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Table 1 Instruments to assess primary outcome, secondary outcomes, moderators, mediators, and common factors

From: Cognitive behavioral therapy and mindfulness-based cognitive therapy for depressive symptoms in patients with diabetes: design of a randomized controlled trial

Concept Measurement (items)** Measurement in time points*
T1 T2 T3 T4 T5 T6 T7
Primary outcome measure         
Depressive symptoms BDI-II (21) x   x x x x x
  HAMD-7 (7) x     x   
Secondary outcome measures         
Generalized anxiety GAD-7 (7) x     x x x
Well-being WHO-5 (5) x     x x x
Diabetes-related distress PAID (20) x     x x x
Intersession changes in mood*** Emotion Thermometers (5)        
Glycemic control (from patients’ records) HbA1c x     x   
Moderators         
Psychological moderators         
Neuroticism NEO-FFI (12) x       
Attachment style ECR-S (12) x     x   
History of depression SCID x       
Demographic characteristics - x       
Biological moderators         
Diabetes specific characteristics (from patients’ records) - x       
Degradation of tryptophan trp/kyn x       
Mediators         
Cognitive coping         
Positive re-interpretation and positive refocusing CERQ (8) x    x x x x
Reappraisal and distraction TCQ (12) x    x x x x
Behavioral activation         
Behavioral activation BADS (7) x    x x x x
Rumination         
Rumination RRQ (12) x    x x x x
Mindfulness         
Non-judgmental attitude and act with awareness FFMQ (16) x    x x x x
Attention control Self-Regulation Scale (10) x    x x x x
Self-compassion         
Self-kindness, self-judgment, and overidentification SCS (13) x    x x x x
Common factors         
Therapeutic alliance WAI-12 (12) & 18-item Rapport Quest. (18)    x x    
Patient expectancy - (3)   x      
  1. * T1 baseline; T2 after first session; T3 after second session; T4 after fourth session; T5 after eighth session (post-treatment); T6 three months after training; T7 nine months after training.
  2. ** BDI-II - Beck Depression Inventory-II; HAMD-7 - Hamilton Depression Rating Scale; Emotion Thermometers; GAD-7 - Generalized Anxiety Disorder Scale; WHO-5 Well-being Index; PAID - The Problem Areas in Diabetes scale; NEO-FFI - NEO- Five Factor Inventory; ECR-S - The experiences in close relationship scale short form; SCID - Structured Clinical Interview for DSM-IV; CERQ - Cognitive Emotion Regulation Questionnaire; TCQ - Thought Control Questionnaire; BADS -Behavioral Activation for Depression Scale; RRQ - Rumination-Reflection Questionnaire; FFMQ - Five Facet Mindfulness Questionnaire; Self-Regulation Scale; SCS - Self Compassion Scale; WAI-12 - Working Alliance Inventory; 18-item Rapport Questionnaire.
  3. *** assessed at the start of every treatment session.
  4. Note: this table does not cover measures of treatment integrity.