NCT04458181

Brief Summary

The main objective of this study is to pilot test the Positive Peer Journaling (PPJ) \[later renamed "Positive Recovery Journaling" (PRJ)\] intervention and its feasibility and acceptability. A second objective is to compare individuals assigned to PPJ to individuals in a treatment as usual control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

July 7, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

June 20, 2024

Completed
Last Updated

June 20, 2024

Status Verified

May 1, 2024

Enrollment Period

1.3 years

First QC Date

May 21, 2020

Results QC Date

December 21, 2022

Last Update Submit

May 29, 2024

Conditions

Outcome Measures

Primary Outcomes (12)

  • Satisfaction With Life at Baseline

    Score on the "Satisfaction with Life" scale. This scale has 5 items assessed on a 7 point Likert-type response format. Scores range from 5 to 35 with higher scores representing higher satisfaction with life.

    Baseline

  • Satisfaction With Life at 2 Weeks

    Score on the "Satisfaction with Life" scale. This scale has 5 items assessed on a 7 point Likert-type response format. Scores range from 5 to 35 with higher scores representing higher satisfaction with life.

    2 weeks (after Phase 1, the group phase)

  • Satisfaction With Life at 4 Weeks

    Score on the "Satisfaction with Life" scale. This scale has 5 items assessed on a 7 point Likert-type response format. Scores range from 5 to 35 with higher scores representing higher satisfaction with life.

    4 weeks (after Phase 2, the independent practice phase)

  • Satisfaction With Life at 8 Weeks

    Score on the "Satisfaction with Life" scale. This scale has 5 items assessed on a 7 point Likert-type response format. Scores range from 5 to 35 with higher scores representing higher satisfaction with life.

    8 weeks (the 1-month post-intervention)

  • Happiness With Recovery at Baseline

    Score on a single item, "In general, I am happy with my recovery." This item uses an 11 point scale ranging from 0 to 10. Higher scores represent higher happiness with recovery.

    Baseline

  • Happiness With Recovery at 2 Weeks

    Score on a single item, "In general, I am happy with my recovery." This item uses an 11 point scale ranging from 0 to 10. Higher scores represent higher happiness with recovery.

    2 weeks (after Phase 1, the group phase)

  • Happiness With Recovery at 4 Weeks

    Score on a single item, "In general, I am happy with my recovery." This item uses an 11 point scale ranging from 0 to 10. Higher scores represent higher happiness with recovery.

    4 weeks (after Phase 2, the independent practice phase)

  • Happiness With Recovery at 8 Weeks

    Score on a single item, "In general, I am happy with my recovery." This item uses an 11 point scale ranging from 0 to 10. Higher scores represent higher happiness with recovery.

    8 weeks (the 1-month post intervention)

  • Commitment to Sobriety at Baseline

    Score on a single item, "I am willing to do whatever it takes to recover from my addiction." This item uses an 11 point scale ranging from 0-10. Higher scores represent greater commitment to sobriety.

    Baseline

  • Commitment to Sobriety at 2 Weeks

    Score on a single item, "I am willing to do whatever it takes to recover from my addiction." This item uses an 11 point scale ranging from 0-10. Higher scores represent greater commitment to sobriety.

    2 weeks (after Phase 1, the group phase)

  • Commitment to Sobriety at 4 Weeks

    Score on a single item, "I am willing to do whatever it takes to recover from my addiction." This item uses an 11 point scale ranging from 0-10. Higher scores represent greater commitment to sobriety.

    4 weeks (after Phase 2, the independent practice phase)

  • Commitment to Sobriety at 8 Weeks

    Score on a single item, "I am willing to do whatever it takes to recover from my addiction." This item uses an 11 point scale ranging from 0-10. Higher scores represent greater commitment to sobriety.

    8 weeks (the 1-month post intervention)

Study Arms (2)

Treatment Group

EXPERIMENTAL

Participants in this group will complete the intervention, Positive Peer Journaling (PPJ), while also continuing to attend intensive outpatient treatment for addiction.

Behavioral: Positive Peer Journaling (PPJ)

Control Group

NO INTERVENTION

There will be no intervention for those randomized to the control group. However, they will complete assessment instruments throughout the study period while also continuing to attend intensive outpatient treatment for addiction.

Interventions

PPJ is a journaling practice to support addiction recovery. PPJ encourages past 24 hour review and upcoming 24 hour planning to improve subjective wellbeing in recovery and reduce relapse. PPJ uses 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. Good 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+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • meet DSM-V criteria for past-year Substance Use Disorder 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 Nuway (approximately 2 weeks), an intensive outpatient substance use disorder treatment program and the recruitment site,
  • agree to be audio recorded or transcription recorded in group meetings and in individual meetings with research staff,
  • currently are clients in the Nuway outpatient 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,
  • participants must have an electronic device that connects to the internet and internet connection for online delivery of intervention during COVID-19.

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)

NUWAY

Minneapolis, Minnesota, 55413, United States

Location

MeSH Terms

Conditions

Behavior, Addictive

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehavior

Results Point of Contact

Title
Amy R. Krentzman
Organization
University of Minnesota

Study Officials

  • Amy Krentzman, MSW, PhD

    University of Minenesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2020

First Posted

July 7, 2020

Study Start

July 7, 2020

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

June 20, 2024

Results First Posted

June 20, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations