NCT02835144

Brief Summary

The prevalence of addictive disorders in old age is increasing. Age specific and appropriate therapeutic concepts tailored to in-patients thus represent a promising approach for the future. The investigated therapeutic intervention is a "therapy program for integrated qualified acute treatment of alcohol and drug problems" (TIQAAM).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

February 2, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2017

Completed
Last Updated

November 21, 2017

Status Verified

November 1, 2017

Enrollment Period

10 months

First QC Date

July 13, 2016

Last Update Submit

November 20, 2017

Conditions

Substance Use Disorder

Outcome Measures

Primary Outcomes (1)

  • change in the total score of the Hospital Anxiety and Depression Scale - German version (HADS-D)

    210 days

Study Arms (2)

TIQAAM_therapy

EXPERIMENTAL

Individuals in this group will receive units from the TIQAAM treatment program

Other: TIQAAM_therapy

active_control

ACTIVE COMPARATOR

Individuals in this group will receive units of psychoeducation

Other: Psychoeducation

Interventions

TIQAAM_therapyOTHER

The treatment program consists of TIQAAM therapy blocks to three priority areas: promoting change and motivation, relapse prevention and relapse management, and promote resource and euthymic activities to increase the abstinence motivation. The TIQAAM is based on behavioral approaches as well as motivational interviewing of Miller and Rollnick.

TIQAAM_therapy
PsychoeducationOTHER

This intervention is a psychoeducation module pertaining to substance use disorders.

active_control

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Subjects aged 65 or above with, according to WHO-ASSIST V3.0, a hazardous consumption of alcoholic beverages and / or benzodiazepines and / or non-benzodiazepine hypnotics (zolpidem, zopiclone, zaleplon)
  • The subjects must be able to understand verbal and written information about the study flow and content and to give their written consent.
  • The subjects must be able to understand and perform verbal and written tasks (cognitive tests / questionnaires)

You may not qualify if:

  • Taking medication that could affect cognition outside of benzodiazepines and / or non-benzodiazepine hypnotics (zolpidem, zopiclone, zaleplon).
  • Drug treatments with anxiolytics (benzodiazepines) as part of an ongoing drug-assisted detoxification
  • Taking antidepressant medication
  • Taking sleep-inducing substances (for example Dipiperon®, Trittico®, Valverde Sleep® or Valverde Entspannung®)
  • Taking other anxiolytic active substances (for example, pregabalin, Opipramol). The use of medication is allowed to treat somatic diseases.
  • Use of drugs or substance dependence. Except for alcohol, benzodiazepines and non-benzodiazepine hypnotics (zolpidem, zopiclone, zaleplon)
  • Diseases which prevent the subject from giving consent for this study or which impair cooperation in the investigation.
  • Severe and / or unstable physical illness: severe depression, severe mania, delirium, severe cognitive impairment (mini-mental status test \< 20/30 points), dementia of the Alzheimer type or other dementias, multiple sclerosis, clinically manifest structural brain damage (eg cerebral hemorrhage, brain tumors, MRI findings by Schulthess clinic)
  • Heavily impaired vision and eye diseases
  • Pacemaker, implantable cardioverter defibrillator (ICD), neurostimulator, aneurysm clip, prosthetic heart valve, valve prosthesis, metal prosthesis
  • Clips after surgery, metallic bone plates, artificial joints, metal fragments in the body, professional in the metal processing industry, non-removable piercing, ferruginous tattoo ink
  • Pregnancy
  • Claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gerontopsychiatrisches Zentrum Hegibach

Zurich, 8032, Switzerland

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Egemen Savaskan, Prof. Dr. med.

    Klinik für Alterspsychiatrie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 15, 2016

Study Start

February 2, 2017

Primary Completion

November 15, 2017

Study Completion

November 15, 2017

Last Updated

November 21, 2017

Record last verified: 2017-11

Locations

CH(1)