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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.