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
About this trial
This is an interventional treatment trial for Cognitive Behavioral Therapy
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.
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
NCT ID
NCT05329181
First Posted
March 21, 2022
Last Updated
April 8, 2022
Sponsor
Karolinska Institutet
Collaborators
Ersta Diakoni
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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