Understanding the Person, Exploring Change Across Psychotherapies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorInstitute of Mental Health, Singapore
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-99 years old;
have current or past symptoms of anxiety and/or depression;
able to communicate and read in English;
able to provide informed consent.
Disqualifiers
current active suicidal intention or plan;
cognitively-impaired/are unable to consent/lack capacity to consent.
Trial design
Design model
Parallel
Treatments tested in this trial
Individual Psychotherapy
BehavioralThe 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.
Internet-delivered Cognitive Behavioural Therapy (iCBT)
BehavioralThe 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".
Group Cognitive Behavioural Therapy (group CBT)
BehavioralThe 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.
Treatment groups
250 Participants
are divided into 5 treatment groupsGroup A: Individual TherapyExperimental treatment 1 intervention
Group B: Internet-delivered Cognitive Behavioural Therapy (iCBT)Experimental treatment 1 intervention
Group C: Group CBTExperimental treatment 1 intervention
Group D: Delayed WaitlistNo intervention 0 interventions
Group E: Treatment as Usual (TAU)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
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.2
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.
Time frame
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.3
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.
Time frame
Immediately before each therapy session for 8 sessions (i.e. 8 weeks for iCBT and group therapy, or approximately 16 weeks for individual therapy).4
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.
Time frame
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
1
Change in Self-Referential Encoding Task (SRET) performance
The SRET is a computerized task which involves a self-descriptive judgment phase where participants respond to trait adjectives presented as describing or not describing them, followed by a later recall phase where they attempt to remember the words presented. Only the self-descriptive judgment phase will be included in this study. Words from an SRET validated in predicting depressive relapse, the Revised Interpersonal Adjective Scales: Big Five Version (IASR-B5), as well as words based on the life events used in the LEC, will be incorporated into the SRET as the trait adjectives used in the self-descriptive judgment phase. The self-descriptive judgment phase of the SRET, as a measure of negative implicit self-referential cognition, is associated strongly with depression.
Time frame
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.2
Change in Implicit Association Task (IAT) performance
The IAT is a computerized task which can be used to measure subconscious associations between mental representations of different concepts. For this study, it is designed specifically to assess attitudes towards therapy.
Time frame
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).3
Change in Partner Go/No Go Association Task (P-GNAT) performance
The P-GNAT is a computerized task which is an implicit measure assessing personal evaluations of another individual. For this study, it is designed specifically to assess attitudes towards the therapist.
Time frame
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).4
Change in Go/No Go Association Task (GNAT) performance
The GNAT is a computerized task to assess inhibitory control and processing speed.
Time frame
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).Other outcomes
1
Personality Inventory for DSM-5-Brief Form (PID-5-BF)
The PID-5-BF measures pathological personality traits in 5 dimensions: negative affect, detachment, antagonism, disinhibition, and psychoticism. Each subscale score ranges from 4 to 20, with higher scores representing a greater degree of each trait.
Time frame
At baseline.2
Eysenck Personality Questionnaire-Revised Short Form Neuroticism Scale (EPQ-R-S-N)
The EPQ-R-S-N measures neuroticism as a personality trait. Total scores range from 0 to 12, with higher scores representing higher levels of neuroticism.
Time frame
At baseline.3
Life Experiences Checklist (LEC)
Assesses the number and types of stressful life events experienced, as well as the degree of stress experienced in each.
Time frame
At baseline, and at follow-up every 3 months up to 2 years.4
Childhood Trauma Questionnaire (CTQ)
The CTQ measures traumatic events in childhood across the types of death of a loved one, parental conflict, victim of physical violence, illness or injury, sexual abuse, and others. Responses for each type of trauma are measured on 2 scales: 1. severity of trauma, 2. degree of confiding in others about the traumatic experience. Scores range from 1 to 7 on each scale, with higher scores representing greater severity of trauma or greater degree of confiding respectively.
Time frame
At baseline.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov