Cognitive behavioural therapy and hypnosis in the treatment of major depressive disorder: A randomised control trial

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2020
INTERVENTION: Treatment 1: cognitive behavioural therapy with hypnosis (CBTH). Participants will receive group based therapy for 10 consecutive weeks, lasting approx. 100 minutes (plus a midway break). Participants in this group will receive a 'therapy file' which will contain weekly handouts covering the main themes for each treatment session, group exercise worksheets and self‐report sheets (e.g. activity based self‐monitoring forms, thought record forms), all of which have been specifically designed for this study. The main themes of each treatment session are: Session 1: Welcome Group rules and expectations Psycho‐education on Major Depression Group Exercise: Why change? Roadblocks to change? Home practice task assigned Session 2: Review home practice Session 1 Sleep and sleep hygiene Goal setting: Specific, Measurable, Achievable, Realistic, Time (SMART) system, graded tasks, implementation intentions Group exercise: goal setting for sleep Home practice task assigned Session 3: Review home practice Session 2 Automaticity, routine and daily activity Increasing self awareness Activity Scheduling Part I: Increasing fun and pleasure Group exercise: Goal setting for fun and pleasure Home practice task assigned Session 4: Review home practice Session 3 Ac CONDITION: Depression; ; Depression Mental Health ‐ Depression PRIMARY OUTCOME: ; Clinically Useful Anxiety Outcome Scale (CUXOS) [At four time points:; ‐Baseline (Jan/Feb 2020); ‐Post‐treatment (April 2020); ‐6month follow‐up (Oct 2020) [primary timepoint]; ‐12month follow‐up (April 2021)]; ; Clinically Useful Depression Outcome Scale (CUDOS)[There will be 5 intakes of two groups over about 15 months. The 4 time points will vary across the 5 intakes. For example, Intake 1 the time points are show in brackets:; ‐Baseline (Jan/Feb 2020); ‐Post‐treatment (April 2020); ‐6month follow‐up (Oct 2020) [primary timepoint]; ‐12month follow‐up (April 2021)]; ; Montgomery Asberg Depression Rating Scale – Clinician[At four time points:; ‐Baseline (Jan/Feb 2020); ‐Post‐treatment (April 2020); ‐6month follow‐up (Oct 2020) [primary timepoint]; ‐12month follow‐up (April 2021)]; SECONDARY OUTCOME: ; Cognitive Behaviour Therapy Survey Questionnaire ; Factor analysis shows that there are two primary factors being measured by this survey‐ behavioural activation and cognitive restructuring. I am interested in assessing both of these factors. ; [At 12 time points: ; ‐Baseline (Jan/Feb 2020) ; ‐Sessions 1‐9 (Feb‐Apr 2020) ; ‐Post‐treatment (April 2020) ; ‐6month follow‐up (Oct 2020) [primary time point] ; ‐12month follow‐up (April 2021)] ; ; Home Practice Scale ‐ a measure designed for this research. ; The outcome being assessed is compliance.[Weekly, across the 10 sessions: ; ‐Session 1 Feb (2020) ‐ Session 10 April (2020) ; ] ; ; Overall Anxiety Severity and Intensity Scale (OASIS) [Weekly, across the 10 sessions: ; ‐Session 1 Feb (2020) ‐ Session 9 April (2020) ; ] ; ; Patient Health Questionnaire (PHQ‐9)[Used as a screening questionnaire ; Then weekly, across 10 sessions: ; ‐Session 1 Feb (2020) ‐ Session 9 April (2020) ; ] ; ; PROMIS Sleep Disturbance ‐ Short Form B[At 12 time points: ; ‐Baseline (Jan/Feb 2020) ; ‐Sessions 1‐9 (Feb‐Apr 2020) ; ‐Post‐treatment (April 2020) ; ‐6month follow‐up (Oct 2020) [primary time point] ; ‐12month follow‐up (April 2021)] ; ; Quality of Life Enjoyment and Satisfaction Questionnaire ‐ Short Form[At four time points: ; ‐Baseline (Jan/Feb 2020) ; ‐Post‐treatment (April 2020) ; ‐6month follow‐up (Oct 2020) ; ‐12month follow‐up (April 2021)] ; ; Ruminative Response Scale‐ Short Form[At 12 time points: ; ‐Baseline (Jan/Feb 2020) ; ‐Sessions 1‐9 (Feb‐Apr 2020) ; ‐Post‐treatment (April 2020) ; ‐6month follow‐up (Oct 2020) [primary time point] ; ‐12month follow‐up (April 2021)] ; ; The Credibility/Expectancy Questionnaire[At baseline ; Then weekly, across the 10 sessions: ; ‐Session 1 Feb (2020) ‐ Session 10 April (2020) ; ] ; INCLUSION CRITERIA: 1. Aged between 18‐65 years; 2. Competency in English (both reading comprehension and written); 3. MDD diagnosed on a clinical interview using the MINI (and screened online using the PHQ‐9); 4. No active suicidal ideation; 5. Does not have a disqualifying co‐morbid diagnosis based on the MINI (i.e. Bi‐polar Disorder, Psychosis, Personality Disorder, Alcohol/Drug Dependence, OCD or a primary Eating Disorder); 6. Is not currently receiving psychotherapy (or has in the past 12 months); 7. Can attend 10 weekly sessions during the time frame specified; 8. Is agreeable to being contacted by research assistants for telephonic and electronic based follow up assessments at 6 and 12 months post treatment; 9. Is agreeable to being randomly assigned to one of two treatment groups.
Epistemonikos ID: 64f991af6b5d3f28f38a493bc92132a9a8f23ba6
First added on: Aug 24, 2024