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Cognitive Behavioral TherapyINTERNCT05329181

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

A study testing Integrated cognitive behavioral treatment in people with Cognitive Behavioral Therapy, run by Karolinska Institutet.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 65 years
Conditions the study is for
Cognitive Behavioral Therapy
What is being tested?
Integrated cognitive behavioral treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
No sites listed yet
Study dates
1 Jun 2016to 31 Jan 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official title: Integrated Cognitive Behavioral Treatment for Substance Use and Depressive Symptoms: A Homeless Case Series and Feasibility Study

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.

Read the 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.

Being tested
Integrated cognitive behavioral treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Integrated cognitive behavioral treatmentBehavioural

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

Study groups in NCT05329181
Study groupRoleWhat they receive
Integrated cognitive behavioral therapy adapted for homeless individualsOtherFour 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.
Receives: Behavioral: Integrated cognitive behavioral treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. 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).

    Measured: 1 week

  2. 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).

    Measured: 2 weeks

  3. 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.

    Measured: 1 year

  4. 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.

    Measured: 1 year

  5. 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.

    Measured: 1 day

  6. 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.

    Measured: 1 day

  7. The Client Satisfaction Questionnaire

    Treatment satisfaction was measured with the Client Satisfaction Questionnaire (score range 8-32). Higher scores indicate higher treatment satisfaction.

    Measured: 1 day

  8. 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").

    Measured: Through study completion, 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2022
  2. Study start1 Jun 2016
  3. Primary completion31 Jan 2017
  4. Study completion31 Jan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05329181
Sponsor's protocol ID
INTER
Acronym
INTER
Status last verified
Apr 2022
First submitted
21 Mar 2022
Last updated
14 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data is not possible to share du to integrity reasons, as the study participants were patients.

Publications

  • 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.

    PubMed 37147667

Questions about this trial

What is this clinical trial studying?

A study testing Integrated cognitive behavioral treatment in people with Cognitive Behavioral Therapy, run by Karolinska Institutet.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The TimeLine Follow Back (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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05329181, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.

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