ACT for Life: a Brief Intervention for Maximizing Recovery After Suicidal Crises

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02751983

Enrollment

Registered

2016-04-26

Start date

2016-11-15

Completion date

2018-12-31

Last updated

2019-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychiatric Rehabilitation, Suicide

Keywords

Suicide, Psychiatric Rehabilitation, Acceptance and Commitment Therapy, Brief Psychotherapy, Inpatients

Brief 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. 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.

Interventions

BEHAVIORALACT for Life

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).

OTHERTreatment as usual

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 89 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* Inability to provide informed consent * Inability to complete study measures, e.g.: * due to significant acute intoxication/withdrawal symptoms * mania * psychosis * aggression * catatonia * cognitive impairment * membership in vulnerable population, e.g.: * prisoners

Design outcomes

Primary

Measure	Time frame	Description
Client Satisfaction Questionnaire - 8	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	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)	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.

Secondary

Measure	Time frame	Description
PROMIS Global Short Form v1.1 (Used to Assess Change)	Pre-treatment, and one- and three-month follow-ups	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.
Outcome Questionnaire 45.2 (OQ-45)	Pre-treatment, One-Month Follow-Up, Three-Month Follow-Up	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.
Columbia Suicide-Severity Rating Scale (Used to Assess Change)	Pre-treatment, and one- and three-month follow-ups	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.
PROMIS Short Form v2.0- Satisfaction With Social Roles and Activities 8a (Used to Assess Change)	Pre-treatment, and one- and three-month follow-ups	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.
Valued Living Questionnaire (Used to Assess Change)	Pre-treatment, and one- and three-month follow-ups	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.
Inventory of Psychosocial Functioning (Used to Assess Change)	Pre-treatment, and one- and three-month follow-ups	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.

Countries

United States

Participant flow

Recruitment details

6 participants (1 Treatment as Usual (TAU), 5 TAU plus ACT (ACT)), were enrolled in a pilot to the pilot phase of the current study. Clinicians were trained based on the first 5 ACT participants and qualitative feedback was used to revise the ACT for Life manual prior to enrolling an additional 70 participants who were randomized to ACT or TAU.

Participants by arm

Arm	Count
Treatment as Usual Plus ACT Participants in this condition will be enrolled in the ACT for Life intervention and still able to engage in treatment as usual. ACT for Life: 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 usual: 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.	35
Treatment as Usual 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). Treatment as usual: 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.	35
Total	70

Withdrawals & dropouts

Period	Reason	FG000	FG001
One-Month Follow-Up Assessments	Lost to Follow-up	14	12
Post-Treatment Assessment	Lost to Follow-up	5	0
Three-Month Follow-Up Assessments	Lost to Follow-up	12	16
Treatment	Discharged prior to beginning ACT	2	0
Treatment	Stopped ACT, but Remained in study	2	0

Baseline characteristics

Characteristic	Treatment as Usual Plus ACT	Treatment as Usual	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	1 Participants	4 Participants	5 Participants
Age, Categorical Between 18 and 65 years	34 Participants	31 Participants	65 Participants
Age, Continuous	42 years	49 years	47 years
Race/Ethnicity, Customized Race Asian	1 Participants	1 Participants	2 Participants
Race/Ethnicity, Customized Race Black	3 Participants	4 Participants	7 Participants
Race/Ethnicity, Customized Race Multiracial	5 Participants	6 Participants	11 Participants
Race/Ethnicity, Customized Race Native American/Alaskan native	0 Participants	2 Participants	2 Participants
Race/Ethnicity, Customized Race Other	3 Participants	1 Participants	4 Participants
Race/Ethnicity, Customized Race Pacific Islander	1 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized Race White	22 Participants	21 Participants	43 Participants
Region of Enrollment United States	35 Participants	35 Participants	70 Participants
Sex: Female, Male Female	5 Participants	8 Participants	13 Participants
Sex: Female, Male Male	30 Participants	27 Participants	57 Participants
Sexual Orientation Bisexual	1 Participants	0 Participants	1 Participants
Sexual Orientation Gay/Lesbian/Queer	1 Participants	3 Participants	4 Participants
Sexual Orientation Heterosexual	32 Participants	30 Participants	62 Participants
Sexual Orientation Other	1 Participants	2 Participants	3 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 35	0 / 35
other Total, other adverse events	0 / 35	0 / 35
serious Total, serious adverse events	0 / 35	0 / 35

Outcome results

Primary

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.

Time frame: Post-treatment (0-7 days after treatment completion)

Population: Post-treatment data were collected from participants who engaged in at least one ACT for Life session. 2 of the 35 ACT participants discharged from the hospital prior to receiving any treatment. 3 participants discharged prior to post-treatment assessment and were lost to follow-up.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Treatment as Usual Plus ACT	Client Satisfaction Questionnaire - 8	28 Participants

Primary

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.

Time frame: Post-treatment (0-7 days after treatment completion)

Arm	Measure	Value (NUMBER)
Treatment as Usual Plus ACT	Narrative Evaluation of Intervention Interview	30 participants analyzed

Primary

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.

Time frame: Post-treatment (0-7 days after treatment termination)

Population: Data reflects those who terminated the intervention.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Treatment as Usual Plus ACT	Reasons for Termination (Client and Therapist Versions)	2 Participants

Secondary

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.

Time frame: Pre-treatment, and one- and three-month follow-ups