Understanding the Person, Exploring Change Across Psychotherapies

NCT04106713 | Unknown DMC

• 1 other identifier: 2018/01184
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Identifying predictors and understanding mechanisms of change will inform referral to psychotherapy, triage and right-siting by helping clinicians to understand how their patients are likely to benefit from clinical interventions. This study will be the first of its kind conducted in an Asian hospital setting to identify the predictors of response to individual, group and internet-delivered CBT for the treatment of depressed and anxious patients in the Institute of Mental Health (IMH), Singapore. With increasing challenges with hospital workload, there is an increasing emphasis on group and online interventions. Understanding of the factors that may predict outcome from these therapies can improve right-siting by identifying who will get better without therapy or who may not benefit from a given form of therapy and guide personalisation of care. An important biological predictor of outcome is likely to be genetic risk as it has been demonstrated that patients with greater melancholia and a family history may not be sufficiently treated with brief courses of therapy. Identifying psychological factors underlying psychological distress and determining the extent to which these factors are addressed by these interventions will help to improve and individualise existing psychotherapy and motivate new psychotherapeutic interventions.

Conditions

Depression; Anxiety Disorders

Keywords

Psychotherapy; Cognitive behavioural therapy; Group psychotherapy; Internet-based psychotherapy

Outcome Measures

Primary Outcomes (4)

• Change in Patient Health Questionnaire-9 (PHQ-9) score

  Depression scale. Total scores range from 0 to 27, with higher scores representing more severe depression.

  Immediately before each therapy session for 8 sessions (i.e. 8 weeks for iCBT and group therapy, or approximately 16 weeks for individual therapy), and at follow-up every 3 months up to 2 years.

• Change in Generalized Anxiety Disorder-7 (GAD-7) questionnaire score

  Anxiety scale. Total scores range from 0 to 21, with higher scores representing more severe anxiety.

  Immediately before each therapy session for 8 sessions (i.e. 8 weeks for iCBT and group therapy, or approximately 16 weeks for individual therapy), and at follow-up every 3 months up to 2 years.

• Change in Outcome Rating Scale (ORS) score

  Measure assessing general well-being. Total scores range from 0 to 40, with higher scores representing better general well-being.

  Immediately before each therapy session for 8 sessions (i.e. 8 weeks for iCBT and group therapy, or approximately 16 weeks for individual therapy).

• Change in Work and Social Adjustment Scale (WSAS) score

  The WSAS is a self-report scale of functional impairment attributable to an identified problem. Total scores range from 0 to 40, with higher scores representing greater functional impairment.

  At baseline, at post-intervention (immediately after the final therapy session i.e. at 8 weeks for iCBT and group therapy, or at approximately 16 weeks for individual therapy), and at follow-up every 3 months up to 2 years.

Secondary Outcomes (30)

• Change in Self-Referential Encoding Task (SRET) performance

  At baseline, at post-intervention (immediately after the final therapy session i.e. at 8 weeks for iCBT and group therapy, or at approximately 16 weeks for individual therapy), and at follow-up every 3 months up to 2 years.

• Change in Implicit Association Task (IAT) performance

  At baseline, and at post-intervention (immediately after the final therapy session i.e. at 8 weeks for iCBT and group therapy, or at approximately 16 weeks for individual therapy).

• Change in Partner Go/No Go Association Task (P-GNAT) performance

  At baseline, and at post-intervention (immediately after the final therapy session i.e. at 8 weeks for iCBT and group therapy, or at approximately 16 weeks for individual therapy).

• Change in Go/No Go Association Task (GNAT) performance

  At baseline, and at post-intervention (immediately after the final therapy session i.e. at 8 weeks for iCBT and group therapy, or at approximately 16 weeks for individual therapy).

• Change in Letter-number Sequencing Task performance

  At baseline, and at post-intervention (immediately after the final and final therapy session i.e. at 8 weeks for iCBT and group therapy, or at approximately 16 weeks for individual therapy).

Other Outcomes (16)

• Personality Inventory for DSM-5-Brief Form (PID-5-BF)

  At baseline.

• Eysenck Personality Questionnaire-Revised Short Form Neuroticism Scale (EPQ-R-S-N)

  At baseline.

• Life Experiences Checklist (LEC)

  At baseline, and at follow-up every 3 months up to 2 years.

Study Arms (5)

Individual Therapy

EXPERIMENTAL

The individual therapy program will differ in orientation according to therapist and session notes will be coded according to the Comparative Psychotherapy Process Scale. Therapy sessions take place approximately once every fortnight, with 8 sessions in total, according to the agreed-upon schedule.

Behavioral: Individual Psychotherapy

Internet-delivered Cognitive Behavioural Therapy (iCBT)

EXPERIMENTAL

The iCBT program (clinician follow-up with the therapist and 4 online modules) will be administered for 8 weeks. The four modules: "1) psychoeducation about emotions, including a functional nature of emotions; 2) alteration of antecedent cognitive misappraisals; 3) prevention of emotional avoidance; and 4) modification of emotion-driven \[behaviours\] (EDBs)", are adapted from The Unified Protocol (UP) for transdiagnostic treatment of emotional disorders. UP is a CBT consisting of four overarching themes- "increasing emotional awareness, facilitating flexibility in appraisals, identifying and preventing \[behavioural\] and emotional awareness, and situational and interoceptive exposure to emotion cues".

Behavioral: Internet-delivered Cognitive Behavioural Therapy (iCBT)

Group CBT

EXPERIMENTAL

The group CBT program (for e.g. PsychUp) will be conducted over 8 weeks, with weekly 2-hour sessions. Each group consists of 4-8 patients and are facilitated by two practicing clinical psychologists and one clinical psychologist in training. Sessions are structured such that each session, except the first, begins with a brief review of previous session material and a collaborative review of homework. This is followed by introduction of new material and completion of any in-session exercises, with sessions concluding with homework assignment. Specific treatment content is similarly adapted from UP. Session 1 begins by covering psychoeducation on the CBT model of pathological depression and anxiety and the role of avoidance in maintenance of symptoms. Sessions 2 to 7 covers goal-setting, cognitive reappraisal and development of adaptive emotional coping strategies through situational emotion-focused exposures. Session 8 ends with a discussion on relapse prevention.

Behavioral: Group Cognitive Behavioural Therapy (group CBT)

Delayed Waitlist

NO INTERVENTION

Participants in the Waitlist group will be recruited from those referred for psychotherapy and who are not assigned to either group or iCBT and not planned for psychotherapy at IMH for 8 weeks or more from the point of consent.

Treatment as Usual (TAU)

NO INTERVENTION

Participants in the Treatment as Usual (TAU) group are individuals who are not assigned to psychotherapy at IMH. They will be recruited from outpatient services and emergency services at IMH.

Interventions

Individual Psychotherapy BEHAVIORAL

The individual therapy program will differ in orientation according to therapist and session notes will be coded according to the Comparative Psychotherapy Process Scale. Therapy sessions take place approximately once every fortnight, with 8 sessions in total, according to the agreed-upon schedule.

Individual Therapy

Internet-delivered Cognitive Behavioural Therapy (iCBT) BEHAVIORAL

The iCBT program (clinician follow-up with the therapist and 4 online modules) will be administered for 8 weeks. The four modules: "1) psychoeducation about emotions, including a functional nature of emotions; 2) alteration of antecedent cognitive misappraisals; 3) prevention of emotional avoidance; and 4) modification of emotion-driven \[behaviours\] (EDBs)", are adapted from The Unified Protocol (UP) for transdiagnostic treatment of emotional disorders. UP is a CBT consisting of four overarching themes- "increasing emotional awareness, facilitating flexibility in appraisals, identifying and preventing \[behavioural\] and emotional awareness, and situational and interoceptive exposure to emotion cues".

Internet-delivered Cognitive Behavioural Therapy (iCBT)

Group Cognitive Behavioural Therapy (group CBT) BEHAVIORAL

The group CBT program (for e.g. PsychUp) will be conducted over 8 weeks, with weekly 2-hour sessions. Each group consists of 4-8 patients and are facilitated by two practicing clinical psychologists and one clinical psychologist in training. Sessions are structured such that each session, except the first, begins with a brief review of previous session material and a collaborative review of homework. This is followed by introduction of new material and completion of any in-session exercises, with sessions concluding with homework assignment. Specific treatment content is similarly adapted from UP. Session 1 begins by covering psychoeducation on the CBT model of pathological depression and anxiety and the role of avoidance in maintenance of symptoms. Sessions 2 to 7 covers goal-setting, cognitive reappraisal and development of adaptive emotional coping strategies through situational emotion-focused exposures. Session 8 ends with a discussion on relapse prevention.

Group CBT

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For patients:
• years old;
• have current or past symptoms of anxiety and/or depression;
• able to communicate and read in English;
• able to provide informed consent.
• Waitlist arm:
• \- Referred for psychotherapy but given a waiting time of 8 weeks or more to the first visit or not assigned to therapy at IMH.
• Treatment as usual:
• \- Not assigned to any psychotherapeutic interventions.
• iCBT: - Referred for iCBT;
• \- Identified as a 'P2' patient/appropriate for iCBT by triage.
• Group therapy:
• \- Referred for group therapy;
• \- Identified as a 'P2' patient/appropriate for group therapy by triage.
• Individual psychotherapy:

You may not qualify if:

• \. For patients:
• current active suicidal intention or plan;
• cognitively-impaired/are unable to consent/lack capacity to consent.

Sponsors & Collaborators

• Institute of Mental Health, Singapore: lead

Study Sites (1)

Institute of Mental Health, Singapore

Singapore, 539747, Singapore

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Geoffrey CY Tan

  Institute of Mental Health, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Geoffrey CY Tan

CONTACT

+65 63891923; geoffrey_tan@imh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 27, 2019
• Study Start: October 4, 2019
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2023
• Last Updated: October 8, 2019

Record last verified: 2019-09

Locations

SG (1)