portland	Portland	Oregon	United States	97201
2	VA Puget Sound Health Care System, Seattle	Seattle	Washington	United States	98108

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Amy W. Wagner, PhD, VA Medical Center, Portland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00805532
• Other Study ID Numbers: MHBA-019-06F; PVAMC ID: 1738; VA PSHCS SUB IRB ID: 33950; Grant #: 08-0306
• First Posted: Dec 9, 2008
• Last Update Posted: Nov 5, 2018
• Last Verified: Apr 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by VA Office of Research and Development: PTSD; depression; behavior therapy; veterans; behavioral activation; usual care
• Additional relevant MeSH terms: Depression; Depressive Disorder; Stress Disorders, Post-Traumatic

Study Results

Participant Flow

Arm/Group Title	Behavioral Activation (BA)	Treatment as Usual (TAU)
Arm/Group Description	Behavioral Activation (BA)-BA is a present-focused, well-established treatment for depression that targets patterns of avoidance and involves the identification and enactment of activities that are reinforcing to the individual and consistent with his/her long-term goals. BA has been modified to address PTSD concerns in addition to depression and to be delivered in 6-8, 60-minute sessions. It was delivered by skilled psychotherapists.	Participants randomized to Treatment as Usual (TAU) were referred for treatment within the PTSD Clinical Teams at the VAPORHCS and PSHCS. In both clinics providers are trained in Prolonged Exposure therapy (PE) and Cognitive Processing Therapy (CPT). Both clinics also offer skills-based "coping skills" treatments for PTSD and pharmacotherapy. Actual treatment received was determined collaboratively between the PTSD Clinic Care provider and veteran and could include any of these treatment options or combinations of treatments.
Period Title: Overall Study
STARTED	42	39
COMPLETED	42	38
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Behavioral Activation (BA)	Treatment as Usual (TAU)	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	42	38	80
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.2 (6.4)	30.0 (7.1)	30.1 (6.7)
Sex: Female, Male (Count of Participants)
Female	3 7.1%	2 5.3%	5 6.3%
Male	39 92.9%	36 94.7%	75 93.8%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	0 0%	1 2.6%	1 1.3%
Asian or Native Hawaiian or Pacific Islander	2 4.8%	2 5.3%	4 5%
Black or African American	2 4.8%	2 5.3%	4 5%
White Not Hispanic	34 81%	28 73.7%	62 77.5%
White Hispanic	1 2.4%	2 5.3%	3 3.8%
Other	3 7.1%	3 7.9%	6 7.5%
Region of Enrollment (participants) [Number]
United States	42 100%	38 100%	80 100%

Outcome Measures

1. Primary Outcome

Title	Clinician Administered PTSD Scale (CAPS-IV)
Description	The CAPS is a clinician-administered scale and is considered the "gold standard" for assessing the presence of PTSD. Items are ranked on Likert scales according to both frequency (0=never to 4=daily or almost every day) and intensity (0=none to 4=extreme) of symptoms, yielding an overall severity score by summing frequency and intensity ratings (range 0 to 136, with higher scores reflecting greater symptomatology). Scale scores corresponding to the 3 subcategories of PTSD symptoms (intrusive symptoms, avoidance symptoms, and hyperarousal symptoms) can be similarly obtained (scores range from 0-40, 0-56, 0-40 for the 3 subscales, respectively). Internal consistency, interrater reliability, and validity of this measure are strong and well-documented.
Time Frame	Pre-treatment, post-treatment (12 weeks after 1st therapy session), and 3-month follow-up (24 weeks after first therapy session)

Outcome Measure Data

Analysis Population Description

OIF/OEF Veterans with PTSD

Arm/Group Title	Behavioral Activation	Treatment as Usual
Arm/Group Description	Behavioral Activation (BA)- modified to be delivered in 6-8, 60 minute sessions in to address PTSD-related problems. Behavioral Activation treatment: Behavioral Activation (BA) is a present-focused psychotherapy based on behavioral theory and principles of change, that aims to re-engage individuals with meaningful and pleasurable life activities by targeting and problem-solving patterns of avoidance. It is well-established as a treatment for depression and has been modified for the current study to address PTSD-related problems.	Treatment As Usual for PTSD (TAU)-that is provided in the VA PTSD Specialty clinics. Actual clinical practice varies between sites and between providers within sites, as is typical of the VA health care system. Subjects assigned to TAU will be permitted to receive medical intervention (i.e., pharmacotherapy) and any additional psychotherapy deemed appropriate by the provider. They will also be offered a minimum of 6 sessions of individual therapy. Treatment as Usual: Usual Care for PTSD (UC)-that is provided in the VA PTSD Specialty clinics. Actual clinical practice varies between sites and between providers within sites, as is typical of the VA health care system. Subjects assigned to Usual Care will be permitted to receive medical intervention (i.e., pharmacotherapy) and any additional psychotherapy deemed appropriate by the provider. They will also be offered a minimum of 6 sessions of individual therapy.
Measure Participants	42	38
Pre Treatment	75.9 (15.2)	82.0 (15.7)
Post Treatment	54.4 (23.0)	70.1 (25.7)
3-Mo Follow-Up	56.25 (25.4)	64.6 (28.3)

2. Secondary Outcome

Title	Posttraumatic Stress Disorder Checklist-Military Version (PCL-M)
Description	The PCL-M is a 17 item self-report scale that assesses the presence of DSM-IV PTSD symptoms. Items are rated on a 5-point Likert scale (1= not at all to 5=extremely) according to how much the symptom bothered the respondent over the past month. Scores range from 17-85 with higher scores representing greater symptom severity.
Time Frame	Pre-treatment, post-treatment (12 weeks after first therapy appointment), 3-month follow-up (24 weeks after first therapy appointment)

Outcome Measure Data

Analysis Population Description

OIF/OEF Veterans with PTSD

Arm/Group Title	Behavioral Activation (BA)	Treatment as Usual (TAU)
Arm/Group Description	Behavioral Activation (BA)-BA is a present-focused, well-established treatment for depression that targets patterns of avoidance and involves the identification and enactment of activities that are reinforcing to the individual and consistent with his/her long-term goals. BA has been modified to address PTSD concerns in addition to depression and to be delivered in 6-8, 60-minute sessions. It was delivered by skilled psychotherapists.	Participants randomized to Treatment as Usual (TAU) were referred for treatment within the PTSD Clinical Teams at the VAPORHCS and PSHCS. In both clinics providers are trained in Prolonged Exposure therapy (PE) and Cognitive Processing Therapy (CPT). Both clinics also offer skills-based "coping skills" treatments for PTSD and pharmacotherapy. Actual treatment received was determined collaboratively between the PTSD Clinic Care provider and veteran and could include any of these treatment options or combinations of treatments.
Measure Participants	42	38
Pre-Treatment	59.0 (7.7)	59.0 (8.1)
Post-Treatment	44.1 (12.0)	52.6 (13.0)
3-Mo Follow-Up	48.0 (13.4)	51.4 (15.1)

3. Secondary Outcome

Title	Beck Depression Inventory-II (BDI-II)
Description	The Beck Depression Inventory-II (BDI-II) (Beck, Steer, & Brown, 1996) is a 21-item measure of subjective levels of depression. Items are rated on Likert-scales from 0-3 (individual descriptions are provided for each number ranging from the absence of the symptom to the severe manifestation of the symptom). Scores can range from 0-63 with higher scores representing higher levels of depression. This widely used measure of depression is commonly included in outcome studies in order to determine treatment effects on severity of depressive symptoms and has excellent psychometric properties.
Time Frame	Pre-treatment, post-treatment (12 weeks after first therapy appointment), 3-month follow-up (24 weeks after first therapy appointment)

Outcome Measure Data

Analysis Population Description

OIF/OEF Veterans with PTSD

Arm/Group Title	Behavioral Activation (BA)	Treatment as Usual (TAU)
Arm/Group Description	Behavioral Activation (BA)-BA is a present-focused, well-established treatment for depression that targets patterns of avoidance and involves the identification and enactment of activities that are reinforcing to the individual and consistent with his/her long-term goals. BA has been modified to address PTSD concerns in addition to depression and to be delivered in 6-8, 60-minute sessions. It was delivered by skilled psychotherapists.	Participants randomized to Treatment as Usual (TAU) were referred for treatment within the PTSD Clinical Teams at the VAPORHCS and PSHCS. In both clinics providers are trained in Prolonged Exposure therapy (PE) and Cognitive Processing Therapy (CPT). Both clinics also offer skills-based "coping skills" treatments for PTSD and pharmacotherapy. Actual treatment received was determined collaboratively between the PTSD Clinic Care provider and veteran and could include any of these treatment options or combinations of treatments.
Measure Participants	42	38
Pre-Treatment	24.8 (7.0)	25.2 (8.2)
Post-Treatment	17.5 (10.4)	23.3 (11.4)
3-Mo Follow-Up	21.0 (10.0)	21.5 (11.8)

4. Secondary Outcome

Title	Sheehan Disability Scale (SDS)
Description	The Sheehan Disability Scale (SDS) (Sheehan, 2000) is a three item self-rated scale of impairment that is widely used in psychopharmacology studies (allowing comparison with these studies). The items ask the respondent to rate (on a Likert scale of 0-10, unimpaired to highly impaired) to what extent their symptoms interfere with their functioning in the areas of: work, social, and family life; a summary score can be obtained by summing the three items (range 0-30, unimpaired to highly impaired). The scale's reliability and concurrent validity have been demonstrated in individuals with anxiety disorders and depression.
Time Frame	Pre-treatment, post-treatment (12 weeks after first psychotherapy session), 3-month follow-up (24 weeks after first psychotherapy appointment)

Outcome Measure Data

Analysis Population Description

OIF/OEF Veterans with PTSD

Arm/Group Title	Behavioral Activation (BA)	Treatment as Usual (TAU)
Arm/Group Description	Behavioral Activation (BA)-BA is a present-focused, well-established treatment for depression that targets patterns of avoidance and involves the identification and enactment of activities that are reinforcing to the individual and consistent with his/her long-term goals. BA has been modified to address PTSD concerns in addition to depression and to be delivered in 6-8, 60-minute sessions. It was delivered by skilled psychotherapists.	Participants randomized to Treatment as Usual (TAU) were referred for treatment within the PTSD Clinical Teams at the VAPORHCS and PSHCS. In both clinics providers are trained in Prolonged Exposure therapy (PE) and Cognitive Processing Therapy (CPT). Both clinics also offer skills-based "coping skills" treatments for PTSD and pharmacotherapy. Actual treatment received was determined collaboratively between the PTSD Clinic Care provider and veteran and could include any of these treatment options or combinations of treatments.
Measure Participants	42	38
Pre-Treatment	19.0 (6.0)	18.0 (5.1)
Post-Treatment	15.0 (6.7)	16.0 (8.9)
3-Mo Follow-Up	15.9 (7.6)	16.1 (8.5)

5. Secondary Outcome

Title	Behavioral Activation Scale (BAS)
Description	The BAS is a 25-item self-report measure that assesses overall degree of behavioral activation as well as indicators of inactivation across three subscales: avoidance/rumination, work/school impairment, and social impairment. Items are rated on 7-point Likert scales (0=not at all to 6=completely). The total BAS score reflects overall level of activation with high scores reflecting higher activation (range 0 - 150).
Time Frame	Pre-treatment, post-treatment (12 weeks after 1st therapy appointment), 3-month follow-up (24 weeks after first therapy appointment)

Outcome Measure Data

Analysis Population Description

OIF/OEF Veterans with PTSD

Arm/Group Title	Behavioral Activation (BA)	Treatment as Usual (TAU)
Arm/Group Description	Behavioral Activation (BA)-BA is a present-focused, well-established treatment for depression that targets patterns of avoidance and involves the identification and enactment of activities that are reinforcing to the individual and consistent with his/her long-term goals. BA has been modified to address PTSD concerns in addition to depression and to be delivered in 6-8, 60-minute sessions. It was delivered by skilled psychotherapists.	Participants randomized to Treatment as Usual (TAU) were referred for treatment within the PTSD Clinical Teams at the VAPORHCS and PSHCS. In both clinics providers are trained in Prolonged Exposure therapy (PE) and Cognitive Processing Therapy (CPT). Both clinics also offer skills-based "coping skills" treatments for PTSD and pharmacotherapy. Actual treatment received was determined collaboratively between the PTSD Clinic Care provider and veteran and could include any of these treatment options or combinations of treatments.
Measure Participants	42	38
Pre-Treatment	76.0 (19.8)	74.2 (17.7)
Post-Treatment	89.5 (24.4)	82.0 (27.9)
3-Mo Follow-Up	79.4 (22.4)	83.8 (27.8)

Adverse Events

Time Frame	24 weeks
Arm/Group Title	Behavioral Activation (BA)		Treatment as Usual (TAU)
Arm/Group Description	Behavioral Activation (BA)-BA is a present-focused, well-established treatment for depression that targets patterns of avoidance and involves the identification and enactment of activities that are reinforcing to the individual and consistent with his/her long-term goals. BA has been modified to address PTSD concerns in addition to depression and to be delivered in 6-8, 60-minute sessions. It was delivered by skilled psychotherapists.		Participants randomized to Treatment as Usual (TAU) were referred for treatment within the PTSD Clinical Teams at the VAPORHCS and PSHCS. In both clinics providers are trained in Prolonged Exposure therapy (PE) and Cognitive Processing Therapy (CPT). Both clinics also offer skills-based "coping skills" treatments for PTSD and pharmacotherapy. Actual treatment received was determined collaboratively between the PTSD Clinic Care provider and veteran and could include any of these treatment options or combinations of treatments.
All Cause Mortality
	Behavioral Activation (BA)		Treatment as Usual (TAU)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/38 (0%)
Serious Adverse Events
	Behavioral Activation (BA)		Treatment as Usual (TAU)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/42 (11.9%)		4/38 (10.5%)
Psychiatric disorders
suicidal ideation with hospitalization	2/42 (4.8%)	2	2/38 (5.3%)	2
Suicidal ideation with no hospitalization	2/42 (4.8%)	2	2/38 (5.3%)	2
psychotic symptoms	1/42 (2.4%)	1	0/38 (0%)	0
discharging firearm	0/42 (0%)	0	1/38 (2.6%)	1
aggression with ER visit	1/42 (2.4%)	1	0/38 (0%)	0
homicidal ideation with crisis line call	0/42 (0%)	0	1/38 (2.6%)	1
Other (Not Including Serious) Adverse Events
	Behavioral Activation (BA)		Treatment as Usual (TAU)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/42 (7.1%)		0/38 (0%)
Psychiatric disorders
very brief suicidal ideation, no hospitalization	2/42 (4.8%)	2	0/38 (0%)	0
Reproductive system and breast disorders
polymenorhea with hospitalization	1/42 (2.4%)	1	0/38 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.