NCT03903159

Brief Summary

The main objective of this study is development of the Positive Peer Journaling (PPJ) intervention and the feasibility, acceptability, and logistics of treatment delivery. A second objective is to observe whether PPJ is associated with improvement in hypothesized outcomes. The primary outcomes the investigators will examine are enhanced treatment retention and reduced recurrence of substance use. The investigators will also explore the association between the intervention and a set of hypothesized mediators of the effect of the intervention on outcomes, e.g., improvement in mood and satisfaction with recovery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

January 29, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 4, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

August 26, 2021

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

8 months

First QC Date

January 18, 2019

Results QC Date

August 2, 2021

Last Update Submit

August 2, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • Treatment Retention

    Percentage of participants who were retained in treatment at the host facility until the end of the study or who left the residential treatment facility on good terms during the course of the study.

    8 weeks

  • Substance Use

    Evidence that the individual used drugs or alcohol during the intervention period. This will be assessed via positive drug screen (urine test or breathalizer) or participant self-report of substance use. Reported as the number of participants who use illicit substances during the study.

    8 weeks

  • Percentage of Group Sessions Attended

    Percentage of group sessions will be calculated by taking the number of group sessions attended divided by total number of group sessions offered. Outcome is reported as the overall percentage of group attendance for all 15 participants combined.

    8 weeks

  • Number of PPJ Journal Entries Made

    Total count of the number of PPJ journal entries made over the course of the study

    8 weeks

Study Arms (1)

Treatment Group

OTHER

Positive Peer Journaling (PPJ)

Behavioral: Positive Peer Journaling (PPJ)

Interventions

PPJ is a journaling practice to support addiction recovery. PPJ encourages past 24 hour review and upcoming 24 hour planning to improve quality of life in recovery and reduce relapse. PPJ uses standard lined journals with column headings under which individuals make bullet-pointed lists. On the left hand page, past 24 hours is recalled, itemizing "good" and "bad" things that happened and things for which one is grateful. Wishes for others are also expressed on this page. On the right hand page, values-based activities for the upcoming 24 hours are planned via headings representing valued life domains such as "recovery," "work/school," "spirituality," "home and household," and "health."

Treatment Group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe host setting is a residential substance use disorder treatment facility the serves only women.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • minimum 18 years of age,
  • meet DSM-V criteria for past-year SUD as primary or secondary diagnosis,
  • English literacy sufficient to make short written lists needed to complete PPJ and homework assessments,
  • minimum 2 weeks sustained abstinence,
  • completed first 2 weeks of treatment at Wayside (approximately 2 weeks), a residential substance use disorder treatment program and the recruitment site,
  • priority will go to participants who are from or moving back to a rural area or small town defined as a population less than 10,500,
  • agree to be audio recorded in group meetings and in individual meetings with research staff,
  • currently are clients in the Wayside residential program,
  • participants must be English speaking and literacy must be strong enough to write short lists and to understand the questions asked in the questionnaires.
  • Priority will go to women who will be residing at Wayside for the duration of the study activities (and not moving out after one week, for example).

You may not qualify if:

  • presence of a psychotic disorder, psychiatric condition (e.g., suicidal ideation), or cognitive impairment (e.g., severe dementia, traumatic brain injury) limiting ability to give consent and/or participate in the study;
  • severe psychiatric illness (current schizophrenia, major depression with suicidal ideation);
  • personality disorders that would interfere with satisfactory participation in or completion of the study protocol,
  • inability to give informed, voluntary consent to participate,
  • lack of sufficient English literacy to participate, defined as inability to make a list of 5 things they did yesterday and inability to understand questionnaire items,
  • any impairment, activity, or situation that in the judgement of the research staff would prevent satisfactory participation in or completion of the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wayside Women's Treatment Center

Saint Louis Park, Minnesota, 55416, United States

Location

MeSH Terms

Conditions

Behavior, Addictive

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehavior

Results Point of Contact

Title
Amy Krentzman
Organization
University of Minnesota

Study Officials

  • Amy Krentzman

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2019

First Posted

April 4, 2019

Study Start

January 29, 2019

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

August 26, 2021

Results First Posted

August 26, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations