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

NCT02751983 | Completed Results

• 2 other identifiers: D2048-PI21RX002048-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide; Psychiatric Rehabilitation

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Post-treatment (0-7 days after treatment termination)

Secondary Outcomes (6)

• Outcome Questionnaire 45.2 (OQ-45)

  Pre-treatment, One-Month Follow-Up, Three-Month Follow-Up

• Valued Living Questionnaire (Used to Assess Change)

  Pre-treatment, and one- and three-month follow-ups

• Inventory of Psychosocial Functioning (Used to Assess Change)

  Pre-treatment, and one- and three-month follow-ups

• PROMIS Global Short Form v1.1 (Used to Assess Change)

  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)

  Pre-treatment, and one- and three-month follow-ups

Study Arms (2)

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.

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).

Other: Treatment as usual

Interventions

ACT for Life BEHAVIORAL

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 plus ACT

Treatment as usual OTHER

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.

Treatment as usual; Treatment as usual plus ACT

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Suicide

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Limitations and Caveats

Outcome data are provided, but should not be used to draw conclusions about the efficacy of ACT for Life given recommendations for pilot study best practices (e.g., Eldrige et al., 2016) and data lost to follow up.

Results Point of Contact

• Title: Sean Barnes
• Organization: Rocky Mountain Mental Illness Research, Education, and Clinical Center

Sean.Barnes2@va.gov

720-723-6560

Study Officials

• Sean Michael Barnes, PhD

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2016
• First Posted: April 26, 2016
• Study Start: November 15, 2016
• Primary Completion: August 9, 2018
• Study Completion: December 31, 2018
• Last Updated: November 13, 2019
• Results First Posted: November 13, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)