Anxiety, Depression, Distress, Postconcussive Symptoms
Conditions
Keywords
OEF/OIF, Veterans, Psychotherapy
Brief summary
This trial compares two psychotherapies, Acceptance and Commitment Therapy (ACT) and Present Centered Therapy (PCT), for veterans of the conflicts in Iraq and Afghanistan. We hypothesize that ACT will be more effective than PCT at reducing emotional distress and improving functioning. We further hypothesize that both interventions will be highly acceptable to participants.
Detailed description
The proposed study is a randomized controlled trial (RCT) of Acceptance and Commitment Therapy (ACT) as compared to a control psychotherapy, Present Centered Therapy (PCT), for individuals with distress and impairment who deployed as part of Operation Enduring Freedom and/or Operation Iraqi Freedom (OEF/OIF). ACT was selected for study because it has a number of advantages for this population. It is not tied to any particular symptom constellation, so it can be applied to a variety of presenting concerns (Hayes, Luoma, et al., 2006; Öst, 2008, Powers et al., 2009), resulting in reduced training burden for clinicians and less need for applying sequential treatments to address co-morbidities. ACT has good face validity (i.e., it makes sense) and conveys a compelling message to young Service Members and Veterans. ACT asks individuals to move forward in accordance with one's values regardless of limitations rather than struggling against those limitations. ACT appears to be acceptable to patients (mean attrition of 15.4% in 13 RCTs (Öst, 2008). ACT is being widely disseminated without adequate evidence of its effectiveness for this important population.
Interventions
BEHAVIORALAcceptance and Commitment Therapy
Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
BEHAVIORALPresent Centered Therapy
Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
Sponsors
Veterans Medical Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Previous deployment to OEF or OIF * Current distress and impairment \[at least one Diagnostic and Statistical Manual version IV (DSM-IV) anxiety or depressive disorder as determined by the Mini International Neuropsychiatric Interview (MINI) or post-concussive symptoms (PCS) as determined by a positive traumatic brain injury (TBI) screen with a score of 25 or greater on the Rivermead with distress or impairment related to PCS\]. * Capable of giving informed consent.
Exclusion criteria
* Cognitive impairment that would interfere with treatment. Potential participants will be excluded if they screen positive for more than mild cognitive impairment on the Montreal Cognitive Assessment (MoCA; excluded if score \< 26). * Severe psychopathology (psychosis, bipolar illness, urgent suicidality or self-injurious behavior) or untreated substance dependence in the past month. * Anticipated change in pharmacologic intervention. Patients may stay on their current medications during the study but will be asked to refrain from beginning or altering medication use during the study to the extent possible. * Other psychotherapy focusing on the same target symptoms. Patients may attend self-help groups or treatment for other types of problems (e.g., couples counseling) but not other treatment for the same presenting problems. * Anticipated deployment or other circumstance that would interfere with completion of all study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Symptom Inventory 18 (BSI-18) | Baseline and week 12 | To determine if receiving ACT, as compared to PCT, is associated with reduced distress as measured by the BSI-18 General Symptom Index (GSI) at the end of treatment. The BSI-18 GSI summarizes a respondent's overall level of distress. The score used in a normatively based T-score (range 1-100) calculated from the sum of responses. Higher scores are indicative of greater distress. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sheehan Disability Inventory | Baseline and week 12 | To determine if receiving ACT, as compared to PCT, is associated with reduced functional impairment at the end of treatment. The score used is an average (range 0-10) of completed items, with higher scores indicating greater disability. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Acceptance and Commitment Therapy Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed). | 80 |
| Present Centered Therapy Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed). | 80 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 38 | 29 |
Baseline characteristics
| Characteristic | Present Centered Therapy | Total | Acceptance and Commitment Therapy |
|---|---|---|---|
| Age, Continuous | 34.0 years STANDARD_DEVIATION 8.1 | 34.2 years STANDARD_DEVIATION 8 | 34.5 years STANDARD_DEVIATION 7.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 21 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 65 Participants | 135 Participants | 70 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 18 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 13 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 60 Participants | 120 Participants | 60 Participants |
| Sex: Female, Male Female | 17 Participants | 32 Participants | 15 Participants |
| Sex: Female, Male Male | 63 Participants | 128 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 80 | 0 / 80 |
| serious Total, serious adverse events | 1 / 80 | 3 / 80 |
Outcome results
Primary
Brief Symptom Inventory 18 (BSI-18)
To determine if receiving ACT, as compared to PCT, is associated with reduced distress as measured by the BSI-18 General Symptom Index (GSI) at the end of treatment. The BSI-18 GSI summarizes a respondent's overall level of distress. The score used in a normatively based T-score (range 1-100) calculated from the sum of responses. Higher scores are indicative of greater distress.
Time frame: Baseline and week 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acceptance and Commitment Therapy | Brief Symptom Inventory 18 (BSI-18) | Baseline | 73.3 T-score | Standard Deviation 8.3 |
| Acceptance and Commitment Therapy | Brief Symptom Inventory 18 (BSI-18) | Post-treatment | 65.0 T-score | Standard Deviation 13.1 |
| Present Centered Therapy | Brief Symptom Inventory 18 (BSI-18) | Baseline | 74.0 T-score | Standard Deviation 7.7 |
| Present Centered Therapy | Brief Symptom Inventory 18 (BSI-18) | Post-treatment | 66.8 T-score | Standard Deviation 10.4 |
p-value: 0.912MMRM
Secondary
Sheehan Disability Inventory
To determine if receiving ACT, as compared to PCT, is associated with reduced functional impairment at the end of treatment. The score used is an average (range 0-10) of completed items, with higher scores indicating greater disability.
Time frame: Baseline and week 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acceptance and Commitment Therapy | Sheehan Disability Inventory | Baseline | 6.7 units on a scale | Standard Deviation 2 |
| Acceptance and Commitment Therapy | Sheehan Disability Inventory | Post-treatment | 4.9 units on a scale | Standard Deviation 2.4 |
| Present Centered Therapy | Sheehan Disability Inventory | Baseline | 6.4 units on a scale | Standard Deviation 1.9 |
| Present Centered Therapy | Sheehan Disability Inventory | Post-treatment | 5.3 units on a scale | Standard Deviation 2.2 |
p-value: 0.273MMRM