Invest in My Recovery Bank: A Pilot Study of a Peer-Led Intervention for Co-Occurring Early Psychosis and Substance Use (IMRB)

• ClinicalTrials.gov Identifier: NCT04517279
• Recruitment Status: Not yet recruiting
• First Posted: August 18, 2020
• Last Update Posted: August 18, 2020
• Sponsor: University of Texas at Austin
• Collaborators: Southern Methodist University; Thresholds Inc.
• Information provided by (Responsible Party): Molly Lopez, University of Texas at Austin

Study Description

Brief Summary:

The aim of the study is to pilot a peer-provided, manualized intervention to increase the proportion of young people with first episode psychosis who reduce or stop substance use and improve psychiatric and functional outcomes. Coordinated specialty care teams will be randomly assigned to implement the intervention, Invest in My Recovery Bank (IMRB), or usual care. The pilot study aims to: (a) determine if peer providers can implement IMRB with adequate fidelity; (b) determine if youth and young adults engage in the intervention with peer providers and find it acceptable; (c) estimate the rates of drop-out for each of the two study arms; (d) estimate both between-participant (within-provider team) and between-team variability on key outcome measures; and (e) identify any changes needed to the intervention approach, manual, or training materials. The pilot study will set the stage for a future comparative cluster randomized trial of the intervention;

Condition or disease	Intervention/treatment	Phase
Psychotic Disorders; Substance Use	Behavioral: Invest in My Recovery Bank; Behavioral: Usual Care Peer Services	Not Applicable

Detailed Description:

The pilot study examines the feasibility of a cluster randomized controlled trial to measure the effectiveness of Invest in My Recovery Bank (IMRB) compared to usual care (UC). IMRB is a peer-led, manualized intervention to support youth and young adults receiving treatment for early psychosis with reducing or stopping problematic substance use. Peer providers, who represent clusters of service participants, will participate in a multi-day IMRB training. Training will include exploring the theoretical basis for the intervention approach and logic model, impact of service participant and peer provider on intervention design, the intervention strategies, and opportunities to build skill in each intervention component (e.g., role play with feedback). Peer providers will also receive twice monthly supervision to support intervention fidelity and resolve questions.

The proposed pilot study aims to: (a) determine if peer providers can implement IMRB with adequate fidelity; (b) determine if youth and young adults engage in the intervention with peer providers and find it acceptable; (c) estimate the rates of drop-out for each of the two study arms; (d) estimate both between-participant (within-provider team) and between-team variability (e.g., standard deviation, interquartile range) on key outcome measures for a future comparative cluster randomized trial of the intervention; and (e) identify any changes needed to the intervention approach, manual, or training materials.

Nineteen teams across 16 sites will be randomly assigned to IMRB or UC, ensuring that the three sites with more than one team have at least one team randomized to each arm. All youth meeting eligibility criteria will be enrolled in the study and will receive either IMRB or UC, based on the assignment status of their provider team. Intervention integrity will be measured through a peer-completed fidelity checklist. Participant outcomes will be measured through existing data collection at each participating organization. All participant outcome and service data is reported through the EPINET-TX platform, which allows for measurement-based care at participating sites and research using de-identified data.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The model is a cluster randomized controlled trial with randomization at the team level.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Advancing the Early Psychosis Intervention Network in Texas
• Estimated Study Start Date: May 2022
• Estimated Primary Completion Date: May 2024
• Estimated Study Completion Date: August 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Invest in My Recovery Bank; The Invest in My Recovery Bank arm is an intervention focused on enhancing the recovery capital of individuals in early psychosis care. The intervention is provided by a peer provider, operating on the coordinated specialty care team	Behavioral: Invest in My Recovery Bank; The intervention has not be fully developed. It will be created in partnership with individuals serving in peer provider roles.
Active Comparator: Usual Care; The peer providers operating under the Usual Care condition will continue to provide peer support services to individuals within the coordinated specialty care team.	Behavioral: Usual Care Peer Services; Usual peer services involves supporting the process of change for individuals with mental health disorder to improve their health and wellness, live a self-directed life, and strive to reach their full potential.

Outcome Measures

Primary Outcome Measures :

1. Alcohol Use [ Time Frame: 6 months after initiation of the intervention ]
   The primary outcome is the use of alcohol within the past 6 months as measured by the Alcohol Use Scale. The scale ranges from 1 to 5, with higher scores indicating more significant severity. Alcohol use is measured by a score of 2 or greater.
2. Alcohol Use [ Time Frame: 12 months after initiation of the intervention ]
   The primary outcome is the use of alcohol within the past 6 months as measured by the Alcohol Use Scale. The scale ranges from 1 to 5, with higher scores indicating more significant severity. Alcohol use is measured by a score of 2 or greater.
3. Drug Use [ Time Frame: 6 months after initiation of the intervention ]
   The primary outcome is the use of substances within the past 6 months as measured by the Drug Use Scale. The scale ranges from 1 to 5, with higher scores indicating more significant severity. Drug use is measured by a score of 2 or greater.
4. Drug Use [ Time Frame: 12 months after initiation of the intervention ]
   The primary outcome is the use of substances within the past 6 months as measured by the Drug Use Scale. The scale ranges from 1 to 5, with higher scores indicating more significant severity. Drug use is measured by a score of 2 or greater.
5. Role Functioning [ Time Frame: 6 months after initiation of the intervention ]
   The primary outcome is measured on the Global Functioning: Role scale (current). The scale ranges from 0 to 10, with higher scores reflecting better role functioning.
6. Role Functioning [ Time Frame: 12 months after initiation of the intervention ]
   The primary outcome is measured on the Global Functioning: Role scale (current). The scale ranges from 0 to 10, with higher scores reflecting better role functioning.
7. Social Functioning [ Time Frame: 6 months after initiation of the intervention ]
   The primary outcome is measured on the Global Functioning: Social scale (current). The scale ranges from 0 to 10, with higher scores reflecting better role functioning.
8. Social Functioning [ Time Frame: 12 months after initiation of the intervention ]
   The primary outcome is measured on the Global Functioning: Social scale (current). The scale ranges from 0 to 10, with higher scores reflecting better role functioning.

Secondary Outcome Measures :

1. Stage of Change [ Time Frame: 6 months after initiation of the intervention ]
   This secondary outcome is measured on the Substance Abuse Treatment Scale. The scale is ordinal, with 1 reflecting the "pre-engagement" stage and 7 reflecting "relapse prevention." Higher numbers reflect a more advanced stage of substance use treatment.
2. Stage of Change [ Time Frame: 12 months after initiation of the intervention ]
   This secondary outcome is measured on the Substance Abuse Treatment Scale. The scale is ordinal, with 1 reflecting the "pre-engagement" stage and 7 reflecting "relapse prevention." Higher numbers reflect a more advanced stage of substance use treatment.
3. Perceived Well-being [ Time Frame: 6 months after initiation of the intervention ]
   This secondary outcome is measured by the Personal Well-being Inventory. The summary score ranges from 0 to 100, with higher scores reflecting greater subjective well-being.
4. Perceived Well-being [ Time Frame: 12 months after initiation of the intervention ]
   This secondary outcome is measured by the Personal Well-being Inventory. The summary score ranges from 0 to 100, with higher scores reflecting greater subjective well-being.
5. Recovery [ Time Frame: 6 months after initiation of the intervention ]
   This secondary outcome is measured by the Questionnaire about the Process of Recovery. The total score ranges from 0 to 60, with higher scores reflecting greater recovery.
6. Recovery [ Time Frame: 12 months after initiation of the intervention ]
   This secondary outcome is measured by the Questionnaire about the Process of Recovery. The total score ranges from 0 to 60, with higher scores reflecting greater recovery.
7. Severity of Psychiatric Symptomatology [ Time Frame: 6 months after initiation of the intervention. ]
   This secondary outcome is measured by the Brief Psychiatric Rating Scale. The total score ranges from 0 to 108, with higher scores reflecting greater severity.
8. Severity of Psychiatric Symptomatology [ Time Frame: 12 months after initiation of the intervention. ]
   This secondary outcome is measured by the Brief Psychiatric Rating Scale. The total score ranges from 0 to 108, with higher scores reflecting greater severity.

Other Outcome Measures:

1. Participant qualitative feedback [ Time Frame: 12 months after initiation of the intervention. ]
   Some participants will participate in qualitative interviews on acceptability of the intervention.

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 32 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• enrolled in a CSC program during the defined study period;
• continued program enrollment at six month follow-up from program entry;
• continued alcohol/substance use at six-month follow-up from program entry.

Exclusion Criteria:

• none

Contacts and Locations

Contacts

Contact: Molly Lopez, PhD; 5125600484; mlopez@austin.utexas.edu

Contact: Deborah Cohen, PhD; 512-232-0618; dacohen@austin.utexas.edu

Sponsors and Collaborators

University of Texas at Austin

Southern Methodist University

Thresholds Inc.

More Information

• Responsible Party: Molly Lopez, Research Associate Professor, University of Texas at Austin
• ClinicalTrials.gov Identifier: NCT04517279
• Other Study ID Numbers: 1R01MH120599 ( U.S. NIH Grant/Contract )
• First Posted: August 18, 2020
• Last Update Posted: August 18, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Individual data on participants will be shared through a national data coordinated center as a component of the EPINET initiative.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Molly Lopez, University of Texas at Austin:

early psychosis; cannabis use; alcohol use; substance use

Additional relevant MeSH terms:

Psychotic Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders