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Integrated Cognitive Behavioral Treatment for Substance Use and Depressive Symptoms: a Homeless Case Series (INTER)

Primary Purpose

Cognitive Behavioral Therapy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Integrated cognitive behavioral treatment
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Behavioral Therapy

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Integrated cognitive behavioral therapy adapted for homeless individuals

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    The Patient Health Questionnaire
    The Patient Health Questionnaire is a 9-item self-report measure (score range 0-27) that assesses depression severity with the following cut-off categories: None-minimal (0-4), mild (5-9), moderate (10-14), moderately-severe (15-19), severe (20-27).
    The Generalized Anxiety Questionnaire
    The Generalized Anxiety Questionnaire is a 7 item self- report measure (score range 0-21) to assess anxiety, with the following cut-off categories: Mild (5-9), moderate (10-14), severe (15-21).
    The Alcohol Use Disorders Identification Test
    The Alcohol Use Disorders Identification Test is a 10 item self-report measure (score range 0-40) that assesses alcohol consumption. A cut-off of 8 and 6, indicates a hazardous and harmful pattern of alcohol consumption for men and women, respectively.
    The Drug Use Disorders Identification Test
    The Drug Use Disorders Identification Test is a 11 item self-report measure (score range 0-44) to identify and assess non-alcohol drug use patterns. A cut-off score of 6 and 2 indicates problematic drug use for men and women, respectively; and a score of ≥25 indicates heavily dependence on drugs.
    Housing status
    The degree of homelessness was assessed with the questions "When was the last time that you had a housing of your own?" and "Where did you sleep last night?", with response alternatives based upon the Swedish national definition of homelessness: "Outside"; "At a shelter"; "In a temporary (sober) residential institution", "In a reference-based training or trial apartment", or "In my own apartment (own lease)". In addition, information of the participants' housing status was collected from the registers of the social welfare office for the homeless at baseline and follow up.
    The Credibility/Expectancy Questionnaire
    Treatment credibility and expectancy was measured with the Credibility/Expectancy Questionnaire (score ranges credibility 1-19, and expectancy 0-100%, respectively). Higher scores indicate higher treatment credibility/expectancy.
    The Client Satisfaction Questionnaire
    Treatment satisfaction was measured with the Client Satisfaction Questionnaire (score range 8-32). Higher scores indicate higher treatment satisfaction.
    Adverse events
    The participants reported adverse events using a self-report measure adapted for psychological treatment. The adverse events measure does not include a total score or a score range, instead each adverse event experienced during treatment is reported. For each adverse event reported participant also rated the discomfort caused by the event when it occurred, as well as residual discomfort (level of discomfort at the time of assessment). Each adverse event reported is rated between 0 ("did not affect me at all") and 3 ("affected me very negatively").

    Full Information

    First Posted
    March 21, 2022
    Last Updated
    April 8, 2022
    Sponsor
    Karolinska Institutet
    Collaborators
    Ersta Diakoni
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05329181
    Brief Title
    Integrated Cognitive Behavioral Treatment for Substance Use and Depressive Symptoms: a Homeless Case Series
    Acronym
    INTER
    Official Title
    Integrated Cognitive Behavioral Treatment for Substance Use and Depressive Symptoms: A Homeless Case Series and Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2016 (Actual)
    Primary Completion Date
    January 31, 2017 (Actual)
    Study Completion Date
    January 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Karolinska Institutet
    Collaborators
    Ersta Diakoni

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    All study participants were clients at the social welfare office for the homeless, a specialized unit within the social services in Stockholm, Sweden. The participants were referred to outpatient treatment at Pelarbacken, a specialized primary care center for homeless patients. The integrated cognitive behavioral treatment was developed as part of a collaborate treatment program between the social welfare office for the homeless and Pelarbacken. Post treatment interviews and individual behavioral analyses of prior patients showed that the far most common reason for alcohol or drug use, was coping with negative affect (46% reported this reason). The integrated cognitive behavioral treatment was developed emanating from the following analysis (1) being homeless often implicates having lost contact with several important life areas, substance use might be the only reinforcing activity left; (2) common reactions are stress and depressive symptoms, and avoidance based strategies such as passivity, isolation, avoidance of social contact, or substance use; (3) when decreasing substance use, a transient approximate 3 month period of increased "depression-like" symptoms occurs, which might lead to lapses or relapses (this period is also called post-acute abstinence, or protracted abstinence). The ICBT (5-15 sessions) was developed to extend over this time period, with the overall aim of participants to (1) access a stable, sober housing milieu, and decrease substance use; (2) learn strategies to cope with negative affect; and (3) learn strategies to cope with life changes, increase activities such as work, social contact, exercise or leisure activities. Measures were administered at pre treatment, weekly during treatment, after treatment, and at 3-, 6- and 12-month following treatment cessation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cognitive Behavioral Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    4 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Integrated cognitive behavioral therapy adapted for homeless individuals
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Integrated cognitive behavioral treatment
    Intervention Description
    Integrated cognitive behavioral treatment adapted specifically for homeless individuals and developed to treat substance use and depressive symptoms simultaneously
    Primary Outcome Measure Information:
    Title
    The TimeLine Follow Back
    Description
    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.
    Time Frame
    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 Outcome Measure Information:
    Title
    The Patient Health Questionnaire
    Description
    The Patient Health Questionnaire is a 9-item self-report measure (score range 0-27) that assesses depression severity with the following cut-off categories: None-minimal (0-4), mild (5-9), moderate (10-14), moderately-severe (15-19), severe (20-27).
    Time Frame
    1 week
    Title
    The Generalized Anxiety Questionnaire
    Description
    The Generalized Anxiety Questionnaire is a 7 item self- report measure (score range 0-21) to assess anxiety, with the following cut-off categories: Mild (5-9), moderate (10-14), severe (15-21).
    Time Frame
    2 weeks
    Title
    The Alcohol Use Disorders Identification Test
    Description
    The Alcohol Use Disorders Identification Test is a 10 item self-report measure (score range 0-40) that assesses alcohol consumption. A cut-off of 8 and 6, indicates a hazardous and harmful pattern of alcohol consumption for men and women, respectively.
    Time Frame
    1 year
    Title
    The Drug Use Disorders Identification Test
    Description
    The Drug Use Disorders Identification Test is a 11 item self-report measure (score range 0-44) to identify and assess non-alcohol drug use patterns. A cut-off score of 6 and 2 indicates problematic drug use for men and women, respectively; and a score of ≥25 indicates heavily dependence on drugs.
    Time Frame
    1 year
    Title
    Housing status
    Description
    The degree of homelessness was assessed with the questions "When was the last time that you had a housing of your own?" and "Where did you sleep last night?", with response alternatives based upon the Swedish national definition of homelessness: "Outside"; "At a shelter"; "In a temporary (sober) residential institution", "In a reference-based training or trial apartment", or "In my own apartment (own lease)". In addition, information of the participants' housing status was collected from the registers of the social welfare office for the homeless at baseline and follow up.
    Time Frame
    1 day
    Title
    The Credibility/Expectancy Questionnaire
    Description
    Treatment credibility and expectancy was measured with the Credibility/Expectancy Questionnaire (score ranges credibility 1-19, and expectancy 0-100%, respectively). Higher scores indicate higher treatment credibility/expectancy.
    Time Frame
    1 day
    Title
    The Client Satisfaction Questionnaire
    Description
    Treatment satisfaction was measured with the Client Satisfaction Questionnaire (score range 8-32). Higher scores indicate higher treatment satisfaction.
    Time Frame
    1 day
    Title
    Adverse events
    Description
    The participants reported adverse events using a self-report measure adapted for psychological treatment. The adverse events measure does not include a total score or a score range, instead each adverse event experienced during treatment is reported. For each adverse event reported participant also rated the discomfort caused by the event when it occurred, as well as residual discomfort (level of discomfort at the time of assessment). Each adverse event reported is rated between 0 ("did not affect me at all") and 3 ("affected me very negatively").
    Time Frame
    Through study completion, 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Data is not possible to share du to integrity reasons, as the study participants were patients.

    Learn more about this trial

    Integrated Cognitive Behavioral Treatment for Substance Use and Depressive Symptoms: a Homeless Case Series

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