Cognitive Behavioral Therapy Clinical Trial
— INTEROfficial title:
Integrated Cognitive Behavioral Treatment for Substance Use and Depressive Symptoms: A Homeless Case Series and Feasibility Study
NCT number | NCT05329181 |
Other study ID # | INTER |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2016 |
Est. completion date | January 31, 2017 |
Verified date | April 2022 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 4 |
Est. completion date | January 31, 2017 |
Est. primary completion date | January 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Ersta Diakoni |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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). | 1 week | |
Secondary | 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). | 2 weeks | |
Secondary | 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. | 1 year | |
Secondary | 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. | 1 year | |
Secondary | 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. | 1 day | |
Secondary | 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. | 1 day | |
Secondary | The Client Satisfaction Questionnaire | Treatment satisfaction was measured with the Client Satisfaction Questionnaire (score range 8-32). Higher scores indicate higher treatment satisfaction. | 1 day | |
Secondary | 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"). | Through study completion, 1 year |
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