Efficacy of Group Tobacco Cessation Interventions Among Tobacco Users With Mental Illness: Controlled Clinical Trial

NCT04013724 | Completed

• 1 other identifier: P641/09/2016
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The study seeks to provide group tobacco cessation interventions among patients who use tobacco, and who attend Mathari National referral hospital on outpatient follow up. They will also be assessed on changes in quality of life before and after provision of the intervention.

Conditions

Mental Illness

Keywords

Tobacco cessation, mental illness, tobacco dependence, Kenya

Outcome Measures

Primary Outcomes (2)

• Self reported continued tobacco use abstinence

  The study's primary outcome was self-reported continuous tobacco use abstinence, biochemically verified.

  Week 4, 12 and 26

• Health related quality of life

  Secondary outcome assessed included changes in health related quality of life as assessed by WHOQOL

  Week 26

Secondary Outcomes (2)

• Quit attempts

  Week 4, 12 and 26

• Reduction in amounts used

  Week 4, 12 and 26

Study Arms (2)

Intervention group

EXPERIMENTAL

The behavioral group intervention consisted of 6 sessions over 12 weeks and were led by 2 trained facilitators, followed by monthly group meetings from weeks 14 to 26. This program was adapted from the Royal Australian College of General Practitioners' Supporting Smoking Cessation Guide for Health Professionals17 and the World Health Organization's Strengthening Health Systems for Treating Tobacco Dependence in Primary Care training package.18 The topics that were explored during the group sessions include: 1. Introduction to the Program and Reasons to Quit 2. Benefits of Quitting and Understanding Why We Smoke and Ways of Quitting 3. Withdrawal Symptoms and Social Support 4. Dealing with Stress and Anxiety and Coping with Depression 5. Assertiveness Training and Anger Management 6. Tobacco-Free Lifestyle and Dealing with High Risk Situations

Behavioral: Group tobacco cessation interventions

Control

NO INTERVENTION

The control group was provided questionnaires to fill at the end of Weeks 4, 12, and 26. During the rest of the study, they continued receiving usual care, including clinical care at CSAT.

Interventions

Group tobacco cessation interventions BEHAVIORAL

Group Session Week 1 Participants were introduced to the specific components of the group behavioral intervention. Participants shared their expectations and experiences in their goal of tobacco cessation. Group Sessions Weeks 2-11 Participants set their anticipated quit date on the 2nd week. During weeks 2 through 11, before the start of the session, feelings of participants were explored, the previous week's self-reported tobacco consumption or cessation attempt was recorded. The topic of each week was explored first by lecture to explain the topic, and then group members took turns sharing their experiences on the topic. Group Sessions Weeks 14-26 Behavioral group sessions weeks 14-26 were conducted once a month. Each session began with a round of discussion on how participants were feeling about their cessation attempts, including any challenges they had experienced. The self-reported amount of tobacco used and quit attempts were documented.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and above.
• History of tobacco use for more than 6 months.
• A Fagerstrom score of 6 and above, which is a threshold consistent with dependence.16
• Currently on outpatient follow up treatment for a diagnosed mental health condition.
• Willing to be part of the study for 6 months.

You may not qualify if:

• Patients on nicotine replacement therapy (NRT) or other pharmacotherapy for tobacco cessation.
• Patients currently experiencing severe psychotic episodes judged by their treating health care provider.
• Patients who would not be able to commit to the group sessions, defined as those who would not be able to attend group sessions for any reason, including transport-related reasons.

Sponsors & Collaborators

• University of Nairobi: lead

Study Sites (1)

Mathari Treatment and Referral Hospital

Nairobi, Kenya

Location

Related Publications (23)

• World Health Organization. International Classification of Diseases (ICD-10) and Health Problems. Geneva, Switzerland. 2015

  BACKGROUND

• American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders (Fifth version). Arlington, VA: American Psychiatric Association. 2013

  BACKGROUND

• Action on Smoking and Health (ASH) Fact sheet. Smoking and Mental Health. 2016. Available at: http://ash.org.uk/category/information-and-resources/fact-sheets/. Accessed 15 May 2019.

  BACKGROUND

• Heiligenstein E, Smith SS. Smoking and mental health problems in treatment-seeking university students. Nicotine Tob Res. 2006 Aug;8(4):519-23. doi: 10.1080/14622200600789718.

  PMID: 16920649 BACKGROUND

• Brown C. Tobacco and Mental Health: A review of the literature. Edinburgh: ASH Scotland. 2004

  BACKGROUND

• Royal College of Psychiatrists. Liaison Psychiatry for acute hospital: Integrated mental and physical healthcare. London: College Report, Royal College of Psychiatrists. 2013

  BACKGROUND

• John U, Meyer C, Rumpf HJ, Hapke U. Smoking, nicotine dependence and psychiatric comorbidity--a population-based study including smoking cessation after three years. Drug Alcohol Depend. 2004 Dec 7;76(3):287-95. doi: 10.1016/j.drugalcdep.2004.06.004.

  PMID: 15561479 BACKGROUND

• Weir, K. Smoking and mental illness. American Psychological Association Science Watch. 2013; 44 (6): 36.

  BACKGROUND

• Hall SM, Prochaska JJ. Treatment of smokers with co-occurring disorders: emphasis on integration in mental health and addiction treatment settings. Annu Rev Clin Psychol. 2009;5:409-31. doi: 10.1146/annurev.clinpsy.032408.153614.

  PMID: 19327035 BACKGROUND

• Cavazos-Rehg PA, Breslau N, Hatsukami D, Krauss MJ, Spitznagel EL, Grucza RA, Salyer P, Hartz SM, Bierut LJ. Smoking cessation is associated with lower rates of mood/anxiety and alcohol use disorders. Psychol Med. 2014 Sep;44(12):2523-35. doi: 10.1017/S0033291713003206.

  PMID: 25055171 BACKGROUND

• Prochaska JJ, Delucchi K, Hall SM. A meta-analysis of smoking cessation interventions with individuals in substance abuse treatment or recovery. J Consult Clin Psychol. 2004 Dec;72(6):1144-56. doi: 10.1037/0022-006X.72.6.1144.

  PMID: 15612860 BACKGROUND

• Gulliver SB, Wolfsdorf BA, Morissette SB. Treating tobacco dependence: Development of a smoking cessation treatment program for outpatient mental health clinics. Cogn Behav Pract. 2004; 11, 315-330

  BACKGROUND

• Morris CD, Tedeschi GJ, Waxmonsky JA, May M, Giese AA. Tobacco quitlines and persons with mental illnesses: perspective, practice, and direction. J Am Psychiatr Nurses Assoc. 2009 Feb;15(1):32-40. doi: 10.1177/1078390308330050.

  PMID: 21665792 BACKGROUND

• Tsoi DT, Porwal M, Webster AC. Interventions for smoking cessation and reduction in individuals with schizophrenia. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD007253. doi: 10.1002/14651858.CD007253.pub3.

  PMID: 23450574 BACKGROUND

• Bron C, Zullino D, Besson J, Borgeat F. [Smoking in psychiatry, a neglected problem]. Praxis (Bern 1994). 2000 Oct 19;89(42):1695-9. French.

  PMID: 11105610 BACKGROUND

• Fagerstrom KO, Schneider NG. Measuring nicotine dependence: a review of the Fagerstrom Tolerance Questionnaire. J Behav Med. 1989 Apr;12(2):159-82. doi: 10.1007/BF00846549.

  PMID: 2668531 BACKGROUND

• The Royal Australian College of General Practitioners. Supporting smoking cessation: Guide for health professionals. Royal College of General Practitioners. Melbourne, Australia. 2011

  BACKGROUND

• World Health Organization. Strengthening health systems for treating tobacco dependence in primary care: Building capacity for tobacco control: Training package.Geneva, Switzerland. 2013

  BACKGROUND

• Bentz CJ, Bayley KB, Bonin KE, Fleming L, Hollis JF, Hunt JS, LeBlanc B, McAfee T, Payne N, Siemienczuk J. Provider feedback to improve 5A's tobacco cessation in primary care: a cluster randomized clinical trial. Nicotine Tob Res. 2007 Mar;9(3):341-9. doi: 10.1080/14622200701188828.

  PMID: 17365766 BACKGROUND

• Buckley TC, Mozley SL, Holohan DR, Walsh K, Beckham JC, Kassel JD. A psychometric evaluation of the Fagerstrom Test for Nicotine Dependence in PTSD smokers. Addict Behav. 2005 Jun;30(5):1029-33. doi: 10.1016/j.addbeh.2004.09.005.

  PMID: 15893100 BACKGROUND

• Study protocol for the World Health Organization project to develop a Quality of Life assessment instrument (WHOQOL). Qual Life Res. 1993 Apr;2(2):153-9.

  PMID: 8518769 BACKGROUND

• Mas-Exposito L, Amador-Campos JA, Gomez-Benito J, Lalucat-Jo L; Research Group on Severe Mental Disorder. The World Health Organization Quality of Life Scale Brief Version: a validation study in patients with schizophrenia. Qual Life Res. 2011 Sep;20(7):1079-89. doi: 10.1007/s11136-011-9847-1. Epub 2011 Feb 3.

  PMID: 21290191 BACKGROUND

• Olando Y, Kuria M, Mathai M, Huffman MD. Efficacy of a group tobacco cessation behavioral intervention among tobacco users with concomitant mental illness in Kenya: protocol for a controlled clinical trial. BMC Public Health. 2019 Dec 18;19(1):1700. doi: 10.1186/s12889-019-8040-2.

  PMID: 31852536 DERIVED

MeSH Terms

Conditions

Mental Disorders; Tobacco Use Cessation; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Yvonne Olando

  University of Nairobi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: At the group assessments (Weeks 4, 12, and 26), participants who reported continued tobacco use abstinence and consented to a saliva test were tested using a nicotine cotinine strip (Devon Medical: Nicotine/tobacco test kit). The saliva tests were evaluated by the nurses working at the hospital who were blinded to treatment allocation and were not otherwise part of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist

Model Details: The participants in the intervention group were introduced to a structured group tobacco cessation program. They met twice a month, for a period of 3 months, then were followed up once a month for a period of 3 months. Each meeting session lasted for a period of 45 minutes. They shared their feelings, and experiences with cessation attempt at the beginning of each session. The facilitator then documented their quit attempts, any changes in numbers of cigarettes smoked, and any challenges with cessation attempts noted. The facilitator then introduced the topic of the day and facilitated discussion on the same. Where skills practice was involved, the facilitator demonstrated to the participants how to apply the skill.

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 10, 2019
• Study Start: April 10, 2017
• Primary Completion: July 5, 2019
• Study Completion: August 9, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available after analysis is complete. This should be in November 2019.
• Access Criteria: On request

Locations

KE (1)