NCT05329181

Brief Summary

This case series and feasibility trial evaluated a novel integrated cognitive behavioral treatment, which was adapted specifically for homeless individuals and developed to treat substance use and depressive symptoms simultaneously. The integrated cognitive behavioral treatment was delivered among four homeless individuals enrolled in the Treatment First program (a social services program where treatment is offered in conjunction with temporary transitional housing), who had access to stable and sober housing milieus.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

June 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2017

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

8 months

First QC Date

March 21, 2022

Last Update Submit

April 8, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • The TimeLine Follow Back

    The TimeLine Follow Back, a retrospective calendar instrument to assess days and quantity of alcohol and drug use, was used as primary measure for substance use. The TimeLine Follow Back have been found to have good psychometric properties in a homeless population (Sacks et al., 2003). Number of units (alcohol or drug use) per week were reported as means per week, during baseline and treatment. The TimeLine Follow Back was not administered at follow up.

    A retrospective 90-day TimeLine Follow Back interview at baseline, and a retrospective 7 days TimeLine Follow Back self-report measure assessed weekly during treatment sessions (up to 15 sessions/weeks).

Secondary Outcomes (8)

  • The Patient Health Questionnaire

    1 week

  • The Generalized Anxiety Questionnaire

    2 weeks

  • The Alcohol Use Disorders Identification Test

    1 year

  • The Drug Use Disorders Identification Test

    1 year

  • Housing status

    1 day

  • +3 more secondary outcomes

Study Arms (1)

Integrated cognitive behavioral therapy adapted for homeless individuals

OTHER

Four homeless individuals enrolled in the Treatment First program (a social services program where treatment is offered in conjunction with temporary transitional housing), who had access to stable and sober housing milieus, received the integrated cognitive behavioral treatment.

Behavioral: Integrated cognitive behavioral treatment

Interventions

Integrated cognitive behavioral treatment adapted specifically for homeless individuals and developed to treat substance use and depressive symptoms simultaneously

Integrated cognitive behavioral therapy adapted for homeless individuals

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Fulfilled the Diagnostic and Statistical Manual of Mental Disorders criteria for Alcohol Use Disorder or Substance Use Disorder
  • Fulfilled the Swedish criteria for homelessness and had access to "steady housing" (defined as situation 3 or 4 according to Sun et al. \[2012\])
  • Were between 16-65 years old
  • Were able to read and write Swedish and were able to carry out treatment, 5-15 sessions together with homework assignments
  • Had regular contact with a social worker at the social welfare office for the homeless.

You may not qualify if:

  • Another primary psychiatric condition (e.g., bipolar disorder, psychosis, suicidal ideation)
  • Failure to attend first two treatment sessions
  • Other aggravating circumstances, for example violence in close relationships.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Molander O, Bjureberg J, Sahlin H, Beijer U, Hellner C, Ljotsson B. Integrated cognitive behavioral treatment for substance use and depressive symptoms: a homeless case series and feasibility study. Pilot Feasibility Stud. 2023 May 5;9(1):76. doi: 10.1186/s40814-023-01305-2.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 21, 2022

First Posted

April 14, 2022

Study Start

June 1, 2016

Primary Completion

January 31, 2017

Study Completion

January 31, 2017

Last Updated

April 14, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Data is not possible to share du to integrity reasons, as the study participants were patients.