- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04458181
Journaling and Addiction Recovery: Piloting "Positive Peer Journaling" (PPJ)
December 14, 2021 updated by: University of Minnesota
The main objective of this study is to pilot test the Positive Peer Journaling (PPJ) 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
81
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55413
- NUWAY
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Group
Participants in this group will complete the intervention, Positive Peer Journaling (PPJ), while also continuing to attend intensive outpatient treatment for addiction.
|
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."
|
No Intervention: Control Group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction with Life
Time Frame: 9 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.
|
9 weeks
|
Happiness with recovery
Time Frame: 9 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 11.
Higher scores represent higher happiness with recovery.
|
9 weeks
|
Commitment to sobriety
Time Frame: 9 weeks
|
Score on a single item, "I will do whatever it takes to recover from my addiction."
This item uses an 11 point scale ranging from 0-11.
Higher scores represent greater commitment to sobriety.
|
9 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amy Krentzman, MSW, PhD, University of Minenesota
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 7, 2020
Primary Completion (Actual)
November 1, 2021
Study Completion (Actual)
November 1, 2021
Study Registration Dates
First Submitted
May 21, 2020
First Submitted That Met QC Criteria
June 30, 2020
First Posted (Actual)
July 7, 2020
Study Record Updates
Last Update Posted (Actual)
December 15, 2021
Last Update Submitted That Met QC Criteria
December 14, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00004619-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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