SuicideNCT02751983
ACT for Life: a Brief Intervention for Maximizing Recovery After Suicidal Crises
A study testing ACT for Life and Treatment as usual in people with Suicide and Psychiatric Rehabilitation, run by VA Office of Research and Development at 1 site in United States.
Trial summary
An estimated 20 Veterans kill themselves every day. Suicide prevention literature and public health policy both call for treatment targeting high-risk populations, such as Veterans hospitalized due to suicidal intent and/or attempts. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Suicide, Psychiatric Rehabilitation
- What is being tested?
- ACT for Life and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2016to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible for Veterans Health Administration care
- Age 18-89
- Currently hospitalized due to suicide risk
- Willing to be randomized and participate in the two conditions
Who cannot join
- Inability to provide informed consent
- Inability to complete study measures, e.g.:
- due to significant acute intoxication/withdrawal symptoms
- mania
- psychosis
- aggression
Show all 10Show fewer
- catatonia
- cognitive impairment
- membership in vulnerable population, e.g.:
- prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045
About this study
An estimated 20 Veterans kill themselves every day. Suicide prevention literature and public health policy both call for treatment targeting high-risk populations, such as Veterans hospitalized due to suicidal intent and/or attempts. Psychiatric hospitalization is a critical opportunity to provide treatment to reduce the risk of suicide and lay the groundwork for functional recovery. Yet, there are no interventions specifically for suicide prevention that meet Veterans Health Affairs' quality recommendations requiring the provision of evidence-based, recovery-oriented psychotherapy, which are also feasible to use during a typical inpatient stay. The proposed study seeks to take a first step toward filling this gap. In consultation with experts in the field, the authors have developed a protocol applying a recovery-oriented, evidence-based treatment approach to Veteran inpatient care. The proposed pilot study will provide critical information to inform final revisions of the treatment manual and research design for a future study evaluating the efficacy of the intervention.
Read the detailed description
Psychiatric hospitalization presents a critical opportunity for delivering targeted treatment to reduce suicide risk and promote functional recovery. Yet, there are no suicide-specific empirically-supported interventions that can be feasibly delivered during a typical Veterans Health Affairs (VHA) inpatient stay. Although VHA now requires the provision of evidence-based, recovery-oriented inpatient psychotherapy, extant empirically-supported interventions for patients at high risk of suicide were developed for use in outpatient settings and are too time- and resource-intensive to implement as intended in inpatient psychiatric settings, where shorter lengths of stay are expected. Furthermore, these interventions focus nearly entirely on preventing suicidal behavior without also targeting functional recovery. Similarly, inpatient psychiatric treatment has traditionally focused on medical management of acute illness, not on improving patient functioning. Preventing suicide during a crisis is only a short-term solution if the investigators fail to assist patients in understanding how they can rebuild a life they deem worth living. Given that approximately 50% of inpatients do not engage in recommended outpatient mental health care and are at the highest risk of death by suicide, it is vital that inpatient care promote functional recovery. The ideal brief intervention for Veterans at risk for suicide needs to reduce risk of suicidal behavior while simultaneously fostering recovery.
Acceptance and Commitment Therapy (ACT) is a recovery-oriented, psychosocial treatment approach ideally suited for utilization among Veterans hospitalized for suicide risk. ACT teaches psychological skills to handle painful thoughts, emotions, and sensations, but rather than focusing on symptom reduction, ACT directly targets functional recovery by assisting patients in identifying and engaging in value-consistent behaviors despite the potential for distress. There are no brief, ACT-based, transdiagnostic treatment protocols designed to address suicide risk. In order to fill this gap, the investigators consulted with leading experts in ACT to develop and manualize "ACT for Life", a brief, transdiagnostic, recovery-oriented intervention for Veterans hospitalized due to suicide risk. The ACT for Life manual details the application of ACT to recovery from suicidal crises and consists of three modules, [designed to be utilized in three to four 60-minute individual sessions.] This two arm, randomized, controlled pilot study will provide critical information to inform final revisions to the treatment manual and research design for a future efficacy study of ACT for Life. Veterans who enroll in the study will be randomized to: (a) treatment as usual or (b) treatment as usual plus ACT. The specific aims of this study are to: (1) Determine the acceptability of ACT for Life. (2) Determine the feasibility of the study design and research procedures. (3) Characterize participants' psychosocial functioning and self-directed violence using candidate outcome measures for a future efficacy trial. All participants will complete a baseline assessment, and follow-up assessments one and three months after hospital discharge. Participants in the ACT group will also complete a post-treatment assessment on acceptability of the intervention.
- Conditions
- Suicide, Psychiatric Rehabilitation
- Being tested
- ACT for Life, Treatment as usual
- Keywords
- Suicide, Psychiatric Rehabilitation, Acceptance and Commitment Therapy, Brief Psychotherapy, Inpatients
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT for LifeBehavioural
A novel protocol detailing the application of Acceptance and Commitment Therapy (ACT) to recovery from suicidal crises. Consists of three modules designed to be delivered in three to four 60-minute individual talk therapy sessions. Nearly all of the metaphors and experiential exercises are adaptations of core ACT techniques included in various empirically-supported applications of ACT to other health conditions. Additionally, the adjunctive intervention is designed to augment safety planning (a hierarchical list of strategies to recognize and cope with a suicidal crisis).
Treatment as usualOther
All participants will be able to engage in treatment as usual. Psychiatric inpatient care typically consists of behavioral mental health group and/or individual therapy and pharmacological treatment. Outpatient care is offered upon discharge. This typically consists of both group and individual therapy and medication management.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual plus ACT | Experimental | Participants in this condition will be enrolled in the ACT for Life intervention and still able to engage in treatment as usual. Receives: Behavioral: ACT for Life; Other: Treatment as usual |
| Treatment as usual | Active comparator | Participants in this condition will not be enrolled in ACT for Life, but will continue to participate in treatment as usual (e.g., inpatient and outpatient mental health care). Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Client Satisfaction Questionnaire - 8
Self-report measure that will be used to assess participants' satisfaction with ACT for Life. Scale scores range from 8 to 32 with higher scores indicating greater satisfaction. For the purposes of the current study scores greater than or equal to 24 were considered acceptable. The number of participants scoring ≥ 24 is reported below.
Measured: Post-treatment (0-7 days after treatment completion)
Narrative Evaluation of Intervention Interview
Semi-structured interview assessing each participants' perspective of the impact of the intervention, helpful and unhelpful components, and comparison to other interventions. Will be used to assess acceptability and inform revisions to the treatment manual. Qualitative Thematic Analysis was conducted. There are no objective data to report from this interview. Please contact the PI for reference to a manuscript with the qualitative results.
Measured: Post-treatment (0-7 days after treatment completion)
Reasons for Termination (Client and Therapist Versions)
Self-report scale which assesses the impact of 19 common reasons why patients terminate therapy. Will be used to assess treatment acceptability. These participants reported reasons for termination of ACT, but this did not produce quantitative data.
Measured: Post-treatment (0-7 days after treatment termination)
Secondary outcomes (6)
Outcome Questionnaire 45.2 (OQ-45)
The Outcome Questionnaire 45.2 is a 45-item self-report scale that assesses symptom distress, interpersonal relationships, and social role (functioning in the workplace, school, and home) for the past week. The OQ-45 total score ranges from 0-180 with higher scores indicating greater distress and impairment. Scores of 63 or more generally indicate symptoms of clinical significance and changes of 14 points or more are typically considered a "reliable change."
Measured: Pre-treatment, One-Month Follow-Up, Three-Month Follow-Up
Valued Living Questionnaire (Used to Assess Change)
Self-report measure that assesses participants' life values as well as the perceived consistency with which they have been living according to their values. Will be examined as a candidate outcome measure for a future efficacy trial. The reported "composite score" accounts for both importance and consistency (mean of the products of importance and consistency scores within each domain) to quantify the extent to which one is contacting values in everyday life. Scores can range from 1 to 100 with higher scores indicating greater contact with values in everyday life, which is generally considered desirable and a sign of good functioning.
Measured: Pre-treatment, and one- and three-month follow-ups
Inventory of Psychosocial Functioning (Used to Assess Change)
Self-report measure that assesses impairment within the last 30 days across a spectrum of psychosocial domains. Will be examined as a candidate outcome measure for a future efficacy trial. Response options range from 0 = never to 6 = always. The measure yields a mean score for the total scale. Higher scores indicate less functional impairment. The total scale score is reported.
Measured: Pre-treatment, and one- and three-month follow-ups
PROMIS Global Short Form v1.1 (Used to Assess Change)
Self-report measure assessing multiple domains of health. The scale yields two subscales: Global Physical Health and Global Mental Health. Global Mental Health will be examined as a candidate outcome measure for a future efficacy trial. The Global Mental Health sum score can range from 4 to 20, with higher scores indicating greater mental health.
Measured: Pre-treatment, and one- and three-month follow-ups
PROMIS Short Form v2.0- Satisfaction With Social Roles and Activities 8a (Used to Assess Change)
Self-report measure that assesses satisfaction with respondents' ability to perform various social activities. Will be examined as a candidate outcome measure for a future efficacy trial. Scale scores range from 8 to 40 with higher scores indicating greater satisfaction with ability to perform social activities.
Measured: Pre-treatment, and one- and three-month follow-ups
Columbia Suicide-Severity Rating Scale (Used to Assess Change)
Clinician-administered interview that assesses suicidal ideation and behavior. Will be examined as a candidate outcome measure for a future efficacy trial. Suicidal ideation intensity scores can range from 0 to 25 with higher scores indicating a greater intensity of suicidal ideation. Suicidal ideation intensity scale scores are reported.
Measured: Pre-treatment, and one- and three-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study start15 Nov 2016
- Primary completion9 Aug 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Sean Michael Barnes, PhD, Principal investigator, Rocky Mountain Regional VA Medical Center, Aurora, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751983
- Sponsor's protocol ID
- D2048-P
- Other IDs
- I21RX002048-01
- Status last verified
- Oct 2019
- First submitted
- 21 Apr 2016
- Last updated
- 13 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACT for Life: a Brief Intervention for Maximizing Recovery After Suicidal Crises
- ClinicalTrials.gov ID
- NCT02751983
- Acronym / sponsor ID
- D2048-P
- Conditions
- Suicide, Psychiatric Rehabilitation
- Keywords
- Suicide, Psychiatric Rehabilitation, Acceptance and Commitment Therapy, Brief Psychotherapy, Inpatients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 9 Aug 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Posted 13 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An estimated 20 Veterans kill themselves every day. Suicide prevention literature and public health policy both call for treatment targeting high-risk populations, such as Veterans hospitalized due to suicidal intent and/or attempts. Psychiatric hospitalization is a critical opportunity to provide treatment to reduce the risk of suicide and lay the groundwork for functional recovery. Yet, there are no interventions specifically for suicide prevention that meet Veterans Health Affairs' quality recommendations requiring the provision of evidence-based, recovery-oriented psychotherapy, which are also feasible to use during a typical inpatient stay. The proposed study seeks to take a first step toward filling this gap. In consultation with experts in the field, the authors have developed a protocol applying a recovery-oriented, evidence-based treatment approach to Veteran inpatient care. The proposed pilot study will provide critical information to inform final revisions of the treatment manual and research design for a future study evaluating the efficacy of the intervention.
Detailed description
Psychiatric hospitalization presents a critical opportunity for delivering targeted treatment to reduce suicide risk and promote functional recovery. Yet, there are no suicide-specific empirically-supported interventions that can be feasibly delivered during a typical Veterans Health Affairs (VHA) inpatient stay. Although VHA now requires the provision of evidence-based, recovery-oriented inpatient psychotherapy, extant empirically-supported interventions for patients at high risk of suicide were developed for use in outpatient settings and are too time- and resource-intensive to implement as intended in inpatient psychiatric settings, where shorter lengths of stay are expected. Furthermore, these interventions focus nearly entirely on preventing suicidal behavior without also targeting functional recovery. Similarly, inpatient psychiatric treatment has traditionally focused on medical management of acute illness, not on improving patient functioning. Preventing suicide during a crisis is only a short-term solution if the investigators fail to assist patients in understanding how they can rebuild a life they deem worth living. Given that approximately 50% of inpatients do not engage in recommended outpatient mental health care and are at the highest risk of death by suicide, it is vital that inpatient care promote functional recovery. The ideal brief intervention for Veterans at risk for suicide needs to reduce risk of suicidal behavior while simultaneously fostering recovery.
Acceptance and Commitment Therapy (ACT) is a recovery-oriented, psychosocial treatment approach ideally suited for utilization among Veterans hospitalized for suicide risk. ACT teaches psychological skills to handle painful thoughts, emotions, and sensations, but rather than focusing on symptom reduction, ACT directly targets functional recovery by assisting patients in identifying and engaging in value-consistent behaviors despite the potential for distress. There are no brief, ACT-based, transdiagnostic treatment protocols designed to address suicide risk. In order to fill this gap, the investigators consulted with leading experts in ACT to develop and manualize "ACT for Life", a brief, transdiagnostic, recovery-oriented intervention for Veterans hospitalized due to suicide risk. The ACT for Life manual details the application of ACT to recovery from suicidal crises and consists of three modules, [designed to be utilized in three to four 60-minute individual sessions.] This two arm, randomized, controlled pilot study will provide critical information to inform final revisions to the treatment manual and research design for a future efficacy study of ACT for Life. Veterans who enroll in the study will be randomized to: (a) treatment as usual or (b) treatment as usual plus ACT. The specific aims of this study are to: (1) Determine the acceptability of ACT for Life. (2) Determine the feasibility of the study design and research procedures. (3) Characterize participants' psychosocial functioning and self-directed violence using candidate outcome measures for a future efficacy trial. All participants will complete a baseline assessment, and follow-up assessments one and three months after hospital discharge. Participants in the ACT group will also complete a post-treatment assessment on acceptability of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual plus ACT | Experimental | Behavioral: ACT for Life, Other: Treatment as usualParticipants in this condition will be enrolled in the ACT for Life intervention and still able to engage in treatment as usual. |
| Treatment as usual | Active comparator | Other: Treatment as usualParticipants in this condition will not be enrolled in ACT for Life, but will continue to participate in treatment as usual (e.g., inpatient and outpatient mental health care). |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Eligible for Veterans Health Administration care
- Age 18-89
- Currently hospitalized due to suicide risk
- Willing to be randomized and participate in the two conditions
Key exclusion criteria (10 listed)
- Inability to provide informed consent
- Inability to complete study measures, e.g.:
- membership in vulnerable population, e.g.:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT for LifeA novel protocol detailing the application of Acceptance and Commitment Therapy (ACT) to recovery from suicidal crises. Consists of three modules designed to be delivered in three to four 60-minute individual talk therapy sessions. Nearly all of the metaphors and experiential exercises are adaptations of core ACT techniques included in various empirically-supported applications of ACT to other health conditions. Additionally, the adjunctive intervention is designed to augment safety planning (a hierarchical list of strategies to recognize and cope with a suicidal crisis). | Behavioural | Treatment as usual plus ACT |
| Treatment as usualAll participants will be able to engage in treatment as usual. Psychiatric inpatient care typically consists of behavioral mental health group and/or individual therapy and pharmacological treatment. Outpatient care is offered upon discharge. This typically consists of both group and individual therapy and medication management. | Other | Treatment as usual, Treatment as usual plus ACT |
Primary outcome
Client Satisfaction Questionnaire - 8
Time frame: Post-treatment (0-7 days after treatment completion)
Self-report measure that will be used to assess participants' satisfaction with ACT for Life. Scale scores range from 8 to 32 with higher scores indicating greater satisfaction. For the purposes of the current study scores greater than or equal to 24 were considered acceptable. The number of participants scoring ≥ 24 is reported below.
Narrative Evaluation of Intervention Interview
Time frame: Post-treatment (0-7 days after treatment completion)
Semi-structured interview assessing each participants' perspective of the impact of the intervention, helpful and unhelpful components, and comparison to other interventions. Will be used to assess acceptability and inform revisions to the treatment manual. Qualitative Thematic Analysis was conducted. There are no objective data to report from this interview. Please contact the PI for reference to a manuscript with the qualitative results.
Reasons for Termination (Client and Therapist Versions)
Time frame: Post-treatment (0-7 days after treatment termination)
Self-report scale which assesses the impact of 19 common reasons why patients terminate therapy. Will be used to assess treatment acceptability. These participants reported reasons for termination of ACT, but this did not produce quantitative data.
6 secondary outcomes
Outcome Questionnaire 45.2 (OQ-45)
Time frame: Pre-treatment, One-Month Follow-Up, Three-Month Follow-Up
Valued Living Questionnaire (Used to Assess Change)
Time frame: Pre-treatment, and one- and three-month follow-ups
Inventory of Psychosocial Functioning (Used to Assess Change)
Time frame: Pre-treatment, and one- and three-month follow-ups
PROMIS Global Short Form v1.1 (Used to Assess Change)
Time frame: Pre-treatment, and one- and three-month follow-ups
PROMIS Short Form v2.0- Satisfaction With Social Roles and Activities 8a (Used to Assess Change)
Time frame: Pre-treatment, and one- and three-month follow-ups
Columbia Suicide-Severity Rating Scale (Used to Assess Change)
Time frame: Pre-treatment, and one- and three-month follow-ups
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Michael Barnes, PhD principal investigator
Rocky Mountain Regional VA Medical Center, Aurora, CO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT for Life and Treatment as usual in people with Suicide and Psychiatric Rehabilitation, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Client Satisfaction Questionnaire - 8 (time frame: Post-treatment (0-7 days after treatment completion)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019.